Dr Falk


DCH Auriga
Concise Prescribing Info
Mild to moderate active Crohn's disease affecting the ileum &/or the ascending colon. Non-cirrhotic active autoimmune hepatitis. Induction of remission in patients w/ active collagenous colitis.
Dosage/Direction for Use
Adult >18 yr Crohn's disease 3 cap once daily in the morning or 1 cap tds for 8 wk. Collagenous colitis 3 cap once daily in the morning for 8 wk. Autoimmune hepatitis Induction of remission: 1 cap tds. Maintenance of remission: 1 cap bd, may increase to 3 cap daily if ALT &/or AST increased during treatment.
Should be taken on an empty stomach: Take at least 30 min before meals.
Hypersensitivity. Hepatic cirrhosis.
Special Precautions
Transfer from other glucocorticosteroid therapy may result in symptoms relating to change in systemic steroid levels. Close medical supervision in patients w/ TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal), glaucoma, cataract, family history of diabetes or glaucoma. Patients w/ Crohn's disease of the upper GI tract. Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma & a wide range of psychiatric/behavioural effects may occur at high doses & for prolonged periods. Regularly perform bone mineral density measurements on patients who are on budesonide for >6 mth. Increased susceptibility & severity to infections; may mask atypical & serious infections (eg, sepsis & TB). Avoid close personal contact w/ chickenpox or shingles for patients w/o history of disease; measles. Do not give live vaccines to persons w/ chronic glucocorticosteroid use. Patients w/ late stage primary biliary & hepatic cirrhosis. Possible visual disturbances; consider referral to an ophthalmologist if patient presents w/ symptoms (eg, blurred vision). Can suppress the response of the hypothalamo-pituitary adrenal axis to stress; supplementary systemic glucocorticoid should be given to patients undergoing surgery or other stresses. Avoid concomitant treatment w/ ketoconazole or other CYP3A inhibitors. Patients w/ rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, sucrase isomaltase insufficiency or glucose galactose malabsorption. Regularly monitor ALT & AST levels every 2 wk for the 1st mth of treatment & at least every 3 mth thereafter in patients w/ autoimmune hepatitis. Severe hepatic dysfunction. Pregnancy & lactation. Childn & adolescent 12-18 yr.
Adverse Reactions
Cushing's syndrome (eg, moon face), truncal obesity, reduced glucose tolerance, DM, HTN, Na retention w/ oedema, increased K excretion, inactivity or atrophy of the adrenal cortex, red striae, steroid acne, disturbance of sex hormone secretion (eg, amenorrhoea, hirsutism, impotence); dyspepsia; increased risk of infection; muscle & joint pain, muscle weakness & twitching, osteoporosis; headache; depression, irritability, euphoria; allergic exanthema, petechiae, delayed wound healing, contact dermatitis.
Drug Interactions
May potentiate action of cardiac glycosides by K deficiency. May enhance K excretion w/ saluretics. Increased risk of systemic side-effects w/ CYP3A inhibitors including cobicistat-containing products. Increased plasma conc w/ ketoconazole; other potent CYP3A4 inhibitors (eg, ritonavir, itraconazole, clarithromycin) & grapefruit juice. May reduce systemic & local exposure at the intestinal mucosa w/ CYP3A inductors (eg, carbamazepine & rifampicin). Increased plasma conc w/ CYP3A substrates (eg, ethinylestradiol). Elevated plasma conc & enhanced glucocorticosteroid effect w/ estrogens or OCs. Effect may be reduced if given at the same time w/ steroid-binding synthetic resins (eg, colestyramine & antacids). Possible false results (low values) on ACTH stimulation test for diagnosing pituitary insufficiency.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Budenofalk cap 3 mg
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