Budesonide (Oral Route) Before Using

Before Using

Drug information provided by: IBM Micromedex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide extended-release capsules in children 8 to 17 years of age and weighing more than 25 kilograms (kg). However, safety and efficacy have not been established in children younger than 8 years of age, or in children 8 to 17 years of age and weighs 25 kg or less.

Appropriate studies have not been performed on the relationship of age to the effects of budesonide extended-release tablets in the pediatric population. Safety and efficacy have not been established. Because budesonide may cause slowed growth in children, those who will be using it for a long time should have their weight and growth measured by the doctor regularly.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving budesonide.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• 
  Aceclofenac
• 
  Acemetacin
• 
  Amtolmetin Guacil
• 
  Balofloxacin
• 
  Bemiparin
• 
  Besifloxacin
• 
  Boceprevir
• 
  Bromfenac
• 
  Bufexamac
• 
  Bupropion
• 
  Celecoxib
• 
  Ceritinib
• 
  Choline Salicylate
• 
  Ciprofloxacin
• 
  Clonixin
• 
  Cobicistat
• 
  Conivaptan
• 
  Darunavir
• 
  Dexibuprofen
• 
  Dexketoprofen
• 
  Diclofenac
• 
  Diflunisal
• 
  Dipyrone
• 
  Droxicam
• 
  Duvelisib
• 
  Enoxacin
• 
  Etodolac
• 
  Etofenamate
• 
  Etoricoxib
• 
  Felbinac
• 
  Fenoprofen
• 
  Fepradinol
• 
  Feprazone
• 
  Fleroxacin
• 
  Floctafenine
• 
  Flufenamic Acid
• 
  Flumequine
• 
  Flurbiprofen
• 
  Fosnetupitant
• 
  Gatifloxacin
• 
  Gemifloxacin
• 
  Ibuprofen
• 
  Idelalisib
• 
  Indomethacin
• 
  Ivosidenib
• 
  Ketoprofen
• 
  Ketorolac
• 
  Larotrectinib
• 
  Lefamulin
• 
  Levofloxacin
• 
  Lomefloxacin
• 
  Lorlatinib
• 
  Lornoxicam
• 
  Loxoprofen
• 
  Lumacaftor
• 
  Lumiracoxib
• 
  Lutetium Lu 177 Dotatate
• 
  Macimorelin
• 
  Meclofenamate
• 
  Mefenamic Acid
• 
  Meloxicam
• 
  Morniflumate
• 
  Moxifloxacin
• 
  Nabumetone
• 
  Nadifloxacin
• 
  Nadroparin
• 
  Naproxen
• 
  Nepafenac
• 
  Netupitant
• 
  Niflumic Acid
• 
  Nimesulide
• 
  Nimesulide Beta Cyclodextrin
• 
  Norfloxacin
• 
  Ofloxacin
• 
  Oxaprozin
• 
  Oxyphenbutazone
• 
  Parecoxib
• 
  Pazufloxacin
• 
  Pefloxacin
• 
  Phenylbutazone
• 
  Piketoprofen
• 
  Piroxicam
• 
  Pranoprofen
• 
  Proglumetacin
• 
  Propyphenazone
• 
  Proquazone
• 
  Prulifloxacin
• 
  Ritonavir
• 
  Rofecoxib
• 
  Rufloxacin
• 
  Salicylic Acid
• 
  Salsalate
• 
  Sargramostim
• 
  Sodium Salicylate
• 
  Sparfloxacin
• 
  Sulindac
• 
  Telaprevir
• 
  Tenoxicam
• 
  Tiaprofenic Acid
• 
  Tolfenamic Acid
• 
  Tolmetin
• 
  Tosufloxacin
• 
  Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• 
  Auranofin
• 
  Erythromycin
• 
  Ketoconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 
  Cataracts (eye disease), or a family history of or
• 
  Diabetes, or a family history of or
• 
  Eczema (skin disease) or
• 
  Glaucoma, or a family history of or
• 
  Hypertension (high blood pressure) or
• 
  Infection (eg, bacteria, virus, fungus) or
• 
  Osteoporosis (thin bones) or
• 
  Rhinitis (inflammation inside your nose) or
• 
  Stomach ulcer, active or history of or
• 
  Tuberculosis, active or history of or
• 
  Weakened immune system—Use with caution. May make these conditions worse.

• 
  Liver disease (including cirrhosis), moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Description and Brand Names
• Proper Use

Portions of this document last updated: Feb. 01, 2021

Copyright © 2021 IBM Watson Health. All rights reserved. Information is for End User’s use only and may not be sold, redistributed or otherwise used for commercial purposes.

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Budesonide and Alcohol / Food Interactions

1. Drugs A to Z
2. Budesonide
3. Interactions

There is 1 alcohol/food/lifestyle interaction with budesonide:

You should avoid the regular consumption of large amounts of grapefruits and grapefruit juice while taking budesonide. Grapefruit can raise the levels of budesonide in your body and lead to increased side effects. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Switch to professional interaction data

Budesonide drug interactions

There are 358 drug interactions with budesonide

Budesonide disease interactions

There are 7 disease interactions with budesonide which include:

More about budesonide

Related treatment guides

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Budesonide – Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol

Budesonide Overview

Updated: November 14, 2014

Budesonide is a prescription medication used in a variety of inflammatory conditions. These include maintaining asthma control and preventing asthma attacks. Budesonide is also used to treat certain inflammatory bowel diseases, as well as symptoms of allergies. Budesonide belongs to a group of drugs called corticosteroids which help to decrease inflammation to relieve symptoms.

This medication comes in multiple forms. The capsule and extended-release tablet forms are usually taken once daily in the morning with or without food. The nasal spray may be used once per day, one to four sprays per nostril. The oral (by mouth) inhalation form is typically used twice daily.

Common side effects of budesonide tablets and capsules include headache, nausea, and stomach pain.

Budesonide may be found in some form under the following brand names:

Side Effects of Budesonide

Oral:

Common side effects include:

• headache
• nausea
• stomach pain
• fatigue
• flatulence
• abdominal problems
• acne
• urinary tract infection
• joint pain
• constipation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Topical:

Common side effects of budesonide nasal spray include:

• nosebleeds
• soar throat
• bronchospasm (narrowing of air passageways)
• coughing
• nasal irritation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Inhalation:

Common side effects reported by patients using budesonide inhalation include:

• sore nose and throat
• stuffy nose
• runny nose
• nausea
• hay fever
• viral infections of the upper respiratory tract
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Symptoms may include stomach area pain, diarrhea, nausea and vomiting, loss of appetite, headaches, and weakness.
• ear infections

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Pulmicort Flexhaler with certain other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a corticosteroid medicine
• anti-seizure medicine (anticonvulsants)
• medicines that suppress your immune system (immunosuppressant)
• ketoconazale (Nizoral)
• clarithromycin (Biaxin)
• erythromycin (Ery-C, Ery Gel, Ery-Tab, PCE)
• indinavir (Crixivan)
• itraconazole (Sporanox, Onmel)
• nefazodone
• nelfinavir (Viracept)
• ritonavir (Norvir, Kaletra)
• telithromycin (Ketek)

This is not a complete list of budesonide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects of budesondie include the following:

Oral:

• Having too much corticosteroid medicine in your blood (hypercorticism). Long-time use can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
  • acne
  • bruise easily
  • rounding of your face (moon face)
  • ankle swelling
  • thicker or more hair on your body and face
  • a fatty pad or hump between your shoulders (buffalo hump)
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
• Adrenal suppression. When taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression:
  • tiredness
  • weakness
  • nausea
  • vomiting
  • low blood pressure
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse.
• Do not take budesonide if you have had an allergic reaction to budesonide or to any of its ingredients.

Topical:

• hole in the cartilage inside the nose (nasal septal perforation). Tell your healthcare provider if you have a whistling sound from your nose when you breathe.

• slow wound healing. You should not use budesonide nasal spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
• fungal infection in your nose.
• allergic reactions. Tell your healthcare provider or get medical help right away if you have
• skin rash, redness or swelling
• severe itching
• swelling of the face, mouth and tongue
• immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while using budesonide nasal spray. Symptoms of infection may include fever, pain, aches, chills, feeling tired, nausea and vomiting.
• adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include tiredness, weakness, nausea, vomiting and low blood pressure.
• slowed or delayed growth in children. A child’s growth should be checked regularly while using budesonide nasal spray.
• eye problems, such as glaucoma and cataracts. Tell your healthcare provider if you have a change in vision or have a history of increased intraocular pressure, glaucoma, and/or cataracts.

Inhalation:

• thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• worsening of asthma or sudden asthma attacks.
• allergic reactions. Tell your healthcare provider or get medical help right away if you have:
  • skin rash, redness or swelling
  • severe itching
  • swelling of the face, mouth, and tongue
  • trouble breathing or swallowing
  • chest pain
  • anxiety (feeling of doom)

• Immune system effects and a higher chance of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using budesonide inhalation. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while you are using budesonide inhalation.
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include: tiredness, weakness, nausea and vomiting and low blood pressure.
• Decrease in bone mineral density. Your healthcare provider should check you for this during treatment with budesonide inhalation.
• Slowed or delayed growth problems in children. A child’s growth should be checked regularly while using budesonide inhalation.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams while using budesonide inhalation.
• Increased wheezing right after taking budesonide inhalation. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden wheezing. 
• Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.
• Do not use budesonide inhalation:
  • to treat sudden severe symptoms of asthma.
  • if you have a severe allergy to milk proteins. Budesonide inhalation contains a small amount of lactose (milk sugar). People with severe allergies to milk protein may have symptoms of an allergic reaction with budesonide inhalation including cough, wheezing, trouble breathing or feeling like your throat is closing.
• Fungal infection of the mouth and throat may occur with budesonide inhalation use. Rinse your mouth following inhalation.

Budesonide Food Interactions

Grapefruit and grapefruit juice may interact with budesonide and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using budesonide tell your healthcare provider if you:

• are allergic to any ingredients in budesonide
• have or had chicken pox or measles, or have recently been near anyone with chicken pox or measles. have or had tuberculosis of your respiratory tract. Have certain kinds of serious infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
• have recently had surgery or an injury to your nose
• herpes simplex infection of the eye (ocular herpes simplex)
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery
• have liver problems
• have decreased bone mineral density

You are at risk for decreased bone mineral density if you:

• are inactive for a long period of time
• have a family history of osteoporosis
• are a woman going through menopause or are past menopause
• smoke or use tobacco
• do not eat well (poor nutrition)
• are elderly
• take bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using budesonide with certain other medicines may affect each other causing side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if budesonide will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in budesonide is excreted in human breast milk. It is not known if budesonide will harm your nursing baby.

Oral:

How should I take budesonide extended release tablets?

• Take budesonide extended release tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many budesonide extended release tablets to take.
• Take budesonide extended release tablets in the morning.
• Take budesonide extended release tablets capsules whole with water. Do not chew, crush, or break budesonide extended release tablets before swallowing.
• If you take too much of budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

How should I take budesonide capsules?

• Take budesonide capsules exactly as your healthcare provider tells you to take it.
• Take budesonide capsules in the morning. Swallow each budesonide capsule whole. Do not open, chew, or crush budesonide capsules.
• Your provider will tell you how long to take budesonide capsules.

Topical:

• Budesonide nasal spray is for use in your nose only. Do not spray it in your eyes or mouth.
• Use budesonide nasal spray exactly as your healthcare provider tells you to use it.
• It is very important that you use budesonide nasal spray regularly. Do not stop using budesonide nasal spray or change your dose without talking to your healthcare provider, even if you are feeling better.
• Talk to your healthcare provider if your symptoms do not improve after taking budesonide nasal spray for 2 weeks or if your symptoms get worse.
• An adult should help a young child use this medicine.

Inhalation:

• Use budesonide inhalation exactly as prescribed by your healthcare provider. 
• You must use budesonide inhalation regularly for it to work.
• Be sure you know the difference between budesonide inhalation and any other inhaled medicines that are prescribed for you, including what you use them for (prescribed use) and what they look like.
• Do not stop using budesonide inhalation, even if your symptoms get better. Your healthcare provider will change your medicines as needed.
• Do not change or stop any medicines used to control or treat your breathing problems, unless your healthcare provider tells you to.
• Rinse your mouth with water and spit the water out after each dose of budesonide inhalation. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• If you miss a dose, just take your next regularly scheduled dose when it is due. Do not use budesonide inhalation more often or use more puffs than you have been prescribed.
• Make sure you always have a short-acting beta2-agonist medicine with you. Use your short acting beta2-agonist medicine if you have breathing problems between doses of budesonide inhalation or if a sudden asthma attack happens.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Budesonide gastro-resistant capsules and extended-release tablets

What is this medicine?

