Budesonide Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

This medication is used to treat a certain bowel condition (ulcerative colitis). While budesonide does not cure this condition, it may decrease symptoms such as pain and diarrhea. Budesonide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body’s natural defense response (immune response).

How to use budesonide oral

Read the Patient Information Leaflet if available from your pharmacist before you start taking budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Swallow this medication whole with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage and length of treatment are based on your medical condition and response to treatment.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin taking budesonide. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

This medication usually has fewer side effects than other corticosteroids because budesonide works in the gut and only small amounts are absorbed into the body. Nausea, abdominal pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn’t go away, fever, chills, cough). This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, puffy face, unusual weight gain, menstrual period changes, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, bone pain, thinning skin, slow wound healing, increased thirst/urination, vision problems, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking budesonide, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as cataracts, glaucoma), high blood pressure, liver problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, herpes), bleeding problems, mental/mood problems (such as psychosis, anxiety, depression).

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

This medication may slow down a child’s growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child’s height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn’t stop, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: aldesleukin, mifepristone, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product may interfere with certain lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Does budesonide oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

If this medication is used for a long time, lab and/or medical tests (such as blood count, bone density, eye exams, height/weight measurements) may be done while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

This medication may increase the risk of bone loss (osteoporosis) if used for a long time. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

budesonide DR-ER 9 mg tablet,delayed and extended release

Color: whiteShape: roundImprint: M BE9

This medicine is a white, round, film-coated, tablet imprinted with “M BE9”.

budesonide DR-ER 9 mg tablet,delayed and extended release

Color: whiteShape: roundImprint: MX9

This medicine is a white, round, film-coated, tablet imprinted with “M BE9”.

budesonide DR-ER 9 mg tablet,delayed and extended release

Color: whiteShape: roundImprint: WPI 2510

This medicine is a white, round, film-coated, tablet imprinted with “M BE9”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Budesonide side effects and how to avoid them

Budesonide side effects include hypercorticism, adrenal gland dysfunction, and more

Common budesonide side effects | Serious side effects | Hypercorticism | Side effects timeline | Contraindications | Warnings | Interactions | How to avoid side effects | How to treat side effects

Budesonide is a generic prescription corticosteroid. As a pill, budesonide is used to treat Crohn’s disease or ulcerative colitis. Rectal foam is an alternative to pills for people with ulcerative colitis located near the anus. Budesonide inhalant provides asthma maintenance treatment for young children, helping to reduce the frequency and severity of asthma attacks. Budesonide is frequently combined with other medications in a single inhaler to help keep airways open in adults with asthma, emphysema, or chronic bronchitis. Finally, as a prescription or over-the-counter nasal spray, budesonide helps relieve nasal symptoms of seasonal allergies such as runny nose. For some, budesonide can be prescribed in a brand-name version like Uceris (tablet or rectal foam), Pulmicort (inhalant), or Rhinocort (nasal spray). As a corticosteroid, budesonide reduces swelling in the colon, lungs, or nose by blocking the immune system. It has many of the standard side effects typical of corticosteroids, though budesonide inhalants, nasal spray, or rectal foam are less likely to cause problems.

Common side effects of budesonide

Based on clinical trials, the most common side effect of budesonide capsules or tablets is headache followed by:

• Respiratory infection
• Nausea
• Hypercorticism (Cushing syndrome)
• Back pain
• Indigestion
• Dizziness
• Stomach pain
• Flatulence
• Vomiting
• Fatigue
• Pain
• Abdominal distension
• Mood changes

Since inhaled budesonide is applied topically to the lung’s surface, less budesonide enters the bloodstream than when taken as a pill. Side effects, then, are less commonly experienced. The most common side effects of inhaled budesonide are:

• Respiratory infections
• Stuffy nose
• Ear infection
• Coughing
• Viral infection
• Digestive system problems
• Diarrhea
• Yeast infection (oral thrush)
• Stomach pain
• Conjunctivitis
• Skin rash
• Vomiting

Budesonide nasal spray is also less likely to cause side effects which mainly affect the nose, sinuses, and throat. The most common side effects of budesonide nasal spray are:

• Nosebleed
• Sore throat
• Airway closure (bronchospasm)
• Coughing
• Nasal irritation

Budesonide aerosol rectal foam is also a topical treatment. In this case, it is applied topically to the first 15 inches or so of the colon near the rectum. The most common side effect is a drop in the body’s cortisol levels. The only other significant side effects are suppression of the adrenal gland (adrenal insufficiency) and nausea.

