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Budesonide tablets side effects: Budesonide (Oral Route) Side Effects

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Budesonide (Oral Route) Side Effects

Side Effects

Drug information provided by: IBM Micromedex

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Bruising easily

  2. chills

  3. colds

  4. cough

  5. diarrhea

  6. fever

  7. general feeling of discomfort or illness

  8. headache

  9. hoarseness

  10. joint pain

  11. loss of appetite

  12. muscle aches and pains

  13. nausea

  14. runny nose

  15. shivering

  16. sneezing

  17. sore throat

  18. sweating

  19. trouble sleeping

  20. unusual tiredness or weakness

  21. vomiting
Less common

  1. Bladder pain

  2. bleeding after defecation

  3. blistering, crusting, irritation, itching, or reddening of the skin

  4. bloody or cloudy urine

  5. blurred vision

  6. burning feeling while urinating

  7. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

  8. changes in vision

  9. chest pain

  10. cough producing mucus

  11. decreased urine

  12. diarrhea

  13. difficult or labored breathing

  14. difficult or painful urination

  15. dizziness

  16. dry mouth

  17. eye pain

  18. fast, irregular, pounding, or racing heartbeat or pulse

  19. feeling of warmth

  20. heartburn

  21. increase in body movements

  22. increased thirst

  23. increased urge to urinate during the night

  24. irregular heartbeat

  25. lower back or side pain

  26. mood changes

  27. nervousness

  28. pain or discomfort in the chest, upper stomach, or throat

  29. pinpoint red or purple spots on the skin

  30. pounding in the ears

  31. rectal bleeding

  32. redness of the face, neck, arms, and occasionally, upper chest

  33. seizures

  34. severe constipation

  35. shakiness in the legs, arms, hands, or feet

  36. shivering

  37. skin rash, encrusted, scaly, and oozing

  38. slow or fast heartbeat

  39. stomach cramps or pain

  40. sweating

  41. swelling of the legs and feet

  42. swelling or puffiness of the face

  43. tightness in the chest

  44. trouble sleeping

  45. uncomfortable swelling around the anus

  46. upper abdominal or stomach pain

  47. waking to urinate at night

  48. weight gain or loss
Incidence not known

  1. Bulging soft spot on the head of an infant

  2. change in the ability to see colors, especially blue or yellow

  3. difficulty with swallowing

  4. hives, itching, or skin rash

  5. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Belching

  2. blemishes on the skin

  3. heartburn

  4. indigestion

  5. pain or tenderness around the eyes and cheekbones

  6. pimples

  7. rounded or moon face

  8. stomach discomfort or upset

  9. stuffy nose
Less common

  1. Accumulation of pus

  2. agitation

  3. bloated or full feeling

  4. change in hearing

  5. cracked, dry, or scaly skin

  6. cracks in the skin at the corners of mouth

  7. difficulty having a bowel movement

  8. difficulty with moving

  9. dizziness or lightheadedness

  10. ear drainage

  11. earache or pain in the ear

  12. excess air or gas in the stomach or bowels

  13. feeling of constant movement of self or surroundings

  14. hair loss or thinning of the hair

  15. increased appetite

  16. increased hair growth, especially on the face

  17. lack or loss of strength

  18. loss of memory

  19. muscle stiffness

  20. nervousness

  21. pain, swelling, or redness in the joints

  22. passing gas

  23. pressure in the stomach

  24. problems with memory

  25. redness, swelling, or soreness of the tongue

  26. sensation of spinning

  27. sleepiness or unusual drowsiness

  28. soreness or redness around the fingernails and toenails

  29. swelling of the abdominal or stomach area

  30. swollen joints

  31. uterine bleeding between menstrual periods

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

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

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Budesonide – Oral | HealthLink BC

Pronunciation: bue-DES-oh-nide

Common Brand Name(s): Entocort

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to treat certain bowel conditions (such as Crohn’s disease, ulcerative colitis). While budesonide does not cure these conditions, 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

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). Do not crush or chew. Doing so can release all of the drug at once, increasing the risk of side effects.

If you are using the extended-release tablets, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you are using the delayed-release or extended-release capsules and have trouble swallowing them whole, tell your doctor or pharmacist. Some brands may be opened and the contents sprinkled onto a spoonful of soft, cool applesauce in a clean container. Stir and take all of the drug/food mixture within 30 minutes. Do not chew the mixture. Then drink a full glass of cool water (8 ounces/240 milliliters) to make sure you have swallowed all of the dose. Do not prepare a supply ahead of time. Ask your pharmacist if you have questions about your brand.

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

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 and exactly as prescribed in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed because this may increase your risk of serious side effects.

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.

Inform your doctor if your condition persists or worsens.

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, heartburn, and headache, may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge.

