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), preferably after defecating. Max treatment duration: 6-8 wk.
Contraindications
Hypersensitivity. Hepatic cirrhosis. Childn & adolescents.
Special Precautions
Transfer from another glucocorticosteroid therapy may result in reappearance or recurrence of symptoms relating to the change in systemic steroid levels. Patients w/ TB, HTN, DM, osteoporosis, peptic ulcer (gastric or duodenal ulcer), glaucoma, cataract; family history of diabetes, glaucoma. Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma & a wide range of psychiatric/behavioural effects may occur, particularly at high doses & prolonged use. Increased susceptibility to infections & their severity. Patients w/o a definite history of chickenpox should avoid close contact w/ persons suffering from chickenpox or shingles. Do not give live vaccines to persons w/ chronic glucocorticosteroid use. Blurred vision or other visual disturbance warrants referral to an ophthalmologist. May suppress the hypothalamic-pituitary-adrenal axis & reduce stress response (supplementary systemic glucocorticoid treatment is recommended where patients are subject to surgery or other stresses). Monitor for skin irritations (eg, contact dermatitis). Avoid concomitant use w/ ketoconazole or other CYP3A inhibitors. Systemic glucocorticoid-like side effects (higher than recommended doses). Late stage primary biliary cirrhosis w/ hepatic cirrhosis; severe hepatic impairment. 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 glycoside action may be potentiated. Increased K excretion w/ saluretics. Increased plasma conc 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 conc w/ CYP3A substrates (eg, ethinyl estradiol, oestrogens, OCs). Potential false +ve ACTH stimulation test results for pituitary insufficiency diagnosis.
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.
Presentation/Packing
Form
Budenofalk Rectal Foam 2 mg/actuation
Packing/Price
14 actuation x 1's
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