Serious side effects of budesonide

The most serious side effects of oral budesonide include:

• High fluid pressure in the brain (intracranial hypertension)
• High blood pressure
• Infection
• High blood sugar 
• Gastrointestinal obstruction
• Suppression of the adrenal gland
• Hypercorticism (Cushing syndrome)
• Suppression of the immune system
• Glaucoma (high pressure in the eye)
• Cataracts
• Osteoporosis
• Growth suppression of children
• Withdrawal symptoms
• Severe allergic reaction

The most serious side effects of inhaled budesonide include:

• Psychiatric disorders
• Hypercorticism
• Cataracts
• Glaucoma
• Osteoporosis
• Growth suppression
• Severe allergic reactions

The most serious side effects of budesonide nasal spray include:

• Cataracts
• Glaucoma
• Osteoporosis
• Growth suppression
• Severe allergic reactions

Budesonide and hypercorticism

The most common side effect of the chronic use of budesonide is hypercorticism, also called Cushing syndrome. Steroids like budesonide imitate a hormone in the body called cortisol. Hypercorticism simply means “too much cortisol.” The incidence is highest in people taking budesonide orally since more of the drug enters the bloodstream. However, even when taken as an inhalant or nasal spray, some budesonide does get into the bloodstream. Over time, the excess corticosteroids—too much cortisol, that is—change the body and the way it works. These changes include acne, easy bruising, swollen face (or “moon face”), unwanted hair growth, stretch marks, and fat buildup at the back of the neck (buffalo hump). Weight gain and muscle weakness can also result from the prolonged use of corticosteroids. Most of these effects will improve once the corticosteroid treatment ends, but some could be long-lasting.

How soon do budesonide side effects start?

Many of the most common side effects of budesonide start early in treatment, sometimes after the first dose. These include headache, dizziness, digestive system problems, and mood changes. Some of the most serious side effects are delayed side effects, but an allergic reaction can happen within minutes of the first dose. Many serious side effects, however, are due to the prolonged use of budesonide or other steroids. 

How long do budesonide side effects last?

Mild side effects might improve over time, but it’s not guaranteed. Some will last as long as the drug is taken. Others, such as loss of bone density, weight gain, acne, cataracts, and glaucoma could worsen the longer budesonide is taken. Additionally, infections due to immune suppression may keep happening over and over again as long as the drug is being taken. 

Most side effects will improve when budesonide is discontinued. It takes a while, however, to stop taking budesonide. To prevent withdrawal, a steadily decreasing dose must be taken over several weeks. By the time the tapering is finished, many mild side effects will have gotten better. Some more serious side effects, like cataracts or osteoporosis, are longer-term problems that may require medical treatment.

What are the long-term side effects of budesonide?

Some of the most serious side effects of budesonide result from prolonged use of budesonide or other corticosteroids. These include:

• Hypercorticism
• Adrenal gland dysfunction
• Immune system suppression
• Cataracts
• Osteoporosis
• Growth suppression

People taking budesonide as a maintenance or long-term treatment for irritable bowel disease (IBD), asthma, or COPD, should discuss the long-term consequences with the prescriber.

Budesonide contraindications

Oral budesonide can never be taken by people with severe liver disease or allergies to budesonide or other corticosteroids.

Budesonide inhalants or nasal sprays are also never prescribed to people with budesonide or corticosteroid allergies. It is not appropriate to use budesonide inhalers to treat an asthma attack.