Tell your doctor right away if any of these rare but serious side effects occur:

  • unusual tiredness
  • vision problems
  • easy bruising/bleeding
  • puffy face
  • unusual hair growth
  • mental/mood changes (such as depression, mood swings, agitation)
  • muscle weakness/pain
  • bone pain
  • thinning skin
  • slow wound healing
  • 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, seek immediate medical attention if you notice any symptoms of a serious allergic reaction:

  • 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 disease (such as cataracts, glaucoma)
  • high blood pressure
  • liver disease
  • thyroid problems
  • diabetes
  • stomach/intestinal problems (such as diverticulitis, ulcer)
  • brittle bones (osteoporosis)
  • current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal)
  • bleeding problems
  • mental/mood conditions (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. Therefore, 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 may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. 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 persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

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

Drug 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 include:

  • 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 at dosages of 81-325 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). Make sure laboratory personnel and all your doctors know you use this drug.

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.

Notes

Do not share this medication with others.

If this medication is used for an extended time, laboratory and/or medical tests (such as blood count, bone density tests, eye exams, height/weight measurements) should be performed regularly to check for side effects. Consult your doctor for more details.

This medication may cause bone problems (osteoporosis). Lifestyle changes that may help reduce the risk of bone problems while taking this drug for an extended time include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.

Missed Dose

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.

Storage

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.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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 capsules and granules. Uses and side effects

About budesonide

Type of medicine A corticosteroid, also commonly called an oral steroid
Used for Inflammatory bowel disease such as Crohn’s disease or ulcerative colitis; chronic diarrhoea due to collagenous colitis; autoimmune hepatitis
Also called Budenofalk®; Entocort® CR; Cortiment®
Available as Capsules, modified-release capsules, modified-release tablets, and granules

Budesonide works by reducing inflammation, and this eases the symptoms of flare-ups of inflammatory bowel conditions.

Crohn’s disease is a condition which causes inflammation in the gastrointestinal system. Any part of the system can be affected, although the most common site for the disease to start is the lower part of the small intestine, called the ileum. Other parts of the small intestine and the colon are also commonly affected. When the disease flares up, the inflammation causes varying symptoms depending on which part of the gastrointestinal system is affected. Common symptoms are pain, diarrhoea, weight loss and ulcers.

Ulcerative colitis causes inflammation of the large intestine, which leads to problems such as ulceration and bleeding. This causes symptoms such as tummy (abdominal) pain and diarrhoea.

A brand of budesonide called Budenofalk® is used to treat some other conditions associated with inflammation too. It is a treatment for a type of chronic liver inflammation known as autoimmune hepatitis, and it also reduces diarrhoea caused by a chronic inflammatory condition of the large bowel (called collagenous colitis).

There are a number of different budesonide preparations and brands. The way the manufacturers make each of these differs slightly; this allows the different brands to release budesonide in specific areas of the intestine. You will be prescribed the brand that allows budesonide to be released in the part of your intestine which requires it most.

Before taking budesonide

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking budesonide it is important that your doctor knows:

  • If you are pregnant or breastfeeding (even though budesonide could still be prescribed for you).
  • If you have any kind of infection, or if you have ever had tuberculosis (TB).
  • If you have had a heart attack, or if you have a heart condition.
  • If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work.
  • If you have diabetes (diabetes mellitus), or if you have an eye condition called glaucoma. You should also tell your doctor if a close member of your family has either of these conditions.
  • If you currently have any of the following conditions: high blood pressure, osteoporosis, diverticulitis, an underactive thyroid gland, epilepsy, cataracts, or a condition causing severe muscle weakness (called myasthenia gravis).
  • If you have ever had any of the following: a blood clot in a blood vessel, a stomach ulcer, or a mental health problem such as depression or psychosis.
  • If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine, or if you have ever developed muscle pain after taking a steroid medicine.

How to take budesonide

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about budesonide, and will also provide you with a full list of the side-effects which you could experience from taking it.
  • Your doctor will tell you how to take budesonide and this information will also be printed on the label of the pack to remind you about what the doctor said to you. It is important that you take your doses exactly as your doctor tells you to. The following doses are intended as a guide only:
    • If you have been given Budenofalk® capsules, the usual dose is one capsule three times daily, 30-60 minutes before a meal, or alternatively, three capsules taken together in the morning before breakfast.
    • If you have been given Entocort® capsules, the usual dose is three capsules taken together in the morning, preferably before breakfast. Swallow the capsules with a drink of water.
    • Budenofalk® granules are taken as a single dose of one sachet in the morning, 30-60 minutes before breakfast. Place the granules on your tongue and swallow them with a drink of water. Do not chew the granules as you swallow.
    • If you have been given Cortiment® tablets, the usual dose is one tablet in the morning. Swallow the tablet with a drink of water. It can be taken with or without food.
  • Do not take antacids or indigestion remedies during the two hours before and the two hours after you take budesonide. This is because antacids could affect the way the medicine is released and could stop it from getting to the correct part of your bowel.
  • Try to take your doses at the same time(s) of day each day. Doing this will help you to remember to take budesonide regularly. If you do forget to take a dose, take it as soon as you remember (unless it is nearly time for your next dose, in which case leave out the missed dose). Do not take two doses together to make up for a forgotten dose.
  • Continue to take budesonide until your doctor tells you to stop. It is usual to be prescribed a course of treatment that lasts for up to eight weeks. Your doctor may ask you to reduce your dose gradually during the last couple of weeks of the course.

