Budesonide is used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract,

causing pain, diarrhea, weight loss, and fever). Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn's disease.

How should this medicine be used?

Budesonide comes as a capsule to take by mouth. It is usually taken once a day in the morning. Take budesonide at around the same time every day. Your doctor will tell you how long to take budesonide. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take budesonide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole; do not split, chew, or crush them. If you are unable to swallow the capsules whole, talk to your doctor. Budesonide may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well budesonide works for you. If your symptoms are controlled, your doctor may decrease your dose of budesonide. After your symptoms have been controlled for 3 months, your doctor may slowly decrease your dose and then stop treating you with this medication. It is important to tell your doctor how you are feeling during your treatment. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

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This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

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Before taking budesonide,

tell your doctor and pharmacist if you are allergic to budesonide, or any other medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: clarithromycin, erythromycin, ketoconazole, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, and telithromycin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with budesonide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. tell your doctor if you or anyone in your family has had diabetes (high blood sugar) or glaucoma, or if you have tuberculosis, high blood pressure, osteoporosis (a condition in which the bones become thin and weak and break easily), stomach ulcer, cataracts, or liver disease. tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, or are breast-feeding. If you become pregnant while taking budesonide, call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide. tell your doctor if you have never had chicken pox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chicken pox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.

What special dietary instructions should I follow?

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Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do if I forget a dose?

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Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

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Budesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
headache dizziness runny nose, sneezing, coughing nausea indigestion abdominal pain gas vomiting fatigue back pain pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
itching skin rash fever swelling of face and neck difficulty breathing severe headache changes in vision acne bruising

Budesonide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication or if your symptoms get worse. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

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Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
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In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

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Keep all appointments with your doctor. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking budesonide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Budesonide is a glucocorticoid steroid for the treatment of asthma and noninfectiousrhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease). It is marketed by AstraZeneca as a nasal inhalant under the brand name Rhinocort (in Denmark, as Rhinosol), as an oral inhalant under the brand name Pulmicort (in Israel,Budicort), and as either an enema or a modified-release oral capsule under the brand name Entocort. It is also sold in combination with formoterol (Oxis) in a single inhaler, under the brand name Symbicort. In Brazil it is marketed by Eurofarma under the brand name Noex. Entocort EC is an oral capsule marketed in the United States by Prometheus Laboratories. A new formulation is in clinical trials for ulcerative colitis. [edit]Pharmacology Budesonide has a high first-pass metabolism. It has efficacy in the terminal ileum and the right colon. Budesonide in comparison with prednisolone has been associated with fewer bone density losses, and, unlike other corticosteroids, has little influence on the hypothalamic-pituitary-adrenal axis, which also [citation needed] limits the need of tapering before discontinuation. Overall, it has a lower incidence of systemic manifestations than similar medications. [edit]Side-effects Budesonide may cause:
[3] [2] [1]

nose irritation or burning bleeding or sores in the nose lightheadedness upset stomach cough hoarseness dry mouth rash sore throat bad taste in mouth change in mucus color

muscle cramps

In addition, the following symptoms should be reported immediately: difficulty breathing or swelling of the face white patches in the throat, mouth, or nose irregular menstrual periods severe acne on rare occasions, behavioral changes when these do occur, they seem to mostly affect children This medication is used to treat a flare/attack of a bowel condition called Crohn'sdisease.
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 provided by your pharmacist before you start using budesonide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once daily before your morning meal, or as directed by your doctor. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can keep the drug from being released properly into the colon and may increase 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 being treated with this medication unless your doctor instructs you otherwise. Grapefruit may increase the amount of certain medications in your body. Consult 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. You may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain,headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are taking budesonide. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. 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.

SE
Budesonide capsules usually have 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 immediately 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 invaginal discharge. Tell your doctor immediately if any of these rare but serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hairgrowth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing. 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.

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 immediately 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). 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, budesonide should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness. This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breast-feeding. Indications Dosage Listed in Dosage. Adult: PO Inflammatory bowel disease Active: 9 mg/day, up to 8 wk. Maintenance: 6 mg once daily, up to 3 mth. Inhalation Asthma As metered dose inhaler: 400 mcg/day in 2 divided doses, up to 1.6 mg/day in severe cases. Maintenance: 200-400 mcg/day. As dry powd inhaler: 200-800 mcg/day. As nebulised soln: Inhale 1-2 mg twice daily. Maintenance: 0.5-1 mg twice daily. Nasal Prophylaxis and treatment of rhinitis Initial: 200 mcg into each nostril daily, may reduce to 100 mcg into each nostril daily until symptoms are controlled. Nasal polyps 100 mcg twice daily into each nostril for up to 3 mth. Click to view budesonide Dosage by Indications Should be taken with food. (Swallow whole, do not chew/crush. Avoid grapefruit juice.) Hypersensitivity. Acute infections uncontrolled by antimicrobial chemotherapy. Active or doubtfully quiescent tuberculosis, paradoxical bronchospasm; children, elderly; pregnancy, lactation. Loss of skin collagen and SC atrophy; local hypopigmentation of deeply pigmented skin; dryness, irritation, epistaxis, rarely ulceration or perforation of the nasal septum; smell and taste disturbances; hoarseness and candidiasis of the mouth or throat.

Administration Contraindications Special Precautions

Adverse Drug Reactions

Pregnancy Category (US FDA)

ROUTE(S) : Inhalation / Nasal

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies st in women in the 1 trimester (and there is no evidence of a risk in later trimesters).

ROUTE(S) : Oral / Rectal

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Mechanism of Action For details of the mechanism of action, pharmacology and pharmacokinetics and toxicology ... click to view budesonide Corticosteroid Hormones / Nasal Decongestants & Other Nasal Preparations / Antiasthmatic & COPD Preparations R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids. D07AC09 - budesonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis. A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.

MIMS Class

ATC Classification