BUDESONIDE (bue DES oh nide) is a corticosteroid. It is used in the treatment of Crohn’s disease and ulcerative colitis which are types of inflammatory bowel disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Entocort EC, UCERIS

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection
• cataracts
• diabetes
• immune system problems
• glaucoma
• high blood pressure
• history of stomach ulcers
• liver disease
• osteoporosis
• an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your dose in the morning. Do not take with grapefruit juice. You can take it with or without food. If it upsets your stomach, take it with food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• antacids
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• cimetidine
• cyclosporine
• grapefruit juice

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse. If you are taking this medicine over a prolonged period, carry an identification card with your name and address, the type and dose of your medicine, and your doctor’s name and address.

This medicine may increase your risk of getting an infection. Tell your doctor or health care professional if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

If you are going to need surgery or other procedure, tell your healthcare professional that you are using this medicine.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in emotions or moods
• eye pain
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• slow growth in children (if used for longer periods of time)
• swelling of ankles, feet
• trouble sleeping
• weak bones (if used for longer periods of time)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• back pain
• dizziness
• gas
• headache
• nausea
• tiredness
• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Budesonide inhalers: steroid medicine used for asthma and COPD

The usual dose for the inhaler is 1 or 2 puffs, once or twice a day. If you use your inhaler once a day, it may work better if you take it in the evening.

It’s important to use your budesonide inhaler or nebuliser regularly to manage your symptoms. Use it regularly, even if you do not have any symptoms. After using your inhaler, always put the lid back on to keep it clean.

Budesonide inhalers come in different strengths. Your doctor, asthma or respiratory nurse will tell you which strength is right for you. Always follow their instructions. They may tell you to have more than 2 puffs at a time from your inhaler. It depends on how bad your breathing is and which inhaler you’re using.

How to use a nebuliser

Your doctor or nurse will give you clear instructions on how to use the nebuliser.

Nebulisers can give higher doses of budesonide than inhalers. They are sometimes used when inhalers (and other asthma medicines) are not working or if you cannot use inhalers.

The usual dose for the nebuliser is 1 or 2 nebules, breathed in from the nebuliser, twice a day. You will use it for 5 to 10 minutes each time.

Watch a video

Asthma UK has some short videos showing you how to use your inhaler to help you manage your symptoms. You can search by type of inhaler and by brand (such as Pulmicort Turbohaler or DuoResp Spiromax).

If you use a pressurised metered-dose inhaler (pMDI), for example, you can watch the pMDI video.

Different types of inhalers

There are different types of budesonide inhaler. It’s very important to use your inhaler properly. This is so you get the right amount of budesonide into your lungs and the most benefit from your medicine.

Before using your inhaler, read the information leaflet that comes with it. This leaflet contains instructions and diagrams to show you how to use the inhaler, how to keep it clean, and how long to use it before getting a replacement.

If your inhaler also contains formoterol (a bronchodilator) your doctor or asthma nurse might tell you to also use it when you are wheezy or tight chested. This can be up to 12 puffs a day in total. Let your doctor know if you need to use more than 8 puffs in a day.

Check your inhaler technique

To get the most from your inhaler, it’s important to have your technique checked regularly.

If you’re not sure how to use your inhaler, or your technique has not been checked for a year, ask your doctor, nurse or a pharmacist to watch you use it.

It’s very important to use your inhaler properly. This is so you get the right amount of budesonide into your lungs and the most benefit from your medicine.

Will my dose go up or down?

Your dose may go up or down depending on how bad your breathing is. You will be prescribed the lowest dose that controls your symptoms.

If you have agreed a personal action plan with your doctor or nurse, follow your action plan.

What if I forget to use it?

Use your inhaler as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed one and take your next dose as usual.

Do not take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

Do not stop using budesonide suddenly, even if you feel better, without speaking to your doctor or nurse first.

What if I take too much?

Taking too much budesonide is unlikely to harm you.

If you’re worried, talk to your doctor or a pharmacist.

Steroid cards

If you are using a steroid inhaler regularly, ask your doctor, nurse or a pharmacist if you need to carry a blue steroid card.

ENTOCORT (BUDESONIDE) | Crohn’s & Colitis Foundation

Dear @[email protected],

Your doctor has discussed the following subject with you: Entocort. Here is some additional information. Let us know if you have any questions regarding this information.

• This medication belongs to a class of drugs called corticosteroids.

• These powerful and fast-acting medications help reduce irritation and swelling (inflammation) in the intestines.

• This medication is given as a pill.

• You should notice an improvement of symptoms within days of starting this medication.

• While steroids can be used for weeks or months, they should only be used for short periods of time because of their side effects. Steroids can be used to get you well in the short term, but should never be a long term maintenance medication.

• Budesonide (Entocort) is a type of steroid that is targeted to the intestine. The liver breaks it down before it affects the rest of the body, so it usually has fewer side effects than other corticosteroids.

• Side effects can include yeast infections (in the mouth or female reproductive organs), urinary tract infections, high blood pressure, high blood sugar levels, weight gain, stretch marks, acne, rounding of the face (moon face), facial hair, difficulty sleeping, mood swings, and psychiatric symptoms. These side effects will usually go away when the medication is stopped. Long-term use of steroids can result in a weakening of the bones (osteoporosis) and cataracts.

• Before taking this medication, let your doctor know about other medical conditions that you may have or other medications (even over-the-counter medications or alternative therapies) you may be taking.

• The best way to control your disease is by taking your medication as directed. Even when you do not have any symptoms, it is very important to continue taking your medication to prevent your disease from becoming active again. Do not alter the amount of the medication or how frequently you take it on your own.

• If you have any side effects or you continue to have symptoms, speak to your doctor immediately.

For further information, please check out http://www.ibdmedicationguide.org/ or follow this link:

Dosage, side effects, alternatives, and more

Symbicort is a brand-name prescription medication that’s FDA-approved:

Symbicort isn’t approved to help ease sudden breathing problems. (It’s not a rescue inhaler.)

Symbicort includes two active ingredients: budesonide and formoterol. Budesonide belongs to a class of medications called corticosteroids. (A class of medications is a group of drugs that work in a similar way.) Budesonide helps decrease irritation in the lungs. Formoterol belongs to a class of medications called long-acting beta2-agonists, which help open up the airways.

Symbicort comes as a metered-dose inhaler and is available in the following strengths:

• 80 mcg of budesonide/4.5 mcg of formoterol
• 160 mcg of budesonide/4.5-mcg of formoterol

You’ll take two inhalations (puffs) of Symbicort twice a day.

Effectiveness

Here’s some information about the effectiveness of Symbicort in treating asthma and COPD.

Asthma

Two studies looked at asthma in adults as well as children ages 12 years and older. The people were given Symbicort; either of the individual drugs in Symbicort, budesonide and formoterol; or a placebo (treatment with no active drug).

To track lung function, researchers looked at forced expiratory volume in 1 second (FEV1). This is a standard measure of how much air you can force out of your lungs in 1 second. Asthma and other breathing conditions may make your FEV1 lower due to tightness in your airways.

Compared with people who took a placebo or other drug, people who took Symbicort had a greater improvement in their baseline FEV1. This is FEV1 before taking a dose of medication. In one study, the average FEV1 improvement by the end of treatment for people who took Symbicort was 9%. This was compared with 5% for people who took budesonide, -5% for those who took formoterol, and -7% for those who took a placebo. The -5% and -7% values show that the FEV1 got worse.

COPD

Studies also looked at people with COPD who took Symbicort; one or both of the ingredients in Symbicort, budesonide and formoterol; or a placebo. The group that took 160 mcg/4.5 mcg of Symbicort had a greater improvement in their FEV1 compared with the other groups.

In one study, the average FEV1 improvements from baseline were:

• 11% in the group that took 160 mcg/4.5 mcg of Symbicort
• 8% in the group that took 160 mcg of budesonide plus 4.5 mcg formoterol
• 7% in the group that took 4.5 mcg of formoterol
• 2% in the group that took 160 mcg of budesonide
• 2% in the group that took a placebo

The group that took 80 mcg/4.5 mcg of Symbicort had an FEV1 improvement that was similar to the group that took formoterol.

For more information about the effectiveness of Symbicort, see the “Symbicort Uses” section below.

Symbicort is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. Generics also tend to cost less than brand-name drugs.

Symbicort contains two active drug ingredients: budesonide and formoterol. This means budesonide and formoterol are the ingredients that make Symbicort work.

Budesonide is available as a generic medication called “budesonide” in various dosage forms. The inhaled versions of budesonide are also available as the brand-name drugs Pulmicort and Pulmicort Respules.

Formoterol is available as a brand-name inhaled medication called Perforomist.

The Symbicort dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using Symbicort to treat
• your age
• other medical conditions you may have

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Symbicort comes as a metered-dose inhaler, which dispenses the drug in a spray that you inhale. The inhaler releases the medication in premeasured puffs. Symbicort is available in the following strengths:

• 80 mcg of budesonide/4.5 mcg of formoterol
• 160 mcg of budesonide/4.5 mcg of formoterol

Each inhaler contains either 60 or 120 puffs.

Dosage for asthma

The typical dosage of Symbicort for adults with asthma is two inhalations (puffs) twice a day. The strength that your doctor recommends will depend on your asthma symptoms.

Dosage for COPD

The typical dosage of Symbicort for people with chronic obstructive pulmonary disorder (COPD) is two puffs of the 160-mcg/4.5-mcg strength of Symbicort twice a day.

Pediatric dosage

The typical dosage of Symbicort for children ages 6 to 11 years with asthma is two puffs of the 80-mcg/4.5-mcg strength of Symbicort twice a day.

Children ages 12 years and older with asthma will take Symbicort as two puffs twice a day. The medication strength and dosage your child’s doctor recommends will depend on their asthma symptoms.

What if I miss a dose?

If you miss a dose of Symbicort, take your next dose at the regularly scheduled time.

It’s important to try to take your doses about 12 hours apart. To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Symbicort is meant to be used as a long-term treatment. If you and your doctor determine that Symbicort is safe and effective for you, you’ll likely take it long term.

Symbicort can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Symbicort. These lists don’t include all possible side effects. Side effects might differ slightly between people with asthma and people with chronic obstructive pulmonary disorder (COPD).

For more information on the possible side effects of Symbicort, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Symbicort, you can do so through MedWatch.

Mild side effects

The mild side effects of Symbicort that are more common* can include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

* occurred in more than 3% of people in clinical studies

Serious side effects

Serious side effects from Symbicort aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Pneumonia (a type of lung infection). Symptoms can include:
• Decreased growth in children. Symptoms can include:
  • slower than expected growth in children
• Decrease in bone density. Symptoms can include:
  • bone breaks (if bone density changes are severe)
• Paradoxical bronchospasm (unexpected tightening of your airways because the drug is supposed to treat bronchospasm). Symptoms can include:
• Increased level of a hormone called cortisol, which may reduce the activity of your adrenal glands. Symptoms can include:
• Eosinophilia (high level of certain white blood cells). Symptoms can include:
• Hypokalemia (low level of potassium). Symptoms can include:
• Hyperglycemia (high blood sugar). Symptoms can include:
• Cardiovascular (heart and blood vessel) problems. Symptoms can include:
• Central nervous system problems. Symptoms can include:
• Increased risk of infection, such as chickenpox or measles
• Serious asthma-related events that can include:
  • intubation (tube inserted into airway for breathing)

Other serious side effects, explained in more detail below in “Side effect details,” include:

Side effects in children

Side effects of Symbicort are similar in both adults and children. In one study of children ages 6 to 11 years, the mild side effects of Symbicort that were more common* included common cold symptoms such as cough, sore throat, and stuffy or runny nose, as well as headache.

* occurred in more than 3% of children in the study

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Symbicort. However, it’s not known how often allergic reactions occur with the drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing or speaking

Call your doctor right away if you have a severe allergic reaction to Symbicort. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Weight gain

Weight gain hasn’t been reported as a side effect of Symbicort. However, a class of medications known as corticosteroids can cause weight gain. (A class of medications is a group of drugs that work in a similar way.) And one of the ingredients in Symbicort is a corticosteroid called budesonide.

If you’re concerned about weight gain, talk with your doctor. They can review your diet and exercise routine, as well as your medications.

Eye problems

Eye problems aren’t likely to occur with Symbicort, but it’s possible. Glaucoma, increased eye pressure, and cataracts have been reported after long-term use of inhaled corticosteroids. And Symbicort contains an inhaled corticosteroid called budesonide. However, it’s not known how often problems occur with Symbicort treatment.

During your Symbicort treatment, your doctor will monitor your vision closely, especially if you have a history of certain eye conditions. And if you have blurred vision, changes in your sight, or pain in your eyes, tell your doctor right away.

Sore throat

A sore throat may occur with Symbicort use. The drug can cause laryngitis (inflammation of the voice box), which can cause discomfort or pain. Other possible side effects of Symbicort can also make your throat sore. These include symptoms of the common cold, such as a runny or stuffy nose, or cough.