Getting the most from your treatment

  • You will be given a ‘steroid treatment card’ which says that you are on steroids and which contains some important advice for you. It is important that you read this card and carry it with you while you are taking budesonide. It contains details about your dose, how long you have been taking a steroid for, and who prescribed it for you. Please make sure that this information is kept up to date. If you are having an operation or any medical treatment, please tell the person carrying out the treatment that you are taking budesonide and show them your treatment card.
  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. You may need to have some blood tests from time to time.
  • Budesonide can suppress your immune system, so it is important if you become ill that you make an appointment to see your doctor straightaway. Also, if you come into contact with anyone who has measles, shingles or chickenpox (or who suspects they may have one of these viruses), you must see your doctor as soon as possible.
  • It is recommended that you do not drink grapefruit juice while you are on budesonide. This is because a chemical in grapefruit increases the amount of budesonide in your bloodstream. This makes side-effects more likely.
  • If you buy any medicines, check with a pharmacist that they are suitable to take with budesonide.
  • Some vaccines may not be suitable for you while you are being treated with budesonide. If you need any immunisations, make sure you mention that you are taking a steroid medicine.
  • Do not stop taking budesonide without speaking with your doctor first. This is particularly important if you have been taking budesonide for more than three weeks. Your doctor will want you to reduce your dose gradually when this is necessary, as stopping suddenly can lead to problems. 

Can budesonide cause problems?

Along with its useful effects, budesonide can cause unwanted side-effects which your doctor will discuss with you. The benefits of taking budesonide usually outweigh the side-effects; however, they can sometimes be troublesome. Although not everyone experiences side-effects, and some will improve as your body adjusts to the new medicine, speak with your doctor or pharmacist if you become concerned about any of the following:

Common budesonide side-effects What can I do if I experience this?
Tummy (abdominal) pain, feeling sick (nausea), indigestion Stick to simple or bland foods – avoid fatty or spicy foods
Changes in behaviour or mood If you become anxious, confused, or start having worrying thoughts about harming yourself, speak with your doctor as soon as possible
Feeling tired If this becomes troublesome, speak with your doctor
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
Cold or flu-like symptoms, other infections Speak with your doctor about this, especially if you have been in contact with someone with chickenpox, measles or shingles
Blurred eyesight, muscle cramps, itchy skin rash, heavy or irregular periods, the sensation of having a ‘thumping heart’ (palpitations), problems sleeping (insomnia) If any of these become troublesome, speak with your doctor

For more information about side-effects which can develop when steroids are taken longer-term, please see the separate leaflet called Oral Steroids.

If you experience any other symptoms which you think may be due to budesonide, speak with your doctor or pharmacist for further advice.

How to store budesonide

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Budesonide (Systemic): Pediatric Medication | Memorial Sloan Kettering Cancer Center

This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Entocort EC; Ortikos; Uceris

Brand Names: Canada

Cortiment; Entocort; Jorveza

What is this drug used for?

  • It is used to treat Crohn’s disease.
  • It is used to treat ulcerative colitis.
  • It may be given to your child for other reasons. Talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
  • If your child has liver disease.
  • If your child is taking any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
  • Check your child’s blood sugar as you have been told by the doctor.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
  • This drug may lower how much natural steroid is in your child’s body. If your child has a fever, an infection, surgery, or is hurt, talk with the doctor. Your child may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Carry a warning card saying that there may be times when your child needs extra steroids.
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Your child may need to have a bone density test. Talk with the doctor.
  • Have your child’s eye pressure checked if your child is on this drug for a long time. Talk with the doctor.
  • Avoid giving your child grapefruit and grapefruit juice.
  • Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • Tell the doctor if your child has missed a dose or recently stopped this drug and feels very tired, weak, or shaky, or has a fast heartbeat, confusion, sweating, or dizziness.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

If your child is pregnant or breast-feeding a baby:

  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Any unexplained bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • A fatty pad or hump between the shoulders.
  • Round face.
  • Swelling of the ankles.
  • Bone pain.
  • Change in eyesight.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

  • Headache.
  • Signs of a common cold.
  • Constipation, diarrhea, stomach pain, upset stomach, or throwing up.
  • Heartburn.
  • Gas.
  • Feeling dizzy, tired, or weak.
  • Back pain.
  • Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All products:

  • Give in the morning if giving once a day.
  • Give this drug with or without food.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.