Pregnancy

When taken as a tablet or capsule during pregnancy, budesonide could cause birth defects or worse, especially during the first trimester. Oral budesonide is not prohibited during pregnancy, but the risks to the fetus will have to be weighed against the benefits of taking the drug.

There is not enough information to determine if inhaled budesonide or nasal spray is safe to take during pregnancy. Again, risks and benefits will have to be weighed against each other.

Breastfeeding

Budesonide is present in human breast milk but in small amounts. Healthcare professionals consider oral, inhaled, and nasal budesonide to be acceptably safe in breastfeeding mothers.

Children

Inhaled budesonide is FDA approved for use in children from the ages of 12 months to 8 years old. However, individual brand-name products may be approved for different age ranges. Budesonide capsules and tablets can be taken by children as young as 8 years old. The nasal spray can be used by children as young as 6 years old. The biggest worry is the effects of oral, inhaled, or nasal budesonide on a child’s growth, particularly when used for a prolonged time. Growth—both height and weight—should be monitored carefully when a child is taking budesonide.

Seniors

Dosage reductions are not required in people older than 65. However, healthcare providers will try to start with lower doses. 

Budesonide warnings

All corticosteroids can cause problems due to pre-existing conditions, overuse, or overdose. Budesonide is no exception, though it’s generally less worrisome when taken as an inhalant or nasal spray.

Cautions

Many of budesonide’s side effects can exacerbate existing medical conditions. Budesonide isn’t necessarily prohibited, but it may require dose adjustments or careful monitoring by a healthcare professional. These conditions include:

• Weakened immune system
• Diabetes (or a family history of diabetes)
• High blood pressure
• High pressure in the eye
• High fluid pressure in the skull
• Active infections
• Active chickenpox, shingles, or measles infections or exposure to measles or varicella
• A past tuberculosis infection
• Osteoporosis 
• Malnutrition
• Cataracts
• Glaucoma (or a family history of glaucoma)
• Gastrointestinal perforation
• Ulcers
• Nasal trauma, surgery, sores, or perforation
• Myasthenia gravis
• Seizure disorders
• Cushing’s syndrome

Abuse

Budesonide is not associated with drug abuse.  

Dependence and withdrawal

Like all corticosteroids, budesonide reduces or suppresses the body’s natural production of the hormone cortisol. This disrupts an entire complex of hormone production in the body. For this reason, the sudden discontinuation of budesonide or any other corticosteroid can produce unpleasant side effects like tiredness, weakness, muscle pain, nausea, headaches, dizziness, blurred vision, loss of appetite, weight loss, and other problems. When it’s time to stop taking budesonide, the doses should be tapered gradually.

Overdose

If too much budesonide is taken at one time, call a poison control center or get medical attention. 

Budesonide interactions

Budesonide has many different and powerful effects on the body, so it interacts with a number of prescription drugs, over-the-counter medications, and even dietary supplements. The list is very long, but the most important are:

• Live vaccines. Budesonide is prohibited in anyone getting a live vaccine. Budesonide suppresses the immune systems, so vaccines containing weakened bacteria or viruses could potentially blow up into active and life-threatening infections.

• Vaccines. Other vaccines are safe, but because budesonide weakens the immune system, they’re less effective.

• • Immune suppressants. Combining budesonide with immune suppressants weakens the immune system even further, leaving people more vulnerable to infections.
  • Other corticosteroids. Taking more than one corticosteroid increases the risk for side effects, particularly adrenal gland problems.

• Drugs and foods that block the body’s metabolism of budesonide. Some substances tie up the liver enzyme that breaks down budesonide. As a result, budesonide builds up in the blood, increasing the risk for side effects. Healthcare providers are aware of these drugs and will adjust doses accordingly. Grapefruit and grapefruit juice are also in this category, so they should be avoided when taking budesonide.

• Desmopressin. Used to treat frequent urination or bedwetting, desmopressin should never be combined with budesonide because of the risk of low blood sodium. Mifepristone is also contraindicated in anyone taking budesonide.