About 6% to 9% of people who took Symbicort in clinical studies had throat pain compared with 5% of those who took a placebo (treatment with no active drug).

If your throat becomes sore while taking Symbicort, ask your doctor what treatments may help.

High blood pressure

It’s possible that taking Symbicort could cause high blood pressure. This doesn’t usually happen with the usual doses, but the side effect may occur in people who are more likely to have blood pressure problems. Clinical studies have found that people who took Symbicort didn’t have blood pressure changes more often than those who took a placebo.

While taking Symbicort, it’s important to tell your doctor right away if you notice dizziness, headaches, or heart palpitations (feeling of skipped or extra heartbeats). And tell your doctor if you have a history of blood pressure conditions or heart conditions before taking the drug.

Other drugs are available that can treat asthma or chronic obstructive pulmonary disorder (COPD). Some may be a better fit for you than others. If you’re interested in finding an alternative to Symbicort, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for asthma

Asthma treatment usually includes a combination of maintenance medications (used routinely) and rescue medications (used when you’re having symptoms). Symbicort, which includes a corticosteroid and a long-acting beta2-agonist, is considered a maintenance medication.

Examples of other maintenance drugs that may be used to treat asthma include:

• certain inhaled corticosteroids, such as:
• certain long-acting beta2-agonists (LABAs), such as:
• certain combinations of inhaled corticosteroids and LABAs, such as:
  • fluticasone/salmeterol (Advair)
  • mometasone/formoterol (Dulera)
• certain leukotriene receptor antagonists, such as:
• certain oral corticosteroids, such as:
  • methylprednisolone (Medrol)
• certain immunomodulators, such as:

Alternatives for COPD

COPD treatment usually includes a combination of maintenance medications and rescue medications. Symbicort, which includes a corticosteroid and a long-acting beta2-agonist, is considered a maintenance medication.

Examples of other maintenance drugs that may be used to treat COPD include:

• certain LABAs, such as:
  • indacaterol (Arcapta Neohaler)
  • olodaterol (Striverdi Respimat)
• certain anticholinergics, such as:
  • umeclidinium (Incruse Ellipta)
• certain combinations of inhaled beta2-agonists and anticholinergics, such as:
  • formoterol/aclidinium (Duaklir Pressair)
  • formoterol/glycopyrrolate (Bevespi)
• certain combinations of LABAs and inhaled corticosteroids, such as:
  • formoterol/mometasone (Dulera)
  • salmeterol/fluticasone (Advair)
• certain combinations of LABAs, anticholinergics, and inhaled corticosteroids, such as:
  • fluticasone/umeclidinium/vilanterol (Trelegy Ellipta)

You may wonder how Symbicort compares with other medications that are prescribed for similar uses. Here we look at how Symbicort and Breo are alike and different.

Ingredients

Both Symbicort and Breo contain a combination of two active ingredients, an inhaled corticosteroid and long-acting beta2-agonist. Symbicort contains budesonide and formoterol. Breo contains fluticasone and vilanterol.

Uses

The Food and Drug Administration (FDA) has approved Symbicort:

Symbicort isn’t approved to help ease sudden breathing problems.

Breo is FDA-approved:

• to treat asthma in people ages 18 years and older. Breo isn’t approved to help ease sudden breathing problems.
• as a long-term treatment for COPD. In addition to helping keep your airways clear, Breo reduces the number of COPD flare-ups and how severe they are.

Drug forms and administration

Symbicort comes as a metered-dose inhaler, which dispenses the drug in a spray that you inhale. The inhaler releases the medication in premeasured puffs. You’ll take two puffs of Symbicort twice a day for the treatment of asthma or COPD.

Breo comes as a dry powder inhaler, which dispenses the drug as a fine powder that you inhale. You’ll take one puff of Breo once a day for the treatment of asthma or COPD.

Side effects and risks

Symbicort and Breo contain drugs from the same medication classes. (A class of medications is a group of drugs that work in a similar way.) Therefore, these medications can cause some very similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain examples of more mild side effects that can occur with Symbicort, with Breo, or with both drugs (when taken individually).

• Can occur with Symbicort:
  • few unique mild side effects
• Can occur with Breo:
• Can occur with both Symbicort and Breo:
  • pain when speaking and trouble speaking

Serious side effects

This list contains examples of serious side effects that can occur with both Symbicort and Breo (when taken individually):

Effectiveness

Both Symbicort and Breo are used to treat asthma and COPD.

Effectiveness in treating asthma

The use of Symbicort and Breo in treating asthma has been directly compared in clinical studies of people with asthma. In one clinical study, people with asthma that was controlled and stable tried Symbicort for 8 weeks and Breo for 8 weeks.

The study looked at changes in forced expiratory volume in 1 second (FEV1). FEV1 is the amount of air that you can force out of your lungs in 1 second. Changes in FEV1 were about the same between Symbicort and Breo, which showed that the drugs were similarly effective in easing people’s asthma symptoms.

A second study looked at people with asthma symptoms that weren’t controlled. The people were given either Symbicort, Breo, or fluticasone propionate/salmeterol (Advair). Based on results from an Asthma Control Test questionnaire, Symbicort and Breo were similarly effective in easing asthma symptoms.

Effectiveness in treating COPD

These drugs haven’t been directly compared in clinical studies of COPD, but studies have found both Symbicort and Breo to be effective for treating the condition.

Costs

Symbicort and Breo are both brand-name drugs. There are currently no generic forms of either drug combination. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Symbicort generally costs more than Breo when considering the differences in dosages. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Like Breo (above), the drug Dulera has uses similar to those of Symbicort. Here’s a comparison of how Symbicort and Dulera are alike and different.

Ingredients

Both Symbicort and Dulera contain a combination of two active ingredients, an inhaled corticosteroid and long-acting beta2-agonist. Symbicort contains budesonide and formoterol. Dulera contains mometasone and formoterol.

Uses

The Food and Drug Administration (FDA) has approved Symbicort:

Symbicort isn’t approved to help ease sudden breathing problems.

Dulera is FDA-approved for the treatment of asthma in adults as well as children ages 5 years and older. The drug isn’t approved to help ease sudden breathing problems. Dulera also isn’t approved to treat COPD.

Drug forms and administration

Both Symbicort and Dulera come as a metered-dose inhaler, which dispenses the drug in a spray that you inhale. The inhaler releases the medication in premeasured puffs.

You’ll take two puffs of Symbicort twice a day for the treatment of asthma or COPD.

You’ll take two puffs of Dulera twice a day for the treatment of asthma.

Side effects and risks

Symbicort and Dulera contain drugs from the same medication classes. (A class of medications is a group of drugs that work in a similar way.) Therefore, these medications can cause some similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain examples of more mild side effects that can occur with Symbicort, with Dulera, or with both drugs (when taken individually).

• Can occur with Symbicort:
• Can occur with Dulera:
  • few unique mild side effects
• Can occur with Symbicort and Dulera:

Serious side effects

These lists contain examples of serious side effects that can occur with Symbicort, with Dulera, or with both drugs (when taken individually).

• Can occur with both Symbicort:
• Can occur with both Dulera:
  • few unique serious side effects
• Can occur with both Symbicort and Dulera:

Effectiveness

The only condition both Symbicort and Dulera are used to treat is asthma.

These drugs haven’t been directly compared in clinical studies, but studies have found both Symbicort and Dulera to be effective for treating asthma.

Costs

Symbicort and Dulera are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Symbicort and Dulera generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Symbicort can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Symbicort and other medications

Below is a list of medications that can interact with Symbicort. This list doesn’t contain all drugs that may interact with Symbicort.

Before taking Symbicort, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Symbicort and strong CYP3A4 inhibitors

Drugs called CYP3A4 inhibitors slow or block the action of an enzyme called CYP3A4. (An enzyme is a protein that aids chemical changes in your body.) This effect can interfere with how your body breaks down budesonide, which is an active ingredient in Symbicort. So taking a CYP3A4 inhibitor with Symbicort may increase the level of budesonide in your body and lead to side effects. (For more about side effects, see the “Symbicort side effects” section above.)

Examples of CYP3A4 inhibitor medications include:

• ritonavir (Norvir)
• atazanavir (Reyataz)
• indinavir (Crixivan)
• nelfinavir (Viracept)
• saquinavir (Invirase)
• clarithromycin
• telithromycin
• itraconazole (Sporanox)
• ketoconazole

Before using Symbicort, tell your doctor if you’re taking any of the medications listed above. They may choose a different drug to treat your condition.

Symbicort and certain antidepressants

Using certain antidepressants within 2 weeks of taking Symbicort may increase your risk for heart-related side effects. (For more about side effects, see the “Symbicort side effects” section above.)

Examples of antidepressants include:

• nefazodone
• monoamine oxidase inhibitors (MAOIs), such as:
• tricyclic antidepressants, such as:

If you’re taking an antidepressant, tell your doctor before you start using Symbicort. They can suggest a different antidepressant for you.

Symbicort and beta-blockers

Taking a beta-blocker with Symbicort may reduce the effectiveness of Symbicort to treat your symptoms. Using beta-blockers may also make it more likely that you’ll have bronchospasms (tightening of your airways that can make it hard for you to breathe).

Examples of beta-blockers include:

• atenolol (Tenormin)
• metoprolol (Toprol)
• bisoprolol (Zebeta)
• labetalol (Trandate)

If you need to take a beta-blocker, your doctor may recommend a drug other than Symbicort for you.

Symbicort and certain diuretics

Taking Symbicort may lower your potassium level or cause changes to your heart rhythm. And taking Symbicort with a diuretic may make these side effects more severe

Symptoms of a low potassium level include problems with your heart rhythm, muscle cramps, dizziness, and fainting. Symptoms of heart rhythm changes can also include dizziness and fainting, but they may also involve a racing heart or palpitations (feeling of skipped or extra heartbeats).

Typically, changes in your potassium level that are caused by taking Symbicort are temporary. The level usually returns to normal without treatment. But this may not be the case if you’re taking Symbicort with a diuretic.

Examples of diuretics include:

• hydrochlorothiazide (Microzide)
• furosemide (Lasix)
• bumetanide (Bumex)

If you’re taking a diuretic, tell your doctor before you start using Symbicort. They may choose to monitor your potassium levels more often than usual. They may also suggest other diuretics or breathing medications.

Symbicort and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Symbicort. However, you should still check with your doctor or pharmacist before using any of these products while taking Symbicort.

Symbicort and foods

Eating grapefruit or drinking grapefruit juice may increase the level of Symbicort in your body, which may lead to potentially dangerous side effects. (For more about side effects, see the “Symbicort side effects” section above.)

You should take Symbicort according to your doctor’s or healthcare provider’s instructions.

Symbicort comes as a metered-dose inhaler, which dispenses the drug in a spray that you inhale. The inhaler releases the medication in premeasured puffs.

To avoid a yeast infection in your mouth called oral thrush, rinse your mouth with water and spit the water out after each dose (two puffs). Be sure to do this when you take your dose in the morning and at night.

If your child is taking Symbicort, help them with their doses to be sure they’re using the medication correctly. This should help their symptoms be better controlled.

For more information about how to use Symbicort, visit the manufacturer’s website for instructions and a video.

When to take

You’ll usually take Symbicort as two puffs twice a day, about 12 hours apart. It’s important to take your doses regularly. To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

The Food and Drug Administration (FDA) approves prescription drugs such as Symbicort to treat certain conditions.

Symbicort for asthma

Symbicort is FDA-approved to treat asthma in adults as well as children ages 6 years and older. The medication isn’t approved to help ease sudden breathing problems.

Asthma is a chronic (long-term) condition that affects the airways. Inflammation (swelling) of the airways leads to trouble breathing. Although there isn’t a cure for asthma, you may be able to manage your symptoms to help improve your quality of life and prevent complications.

Effectiveness

Two studies looked at asthma in adults as well as children ages 12 years and older. The people were given Symbicort; either of the individual drugs in Symbicort, budesonide and formoterol; or a placebo (treatment with no active drug). To track lung function, researchers looked at forced expiratory volume in 1 second (FEV1). This is a standard measure of how much air you can force out of your lungs in 1 second. Asthma and other breathing conditions may make your FEV1 lower due to tightness in your airways.

Compared with people who took a placebo or other drug, people who took Symbicort had a greater improvement in their baseline FEV1. This is FEV1 before taking a dose of medication. In one study, the average FEV1 improvement by the end of treatment for people who took Symbicort was 9%. This was compared with 5% for people who took budesonide, -5% for those who took formoterol, and -7% for those who took a placebo. The -5% and -7% values show that the FEV1 got worse.

Symbicort for COPD

Symbicort is FDA-approved as a long-term treatment for people with chronic obstructive pulmonary disorder (COPD). COPD is a group of lung conditions that include chronic bronchitis (irritation of the airways) and emphysema, which is damage to the air sacs of the lungs. In addition to helping keep your airways clear, Symbicort reduces the number of COPD flare-ups and how severe they are.