Extended-release tablets:

  • Have your child swallow whole. Do not let your child chew, break, or crush.

Extended-release capsules:

  • Have your child swallow whole. Do not let your child chew or crush.
  • Some products may be opened and sprinkled on a spoonful of applesauce. Some products must be swallowed whole. Check with your pharmacist to see if you can open this product.

What do I do if my child misses a dose?

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www. wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2020-06-04

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

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:

Cortiment – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Budesonide belongs to the class of medications called corticosteroids. Budesonide capsules are used to treat mild-to-moderate Crohn’s disease, an inflammatory disease of the bowel. It works by decreasing inflammation in the intestine and colon.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white-to-off-white, round, double-convex tablet with a film coating and “MX9” engraved on one side of the tablet contains 9 mg of budesonide. Nonmedicinal ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose monohydrate, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethylcitrate, and titanium dioxide.

How should I use this medication?

The recommended adult dose to treat a flare-up of Crohn’s disease is 9 mg taken once daily in the morning, preferably after breakfast, for up to 8 weeks.

Finish all this medication, even if you have started to feel better.

The capsules should be swallowed whole with water and not chewed, broken, or crushed before being swallowed. People who are taking this medication should avoid drinking grapefruit juice or eating grapefruit on a regular basis. Grapefruit may increase the amount of budesonide that stays in the body and increase the risk of side effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to budesonide or any ingredients of the medication
  • are allergic to soya
  • have a bacterial, fungal or viral infection
  • have active tuberculosis

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • back pain
  • blurred vision
  • dizziness
  • dry mouth
  • fatigue
  • headache
  • feeling faint
  • muscle cramps
  • muscle weakness
  • stomach bloating or gas
  • trouble sleeping

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • decreased bone strength (e.g., bone pain or fractures)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • mood swings
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • palpitations (fast or pounding heartbeat)                   
  • signs of effects on the adrenal gland (decreased natural glucocorticoid production)
    • fatty pad between the shoulders
    • filling or rounding out of the face
    • menstrual problems
    • thinning skin
    • unusual increase in hair growth
  • swelling feet or lower legs
  • symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
  • wounds that will not heal

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Corticosteroids: Inform all of your doctors if you have recently taken or are taking corticosteroids.

Diabetes: Corticosteroids such as budesonide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of high blood sugar, such as excessive thirst, a fruity odour to your breath, frequent urination, or increased infections, contact your doctor.

High blood pressure: Corticosteroids can cause buildup of fluid in the body, which can increase the work necessary for the heart to pump the blood around the body. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Illness and surgery: People who take this medication, or have taken other corticosteroids (e.g., prednisone) in the last several months, may need additional corticosteroids (e.g., prednisone) during times of any unusual stress, such as trauma, surgery, or infection.

Infections: When taken by mouth, this medication may mask some signs of infection and put people at increased risk for new infections. Viral infections such as chickenpox, measles, or herpes can be more serious and possibly fatal for people who are taking budesonide. Adults who have not had these diseases should try to avoid exposure to individuals with these infections.

Galactose intolerance: This medication is prepared with lactose. If you have lactose or galactose intolerance you should not take these medications.

Liver problems: Decreased liver function or liver disease can cause this medication to build up in the body, increasing the possibility of side effects. If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health: Corticosteroids appear to make behavior and thought disturbances worse for people who have psychotic conditions. They may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Corticosteroids such as budesonide can cause muscle wasting, decreasing muscle. People with myasthenia gravis should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Osteoporosis: Long-term use of corticosteroids may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use this medication for a long period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.

Steroid medication use: If you have recently taken or are still taking a different oral steroid medication (e.g., prednisone), consult your doctor before using this medication. If you experience symptoms such as tiredness, headache, nausea, or vomiting while taking this medication, contact your doctor. This may be a sign of withdrawal from the previous corticosteroid.

Stomach and intestinal problems: When taken by mouth, budesonide may cause heartburn or even stomach ulcers. Tell your doctor if you have had any stomach discomfort or signs of bleeding in the stomach (black, tarry stools). If you have certain stomach and intestinal problems (e.g., blockage, infection), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Budesonide can increase the risk of developing cataracts or glaucoma. If you have glaucoma or cataracts, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience changes in your vision while taking budesonide, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Budesonide passes into breast milk. If you are a breast-feeding mother and are taking budesonide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between budesonide delayed release and any of the following:

