A. Menarini
Concise Prescribing Info
Mild to moderate active Crohn's disease affecting the ileum &/or the ascending colon (part of the large intestine). Collagenous colitis. Patients ≥18 yr w/ autoimmune hepatitis.
Dosage/Direction for Use
Adult >18 yr Crohn's disease 3 cap once daily in the morning or 1 cap tid for 8 wk. Collagenous colitis 3 cap once daily in the morning for 8 wk. Autoimmune hepatitis Induction of remission: 1 cap tid. Maintenance of remission: 1 cap bid. If the transaminase ALT &/or AST increase during treatment, increase to 3 cap daily.
Should be taken on an empty stomach: Take at least 30 min before meals. For patients w/ swallowing difficulties, open cap & swallow pellets, do not chew.
Hypersensitivity. Hepatic cirrhosis. Childn.
Special Precautions
TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma, cataract, family history of diabetes or glaucoma. Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma & psychiatric/behavioural effects (very rarely). Suppression of inflammatory response & immune function; response of the hypotalamo-pituitary-adrenal axis to stress. Chickenpox or herpes zoster & measles. Do not administer live vaccines. Galactose or fructose intolerance, lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption. Regularly monitor serum transaminase levels (ALT, AST) every 2 wk for the 1st mth of treatment & at least every 3 mth thereafter. Severely impaired hepatic function. Pregnancy & lactation. Childn & adolescents.
Adverse Reactions
Cushing's syndrome eg, moon face, truncal obesity, increased glucose tolerance, DM, HTN, Na retention w/ edema, increased K excretion, inactivity or atrophy of the adrenal cortex, red striae, steroid acne, disturbance of sex hormone secretion (eg, amenorrhea, hirsutism, impotence); increased risk of infection; muscle weakness & twitching, osteoporosis; headache; depression, irritability, euphoria; allergic exanthema, petechiae, ecchymosis, delayed wound healing, contact dermatitis.
Drug Interactions
Potentiated glycoside action by K deficiency w/ cardiac glycosides. Enhanced K excretion w/ saluretics. Increased plasma conc w/ CYP3A inhibitors eg, ketoconazole, ritonavir, itraconazole, clarithromycin & grapefruit juice. Reduced systemic & local exposure of budesonide at the gut mucosa w/ CYP3A inducers eg, carbamazepine & rifampicin. Elevated plasma conc & enhanced effects of corticosteroids w/ oestrogens or OCs. Do not take simultaneously w/ steroid binding synthetic resins eg, colestyramine & antacids.
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Budenofalk EC cap 3 mg
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