COPD requires treatment with lifestyle changes and medication. The condition isn’t curable, but you may be able to manage your symptoms to help improve your quality of life and prevent complications.

Effectiveness

Studies also looked at people with COPD who took Symbicort; one or both of the ingredients in Symbicort, budesonide and formoterol; or a placebo. The group that took 160 mcg/4.5 mcg of Symbicort had a greater improvement in their FEV1 compared with the other groups.

In one study, the average FEV1 improvements from baseline were:

• 11% in the group that took 160 mcg/4.5 mcg of Symbicort
• 8% in the group that took 160 mcg of budesonide plus 4.5 mcg formoterol
• 7% in the group that took 4.5 mcg of formoterol
• 2% in the group that took 160 mcg of budesonide
• 2% in the group that took a placebo

The group that took 80 mcg/4.5 mcg of Symbicort had an FEV1 improvement that was similar to the group that took formoterol.

Symbicort for other conditions

You may wonder if Symbicort has any uses in addition to the uses listed above.

Symbicort for allergies (not an appropriate use)

Symbicort isn’t approved for the treatment of allergies and shouldn’t be used for this condition.

If you have breathing issues related to allergies, other treatment options are available. Seasonal or year-round allergies affect many people. So talk with your doctor if you have symptoms that are bothersome or want to learn how to find relief.

Symbicort and children

Symbicort is approved for the treatment of asthma in children ages 6 years and older.

A study of children ages 6 to 11 years with asthma looked at changes in their FEV1 an hour after dosing. The children took either Symbicort or one of its ingredients, budesonide. By 12 weeks, the Symbicort group had almost double the improvement in FEV1 (0.28 L) at 1 hour after dosing compared with the budesonide group (0.17 L) from their baseline reading. This means that the children who took Symbicort had better lung function than those who took budesonide.

Here are answers to some frequently asked questions about Symbicort.

How should I quit taking Symbicort?

Talk with your doctor before changing or stopping the use of any of medications for your asthma or chronic obstructive pulmonary disorder (COPD) symptoms. If you suddenly stop taking your medication, including Symbicort, you may have trouble breathing and your condition may worsen. This can lead to complications such as being less active, having lung infections, having trouble breathing that requires care right away, or needing a hospital stay.

If you have questions about stopping the use of Symbicort, talk with your doctor.

Is Symbicort a rescue inhaler?

No, you shouldn’t use Symbicort as a rescue inhaler. The drug isn’t meant to help you with sudden breathing problems. Instead, you take Symbicort consistently to help control your symptoms. Your doctor will prescribe a different medication for you that’s considered a rescue inhaler. You’ll use it when needed for flare-ups of asthma or COPD. Don’t take extra doses of Symbicort.

Tell your doctor if you don’t feel like your asthma or COPD is well controlled. They can review your treatment plan with you.

Is Symbicort a corticosteroid?

Symbicort contains two active ingredients, budesonide and formoterol. Budesonide is an inhaled corticosteroid. This type of drug helps ease inflammation (irritation) in the airways, making it easier to breathe. Inhaling the medication allows most of it to reach your airways.

Corticosteroids can weaken your immune system’s ability to fight infection. If you’re exposed to certain infections, you may have a greater risk for those infections becoming serious. (To learn more, see the “Symbicort precautions” section below.)

Can I use Flonase and Symbicort together?

Your doctor is unlikely to prescribe both Flonase and Symbicort. This is because both Flonase and Symbicort contain a corticosteroid. And taking two corticosteroids may increase your risk for side effects. (For more about side effects, see the “Symbicort side effects” section above.)

If you have allergies along with asthma or COPD, your doctor may prescribe antihistamine allergy drugs such as fexofenadine (Allegra), cetirizine (Zyrtec), loratadine (Claritin), or allergy shots. These would be in addition to your medications for asthma or COPD.

If you’re taking Flonase for allergies, talk with your doctor about other options before using Symbicort.

Is it OK to take Symbicort with over-the-counter cold, flu, or pain medicines?

Probably, but be sure to first check with your doctor or pharmacist. There aren’t any known interactions between Symbicort and over-the-counter cold, flu, or pain medications. These include Nyquil, acetaminophen (Tylenol), ibuprofen (Motrin, Advil, others), and guaifenesin (Mucinex). It’s generally considered safe to use these medications when taking Symbicort as long as you don’t have any conditions that would cause you to have side effects from taking these medications — for example, problems with your kidneys, liver, heart, or blood pressure.

It’s best to ask your doctor prior to taking any over-the-counter medications while taking Symbicort and other medications for asthma or COPD. They can help make sure you’re taking the best treatment options for you.

Can you take Symbicort and prednisone together?

Yes. In some situations, your doctor may have you take Symbicort with an oral corticosteroid (pill or tablet form) such as prednisone. These situations include having severe symptoms of asthma or COPD, or a sudden flare-up for which you need to immediately see your doctor or visit an emergency room.

Your doctor will usually prescribe the oral corticosteroid for a shorter period of time than your maintenance (routine) medications, including Symbicort. The goal is to use the oral corticosteroid for days to weeks to get your condition under control and back on track. How long you should take it will depend on whether you’re being treated for asthma or COPD.

If you have questions about treatment with Symbicort and prednisone, talk with your doctor.

The treatment of asthma and chronic obstructive pulmonary disorder (COPD) usually requires a combination of medications to control symptoms and prevent complications or flare-ups. Medications are generally grouped into two categories: rescue medications and maintenance medications.

Maintenance medications are taken regularly to help prevent symptoms from worsening and keep them under control. (For more information about maintenance medications, see the “Alternatives to Symbicort” section above.) Rescue medications are used as needed when you have flare-ups (worsening of symptoms) or when symptoms pop up. You shouldn’t use maintenance medications as rescue medications. And you shouldn’t take extra doses of a maintenance medication for this purpose.

Examples of rescue medications include short-acting beta2-adrenergic agonists, such as albuterol (Ventolin HFA, ProAir HFA, AccuNeb).

Note: Some of the drugs listed just above are used off-label. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

In people with asthma, the airways become inflamed and narrowed, making it hard to breathe. Their lungs and airways may also be easily irritated, leading to more trouble breathing.

Chronic obstructive pulmonary disorder (COPD) is a group of lung conditions that include chronic bronchitis and emphysema. So people with COPD may have inflammation of their airways due to bronchitis as well as damage to air sacs in their lungs because of emphysema. The irritation, inflammation, and damage to the air sacs cause the lungs to become less effective at moving air.

Both asthma and COPD are chronic (long-term) conditions affecting the airways. Symbicort works to decrease inflammation and irritation while also opening up the airways, relaxing them. This helps make breathing easier and decreases your asthma or COPD symptoms.

How long does it take to work?

You may notice that Symbicort improves your symptoms within minutes, particularly if you’re taking the drug for asthma. However, the timing varies from person to person. It generally takes at least a couple of weeks for Symbicort to reach maximum effect to control your symptoms.

But if your symptoms don’t ease within a few weeks of taking the drug, talk with your doctor. They may adjust the dose or prescribe a different medication. If you have symptoms between your twice-a-day doses of Symbicort, your doctor will likely want you to use a rescue inhaler for quick relief.

It’s unknown whether it’s safe to use Symbicort during pregnancy.

Symbicort contains two active ingredients: formoterol and budesonide. There are no human studies of formoterol in pregnancy. And studies show that when pregnant women take inhaled budesonide by itself, the drug doesn’t increase the risk of birth defects.

If you’re currently pregnant or thinking about becoming pregnant, talk with your doctor. They can recommend the best asthma and chronic obstructive pulmonary disorder (COPD) treatment options for you.

It’s not known if Symbicort is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Symbicort.

It’s unknown whether it’s safe to use Symbicort while breastfeeding.

Symbicort contains two active ingredients: formoterol and budesonide. Budesonide passes into breast milk, but there’s no human data on whether formoterol also passes into breast milk.

If you’re breastfeeding, tell your doctor before taking Symbicort. They’ll help you decide on the best way to feed your child and what asthma and chronic obstructive pulmonary disorder (COPD) treatment options are right for you.

When you get Symbicort from the pharmacy, the pharmacist will add an expiration date to the label. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Symbicort in a dry area and at room temperature (68°F to 77°F/20°C to 25°C) with the mouthpiece down. Avoid storing this medication in areas where it could be exposed to heat or open flame. Don’t expose to temperatures greater than 120°F (49°C) or the canister can burst.

Disposal

If you no longer need to take Symbicort and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Don’t puncture or incinerate (burn) your Symbicort inhaler. Contact your trash or recycling center to ask about proper disposal of your inhaler. Rules can vary from state to state.

Symbicort isn’t known to interact with alcohol. However, drinking alcohol while taking Symbicort may increase your risk for side effects, especially if you have certain conditions such as problems with your blood pressure or heart. (For more about side effects, see the “Symbicort side effects” section above.)

If you drink alcohol, talk with your doctor before taking Symbicort. Ask them how much alcohol is safe for you to drink during your treatment.

As with all medications, the cost of Symbicort can vary. To find current prices for Symbicort in your area, check out GoodRx:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before they approve coverage for Symbicort. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Symbicort.

If you’re not sure if you’ll need to get prior authorization for Symbicort, contact your insurance plan.

Financial assistance

If you need financial support to pay for Symbicort, help is available. AstraZeneca Pharmaceuticals LP, the manufacturer of Symbicort, has a Symbicort Savings Offer and a patient assistance program called AZ&Me. For more information and to find out if you’re eligible for support, call 800-236-9933 or visit the program website.

This drug comes with several precautions. Before taking Symbicort, talk with your doctor about your health history. Symbicort may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Allergic reaction. If you’ve had an allergic reaction to Symbicort or any of its ingredients in the past, you shouldn’t use the drug. Ask your doctor about other treatment options.
• Acute severe asthma. If you have a type of asthma called status asthmaticus (acute severe asthma), Symbicort might not be the best medication for you. Ask your doctor what other treatment options are better choices for you.
• Infections or a weakened immune system. Taking Symbicort may put you at risk for new or worsened infections. You shouldn’t use the drug if you have a fungal, bacterial, or viral infection; tuberculosis (TB); or eye herpes. Your doctor can recommend medications other than Symbicort. If you don’t have an infection and your doctor wants you to take Symbicort, make sure you’re up to date with your vaccines, including chickenpox and measles. These conditions can be very severe or lead to death in people who have a weakened immune system or are taking corticosteroids. (An active ingredient in Symbicort called budesonide is a corticosteroid.)
• Use of oral corticosteroids. If you’re taking an oral corticosteroid (pill or tablet form) before using Symbicort, you’ll need to wean off the corticosteroid slowly. Decreasing or stopping the use of an oral corticosteroid too quickly can cause side effects. These include the adrenal glands not making enough hormones, flare-ups of arthritis or eczema, and withdrawal symptoms such as joint or muscle pain and depression. Before taking Symbicort, tell your doctor if you’re taking a corticosteroid or recently stopped using one.
• Use of just a long-acting beta2-agonist. Symbicort contains two drugs: budesonide and formoterol. Budesonide is an inhaled corticosteroid (ICS), and formoterol is a long-acting beta2-agonist (LABA). Taking a LABA without an ICS may increase your risk for serious asthma-related events such as a hospital stay, intubation (tube inserted into an airway for breathing), or death. The risk isn’t increased when a LABA is taken with an ICS. Don’t take a LABA without an ICS unless your doctor tells you to.
• Heart or central nervous system conditions. If you have certain heart or central nervous system (brain and spinal cord) conditions, taking Symbicort may increase your risk for side effects. (For more about side effects, see the “Symbicort side effects” section above.) Some of these conditions include abnormal heart rhythms, high or low blood pressure, seizures, and other convulsive disorders. Talk with your doctor before taking Symbicort if you have any of these conditions. They can help choose the best treatment options for you.
• Osteoporosis. If you have a condition such as osteoporosis or osteopenia in which you have low bone density, tell your doctor before taking Symbicort. An active drug in Symbicort is called budesonide, and it’s a corticosteroid. Using corticosteroids for a long time can decrease bone density. Your doctor may monitor you more closely, especially if you have other risk factors for decreased bone density. These include having gone through menopause, being an older adult, using certain medications, or using tobacco. Your doctor may also prescribe a different medication to treat your condition.
• Glaucoma and cataracts. Eye problems such as glaucoma and cataracts have been reported in people taking inhaled corticosteroids such as budesonide. (Budesonide is an active ingredient in Symbicort.) Before taking Symbicort, it’s important to tell your doctor if you have a history of glaucoma or cataracts. They’ll likely monitor you more closely during your treatment to make sure your eye condition doesn’t worsen.
• Thyrotoxicosis. If you have thyrotoxicosis (too much thyroid hormone in your body), you may be more likely to have side effects from taking Symbicort. (For more about side effects, see the “Symbicort side effects” section above.) This is because thyrotoxicosis can cause some of the same symptoms. Talk with your doctor before taking Symbicort if you have thyroid problems. They may choose a different medication or treat your thyroid condition first.
• Ketoacidosis or diabetes. If you have ketoacidosis or diabetes, taking Symbicort may make your condition worse. Ketoacidosis is a complication of diabetes that occurs when the body breaks down fat too quickly. If you’ve had ketoacidosis in the past or currently have diabetes, talk with your doctor before taking Symbicort. The drug may increase your blood sugar, and you may need to be monitored more closely.
• Pregnancy and breastfeeding. It’s unknown whether it’s safe to take Symbicort while pregnant or breastfeeding. For more information, please see the “Symbicort and pregnancy” and “Symbicort and breastfeeding” sections above.

