Budenofalk Rectal Foam

Budenofalk Rectal Foam

budesonide

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Acute treatment of active ulcerative colitis limited to the rectum & the sigmoid colon.
Dosage/Direction for Use
Adult 1 actuation into the rectum daily (morning or evening).
Contraindications
Hypersensitivity. Hepatic cirrhosis. Childn & adolescents.
Special Precautions
Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma & a wide range of psychiatric/behavioural effects. Increased susceptibility to infections & their severity. Liver function disorders. Visual disturbance. Patients w/ TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma, cataract; family history of diabetes, glaucoma. Monitor for infections or skin irritations. Do not give live vaccines to persons w/ chronic glucocorticosteroid use. May cause suppression of the hypothalamic-pituitary-adrenal axis & reduce the stress response (supplementary systemic glucocorticoid treatment is recommended where patients are subject to surgery or other stresses). Concomitant use w/ ketoconazole or other CYP3A inhibitors. Systemic glucocorticoid-like effects (higher than recommended doses). Pregnancy & lactation.
Adverse Reactions
Cushing's syndrome: eg, w/ 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. Burning sensation in the rectum & pain.
Drug Interactions
Cardiac glycosides. Increased K excretion w/ saluretics. Increased plasma concentration w/ CYP3A inhibitors (eg, cobicistat, ketoconzaole, ritonavir, itraconazole, clarithromycin & grapefruit juice). CYP3A inducers eg, carbamazepine, rifampicin can reduce systemic & local exposure of budesonide. Elevated plasma concentrations w/ CYP3A substrates (eg, ethinyl estradiol, oestrogens, OCs).
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Budenofalk Rectal Foam 2 mg/actuation
Packing/Price
14 actuation x 1's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in