Budenofalk

Budenofalk

budesonide

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
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 (morning & evening).
Administration
Should be taken on an empty stomach: Take at least 30 min before meals.
Contraindications
Hypersensitivity. Hepatic cirrhosis.
Special Precautions
Visual disturbance. Close medical supervision in patients w/ TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal), glaucoma, cataract; family history of diabetes or glaucoma. Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract & glaucoma & a wide range of psychiatric/behavioural effects. Increased susceptibility & severity to infections. Do not give live vaccines to persons w/ chronic glucocorticosteroid use. Monitor ALT & AST levels regularly (every 2 wk for the 1st mth & at least every 3 mth thereafter) in patients w/ autoimmune hepatitis. Severe hepatic dysfunction. 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. Galactose intolerance, fructose intolerance, Lapp lactase deficiency, sucrase isomaltase insufficiency, glucose galactose malabsorption. Pregnancy & lactation. Childn & adolescent (12-18 yr).
Adverse Reactions
Headache, blurred vision, constipation, muscle & joint pain, muscle weakness & twitching, osteoporosis, pseudotumor cerebri including papilloedema in adolescents, psychomotor hyperactivity, anxiety, aggression, fatigue, malaise. Allergic exanthema, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis; osteonecrosis; blurred vision, glaucoma, cataract; depression, irritability, euphoria; dyspepsia, duodenal or gastric ulcer, pancreatitis; Cushing's syndrome, moon-face, truncal obesity, reduced glucose tolerance, DM, Na retention w/ oedema formation, increased excretion of K, inactivity &/or atrophy of the adrenal cortex, growth retardation in childn, disturbance of sex hormone secretion (eg, amenorrhoea, hirsutism, impotence); HTN, increased risk of thrombosis, vasculitis (w/drawal syndrome after long-term therapy); exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin & joints) occurring on switching from systemically acting glucocorticosteroids to the locally acting budesonide. Increased risk of infection.
Drug Interactions
Reduction in effect if given at same time as steroid-binding synthetic resins eg, colestyramine, antacids. Cardiac glycosides; enhanced K excretion w/ saluretics; CYP3A inhibitors eg, ketoconazole, cobicistat, ritonavir, itraconazole, clarithromycin & grapefruit juice can potentiate effect of corticosteroid. CYP3A inductors eg, carbamazepine, rifampicin may reduce systemic & local exposure of budesonide. Increased plasma conc w/ CYP3A substrate eg, ethinylestradiol, estrogens & OCs, cimetidine.
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Budenofalk cap 3 mg
Packing/Price
100's
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