Note: For more information about the potential negative effects of Symbicort, see the “Symbicort side effects” section above.

Using more than the recommended dosage of Symbicort can lead to serious side effects. Symbicort contains two active ingredients: budesonide and formoterol. An overdose of budesonide isn’t as severe or life threatening as an overdose of formoterol. Taking too much budesonide for a long time can lead to overdose symptoms, but an overdose of formoterol can cause symptoms almost right away. For more information, see below.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

The following information is provided for clinicians and other healthcare professionals.

Indications

The Food and Drug Administration (FDA) has approved Symbicort for:

It should not be used as a rescue medication and is not indicated for the relief of acute bronchospasm. Safety and efficacy have not been validated in people younger than age 6 years.

Mechanism of action

Symbicort contains two active ingredients: budesonide and formoterol. Budesonide is an inhaled corticosteroid that works to mitigate inflammation through its strong glucocorticoid activity. It is a weak inhibitor of mineralocorticoids. Corticosteroids such as budesonide inhibit inflammatory cells like lymphocytes, neutrophils, eosinophils, mast cells, and macrophages. They also inhibit mediators of inflammatory cells, such as histamine and cytokines.

Formoterol is a long-acting selective beta2-agonist. It exhibits activity directly in the lungs to cause bronchodilation. Formoterol also increases cyclic AMP levels to relax smooth muscles in the bronchial system and inhibits the release of inflammatory mediators.

Pharmacokinetics and metabolism

The peak concentration of budesonide is typically reached at about 20 to 30 minutes after dosing. Most of the drug is absorbed systemically when taking via inhalation. Formoterol is absorbed even more quickly, reaching peak levels within about 15 minutes.

Budesonide is metabolized via the cytochrome P450 system, and CYP3A4 specifically. It is broken down into two major metabolites that have little activity compared with the parent drug. Formoterol is metabolized via glucuronidation and O-demethylation to inactive metabolites via CYP2D6 and CYP2C.

Contraindications

The use of Symbicort is contraindicated in people who have had a hypersensitivity reaction to it in the past. Symbicort is also contraindicated in the treatment of people with status asthmaticus or acute episodes of asthma or COPD requiring urgent or emergent treatment. Other treatment options are considered standard care.

Storage

Symbicort tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) with the mouthpiece down. Avoid storing this medication in areas where it could be exposed to heat or open flame. Don’t expose it to temperatures greater than 120°F (49°C) or the canister can burst.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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Therapy of diseases of the gastrointestinal tract and liver

Published on 06 February 2014

Views: 2014 90 081

In modern medicine, glucocorticosteroids (GCS), synthetic analogs of adrenal cortex hormones, are actively used.They have long-term anti-inflammatory, antitoxic, immunosuppressive effects.

One of the effective drugs of this group in the world practice of treating diseases of the gastrointestinal tract and liver is the drug “Budenofalk”, which is little known in Russia (the active ingredient is corticoid “budesonide”).

This drug has a number of advantages. It has a powerful local action, specifically targeting the area of ​​inflammation. These zones are:
– the intestine, starting from the terminal ileum, and the large intestine with the preservation of the maximum concentration of the drug up to the transverse colon;
– the liver is the last organ on the path of transformation of its active substance – budesonide.Receptors of liver cells easily recognize budesonide and quickly interact with it, which leads to its strong anti-inflammatory activity.

“Budenofalk” practically does not enter the systemic circulation and has a significantly lower risk of developing systemic side effects (occur 2.4 times less often than when taking equivalent doses of other glucocorticosteroids).

Therapy of gastrointestinal diseases

• Crohn’s disease, that is, chronic nonspecific granulomatous inflammation of the gastrointestinal tract, has a frequent localization of the inflammatory process in the terminal ileum and right colon.

In this case, as well as under conditions that the disease is mild or moderate in the absence of extraintestinal manifestations, the drug of choice for its therapy is “Budenofalk”.

Its effectiveness is equal to that of systemic corticosteroids, and the risk of developing systemic side effects is 62% lower. Achievement of remission in 51-60% of patients with this drug occurs within 8-10 weeks. According to the latest studies on the treatment of Crohn’s disease, carried out in Europe, the dose of “Budenofalk” in children is the same as in adults.Moreover, it is advisable to prescribe the full dose within 6 months before the onset of complete remission and only then gradually reduce it.

• Clinical studies have proven the effectiveness of the drug in ulcerative colitis. Reception of “Budenofalk” for 6 months in the case of severe exacerbation of steroid-dependent ulcerative colitis led to a significant decrease in the index of clinical activity and made it possible to abandon the use of systemic corticosteroids in the vast majority of patients (79%).

In the course of careful clinical studies, the effectiveness of “Budenofalk” in capsules was shown even for distal forms of ulcerative colitis after 8 weeks of treatment in 71% of patients.

• A large evidence base has accumulated on the treatment of microscopic colitis (in addition to symptomatic therapy, anti-inflammatory therapy is mandatory).

This is an inflammatory disease of the colon with lymphocytic infiltration of the mucous membrane, characterized by a prolonged course with recurrent diarrhea (caused by impaired absorption of water and sodium chloride in the intestine).There are two forms of microscopic colitis: lymphocytic and collagenous (the diagnosis is made on the basis of histological data).

Budenofalk is the only drug with an IA level of evidence for the treatment of collagen colitis. According to the international non-profit organization Cochrane Collaboration, which studies the effectiveness of medical products, the use of budesonide reliably leads to: 90,088 – relief of clinical symptoms (81% versus 17% with placebo), 90,088 – reduction of infiltration and thickness of the collagen layer (72% versus 17% with placebo).

A number of patients may require long-term maintenance therapy with Budenofalk to prevent relapse.

The efficacy of a course of treatment for lymphocytic colitis for 6 weeks has also been confirmed in several studies, and the reliability of the results was confirmed in a 2011 meta-analysis.

Therapy for liver diseases

The problem of effective treatment of autoimmune liver damage remains extremely urgent. Such diseases include:
– autoimmune hepatitis,
– primary biliary cirrhosis,
– primary sclerosing cholangitis,
– autoimmune cholangitis,
– overlapping syndromes of the aforementioned diseases.

Traditionally used glucocorticosteroids in the treatment of autoimmune liver damage for a long time are dangerous with a high risk of developing a variety of side effects. Almost 10% of patients are forced to stop using them because of this.

Budenofalk is used as an alternative first-line therapy to achieve remission in most patients. It is also the drug of choice if the patient has contraindications to traditional corticosteroid therapy (obesity, osteoporosis, diabetes, hypertension).

According to a large study using the combined treatment of autoimmune hepatitis with glucocorticosteroids together with azathioprine, after 6 months, the normalization of biochemical parameters and the absence of adverse effects of steroid therapy were observed only in 18.4% of patients, and with the use of Budenofalk and azathioprine – already in 47 % of patients.

Further continuation of treatment in both groups for 6 months increased the effectiveness of treatment to 60% in the budesonide group and to 38.8% in the other group receiving Budenofalk.

Thus, it was proved that “Budenofalk” has a higher efficacy and better tolerance than other glucocorticosteroids, and in combination with azathioprine is able to induce and maintain remission of autoimmune hepatitis without signs of liver cirrhosis.

Due to the best risk / benefit ratio, Budenofalk is the preferred drug for the treatment of autoimmune hepatitis not only in adults, but also in children.

Alcohol abuse is one of the most significant causes of acute and chronic liver diseases.The use of systemic corticosteroids in the treatment of patients with severe alcoholic hepatitis is associated with two main problems: resistance to drugs of this group and the frequent development of side effects.

In order to reduce the number of undesirable effects, the use of the topical glucocorticosteroid “Budenofalk” seems to be promising as an alternative in the treatment of this disease.

For any nosology of the intestine or liver with the development of significant side effects due to the intake of systemic corticosteroids, it is possible to transfer patients to Budenofalk.

Vera BURKOVSKAYA, Candidate of Medical Science,
Associate Professor at the Department of Therapy
FPK and teaching staff of the Siberian State Medical University.

Availability of the drug
in pharmacies can be specified by calling: 8 (3822) 51-57-15,
51-08-47.
www.drfalkpharma.ru

MECHANISM OF ACTION “BUDENOFALKA”

Specially designed dosage form “Budenofalk” most optimally takes into account the physiological conditions of the passage through the gastrointestinal tract: the gelatin capsule dissolves in the stomach, releasing about 350 microspherical particles in a special acid-resistant, but enteric-soluble shell.

Due to the pH-modified control, the release of the active substance does not take place in the acidic environment of the stomach, but in the neutral environment of the intestine. The highest intraluminal drug concentration is achieved from the terminal ileum to the transverse colon.

The active substance is rapidly absorbed into the mucous membrane, due to which it penetrates well into the tissues. When absorbed, budesonide undergoes a very high metabolism (90%) already at the “first pass” through the liver, providing a level of systemic bioavailability of only 10%.

Of these 10%, almost everything binds to albumin and is biologically inactivated. Such an active metabolism of the drug in the liver (before it enters the systemic circulation) leads to a low likelihood of side effects.

Cell receptors interact with budesonide 60 times better than with other glucocorticosteroids, due to which the activity of “Budenofalk” is many times higher.

There are contraindications. A specialist consultation is required.
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BUFOMIX ISIHEILER instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | BUFOMIX EASYHALER powder for inhalation of the company “Orion Corporation”

pharmacodynamics . Bufomix Easyhaler contains formoterol and budesonide, which have different modes of action and show additive effects to reduce the severity of asthma exacerbations.

Budesonide . Budesonide is a corticosteroids; when inhaled, it has a dose-dependent anti-inflammatory effect in the respiratory tract, as a result of which the severity of asthma symptoms decreases.Inhaled budesonide has less severe side effects than systemic corticosteroids. The exact mechanism of the anti-inflammatory effect of GCS is unknown.

Formoterol . Formoterol is a selective adrenostimulant of β ₂ -adrenergic receptors, which, when inhaled, provides rapid and long-term relaxation of bronchial smooth muscles in patients with reverse airway obstruction. The bronchodilator effect is dose-dependent and occurs within 1-3 minutes.The duration of the effect is not less than 12 hours after taking a single dose.

Pharmacokinetics

Suction. It has been shown that the combination of fixed doses of budesonide and formoterol Bufomix Easyhaler and the corresponding monopreparations are bioequivalent in terms of the systemic effects of budesonide and formoterol, respectively. Despite this, after administration of the fixed-dose combination, there was a slight suppression of cortisol compared with monotherapy. The difference is not believed to affect clinical efficacy.

There is no evidence of pharmacokinetic interactions between budesonide and formoterol.

The pharmacokinetic parameters of budesonide and formoterol were comparable after their administration as monopreparations or as a combination of fixed doses. In budesonide, the AUC and absorption rate were slightly higher, and the C _max in the blood plasma was higher after the administration of the fixed combination. Formoterol C _max in blood plasma was similar after administration of the fixed combination.Inhaled budesonide is rapidly absorbed, and C _max in blood plasma is reached within 30 minutes after inhalation. In studies, the average deposition in the lungs of budesonide after inhalation with a powder inhaler varied from 32 to 44% of the delivered dose. Systemic bioavailability was approximately 49% of the delivered dose. In children aged 6 to 16 years, lung deposition is in the same range as in adults after the same prescribed dose. The resulting plasma concentrations were not determined.

Inhaled formoterol is rapidly absorbed, and C _max in blood plasma is reached within 10 minutes after inhalation. In studies, the average deposition in the lungs of formoterol after inhalation with a powder inhaler ranged from 28 to 49% of the delivered dose. Systemic bioavailability was approximately 61% of the delivered dose.

Distribution and metabolism. Plasma protein binding is about 50% for formoterol and 90% for budesonide.The volume of distribution is approximately 4 L / kg for formoterol and 3 L / kg for budesonide. Formoterol is inactivated as a result of conjugation reactions (active O-demethylated and deformed metabolites are formed, but they are predominantly inactivated conjugates). Budesonide undergoes significant (about 90%) biotransformation during the first passage through the liver to metabolites with low GCS activity. The GCS activity of the main metabolites – 6-β-hydroxy-budesonide and 16-α-hydroxy-prednisolone – is less than 1% of the GCS-activity of budesonide.There are no signs of any metabolic interactions or any substitution reactions between formoterol and budesonide.