  • abiraterone acetate
  • aldesleukin
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • amiodarone
  • aprepitant
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • BCG
  • bicalutamide
  • boceprevir
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cholestyramine
  • colestipol
  • conivaptan
  • crizotinib
  • cyclosporine
  • dasatinib
  • deferasirox
  • denosumab
  • desipramine
  • dronedarone
  • echinacea
  • fingolimod
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hyaluronidase
  • imatinib
  • leflunomide
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • metronidazole
  • natalizumab
  • nefazodone
  • nivolumab
  • norfloxacin
  • pimecrolimus
  • roflumilast
  • sertraline
  • simeprevir
  • sitaxentan
  • tacrolimus
  • telaprevir
  • tetracycline
  • trastuzumab
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Cortiment

90,000 Budesonide for the treatment of people with active Crohn’s disease

What is Crohn’s disease?
Crohn’s disease is a debilitating, long-term (chronic) inflammatory bowel disease that can affect any part of the gastrointestinal tract from the mouth to the anus. Symptoms include abdominal pain, non-bloody diarrhea, and weight loss. The most common starting treatment for Crohn’s disease is oral steroid therapy. Unfortunately, traditional steroids are usually absorbed into the body and cause significant unwanted side effects.These can include (but are not limited to) weight gain, diabetes, stunted growth, acne (acne), mood instability, and high blood pressure. When people with Crohn’s disease experience symptoms of the disease, it is called the “active” stage of the disease; the period when symptoms stop is called “remission”.

What is budesonide?
Budesonide is a steroid that is rapidly metabolized by the liver, thereby reducing corticosteroid-related side effects.

What did the researchers learn?
Researchers have studied whether the use of budesonide leads to remission in people with active Crohn’s disease; and whether these medications cause any harm (side effects). Researchers searched the medical literature up to June 12, 2014.

What did the researchers find?
Researchers identified 14 studies that included a total of 1805 participants.Nine studies (779 participants) compared budesonide to conventional corticosteroids, three studies (535 participants) compared budesonide to a placebo (such as a sugar pill), and two studies (491 participants) compared budesonide to mesalamine (an anti-inflammatory drug composed of 5-aminosalicylic acid ). Ten studies were rated as high quality. The quality of four studies was rated as low.

Budesonide was superior to placebo for induction of remission.There was no increase in side effects when comparing budesonide and placebo. Withdrawal from the study due to worsening disease was similar in the budesonide and placebo groups. Patients taking budesonide were more likely than those taking placebo to develop adrenal suppression, a condition in which the adrenal glands do not produce adequate amounts of steroid hormones.

Budesonide was significantly less effective than conventional steroids in inducing remission in people with Crohn’s disease.However, those treated with budesonide had fewer side effects (compared to traditional steroids) and budesonide was better than traditional steroids in preserving adrenal function.

One study (182 participants) found that budesonide was superior to mesalamine in induction of remission in patients with Crohn’s disease, while another study found no difference in the frequency of achieving remission.

The available evidence does not allow us to draw unambiguous conclusions regarding the effectiveness of budesonide in comparison with 5-aminosalicylic acid products.Budesonide is more effective than placebo in inducing remission of Crohn’s disease. Although budesonide is less effective than traditional steroids for inducing remission, the likelihood of side effects and adrenal suppression is lower than with traditional steroids.

Budesonide Easyhaler instructions for use: indications, contraindications, side effects – description Budesonide Easyhaler powder for inhalation. dosed 200 mcg / 1 dose: inhaler 200 doses (13000)

The method of administration and dosage regimen of a particular drug depends on its form of release and other factors.The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Budenite Steri-Neb is used by inhalation using nebulizer inhalers (see below – “Technique of use”).

Recommended doses of the drug in case of initiation of inhaled GCS therapy in case of severe bronchial asthma , as well as against the background of dose reduction or cancellation of oral GCS for adults (including the elderly) and children over 12 years old – 1-2 mg 2 times / day, maintenance dose – 0.5-4 mg / day; for children from 6 months to 12 years old – 0.25-0.5 mg 2 times / day, maintenance dose – 0.25-2 mg / day. In the event that the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken at one time (at a time).

The maintenance dose must be adjusted individually. When a therapeutic effect is achieved, the maintenance dose must be reduced to the lowest dose at which the patient has no symptoms of the disease: for adults (including the elderly) and children over 12 years old, – 0.5-1 mg 2 times / day; for children from 6 months to 12 years old – 0.25-0.5 mg 2 times / day.

Dose conversion table for patients receiving oral corticosteroids in terms of budesonide

Dose (mg) of budesonide taken orally Budenite Steri-Neb
0.5 mg / 2 ml (0.25 mg / ml)
volume (ml)
Budenite Steri-Neb
1 mg / 2 ml (0.5 mg / ml)
volume (ml)
0.25 1
0.5 2 1
0.75 3
1 4 2
1.5 6 3
2 8 4

If it is necessary to achieve an additional therapeutic effect, it is possible to recommend an increase in the dose of Budenite Steri-Neb instead of a combination with oral corticosteroids (to reduce the risk of developing systemic effects).