How to avoid budesonide side effects

Adverse effects are a fact of life when taking corticosteroids, but they’re not entirely unavoidable. Here are a few tips to keep budesonide side effects at arm’s length. 

1. Follow instructions

The first and best rule is to take budesonide exactly as instructed. Don’t take too much. Don’t take doses too frequently. If taking over-the-counter nasal spray, read the drug information carefully and follow all its directions.

2. Tell the prescriber about all medical conditions and medications

Some of budesonide’s most serious side effects involve making existing medical conditions worse. The prescriber should have a complete medical history that includes: 

• Any active infection
• Any past infection with tuberculosis
• Exposure to measles or chickenpox
• A weakened immune system
• Stomach ulcers
• High blood pressure
• Diabetes
• Thyroid problems
• Osteoporosis or low bone mineral density
• Myasthenia gravis
• Liver problems
• Pregnancy or pregnancy plans
• Breastfeeding or any plans to breastfeed

3. Tell the prescriber about all medications being taken

Drug interactions are another common source of trouble when taking budesonide, so make sure the prescriber has a complete picture of all drugs and supplements being taken. When seeing any other healthcare provider, tell them about budesonide before they prescribe another drug.

4. Avoid grapefruit and grapefruit juice

Do not eat grapefruits or drink grapefruit juice throughout the duration of budesonide treatment. Grapefruit could increase the risk and severity of budesonide side effects.

5. Take calcium and vitamin D supplements

To avoid bone loss during prolonged budesonide treatment, take calcium and vitamin D supplements or eat foods rich in these two bone-healthy nutrients.

6. Avoid infections

Because budesonide weakens the immune system, take precautions to avoid getting an infection. Try to avoid people who are sick. Wear a face covering and keep your distance when in public.

7. Rinse out the mouth after taking a puff of budesonide inhalant

To prevent yeast infections of the mouth, rinse out the mouth with water and spit it out shortly after taking a puff of budesonide. 

8. Do not stop taking budesonide

To avoid withdrawal symptoms, do not stop taking budesonide until talking to the prescriber.

How to treat side effects of budesonide

If they do happen, some side effects can be handled at home. Others, however, may require medical attention.

Infection

Contact the prescriber if signs of an infection are noticed. It may be nothing, but because budesonide weakens the immune system, a healthcare professional should be aware of the infection.

Digestive system problems

Contact the prescriber if there’s any evidence of gastrointestinal problems such as stomach pain, black and tarry stools, bloody stools, vomiting, or blood in the vomit.

Hypercorticism

Tell the prescribing healthcare provider if problems emerge due to taking too much budesonide for too long including acne, unwanted hair growth, changes in the face’s shape, unexplained stretch marks on the skin, and easy bruising. The prescriber may need to adjust the dose.

Sources

• Budesonide, Drugs and Lactation Database
• Budesonide, Epocrates
• Budesonide capsule prescribing information, U. S. National Library of Medicine
• Budesonide capsule delayed-release prescribing information, U.S. National Library of Medicine
• Budesonide drug summary, Prescriber’s Digital Reference
• Budesonide inhalation prescribing information, U.S. National Library of Medicine
• Budesonide inhaled, Epocrates 
• Budesonide nasal prescribing information, U.S. National Library of Medicine
• Uceris budesonide aerosol foam prescribing information, U.S. National Library of Medicine

Instructions for use Budesonide-intel aerosol (drops): description, composition, FTG, INN

Content

• Composition
• Description
• Pharmacotherapeutic group
• Pharmacological properties

90 005 Indications for use

• Dosage and administration
• Side effects
• Contraindications
• Precautions
• Pregnancy and lactation
• Influence on the ability to drive vehicles and operate mechanisms
• Overdose
• Interaction with other drugs
• Expiration date
• Storage conditions
• Dispensing conditions
• Packaging

Composition

Each dose (inhalation) contains: the active substance is budesonide 50 micrograms or 200 micrograms. Excipients: Oleic acid, ethanol and 1,1,1,2-tetrafluoroethane (HFA-134a propellant).

Description

White suspension.