Derivation. Most of the formoterol dose is transformed by hepatic metabolism, followed by renal excretion. After inhalation, 8-13% of the delivered dose of formoterol is excreted in the urine unchanged. Formoterol has a high systemic clearance (approximately 1.4 l / min), and the final T _½ averages 17 hours.

Budesonide is excreted by metabolism, mainly under the action of a catalyst, which is the CYP 3A4 enzyme. Budesonide metabolites are excreted in the urine in pure form or in conjugated form. Only very small amounts of unchanged budesonide are detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 L / min), and T _½ after an intravenous dose is 4 hours.

The pharmacokinetics of formoterol in children have not been studied. The pharmacokinetics of budesonide or formoterol in patients with renal insufficiency is unknown.The effects of budesonide and formoterol may increase in patients with liver disease.

Bufomix Easyhaler is indicated for the regular treatment of asthma when the use of a combination (inhaled corticosteroids and long-acting β ₂ -adrenoreceptor agonists) is appropriate: for patients in whom adequate control is not achieved with inhaled corticosteroids and β ₂ -adrenoreceptor agonists short-acting, used “as needed”, or for patients who have already achieved adequate control when using both inhaled corticosteroids and long-acting β ₂ -adrenoreceptor agonists.

dosage. Bufomix Easyhaler is not indicated for the initial treatment of asthma. Doses of the components of Bufomix Easyhaler are selected individually and adjusted depending on the severity of the disease. This should be taken into account not only at the beginning of the use of combined drugs, but also when adjusting the maintenance dose. If the patient needs a combination of doses that differ from those available in the combined inhaler, appropriate doses of β ₂ -adrenoreceptor agonists and / or corticosteroids should be prescribed in separate inhalers.

The dose should be titrated to the lowest dose that effectively controls symptoms. Patients need to regularly undergo repeated examinations by the doctor who prescribed the drug so that the dose of Bufomix Easyhaler remains optimal. After long-term symptom control has been achieved with the lowest recommended dose, symptom control should be attempted with an inhaled corticosteroid alone.

The patient should be warned to keep a separate fast acting bronchodilator with him at all times as a lifesaving device.

Recommended doses

Adults : 1-2 inhalations, 2 times a day. Some patients may need up to 4 inhalations 2 times a day (maximum dose).

Children aged 12-17 years : 1-2 inhalations, 2 times a day.

Children under 12 years of age : Bufomix Easyhaler is not recommended for children under 12 years of age.

Usually, after achieving control over the symptoms of the disease when using the drug 2 times a day, the dose is titrated to the lowest effective dose, up to the use of the drug Bufomix Easyhaler 1 time per day, when, according to the doctor, the patient needs maintenance therapy with a long-acting bronchodilator.

The need for more frequent use of a separate fast-acting bronchodilator indicates a worsening of the patient’s condition and the need to revise BA treatment.

Special categories of patients. There are no specific dosage requirements for elderly patients.

There are no data on the use of the drug Bufomix Easyhaler in patients with hepatic or renal insufficiency. Since budesonide and formoterol are predominantly excreted by hepatic metabolism, increased exposure can be expected in patients with severe liver cirrhosis.

Method of application . For inhalation.

How to use Bufomix Easyhaler correctly

The inhaler is controlled by the inhaled air stream. This means that when the patient inhales air through the mouthpiece, the substance enters the respiratory tract along with the inhaled air.

1. Remove the protective cap from the Easyhaler mouthpiece.

2. Shake the inhaler 3-5 times in an upright position.

3. To release the 1st dose of the drug, place the Easyhaler between the thumb and forefinger and press the inhaler once.A click will be heard when pressed.

4. Take a full breath, grasp the mouthpiece tightly with your lips and inhale deeply, holding your breath for 5–10 s.

5. If more than 1 dose is prescribed, repeat steps 2, 3 and 4.

6. Close the Easyhaler mouthpiece with the protective cap.

7. The counter of doses on the inhaler helps to control the number of remaining doses of the drug. The counter switches every 5 doses. A red zone on the counter means there are 20 doses remaining in Easyhaler.

It is important to draw the patient’s attention to the following:

• Carefully read the instructions for medical use.
• After opening the laminated bag, it is recommended to store the device in a protective container to protect it from impact and to ensure reliable operation of the device.
• Shake off the device and activate it before each inhalation.
• Inhale deeply and vigorously through the mouthpiece to ensure that the optimal dose is delivered to the lungs.
• Do not exhale through the mouthpiece as this will reduce the delivered dose. If this does happen, you need to tap the inhaler on the surface of the table or on the palm to remove the powder from the mouthpiece, and then repeat the procedure for taking the drug.
• Do not operate the device more than 1 time without inhaling the powder. If this does happen, the patient needs to tap the inhaler on the table surface or on the palm to remove the powder from the mouthpiece, and then repeat the procedure for taking the drug.
• Always wear a dust cap and close the protective container lid after using the inhaler to prevent accidental spraying of powder from the device (which could result in either an overdose or insufficient inhalation of the drug if the inhaler is used later).
• Rinse mouth with water after inhalation of the prescribed dose to minimize the risk of oral candidiasis. If oral candidiasis occurs, patients should rinse their mouth with water after inhalation “as needed”.
• Clean the mouthpiece regularly with a dry cloth. Do not use water for cleaning, as the powder is hygroscopic.
• Replace the Bufomix Easyhaler inhaler when zero appears on the counter, even if some powder is still visible inside the device.

Hypersensitivity to budesonide, formoterol or lactose (which contains a small amount of milk protein).

Because Bufomix Easyhaler contains both budesonide and formoterol, patients may experience side effects typical of these two substances.After the simultaneous administration of the two compounds, there was no increase in the frequency of adverse reactions. The most common drug-related adverse events correspond to the pharmacologically predictable side effects of treatment with β ₂ agonists. These are phenomena such as tremors and heart palpitations, which are usually mild and disappear after a few days.

Adverse reactions associated with formoterol are listed below for organ systems and frequency of development.The frequency is determined on the following scale: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 to < 1/1000), very rare (<1/10 000), unknown (frequency cannot be estimated from available data).

Infectious and parasitic diseases : often – oropharyngeal candidiasis.

From the immune system : rarely – immediate or delayed hypersensitivity reactions such as rash, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction.

From the endocrine system : very rarely – Cushing’s syndrome, suppression of the function of the adrenal cortex, growth retardation, reduced bone mineral density.

From the side of metabolism and nutrition : rarely – hypokalemia; very rarely – hyperkalemia.

From the side of the psyche : infrequently – aggression, psychomotor hyperactivity, anxiety, sleep disturbances; very rarely – depression, behavior changes (mainly in children).

From the nervous system : often – headache, tremor; infrequently – dizziness; very rarely – taste disturbance.

From the side of the organ of vision : very rarely – cataract and glaucoma.

From the side of the cardiovascular system : often – accelerated heartbeat; infrequently – tachycardia; rarely – arrhythmia, for example atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely – angina pectoris, lengthening of the interval Q – Tc , fluctuations in blood pressure.

On the part of the respiratory system, chest and mediastinal organs : often – moderate irritation in the throat, cough, hoarseness; rarely – bronchospasm.

From the digestive system : infrequently – nausea.

Skin and subcutaneous tissue disorders : infrequently – bruising.

Musculoskeletal and connective tissue disorders : infrequently – muscle cramps.

Oropharyngeal candidiasis caused by drug deposition.The patient should be advised to rinse the mouth with water after each dose to minimize the risk. Oropharyngeal candidiasis usually responds to topical antifungal treatment and does not require withdrawal of inhaled corticosteroids.

As with other types of inhaled therapy, paradoxical bronchospasm may develop in rare cases, affecting 1 in 10,000 patients. In this case, the patient immediately after taking the dose increases wheezing and shortness of breath. Paradoxical bronchospasm responds to rapid-acting inhaled bronchodilators, and patients with this disorder should be treated urgently.It is necessary to immediately stop taking the drug Bufomix Easyhaler, examine the patient and, if necessary, prescribe alternative therapy.

Systemic effects of inhaled corticosteroids can develop, in particular, with the use of high doses for a long time. These effects are much less likely than those of oral corticosteroids. Possible systemic effects include Cushing’s syndrome, cushingoid appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.Increased susceptibility to infections and impaired ability to adapt to stress may develop. These effects are likely to depend on dose, time of exposure, concomitant or prior use of steroids, and individual sensitivity.

Treatment with β ₂ -agonists can lead to an increase in the level of insulin, free fatty acids, glycerol and ketone bodies in the blood.

Reporting suspected adverse reactions . It is important to report a suspicion of adverse reactions after receiving a marketing authorization for a medicinal product.This allows you to constantly monitor the benefit / risk ratio of the drug. Health professionals are requested to report suspected adverse reactions through the national reporting system.

It is recommended to gradually reduce the dose when the drug is discontinued and not to abruptly discontinue the drug.

If patients find that treatment is ineffective, or it becomes necessary to exceed the highest recommended dose of Bufomix Easyhaler, they should consult a doctor.A sudden and progressive deterioration in asthma control is potentially life-threatening, so the patient should undergo immediate medical examination. In this case, consideration should be given to the need to intensify corticosteroid therapy (eg, a course of oral corticosteroids) or antibiotic treatment if infection is present.

Patients should be warned to keep their rescue inhaler with them at all times.

Patients should be reminded to take the maintenance dose of Bufomix Easyhaler as prescribed, even in the absence of symptoms.The prophylactic use of Bufomix Easyhaler, for example before exercise, has not been studied. For this purpose, an additional fast-acting bronchodilator should be used.

Once the symptoms of asthma have been brought under control, a gradual reduction in the dose of Bufomix Easyhaler should be considered. It is important to see patients regularly as the dose is reduced. Use the lowest effective dose of Bufomix Easyhaler.

Do not start treatment with Bufomix Easyhaler in case of exacerbations, significant deterioration or severe complication of asthma.

During treatment with Bufomix Easyhaler, serious adverse events and exacerbations associated with asthma may occur. Patients should be advised of the need to continue treatment and at the same time see a doctor if the symptoms of asthma are not controlled or worsen after starting to take the drug Bufomix Easyhaler.

As with other types of inhalation therapy, there is a risk of developing paradoxical bronchospasm. In this case, the patient immediately after taking the dose increases wheezing and shortness of breath.If a patient develops paradoxical bronchospasm, it is necessary to immediately stop taking the drug Bufomix Easyhaler, examine the patient and, if necessary, prescribe alternative therapy. Paradoxical bronchospasm responds to rapid-acting inhaled bronchodilators, and patients with this disorder should be treated urgently.

Systemic effects of inhaled corticosteroids can develop, in particular, with the use of high doses for a long time. These effects are much less likely than those of oral corticosteroids.Possible systemic effects include Cushing’s syndrome, Cushingoid appearance, adrenal suppression, stunted growth in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and much less often – various psychological and behavioral abnormalities, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggressiveness (especially in children).

The potential effect on bone density should be considered, especially in patients taking high doses for a long time and concomitantly with risk factors for osteoporosis.Long-term studies of inhaled budesonide in children with average daily doses of 400 mcg (metered dose) or in adults with daily doses of 800 mcg (metered dose) have not shown a significant effect on bone mineral density. There is no information available on the effects of high doses.

If there is reason to suspect that the function of the adrenal cortex will deteriorate due to prior systemic steroid therapy, care should be taken when transferring patients to therapy with Bufomix Easyhaler.

The benefits of inhaled budesonide therapy generally minimize the need for oral steroids, but patients who switch from oral steroids are at risk of long-term reduced adrenal reserve. Recovery can take a long time after stopping oral steroid therapy. In this case, it is necessary to regularly monitor the function “hypothalamus – pituitary gland – adrenal cortex”.

Long-term treatment with high-dose inhaled corticosteroids may result in clinically significant suppression of adrenal cortex function.Therefore, during stressful periods, such as severe infections and elective surgery, additional systemic corticosteroid treatment should be considered. A rapid decrease in the dose of steroids can provoke an acute insufficiency of the function of the adrenal cortex. Symptoms that can be seen in acute adrenal insufficiency include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased consciousness, seizures, hypotension, and hypoglycemia.

Treatment with additional systemic steroids or inhaled budesonide should not be discontinued abruptly.

When switching from oral drugs to Bufomix Easyhaler, a general low systemic effect of steroids is noted, which can lead to the appearance of allergic or arthritic symptoms such as rhinitis, eczema, muscle and joint pain. In this case, you need to start a specific treatment. A general insufficient effect of GCS should be suspected if, in some cases, symptoms such as fatigue, headache, nausea and vomiting appear.In such cases, it is sometimes required to temporarily increase the dose of oral corticosteroids.

