DCH Auriga - Universal
Four Star
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
One 9 mg tab in the morning, for up to 8 wk.
May be taken with or without food: Swallow whole w/ a glass of water, do not break/chew/crush. Avoid grapefruit or grapefruit juice.
Hypersensitivity to budesonide, soya oil, peanut oil or any of the excipients.
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. 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 or tiredness may occur. May reduce immune response to vaccines. Avoid concomitant administration w/ ketoconazole or other potent CYP3A4 inhibitors. Contains lecithin. Rare hereditary problems eg, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Adrenocortical suppression; increased susceptibility to infections; suppression of the HPA axis & reduced stress response; more serious course of chicken pox & measles; systemic effects of steroids particularly when prescribed 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. Reduced liver function may affect the elimination of glucocorticoids including budesonide, causing higher systemic exposure. Be aware of possible systemic side effects. Potential systemic effects include glaucoma. Hepatic & renal impairment. Pregnancy & lactation. Childn 0-18 yr. Elderly.
Adverse Reactions
Nausea, upper abdominal pain; headache; insomnia, mood altered; blood cortisol decrease; flu, upper resp tract viral infection. Side effects typical of systemic glucocorticosteroids may occur.
Drug Interactions
Possible increase in systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, HIV PIs & grapefruit juice. Possible reduction in budesonide exposure w/ CYP3A4 inducers eg, carbamazepine. Concomitant use w/ heart glycosides & diuretics may present significant hazard. Cholestyramine or antacids may reduce budesonide uptake. Increased plasma conc of & enhanced effects of corticosteroids have been observed in women also treated w/ oestrogens & contraceptive steroids.
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.
Cortiment PR tab 9 mg
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