Pharmacotherapeutic group

Other inhalation agents for the treatment of obstructive airway diseases. Glucocorticoids. ATX code: R03BA02

Pharmacological properties

Pharmacological and clinical studies have shown that Budesonide has, over a wide dose range, a favorable ratio of local anti-inflammatory activity and systemic side effects of corticosteroids. This is due to the fact that budesonide is rapidly inactivated in the liver after entering the systemic circulation. On the other hand, budesonide has an anti-allergic and anti-inflammatory effect, which is manifested by a decrease in bronchospasm caused by immediate and delayed allergic reactions. Budesonide has also been shown to reduce airway hyperresponsiveness to histamine and methacholine. Pharmacodynamics Local anti-inflammatory effect Budesonide is a non-halogenated corticosteroid effective in the treatment of asthma due to its anti-inflammatory effect. In the course of pharmacological and clinical studies, budesonide has been shown to have, over a wide dose range, a favorable ratio of local anti-inflammatory activity and systemic side effects of corticoids. This is due to the fact that budesonide is rapidly inactivated in the liver after entering the systemic circulation. On the other hand, budesonide has an anti-allergic and anti-inflammatory effect, which is manifested by a decrease in bronchoconstriction caused by immediate and delayed allergic reactions. Airway reactivity Budesonide has also been shown to reduce airway hyperresponsiveness to histamine and methacholine. Pharmacokinetics Oral and inhaled budesonide is rapidly absorbed by the mucosa and lung parenchyma. After inhalation use of budesonide, it can be quickly detected in the blood, which confirms that the drug is absorbed unchanged through the respiratory tract. This high initial plasma concentration also indicates minimal drug metabolism in the lungs. The plasma half-life of unchanged budesonide is 2.0 ± 0.2 hours, which is similar to the value found after intravenous administration of the drug (2.8 ± 1.1 hours). Budesonide undergoes extensive (approximately 90%) biotransformation in the liver, with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites, 6β-hydroxybudesonide and 16ά-hydroxyprednisolone, is less than 1% of the activity of budesonide. The metabolism of budesonide is predominantly mediated by CYP3A4, one of the cytochrome P450 enzymes. Plasma protein binding is 88%. Excretion studies in humans indicate that inhaled ³ H-budesonide is excreted primarily in urine (32%) and faeces (15%). Ketoconazole, given at a dose of 100 mg twice daily, has been found to increase plasma levels of co-administered oral budesonide. Information on such an interaction with the use of inhaled budesonide is not enough, but a pronounced increase in plasma levels can be expected.

Indications for use

Bronchial asthma in the absence of effectiveness as a result of treatment with bronchodilators and / or antiallergic drugs.

Dosage and administration

BUDESONIDE-INTELI is administered by inhalation. A single dose contains 50 micrograms or 200 micrograms of budesonide. Treatment must be individual. The initial dose should always be reduced to the lowest level that provides good control of bronchial asthma. The maximum daily dose for adults is 2000 mcg per day. The daily dose is divided into 2-4 doses. Children aged 2-7 years: 200-400 micrograms daily in divided doses (2-4 doses). Children over 7 years old: 200-800 mcg daily in divided doses (2-4 doses). The maximum daily dose for children is 800 mcg per day. Adults: at the beginning of treatment, during severe asthma attacks and during the period of dose reduction or discontinuation of oral glucocorticosteroids, the adult dose should be 200-1600 micrograms daily, divided into 2-4 doses. The duration of the course of treatment is from 3 to 12 months, depending on the severity of the disease.

Instructions for the correct use of BUDESONIDE-INTELI: 1. Make sure that the aerosol can is properly connected to the plastic adapter. Shake the bottle and remove the cap. 2. Hold the balloon upside down with your thumb and forefinger. Place the mouthpiece in your mouth, clasping it with your lips. 3. Exhale deeply through the nose and immediately then inhale deeply through the mouth, squeezing the balloon between the fingers, releasing one dose. 4. Take the inhaler out of your mouth and hold your breath for a few seconds. Slowly exhale and close the balloon cap. If desired, inhalation chambers may be used to achieve better dose utilization and to facilitate delivery of the drug to the lungs. After each use, the patient should rinse the mouth with water.