With stenosing laryngotracheitis (false croup) children aged 6 months and older The recommended dose is 2 mg / day at a time or in 2 doses of 1 mg with an interval of 30 minutes.

Technique of use

Ultrasonic nebulizers are not suitable for use with Budenite Steri-Neb. The dose required by the patient may vary depending on the nebulizer used. The inhalation time and the dose of the drug depend on the air flow rate, the volume of the nebulizer chamber and the filling volume.Therefore, for inhalation of the drug Budenit Steri-Neb, it is necessary to use an appropriate nebulizer, as well as a mouthpiece and a special face mask. The nebulizer must be connected to an air compressor to create adequate airflow. Before using the medicinal product, you must read the instructions of the manufacturer of the nebulizer.

1. Prepare the nebulizer according to the manufacturer’s instructions.

2. Separate the Steri-Neb (ampoule with sterile solution) from the block by turning and pulling it.

3. Holding the cap vertically upwards, break off the cap.

4. Squeeze the solution into the nebulizer reservoir.

5. Use the nebulizer according to the manufacturer’s instructions.

Rinse your mouth after the end of inhalation. If a mask has been used, it is necessary to rinse the skin of the face.

The solution remaining unused in the nebulizer chamber should be discarded. Wash the nebulizer thoroughly.

When using the drug, avoid contact with the eyes.

instructions for use, dosages, composition, analogs, side effects / Pillintrip

Inhalation. The dose of the drug is selected individually. If the recommended dose does not exceed 1 mg / day, the entire dose of the drug can be taken at one time (at a time). In case of taking a higher dose, it is recommended to divide it into 2 doses.

Recommended starting dose

Children 6 months and older – 0.25-0.5 mg / day. If necessary, the dose can be increased to 1 mg / day.

Adults / elderly patients – 1-2 mg / day.

Dose for maintenance treatment

Children 6 months and older – 0.25–2 mg / day.

Adults – 0.5-4 mg / day. In case of severe exacerbations, the dose may be increased.

Table for dose determination

Dose, mg Preparation volume Pulmicort ® , suspension for inhalation
0.25 mg / ml budesonide 0.5 mg / ml budesonide
0 , 25 1 ml *
0.5 2 ml
0.75 3 ml
1 4 ml 2 ml
1.5 3 ml
2 4 ml

* Should be diluted with 0.9% sodium chloride solution to a volume of 2 ml.

For all patients, it is desirable to determine the minimum effective maintenance dose.

If it is necessary to achieve an additional therapeutic effect, it is possible to recommend an increase in the daily dose of Pulmicort ® (up to 1 mg / day) instead of a combination of the drug with oral corticosteroids, due to the lower risk of developing systemic effects.

Patients receiving oral corticosteroids

Cancellation of oral corticosteroids should be started against the background of a stable patient’s health.Within 10 days, it is necessary to take a high dose of Pulmicort ® while taking oral corticosteroids in the usual dose. In the future, within 1 month, you should gradually reduce the dose of oral corticosteroids (for example, 2.5 mg of prednisolone or its analogue) to the minimum effective dose. In many cases, it is possible to completely abandon the intake of oral corticosteroids.

Since Pulmicort ® , applied as a suspension with a nebulizer, enters the lungs when inhaled, it is important to instruct the patient to inhale the drug through the mouthpiece of the nebulizer calmly and evenly.

There is no data on the use of budesonide in patients with renal insufficiency or with impaired liver function. Taking into account the fact that budesonide is excreted by biotransformation in the liver, an increase in the duration of the drug’s action in patients with severe liver cirrhosis can be expected.

Stenosing laryngotracheitis (false croup)

Children 6 months and older – 2 mg / day. The dose of the drug can be taken 1 time (at a time) or divided into 2 doses of 1 mg with an interval of 30 minutes.

Inhalation, with a nebulizer.

The dosage of the drug should be individualized. Adults: the initial dose is 1-2 mg / day, the maintenance dose is 0.5-4 mg / day. After receiving the effect, the dose is reduced to the lowest effective dose required to maintain a stable state. To achieve a quick therapeutic effect, an increase in the dose is possible.

In the case of taking systemic corticosteroids, it is recommended to transfer to Cortiment treatment using a nebulizer in the stable phase of the disease.For 10-14 days, inhalation and oral corticosteroids are combined at the usual dosage, then the doses of oral corticosteroids are gradually reduced until they are completely canceled.

If necessary, the drug can be diluted with saline to the required volume.

Skin, apply a thin layer of ointment or cream to the affected area 1-2 times a day; with maintenance therapy, it is sufficient to use it once a day. The course is usually no more than 4 weeks.

Intranasal.

