Metro Drug
Concise Prescribing Info
Induction of remission in adult patients w/ mild to moderate active ulcerative colitis where 5-ASA treatment is not sufficient.
Dosage/Direction for Use
Adult 9 mg in the morning, for up to 8 wk.
May be taken with or without food: Swallow w/ a glass of water, do not break/chew/crush.
Hypersensitivity to budesonide, soya oil or peanut oil.
Special Precautions
Patients w/ infections, HTN, DM, osteoporosis, peptic ulcer, glaucoma or cataracts or w/ a family history of diabetes or glaucoma, or w/ any other condition where the use of glucocorticoids may have unwanted effects. Reduced liver function. 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 the change in systemic steroid levels. Occasional dizziness, tiredness, headache, nausea & vomiting may occur. May reduce immune response to vaccines. Avoid concomitant administration w/ ketoconazole or other potent CYP3A4 inhibitors (grapefruit juice). Contains lecithin & lactose monohydrate. Rare hereditary problems eg, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Adrenocortical suppression; suppression of inflammatory response & increased susceptibility to infections; suppression of the HPA axis & reduced stress response; more serious course of chicken pox & measles; systemic effects of steroids may occur at high doses & for prolonged periods. Patients w/ current or previous 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. Hepatic & renal impairment. May affect the ability to drive & use machines. Pregnancy & lactation. Not recommended in childn 0-18 yr. Elderly.
Adverse Reactions
Nausea, upper abdominal pain; headache; insomnia, altered mood; decreased blood cortisol; influenza, upper resp tract viral infection.
Drug Interactions
Increased systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, HIV PIs & grapefruit juice. May reduce budesonide exposure w/ CYP3A4 inducers eg, carbamazepine. Concomitant use w/ heart glycosides (increased effect due to reduced K levels) & diuretics (increased K elimination) may present significant hazard. Increased plasma conc & enhanced effects of corticosteroids in women treated w/ estrogens & contraceptive steroids. May reduce budesonide uptake w/ cholestyramine or antacids.
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Cortiment PR tab 9 mg
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