Side effects

Clinical studies, literature reports and clinical experience indicate that the following undesirable side effects may occur: Cough Rare (>1/10,000, <1> Anxiety, depression, behavioral problems Immediate and delayed hypersensitivity reactions including rash, urticaria, contact dermatitis, bronchospasm Skin bruising may occur Rarely, inhaled corticosteroids may cause signs or symptoms typical of systemic glucocorticosteroids, including decreased function or atrophy of the adrenal cortex, which may depend on dosage, duration of treatment, concomitant or previous treatment with other glucocorticosteroids. In the appointment, the possibility of paradoxical bronchospasm with increased wheezing should be considered. In this case, it is recommended to immediately interrupt therapy and prescribe an alternative treatment.

Contraindications

Precautions

These drugs should be used with extreme caution in patients with pulmonary tuberculosis, fungal or viral infections of the respiratory tract. *After reviewing available data, EMA confirmed the risk of developing pneumonia with the use of inhaled corticosteroids in patients with COPD. There is currently no correlation between the risk of developing pneumonia and the type of inhaled corticosteroid. There is some evidence for an increased risk of pneumonia with increasing steroid doses, but this has not been convincingly demonstrated in all studies. Patients and professionals need to be vigilant about the signs and symptoms of developing pneumonia, as the clinical manifestations of pneumonia overlap with symptoms of an exacerbation of the underlying disease. Patients should be advised to report any worsening of the underlying disease (in particular, increased difficulty in breathing). The use of inhaled corticosteroids can cause side effects, especially at high doses given for a long time. However, it is much less likely that such reactions will occur during treatment with oral corticosteroids, their occurrence also depends on the patient and on treatment with other corticosteroids. As side effects, the development of Cushing’s syndrome, including a Cushingoid face, suppression of the function of the adrenal cortex, developmental delays in children and adolescents, a decrease in bone mineral density, cataracts, glaucoma, less often psychological abnormalities or behavioral disorders, in particular psychomotor hyperactivity, sleep disorder, anxiety, depression, aggressiveness (especially in children). Therefore, it is recommended to reduce the dose of inhaled corticosteroid to the lowest dose that maintains effective control of bronchial asthma. Patients who previously received systemic corticosteroids for a long time or at high doses may develop symptoms of adrenal suppression. In such patients, adrenal function should be regularly monitored and the dose of systemic corticosteroids should be reduced with caution. Patients not taking corticosteroids: therapeutic effect is usually achieved within 7 days. However, for selected patients with excessive secretion of the bronchial mucosa of the bronchi, a short (about 2 weeks) additional oral corticosteroids may be prescribed initially. Exacerbation of asthma caused by a bacterial infection should be controlled with antibiotic therapy and possible increase in the dose of budesonide or, if necessary, the use of systemic corticosteroids. Patients taking corticosteroids: when switching from oral steroids to budesonide, the patient must be in a relatively stable phase. A high dose of budesonide is used in combination with a previous dose of oral steroid for about 10 days. Thereafter, the oral steroid dose should be gradually reduced (eg, by 2.5 mg prednisolone or equivalent every month) to the lowest possible level. In many cases, it is possible to completely replace the oral steroid with BUDESONIDE-INTELI. Switching from oral corticosteroid treatment to inhaled budesonide should be undertaken with special precautions, mainly because of the slow normalization of the function of the hypothalamic-pituitary-adrenal system, previously impaired by oral administration of corticoids. It may take several months to achieve this normalization. During this replacement of oral steroids, patients may experience initial symptoms (rhinitis, eczema) or may suffer from fatigue, headache, muscle or joint pain, and occasionally nausea and vomiting. In such cases, it is necessary to start additional symptomatic treatment. In patients who have previously used systemic steroids for an extended period of time or at high doses, corticoid-adrenal suppression effects may occur. Corticoid-adrenal function in these patients should be regularly monitored and the dose of systemic steroids should be reduced with caution. These drugs are not intended for the relief of an acute asthma attack. Treatment with budesonide should not be stopped abruptly. Therefore, it is very important that the dose of inhaled corticosteroids be reduced to the lowest dose that maintains effective asthma control. In vivo studies have shown that oral administration of ketoconazole and itraconazole (known inhibitors of CYP3A4 activity in the liver and in the intestinal mucosa) cause an increase in the systemic action of budesonide. Concomitant treatment with ketoconazole and itraconazole or other potent inhibitors of CYP3A4 should be avoided (see section “Interaction with other medicinal products”). If this is not possible, the time interval between the use of interacting drugs should be as long as possible. It is also necessary to consider the possibility of reducing the dose of budesonide. Co-administration of CYP3A inhibitors, including cobicistat-containing drugs, increases the risk of systemic adverse reactions. The combined use of corticosteroids and CYP3A inhibitors should be avoided unless the benefit outweighs the risk of systemic adverse reactions. In such cases, patients should be monitored for signs of systemic adverse reactions. Warning: Use of these drugs by athletes may result in a positive doping test result. The drug contains 0.31% ethanol (alcohol), which corresponds to 0.1535 mg/dose.