Adults and children over 6 years of age: Initially 2 doses of 50 mcg of budesonide in each nasal passage 2 times a day.The usual maintenance dose is 1 dose in each nasal passage 2 times a day or 2 doses in each nasal passage 1 time per day in the morning. The maintenance dose should be the lowest effective dose that relieves the symptoms of rhinitis.

The maximum single dose is 200 mcg (100 mcg in each nasal passage), the maximum daily dose is 400 mcg for no more than 3 months.

Regular and correct application is required for full therapeutic effect.

If a dose is missed, it should be taken as soon as possible, but not less than 1 hour before taking the next regular dose.

Indication for the use of the drug Tafen ® nasal

With the correct use of the drug, its therapeutic effect is fully manifested, and the undesirable effects are less pronounced.

1. Thoroughly clear mucus from the nasal passages, preferably with saline.

2. Remove the dustproof cap from the bottle.

3. Shake the bottle.

4. When using Tafen ® nasal for the first time, release a small amount of the drug into the air by pressing the nozzle several times, while placing the index and middle fingers on the side plates of the bottle and support the bottom with your thumb (the bottle must be in an upright position) …

A small spray of spray will be noticeable.

This procedure must be repeated if the patient has not used the drug for several days. If dried substance has accumulated in the hole of the nozzle, remove the nozzle and rinse it (as described in the Cleaning section).

5. Tilt your head forward and down. With your right hand, insert the nozzle into the left nasal passage towards its outer wall.

6. Press the nozzle, thus releasing the metered dose of the drug, and at the same time inhale through the nose.

7. With your left hand, insert the nozzle into the right nasal passage towards its outer wall, press the nozzle and at the same time inhale through the nose.

8. After using the preparation, wipe the nozzle with a clean cloth and close the bottle with a cap. The bottle should be stored upright and tightly closed.

Cleaning

1. The tip and cap should be cleaned regularly.

2. Carefully remove the nozzle and cap, rinse with warm water and rinse with cold water, allow to air dry.Place the tip carefully in its original place and close the cap.

If dried product has accumulated in the hole, hold the nozzle in a container with warm water and then rinse as described above. Do not use a needle or other sharp object to clean the nozzle hole.

Ito Clinic

Drug therapy

There are three treatments: drug therapy (antithyroid drugs), radioiodine therapy (radioactive iodine), and surgery.First of all, treatment usually begins with drug therapy, and then, depending on factors such as symptoms of the disease, age and social status of the patient, other methods are considered.

Drug therapy

The method of regular intake of drugs to suppress the synthesis of thyroid hormones (antithyroid drugs). There are two types of medicines: Mercazolil Mercazole, Methylthiouracil Thiuragyl (Methylthiouracil and Propylthiouracil Propacil contain the same active ingredient).
Provided the patient takes drugs in a dosage corresponding to his condition, the level of thyroid hormones returns to normal in 1 to 3 months, after which the symptoms disappear, and the patient can lead a normal life.
In drug therapy, it is important to regularly measure thyroid hormone levels and continue to take the medication at the correct dosage for the patient’s condition.
Drug therapy continues for at least 2 years, but in some cases it is necessary to take the drug for a longer period.If normal thyroid function persists for more than 6 months at the lowest dosage of the drug, discontinuation of the medication is considered. Since thyroid hormone levels may rise again (relapse) after medication is stopped, it is important to monitor the condition regularly.
In addition, side effects may appear 2-3 months after the start of therapy, therefore, during this period, it is necessary to visit the hospital every 2 weeks.

【Side effects of taking antithyroid drugs】
(1) Itching, rash
Often occurs 2 to 3 weeks after starting the drug. With a mild degree, continuation of treatment is possible while taking antiallergic drugs. If the manifestations do not stop even when taking antiallergic drugs, as well as with severe lesions, drug treatment should be discontinued.
(2) Liver dysfunction
Often occur 2 weeks to 3 months after starting a drug.There are two types of deviations: an abnormal level of AST (GOT) and ALT (HPT) indicators, reflecting the state of the liver, in the analysis of blood, or symptoms manifested not only in a blood test, but also in the form of jaundice. If AST and ALT levels become too high or if symptoms of jaundice develop, the medication should be discontinued. In the case of mild temporary liver dysfunction, antithyroid drugs can often be continued, but regular check-ups should be done some time after starting.
(3) Agranulocytosis
The state of a decrease in the number of granulocytes (a type of leukocytes), which are an integral part of the blood. Since granulocytes protect the body from bacteria and viruses from outside, a decrease in their number causes intense fever and a sharp sore throat. In many cases, symptoms develop between 2 weeks and 3 months after starting the medication, but they can persist after this period, which requires attention.
Although this is a rare occurrence, occurring in 1-3 patients per 1000 people, it can be fatal, so such symptoms cannot be ignored, attributing to ARVI. If the temperature rises after the start of medication, you should stop taking and conduct a blood test to determine the number of granulocytes.
(4) Other rare side effects
Joint pain: Pain, mainly in the joints of the arms and legs, which have varying localization.
Inflammation of the blood vessels associated with ANCA: occurs mainly with methylthiouracil (propylthiouracil). It can manifest itself only with joint pain or inflammation of the blood vessels in the kidneys and lungs, which can lead to pulmonary and renal failure. May occur several years after starting the drug; therefore, you should be careful during the entire period of taking the drug.