In order to reduce the risk of developing oral candidiasis, patients should thoroughly rinse the oral cavity with water after inhalation of a maintenance dose. In case of the appearance of oral candidiasis, patients should rinse the oral cavity with water also after inhalation “as needed”.

Concomitant treatment with itraconazole, ritonavir, or other potent CYP 3A4 inhibitors should be avoided. If this is not possible, the intervals between dosing should be as long as possible.Supportive care is not recommended for patients using potent CYP 3A4 inhibitors.

Bufomix Easyhaler should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, untreated hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular diseases, such as cardiovascular disease failure.

Caution should be exercised when treating patients with an extended Q – Tc interval. Formoterol itself can cause prolongation of the Q – Tc interval.

In patients with active or inactive pulmonary tuberculosis, fungal and viral infections in the airways, the need and dose of inhaled corticosteroids should be reassessed.

When treated with β ₂ β-adrenergic receptor agonists in high doses, potentially life-threatening hypokalemia may develop.The hypokalemic effect of β ₂ -adrenoceptor agonists can be enhanced by simultaneous treatment with β ₂ -adrenoceptor agonists and drugs that can cause hypokalemia or enhance the hypokalemic effect, such as xanthine derivatives, steroids and diuretics. Particular care should be taken in unstable asthma in case of inconsistent use of rescue bronchodilators, in acute severe asthma, since the associated risk is increased by hypoxia, as well as in other conditions when the risk of hypokalemia increases.In these cases, it is recommended to monitor serum potassium levels.

In patients with diabetes mellitus, it is recommended to carry out additional monitoring of the concentration of glucose in the blood.

Bufomix Easyhaler contains approximately 4 mg of lactose per inhalation. Usually, this amount does not cause problems for individuals with lactose intolerance. The excipient lactose contains small amounts of milk proteins that can cause allergic reactions.

Use during pregnancy and lactation

Pregnancy .There are no clinical data on the effect of Bufomix Easyhaler or concomitant treatment with formoterol and budesonide on pregnancy. Studies of embryo / fetal development in animals have not demonstrated any additional effect of the combination.

There are insufficient data on the use of formoterol in pregnant women. Formoterol has caused side effects in animals during reproductive studies at very high levels of systemic exposure.

Data on approximately 2000 pregnancy cases studied did not show an increased teratogenic risk associated with the use of inhaled budesonide.In animal studies, it has been shown that corticosteroids cause malformations. This is unlikely in people who are receiving the recommended doses.

Animal studies have also shown that excessive amounts of perinatal glucocorticoids increase the risk of intrauterine growth retardation, cardiovascular disease in adults, irreversible changes in glucocorticoid receptor density, neurotransmitter turnover and behavior at concentrations below the teratogenic dose range.

During pregnancy, Bufomix Easyhaler should be used only if the expected benefit outweighs the potential risk.The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.

Breastfeeding . Budesonide passes into breast milk. However, at therapeutic doses, no effect on the breastfed baby is expected. It is not known whether formoterol passes into breast milk. Small amounts of formoterol have been found in the breast milk of animals. The use of the drug Bufomix Easyhaler in women who are breastfeeding should be considered only if the expected benefit to the mother outweighs the possible risk to the fetus.

Children . Bufomix Easyhaler is not recommended for children under 12 years of age.

Regular growth measurements are recommended in children receiving long-term inhaled corticosteroid therapy. If growth slows down, the treatment regimen should be revised in order to reduce the dose of inhaled corticosteroid to the minimum, ensuring effective control of asthma. The benefits of corticosteroid treatment should be carefully weighed against the risk of growth suppression.In addition, it is necessary to refer the patient to a pediatric pulmonologist.

Some long-term evidence suggests that most children and adolescents treated with inhaled budesonide eventually reach their target height as they get older. At the same time, an initially small temporary decrease in growth was noted (by about 1 cm). In general, it happens within 1 year of treatment.

The ability to influence the reaction rate when driving or working with other mechanisms.

In case of dizziness, tremors, convulsions during treatment, do not drive vehicles or operate machinery.

pharmacokinetic interactions

Potent CYP 3A4 inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to increase plasma levels of budesonide, so their concomitant use should be avoided. If this is not possible, the intervals between doses of these drugs should be as long as possible.Supportive care is not recommended for patients using potent CYP 3A4 inhibitors.

A potent inhibitor of CYP 3A4, ketoconazole at a dose of 200 mg once a day increases the plasma levels of budesonide, administered simultaneously orally (single dose of 3 mg), by an average of 6 times. When ketoconazole was taken 12 hours after budesonide, the concentration on average increased only 3-fold, indicating that separate administration can reduce the increase in plasma levels.Some data indicate that there may be a significant increase in plasma levels of budesonide (an average of 4 times) when taken simultaneously with inhaled budesonide (a single dose of 1000 mcg) itraconazole at a dose of 200 mg once a day.

Pharmacodynamic interactions. β-adrenergic receptor blockers may weaken the effect of formoterol. Therefore, Bufomix Easyhaler should not be used together with β-adrenergic receptor blockers (including eye drops) unless there is a compelling reason for this.

Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazine, antihistamines (terfenadine) and tricyclic antidepressants may prolong the Q-Tc interval and increase the risk of ventricular arrhythmia.

In addition, levodopa, levothyroxine, oxytocin and alcohol can worsen the tolerance of the heart to β ₂ -sympathomimetics.

Concomitant treatment with monoamine oxidase inhibitors, including drugs with similar properties, such as furazolidone and procarbazine, can cause hypertensive reactions.

The risk of developing arrhythmias increases with anesthesia with halogenated hydrocarbons.

Concomitant use of other β-adrenergic or anticholinergic drugs may enhance the bronchodilatory effect.

Hypokalemia may increase the tendency to cardiac arrhythmias in patients treated with digitalis glycosides.

No interaction of budesonide and formoterol with any other drugs used to treat AD has been observed.

symptoms. An overdose of formoterol may be accompanied by symptoms that usually occur with an overdose of β ₂ -adrenoreceptor agonists: tremor, headache, palpitations. In some cases, symptoms such as tachycardia, hyperglycemia, hypokalemia, prolongation of the interval Q – Tc , arrhythmia, nausea and vomiting were reported. Supportive and symptomatic treatment is indicated. A dose of 90 μg, taken over 3 hours, was safe in patients with acute bronchial obstruction.

In acute overdose of budesonide, even with excessive doses, clinical problems are not expected. With chronic use of excessive doses, GCS effects may appear, such as hypercortisolism and suppression of the function of the adrenal cortex.

If therapy with Bufomix Easyhaler must be discontinued due to an overdose of formoterol, consideration should be given to providing appropriate therapy with inhaled corticosteroids.

the preparation does not require special storage conditions before opening the laminated bag.

After opening the laminated bag, store at a temperature not exceeding 25 ° C, protected from moisture.

Date Added: 09/04/2021

Clinical Study Acute Mountain Sickness: Budesonide 200, Budesonide 800, Placebo – Clinical Trials Registry

Main Objective

The main aim of the study is to investigate the effect of inhaled budesonide on AMS incidence. Key research question to ask:

1.Does inhaled budesonide reduce the frequency of HRP after a rapid and vigorous rise to 4559? m?

In addition, the following additional questions should be asked:

1. Does inhaled budesonide reduce the severity of the AMS after a rapid and vigorous ascent to 4559? m?

2. Are the effects of inhaled budesonide on the incidence and severity of GHP related to its plasma concentration?

Study drug Inhaled budesonide at 2 different concentrations (2 x 200 μg, 2 x 800 μg) versus placebo

Study design Prospective, controlled, single-center study of 51 healthy volunteers at a distance of 4559 m.[Capanna Regina Margherita (Margherita Hut), Italy] Regarding the intervention (inhaled budensoide), double-blind and randomized

Study a population of 51 healthy volunteers

Study site Prior to the study, the university will conduct preliminary studies. Hospital Salzburg, Austria. The high-rise section will take place at Capanna Regina. Margherita (Margherita Hut, Italy) at 4559 m.

Interventions and investigations

– Ascent from Alanya (1130 m, Italy) to Margherita hut (4559 m) in less than 24 hours, with a previous overnight stay at an altitude of 3611 m (Hut Gnifetti, Italy).

– Stay in Margarita’s hut for 48 hours

– Randomized inhalation of budesonide in two different concentrations (2 x 200 mcg 2 x 800 mcg). μg, respectively) or placebo

– Assessment of the incidence and severity of acute mountain sickness using 2 internationally standardized and well-established questionnaires

– Venous (and capillary) blood sampling

– Pulmonary function tests

– Transthoracic echocardiography to assess systolic pressure in the pulmonary artery

Number and volume of blood samples For the study of venous blood samples (volume: 20 ml each) will be drawn at 5 different time points (5 x 20 ml = 100 ml).A total blood volume of 120 ml will be taken together with the blood drawing for preliminary examination (20 ml). At the same time, capillary blood samples (1 ml) will be taken from the earlobe for blood gas analyzes (5 x 1 ml = 5 ml total).

Follow-up Period The study will only commence upon approval by the Ethics Committee. responsible for research (ethics committee of the Medical University of Paracelsus). If approved, the study will be completed in July 2016. 90 016 90 000 For which the skier Legkov was taken away from the medal

The winner of the ski marathon at the Olympic Games in Sochi in 2014, Alexander Legkov, was taken away from the gold medal.And the ski team, which won the second place in the relay, won silver medals (Legkov ran one of the stages).

Vladislav Bachurov, journalist:

Games with the flag: is it worth worrying about the ban of the Russian anthem at the Olympics

Olympiad

Games with the flag: is it worth worrying about the ban of the Russian anthem at the Olympics

Alexander Legkov, the winner of the ski marathon at the Olympic Games in Sochi in 2014, is charged with “doping violation”, which means manipulation of doping samples.On his test tube from Sochi, traces of an autopsy were found.

Legkov was doomed. He was on the list of those athletes who drank the “Rodchenkov cocktail” – a doping mixture invented by the head of the Moscow Anti-Doping Laboratory, Grigory Rodchenkov. The composition included anabolic steroids methenolone, trenbolone and oxandrolone and alcohol: for men – Chivas whiskey, for women – Martini vermouth. The mixture had not to be swallowed, but to dissolve the tablet with a small – half a sip – portion of alcohol, which caused an acceleration of absorption, practically – to rinse your mouth with a mixture of whiskey and a steroid.So doping entered the body not through the stomach, but through the mucous membrane of the mouth, therefore it was absorbed into the blood faster. And it was more difficult to catch the athlete – the timing of doping detection decreased.

In 2016, part of the correspondence between Rodchenkov and Deputy Director of the Sports Training Center Alexei Velikodny was published. After the Games in Sochi, after a doping test at the Russian Championship in Tyumen in March 2014, Rodchenkov decided to clarify which of the athletes had budesonide: “Dear Alexei, here someone got out with an overdose with inhalations, incredibly many, or completely sick (have a permission?), or weird winter “.It turned out that the skier, encrypted under the number A0467, had gone through the doping.

McLaren’s report indicates that before the Olympics in Sochi, Rodchenkov, with the support of the Ministry of Sports, compiled a list of athletes to whom he “prescribed” his cocktail before the Games.

The skier, encrypted under the number A0467, is easy to calculate – the list indicated the disciplines in which each athlete was planned to perform. By the way, Maxim Vylegzhanin, who came second at the Olympic marathon, is also on the list of those who drank the “Rodchenkov cocktail”, and when this number was being prepared, it became known that by the decision of the International Olympic Committee (IOC) commission he was “disqualified for life from participating in the Olympics.”

About Legkov (or rather, about number A0467) Rodchenkov to Velikodnoy wrote in 2014: “The goat was saved.” It turned out to be temporary. Rodchenkov and became the main informant of the Richard McLaren Commission, which investigated the doping system in Russia. Now the data of McLaren’s report are checked at once by two IOC commissions under the leadership of Denis Oswald are dealing with the facts of manipulation of doping samples during the Games in Sochi, and the second – led by Samuel Schmid – with the role of the Ministry of Sports and other state bodies in the system of doping in Russia. sports.

In turn, the Investigative Committee of Russia also made a statement about doping scandals. In relation to Rodchenkov, a decision was issued to bring him into custody as an accused, and the court chose him as a preventive measure in the form of detention. The investigation intends to demand the extradition of Rodchenkov from the United States.

FIS will consider the case of Russian skiers on November 18

Doping scandal

FIS will consider the case of Russian skiers on November 18

The statement reads: “We have collected enough evidence that Grigory Rodchenkov destroyed the athletes’ doping samples and the agency’s letters about the storage of such samples.”At the same time, the UK’s statement denies the existence of a certain state doping program, it is noted that “the violations were of a purely individual nature.”