Pregnancy and lactation

Pregnancy: the use of budesonide during pregnancy is possible if the benefit to the mother outweighs the possible risk to the fetus. Inhaled glucocorticosteroids are preferred over oral glucocorticosteroids because of fewer systemic effects at doses required to achieve a similar pulmonary response. Breast-feeding period: Budesonide is excreted in breast milk, however, when using the drug in therapeutic doses, no effect on the child was noted. When prescribing budesonide to nursing women, it is necessary to take into account the therapeutic benefit of the drug for the mother in relation to the possible risk to the child.

Influence on the ability to drive vehicles and control mechanisms

Budesonide does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Interaction with other drugs

Expiration date

Storage conditions

Dispensing conditions

Prescription.

Packaging

Aluminum can, equipped with dispenser and mouth adapter, packed in a cardboard box along with instructions for medical use. Registration certificate holder UAB “INTELI GENERICS NORD” Seimyniskiu 3.09312 Vilnius, Lithuania CJSC “INTELI GENERICS NORD” st. Šeiminiškiu 3, 09312 Vilnius, Republic of Lithuania

Manufacturer LABORATORIO ALDO-UNION, S.L. c/Baronesa de Malda. 73 08950 Espluges de Llobregat (Barcelona) Spain LABORATORY ALDO-UNION LTD st. Baronesses de Malda, 73 08950 Esplugues de Lebregat (Barcelona) Spain

Budesonide: Effects, Indications, Side Effects 💊 Medical Journal of Science

• How does budesonide work
• When will Budesonide be used?
• How budesonide is used
• What are the side effects of Budesonide?
• What should I consider when taking budesonide?
• How to get medicines with budesonide
• Since when is Budesonide known?

Active ingredient budesonide It is used to treat asthma, COPD (chronic obstructive pulmonary disease), the common cold and inflammatory bowel disease. As a “soft medicine” it is applied locally, reveals its effect and is quickly destroyed once it enters the bloodstream. Here you can read all the important information about budesonide, side effects and uses.

How budesonide works

The active ingredient budesonide acts as an anti-allergic, so-called glucocorticoid, anti-inflammatory and suppresses the immune system. This is due to the body’s stress hormone cortisol (also popularly called cortisone, but it’s an inactivated form). Budesonide, like cortisol, acts at specific junction points in the cell, where it alters metabolic processes to cope with stressful situations. In the immune system, it suppresses inflammation, in the liver it increases the production of sugar (glucose) and the breakdown of fat to provide the body with energy.

The active ingredient budesonide is designed to be inactivated once it enters the bloodstream. Thus, the side effects of budesonide can be minimized. However, this also means that the drug cannot reach the site of action via the bloodstream – so it should always be applied locally, such as as a nasal spray/inhalation drop, inhalation, enteric capsules, granules, or rectal foam (last for local effect) . in the intestine).