Radioisotope therapy (radioactive iodine)

Iodine from food is captured by the thyroid gland and is used as a raw material for the production of thyroid hormones.Radioactive iodine also has the ability to accumulate in the thyroid gland, and its radioactive radiation reduces the number of thyroid cells and decreases the amount of thyroid hormones produced.
After 2-6 months after taking the radioactive iodine capsule, the thyroid gland decreases, and the secretion of hormones gradually decreases. The effectiveness of treatment varies from patient to patient. In some cases, after treatment, the functioning of the thyroid gland is normalized, and the need for drug treatment disappears, but sometimes hypothyroidism occurs, which requires continuing to take thyroid hormone drugs.
Before and after treatment, you should limit the intake of iodine, as well as stop taking antithyroid and iodine-containing drugs. Since thyroid hormone levels can fluctuate significantly for 4-6 months after treatment, it is necessary to visit the hospital once a month and adjust the dosage of drugs.
Since this method uses radioactive radiation, this treatment is not used for pregnant women, nursing mothers, and patients under 18 years old

【Frequently asked questions about radioisotope therapy】

(1) Since the method uses radioactive radiation, many are concerned about the risk of cancer, but the absence of such a risk is statistically confirmed.In addition, the treatment has no effect on the descendants of patients who have undergone it.

(2) It is reported that 2% of patients undergoing radioisotope treatment have deterioration of endocrine ophthalmopathy, which requires treatment by an ophthalmologist. There is a need to undergo an examination by an ophthalmologist (appointment, MRI) before starting treatment and assess whether the patient’s condition allows receiving radioisotope therapy.

Surgical operation

A method of surgical resection of the thyroid gland secreting excess hormone levels and improving the condition caused by an excess of thyroid hormones.
Previously, a partial resection was performed, leaving part of the thyroid tissue, but due to the high recurrence rate of hyperthyroidism, a total thyroidectomy operation is performed in our hospital, which removes the entire thyroid gland.
It is possible to stop taking antithyroid drugs that lower the level of thyroid hormones the next day after the operation, but there is a need to take drugs of the thyroid hormones themselves. Thyroid hormone medications have no side effects, if the dosage is stabilized, they can be taken for a long time, and thus the number of outpatient visits is also reduced.

【Benefits of total resection】

(1) Low relapse rate.
(2) Normalization of antibodies to the TSH receptor (TRAb) earlier than with partial resection.

Choice of treatment method

Each of the 3 methods has advantages and disadvantages. It is necessary to choose a method of treatment based on well-being, age, social status, etc. Sometimes the condition changes during drug therapy, so the course of treatment changes accordingly.

shown

Drug therapy Radioisotope therapy
(reception of radioactive iodine)
Surgical operation
All age groups
・ Patients able to take medicine regularly
・ Patients with small goiter
* It is necessary to select the drug for pregnant women, lactating and young children.
Patients who are not pregnant, who are not breastfeeding and who do not plan to become pregnant in the near future; patients over 19 years old
・ Patients for whom drugs are ineffective
・ Patients who have side effects from medications
・ For large goiter
・ Patients who hope to get a quick effect from treatment
・ Patients for whom drugs are ineffective
・ Patients who have side effects from medications
・ For large goiter
・ Patients who hope to get a quick effect from
treatment
・ Patients with thyroid tumors
Benefits ・ Opportunity to undergo outpatient treatment
・ Possibility to start treatment on the day of diagnosis
・ Achievement of the treatment result in a shorter time than with drug therapy
・ Low likelihood of side effects and comorbidities
・ Rarity of relapse
・ Achievement of the treatment result in a shorter time than with other methods of therapy
・ Ability to stop taking antithyroid drugs the next day after surgery
・ Rarity of relapse
・ Possibility of obtaining a prescription for long-term use of thyroid hormone preparation
Disadvantages ・ In most cases, it takes some time for the complete cure of the disease.
・ Frequent relapses
・ The likelihood of developing side effects
・ Probability of no effect with 1 course of treatment
・ The period until the discontinuation of antithyroid drugs takes St.1 year.
・ Probability of developing hypothyroidism
The need to stay in a hospital if the patient has a large goiter or complications such as cardiovascular diseases, diabetes, etc., and is also at an advanced age
Rarely there is a possibility of worsening ophthalmic symptoms
・ The appearance of a scar
・ Development of hypothyroidism
・ Probability of postoperative complications
・ Need for hospitalization

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