However, there is evidence that at various times before the Games in Sochi, athletes from the list had to take samples of “clean” urine. These samples were tested in the Moscow laboratory for the absence of banned substances and were stored for future replacement. On the basis of scratches and other mechanical damages on the vials with doping samples, it is concluded that they were replaced during the Games in Sochi.Forensic examinations for the Oswald Commission are carried out by forensic experts from the University of Lausanne. The goal is to find traces of opening the bottles.

Such injuries are found on samples of 27 Russian athletes who competed in Sochi. Of these, 12 became champions or prize winners of the Games. And it will be very difficult to explain that the attempts to substitute doping samples at the Olympic Games in Sochi were “purely individual in nature.”

Select the fragment with the error text and press Ctrl + Enter

Question-answer

Question-answer

10.01.2014 05:21

The main thing for the patient is to quit smoking. This is one of the main causes of the disease. In treatment, bronchodilator drugs play the main role: on demand or regularly, depending on the severity of the disease. They reduce the frequency of exacerbations and improve quality of life, as shown in numerous studies. In case of mild course, short-acting bronchodilator drugs are used, with moderate and severe course – long-acting.For regular therapy, it is better to use long-acting bronchodilators. These are, for example, tiotropium bromide (spiriva), salmeterol, formoterol. In elderly patients with underlying cardiovascular disease, spiriva is preferred as first-line drugs.
Hormonal preparations can only be used in inhalation form. They can improve the quality of life of patients and reduce the frequency of exacerbations. Among these drugs are fluticasone, budesonide.For the convenience of patients, combined preparations have been developed containing an inhalation hormonal drug and a long-acting bronchodilator – symbicort turbuhaler, seretid multidisk and others.
Of the new modern drugs, a selective inhibitor of phosphodiesterase 4 – roflumilast, which has an anti-inflammatory effect, should be noted. In Europe, it was registered only in 2010, now it is already in our pharmacies. Also now available is another effective bronchodilator, indacterol (commercial name Onbrez Breezhaler).It has an ultra-long-lasting effect – for the entire 24 hours.

Diabetes numbers
Recently, during an examination at a mobile diabetes center, I was found to have a blood sugar level of 6.5 mmol / L. Does this mean that there is a risk of developing diabetes? | Yunus, 34 years old, Kaspiysk
It matters whether you donated blood on an empty stomach or after breakfast. When taking capillary blood (from a finger), a blood glucose level of 3.3 to 5.5 mmol / L is considered the norm. If blood was taken from a vein, 6.1 mmol / L is considered the upper limit.We repeat once again: these numbers can be guided only if a person comes to the analysis on an empty stomach, that is, after 8-12 hours of an overnight fast.
If, under all these conditions, the blood glucose level is determined twice on an empty stomach above 7.0 mmol / l or at any time of the day more than 11.0 mmol / l, a person can be diagnosed with diabetes mellitus. In case of doubtful indicators, a specific glucose tolerance test (oral glucose tolerance test) is performed.
Before carrying out it, you need to observe the usual diet (with a carbohydrate content of about 120-150 g per day) and physical activity for at least three days.The study is carried out in the morning on an empty stomach, and before that you can not smoke and take alcohol.
The patient is measured fasting blood glucose, then given a glass of warm water, which is dissolved 75 g of glucose. A blood glucose level of less than 7.8 mmol / L after two hours is considered normal. If glucose rises above 11.0 mmol / L, the test indicates the presence of diabetes mellitus. Intermediate values ​​- from 7.8 to 11.0 mmol / l – are regarded as impaired glucose tolerance (that is, such a person is at risk and may develop diabetes mellitus).In any case, if abnormalities are found, you should contact an endocrinologist who will give recommendations and, if necessary, prescribe additional studies.

instructions for use, analogs, composition, indications

It is recommended to gradually reduce the dose when discontinuing the drug and not to abruptly discontinue the drug.

If patients find that treatment is ineffective, or exceed the highest recommended dose of Bufomix Easyhaler, they should consult a doctor.A sudden and progressive deterioration in the control of bronchial asthma or COPD is potentially life-threatening, therefore, the patient should immediately undergo a medical examination. In such a case, consideration should be given to the need to intensify corticosteroid therapy, for example, a course of oral corticosteroids or antibiotic treatment if an infection is present.

Patients should be warned about the need to keep their rescue inhaler with them at all times – either Bufomix Easyhaler (for patients with bronchial asthma who use Bufomix Easyhaler as maintenance and relief therapy), or a separate fast-acting bronchodilator (for all patients who use Bufomix Easyhaler only as a maintenance therapy).

Patients should be reminded to take the maintenance dose of Bufomix Easyhaler as prescribed, even in the absence of symptoms. The prophylactic use of Bufomix Easyhaler, for example, before exercise, has not been studied. Facilitating inhalation of the drug Bufomix Easyhaler should be done in response to the symptoms of bronchial asthma, and they are not intended for regular prophylactic use, for example, before physical activity.A separate fast acting bronchodilator should be considered for each use.

Only the symptoms of bronchial asthma have been brought under control, the issue of a gradual reduction in the dose of the drug Bufomix Easyhaler should be considered. It is important to see patients regularly as the dose is reduced. Use the lowest effective dose of Bufomix Easyhaler.

You should not start treatment with Bufomix Easyhaler in case of exacerbations or significant deterioration or severe complication of bronchial asthma.

During treatment with Bufomix Easyhaler, serious undesirable effects and exacerbations associated with bronchial asthma may occur. Patients should be advised of the need to continue treatment and at the same time see a doctor if the symptoms of bronchial asthma are not controlled or worsen after starting to take the drug Bufomix Easyhaler.

As with other types of inhalation therapy, there is a risk of developing paradoxical bronchospasm. In this case, the patient immediately after taking the dose increases wheezing and shortness of breath.If a patient develops paradoxical bronchospasm, it is necessary to immediately stop taking the drug Bufomix Easyhaler, examine the patient and, if necessary, prescribe alternative therapy. Paradoxical bronchospasm responds to rapid-acting inhaled bronchodilators and must be treated urgently.

The systemic effects of inhaled corticosteroids can be observed, in particular, when high doses are prescribed for a long period of time. These effects are much less likely than those of oral corticosteroids.Possible systemic effects include Cushing’s syndrome, Cushingoid appearance, adrenal suppression, stunted growth in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and, much less commonly, various psychological and behavioral abnormalities, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggressiveness (especially in children).

Regular growth measurements are recommended in children receiving long-term inhaled corticosteroid therapy.If growth slows down, the treatment regimen should be revised in order to reduce the dose of inhaled corticosteroid, if possible, to the minimum, ensuring that effective control of the course of bronchial asthma is maintained. The benefits of corticosteroid treatment should be carefully weighed against the possible risks of inhibiting growth. In addition, it is necessary to refer the patient to a pediatric pulmonologist.

Limited evidence from long-term studies suggests that most children and adolescents treated with inhaled budesonide eventually reach target height in adulthood.At the same time, there was initially a small temporary decrease in growth (by about 1 cm). It generally occurs within the first year of treatment.

The potential effect on bone density should be considered, especially in patients taking high doses for a long period of time and in whom there are concomitant risk factors for osteoporosis. Long-term studies of inhaled budesonide in children at average daily doses of 400 mcg (metered dose) or in adults at daily doses of 800 mcg (metered dose) have not shown a significant effect on bone mineral density.There is no information available on the effects of high doses.

If there is reason to believe that the function of the adrenal cortex will deteriorate through prior systemic steroid therapy, care should be taken when transferring patients to therapy with Bufomix Easyhaler.

The benefits of inhaled budesonide therapy usually minimize the need for oral steroids, but patients who switch from oral steroids may continue to be at risk of decreased adrenal reserve for a long time.Recovery can take a long time after stopping oral steroid therapy, so patients who are dependent on oral steroid therapy, which are switched to inhaled budesonide, may remain at risk of a reduced adrenal cortex for a long time. In this case, it is necessary to regularly monitor the function “hypothalamus – pituitary gland – adrenal cortex”.

Long-term treatment with high doses of inhaled corticosteroids, especially above the recommended doses, can lead to clinically significant suppression of the adrenal cortex.Therefore, during stressful periods, such as severe infections and elective surgery, additional systemic corticosteroid treatment should be considered. A rapid decrease in the dose of steroids can provoke an acute insufficiency of the function of the adrenal cortex. Symptoms and signs that can be seen in acute adrenal insufficiency may be somewhat vague, but may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased consciousness, seizures, hypotension, and hypoglycemia.

Treatment with additional systemic steroids or inhaled budesonide should not be stopped abruptly.

When switching from oral drugs to Bufomix Easyhaler, there is an overall low systemic effect of steroids, which can lead to the appearance of allergic or arthritic symptoms such as rhinitis, eczema, muscle and joint pain. In this case, you need to start a specific treatment. A general inadequate effect of glucocorticosteroids should be suspected if symptoms such as fatigue, headache, nausea and vomiting appear in isolated cases.In such cases, it is sometimes necessary to temporarily increase the dose of oral glucocorticosteroids.

In order to reduce the risk of developing oral candidiasis, patients should thoroughly rinse the oral cavity with water after inhaling a maintenance dose. In case of the appearance of oral candidiasis, patients should rinse the oral cavity with water also after inhalation on demand.

Simultaneous treatment with itraconazole, ritonavir, or other potent CYP3A4 inhibitors should be avoided.If this is not possible, the intervals between doses of interacting drugs should be set as long as possible. For patients using potent CYP3A4 inhibitors, maintenance and relief therapy is not recommended.

Bufomix Easyhaler should be used with caution in patients with thyrotoxicosis, pheochromacytoma, diabetes mellitus, untreated hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular diseases such as cardiovascular disease …

Caution should be exercised when treating patients with an extended QTc interval. Formoterol itself can cause prolongation of the QTc interval.

In patients with active or inactive pulmonary tuberculosis, fungal and viral infections in the airways, the need and dose of inhaled corticosteroids should be reassessed.

Potentially life-threatening hypokalemia can develop when treated with high doses of β2-adrenoceptor agonists.The possible hypokalemic effect of β2-adrenoceptor agonists may be enhanced by concomitant treatment with β2-adrenoceptor agonists with drugs that can cause hypokalemia or enhance the hypokalemic effect, for example, xanthine derivatives, steroids and diuretics. You need to be especially careful with unstable bronchial asthma with inconsistent use of rescue bronchodilators, with acute severe bronchial asthma, since the associated risk can be increased by hypoxia, as well as in other conditions when the risk of hypokalemia increases.In these cases, it is recommended to monitor serum potassium levels.

As with all β2-adrenergic receptor agonists, additional monitoring of blood glucose concentration is recommended in patients with diabetes mellitus.

Bufomix Easyhaler contains approximately 4 mg of lactose per inhalation. Usually, this amount does not cause problems for individuals suffering from lactose intolerance. The excipient lactose contains small amounts of milk proteins that can cause allergic reactions.

Children

Regular growth measurements are recommended in children receiving long-term inhaled corticosteroid therapy. If growth slows down, the treatment regimen should be revised in order to reduce the dose of inhaled corticosteroid, if possible, to the minimum, ensuring that effective control of the course of bronchial asthma is maintained. The benefits of corticosteroid treatment should be carefully weighed against the possible risks of inhibiting growth. In addition, it is necessary to refer the patient to a pediatric pulmonologist.

Limited evidence from long-term studies suggests that most children and adolescents treated with inhaled budesonide eventually reach target height in adulthood. At the same time, there was initially a small temporary decrease in growth (by about 1 cm). It generally occurs within the first year of treatment.

Pregnancy

For the drug Bufomix Easyhaler or the simultaneous treatment with formoterol and budesonide, there are no clinical data on the effect on pregnancy.Data from rat fetal development studies did not demonstrate any additional effect of the combination.

There are insufficient data on the use of formoterol in pregnant women. In animal studies, formoterol has caused side effects in reproductive studies at very high levels of systemic exposure.

Data from approximately 2000 pregnancy cases studied did not show an increased teratogenic risk associated with the use of inhaled budesonide.In animal studies, GCS has been shown to cause malformations. This is unlikely for people on the recommended dosage.

Animal studies have also shown the effect of excessive amounts of perinatal glucocorticoids on an increased risk of intrauterine growth retardation, cardiovascular disease in adults, irreversible changes in glucocorticoid receptor density, neurotransmitter turnover, and behavior at concentrations below the teratogenic dose range.

During pregnancy, Bufomix Easyhaler should be used only if the expected benefit outweighs the potential risk. It is necessary to use the lowest effective dose of budesonide necessary to maintain adequate control of bronchial asthma.

Lactation period

Budesonide passes into breast milk. However, at therapeutic doses, no effect on a breastfed baby is expected.It is not known whether formoterol passes into breast milk. Small amounts of formoterol were found in the breast milk of rats. Taking the drug Bufomix Easyhaler in women who are breastfeeding should be considered only if the expected benefit to the mother outweighs the possible risk to the fetus.