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Cortiment

Cortiment

budesonide

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Induction of remission in adult patients w/ mild to moderate active ulcerative colitis where 5-ASA is not sufficient.
Dosage/Direction for Use
Adult Recommended daily dose: 1 PR tab in the morning for up to 8 wk.
Administration
May be taken with or without food: Swallow w/ a glass of water, do not break/chew/crush.
Contraindications
Hypersensitivity to budesonide, lecithin (derived from soya oil, peanut oil).
Special Precautions
Patients w/ infections, HTN, DM, osteoporosis, peptic ulcer, glaucoma, cataracts; w/ family history of diabetes or glaucoma or w/ any other condition where use of glucocorticoids may have unwanted effects. Possible visual disturbance w/ systemic & topical corticosteroid use; consider referral to ophthalmologist for evaluation of possible causes if patient presents w/ symptoms (eg, blurred vision or other visual disturbances). Reduced liver function may cause higher systemic exposure; potential systemic effects including glaucoma. Gradually reduce dose when treatment is to be discontinued. May result in lower systemic steroid levels than conventional oral glucocorticoid therapy. Transfer from other steroid therapy may result in symptoms relating to change in systemic steroid levels. May reduce immune response to vaccines. Avoid concomitant administration w/ ketoconazole or other potent CYP3A4 inhibitors; regular ingestion of grapefruit or its juice. Contains lecithin & lactose monohydrate. Not to be taken by patients w/ rare hereditary problems (eg, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption). Adrenocortical suppression; increased susceptibility to infections; HPA axis suppression & reduced stress response; systemic effects of steroids may occur particularly at high doses & prolonged periods. More serious course of chicken pox & measles; consider reduction or discontinuation of treatment if patients are infected or suspected of being infected. Current or history of severe affective disorders in the patient or any 1st degree relatives. Replacement of high systemic effect corticosteroid treatment sometimes unmasks allergies (eg, rhinitis & eczema). Occasional dizziness or tiredness may occur; may affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Not recommended in childn 0-18 yr. Elderly.
Adverse Reactions
Insomnia; headache; nausea, upper abdominal pain, abdominal distension & pain, dry mouth, dyspepsia; acne; myalgia; fatigue; decreased blood cortisol.
Drug Interactions
Increased systemic exposure w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, HIV PIs & grapefruit juice). May reduce exposure w/ CYP3A4 inducers (eg, carbamazepine). Concomitant use w/ heart glycosides & diuretics may present significant hazard. Increased plasma conc & enhanced effects of corticosteroids in women also treated w/ oestrogens & contraceptive steroids. May reduce budesonide uptake w/ colestyramine or antacids. May show false results (low cortisol values) w/ ACTH stimulation test for diagnosing pituitary or adrenal 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.
Presentation/Packing
Form
Cortiment PR tab 9 mg
Packing/Price
30's
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