País: Canadá
Idioma: inglés
Fuente: Health Canada
COLCHICINE
SANDOZ CANADA INCORPORATED
M04AC01
COLCHICINE
0.6MG
TABLET
COLCHICINE 0.6MG
ORAL
100
Prescription
ANTIGOUT AGENTS
Active ingredient group (AIG) number: 0107264001; AHFS:
APPROVED
2017-11-10
1 PRESCRIBING INFORMATION PR SANDOZ COLCHICINE Colchicine Tablets, 0.6 mg, Oral USP Antigout preparations Sandoz Canada Inc. Date of Revision: 145 Jules-Léger December 8, 2017 Boucherville, Quebec, Canada J4B 7K8 Submission Control No: 205056 2 SANDOZ COLCHICINE 0.6 mg per Tablet Proper name: colchicine Molecular formula and molecular mass: C 22 H 25 NO 6 399.44 Structural Formula: SUMMARY PRODUCT INFORMATION: PRESENTATION: Tablet for oral administration available in bottles of 100’s for pharmacy and hospital use only. DESCRIPTION: Yellow, round, biconvex tablet plain on one side and scored on the other side with the engraving “E” above and “0.6” below the score line. NON-MEDICINAL INGREDIENTS: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch. Color composition: D&C Yellow No. 10 Aluminum Lake; FD&C Yellow No. 6 Aluminum Lake. INDICATIONS Sandoz COLCHICINE is indicated for gout therapy: prophylaxis and treatment of gout flares in adults. CONTRAINDICATIONS Sandoz COLCHICINE is contraindicated in patients with: impaired renal or hepatic function who are also receiving a strong CYP3A4 inhibitor (clarithromycin, etc.). 3 impaired renal or hepatic function who are also receiving a p-glycoprotein inhibitor (cyclosporin, etc.). a known hypersensitivity to colchicine. serious gastrointestinal, hepatic, renal and cardiac disease. DOSAGE AND ADMINISTRATION ORAL ADMINISTRATION DOSAGES: Administer orally with water and maintain adequate fluid intake. May be administered without regard to meals. May need to supplement with Vitamin B12. Avoid grapefruit juice. Sandoz COLCHICINE is not an analgesic medication and should not be used to treat pain from other causes. SANDOZ COLCHICINE 0.6 MG TABLET USE ONLY AS PRESCRIBED BY A PHYSICIAN. PROPHYLAXIS OF GOUT FLARES IN ADULTS: 1 tablet once or twice daily. The maximum recommended dose for prophylaxis is 2 tablets per 24 hours. Elderly use: use with caution; reduce proph Leer el documento completo