Degradation and excretion of budenoside

Once the agent budesonide enters the bloodstream, it is metabolized in the liver to degradation products with low glucocorticoid activity. After three to four hours, about half of the drug is excreted through the stool (the so-called “half-life”).

When will Budesonide be used?

The active substance budesonide is used in:

• Bronchial asthma
• allergic rhinitis like hay fever
• inflammatory bowel disease (Crohn’s disease, ulcerative colitis)

In principle, treatment is usually carried out over several weeks, but this may differ on an individual basis.

This is how budesonide is used

For respiratory problems, budesonide spray is used once or twice daily by inhalation. The full effect occurs after more than a week of continuous use, so the spray is not suitable for the relief of acute asthmatic complaints. After inhalation, something should always be eaten or drunk, otherwise local suppression of the immune system in the mouth can lead to fungal infections.

There are combination preparations containing budesonide and a long-acting beta-sympathomimetic (eg formoterol). In addition, it relieves asthmatic symptoms by expanding the bronchi, thus helping to improve the exchange of gas in the lungs.

Budesonide nasal spray for allergic rhinitis is available as a suspension and must be shaken before use. The standard dose is usually a twice daily spray in each nostril.

Gastrointestinal capsules or granules are often used in inflammatory bowel disease. The stomach is stable because stomach acid degrades budesonide. Especially if the descending colon is affected, rectal foam or rectal suspension may be used. The application usually occurs once a day for several weeks.

What are the side effects of Budesonide?

Budesonide side effects depend in part on the route of administration:

During inhalation and nasal sprays, side effects are common, such as fungal infections in the oropharynx, hoarseness, cough, epistaxis, and irritation of the pharynx and oral mucosa (i.e. one in ten or the 100th person being treated).

Common side effects from intestinal exposure include: upset stomach, muscle cramps, palpitations, nervousness, mood swings, blurred vision, skin reactions, low blood potassium levels, edema, and fat distribution disorders.

What should be considered when taking budesonide?

Degradation of the active ingredient budesonide in the liver is achieved by an enzyme system that also degrades many other drugs (CYP3A4 enzyme). Therefore, combination with other agents that inhibit or stimulate this enzyme may increase or decrease budesonide levels. Said active ingredients include, for example, the antifungal agents ketoconazole and itraconazole, the immune inhibitor cyclosporine (for autoimmune diseases and after transplantation), ethinyl estradiol and other estrogens (female sex hormones), and the antibiotic rifampicin. If the medicine is known to the doctor, he can adjust the dosage of budesonide accordingly.

Because budesonide is placental and passes into breast milk, pregnant and lactating mothers should not take this drug. Marketed medicines are approved for use by children over 6 years of age (nasal spray and inhalers) or by adults over 18 years of age (for inflammatory bowel disease).

In patients with severe liver disease, degradation of budesonide may be inhibited. Therefore, a dose reduction may be required.

How to get medicines with budesonide

Every medicine containing the active substance budesonide is subject to a prescription in Germany.

Since when is Budesonide known?

In 1855, the scientist Thomas Addison described a hormone deficiency that could be treated with an extract of the adrenal cortex. This contained how, in 1936, researchers Kendall and Reichstein discovered the glucocorticoid cortisol. It was first synthesized synthetically in a laboratory in 1948, allowing the structure to be modified to alter and improve its properties. For active ingredient budesonide Deliberately added “tipping point” that works as soon as the active ingredient leaves the site of action.

FAQ – 💬

👉 Budesonide, which is vibrating, building hormone receptor complex, as a result of the development of the antiseptic drug. The ability of budesonide to be formulated with fatty acid conjugates explains the mechanism of the increased type of muscle antiseptic activity and the high level of therapeutic efficacy of the drug.

👉 For patients with chronic obstructive pulmonary disease (COPD), the dose of Budesonide is selected individually based on the severity of the disease.