Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)
Amneal Pharmaceuticals LLC
COLCHICINE
COLCHICINE 0.6 mg
ORAL
PRESCRIPTION DRUG
Colchicine tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. - Prophylaxis of Gout Flares: Colchicine tablets, USP are indicated for prophylaxis of gout flares. - Treatment of Gout Flares: Colchicine tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare. Colchicine tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF). Patients with renal or hepatic impairment should not be given colchicine, USP in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP taken in therapeutic doses. Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal ou
Colchicine tablets, USP, 0.6 mg, are purple, capsule-shaped, film-coated tablets, scored on one side and debossed with ”A10” on the other side. They are available as: Bottles of 30: NDC 65162-710-03 Bottles of 90: NDC 65162-710-09 Bottles of 1,000: NDC 65162-710-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE Colchicine (kol’ chi seen) Tablets, USP for oral use Read the Medication Guide that comes with colchicine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about colchicine tablets when you start taking it and at regular checkups. What is the most important information that I should know about colchicine tablets? Colchicine tablets can cause serious side effects or death if levels of colchicine are too high in your body. • Taking certain medicines with colchicine tablets can cause your level of colchicine to be too high, especially if you have kidney or liver problems. • Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of colchicine tablets may need to be changed. • Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. • Even medicines that you take for a short period of time, such as antibiotics, can interact with colchicine tablets and cause serious side effects or death. • Talk to your healthcare provider or pharmacist before taking any new medicine. • Especially tell your healthcare provider if you take: • atazanavir sulfate (Reyataz) • clarithromycin (Biaxin) • cyclosporine (Neoral, Gengraf, Sandimmune) • darunavir (Prezista) • fosamprenavir (Lexiva) with ritonavir • fosamprenavir (Lexiva) • indinavir (Crixivan) • itraconazole (Sporanox) • ketoconazole (Nizoral) • lopinavir/ritonavir (Kaletra) • nefazodone (Serzone) • nelfinavir mesylate (Viracept) • ritonavir (Norvir) • saquinavir mesylate (Invirase) • telithromycin (Ketek) • tipranavir (Aptivus) Ask your healthcare provider or pharmacist if you are not sure if you take any Baca dokumen lengkapnya
COLCHICINE- COLCHICINE TABLET AMNEAL PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE COLCHICINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLCHICINE TABLETS. COLCHICINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1961 INDICATIONS AND USAGE Colchicine tablets, USP are an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults (1.1). Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). DOSAGE AND ADMINISTRATION GOUT FLARES: PROPHYLAXIS OF GOUT FLARES: 0.6 mg once or twice daily in adults and adolescents older than 16 years of age (2.1). Maximum dose 1.2 mg/day. TREATMENT OF GOUT FLARES: 1.2 mg (two tablets) at the first sign of a gout flare followed by 0.6 mg (one tablet) one hour later (2.1). FMF: Adults and children older than 12 years 1.2 to 2.4 mg; children 6 to 12 years 0.9 to 1.8 mg; children 4 to 6 years 0.3 to 1.8 mg (2.2, 2.3). Give total daily dose in one or two divided doses (2.2). Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the maximum recommended daily dose (2.2). Colchicine tablets, USP are administered orally without regard to meals. See full prescribing information (FPI) for dose adjustment regarding patients with impaired renal function (2.5), impaired hepatic function (2.6), the patient’s age (2.3, 8.5) or use of co-administered drugs (2.4). DOSAGE FORMS AND STRENGTHS Tablets: 0.6 mg colchicine (3). CONTRAINDICATIONS Patients with renal or hepatic impairment should not be given colchicine, USP in conjunction with P-gp or strong CYP3A4 inhibitors (5.3). In these patients, life-threatening and fatal colchicine, USP toxicity has been reported with colchicine, USP taken in therapeutic doses (7). WARNINGS AND PRECAUTIONS _Fatal overdoses_ have been reported with colchicine in adults and children. Keep colchicine out of the reach of children (5.1, 10). _Blood dyscrasias:_ myelosuppre Baca dokumen lengkapnya