País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. Colchicine tablets 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 tablets in conjunction with P-gp or strong CYP3A4 inhibitors (this includes all protease inhibitors except fosamprenavir). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. 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 outcomes (see Data). Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with colchicine tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratoge
16.1 How Supplied Colchicine Tablets USP, 0.6 mg are purple colored, film-coated, capsule shaped tablets debossed with ‘logo372’ on one side and score line on the other side of the tablet. NDC: 71335-1738-1: 30 Tablets in a BOTTLE NDC: 71335-1738-5: 6 Tablets in a BOTTLE NDC: 71335-1738-6: 9 Tablets in a BOTTLE NDC: 71335-1738-2: 20 Tablets in a BOTTLE NDC: 71335-1738-3: 3 Tablets in a BOTTLE NDC: 71335-1738-4: 12 Tablets in a BOTTLE 16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
Bryant Ranch Prepack ---------- MEDICATION GUIDE Colchicine Tablets, USP (KOL-chi-seen) 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) • cyclosporine (Neoral, Gengraf, Sandimmune) • fosamprenavir (Lexiva) with ritonavir • indinavir (Crixivan) • ketoconazole (Nizoral) • nefazodone (Serzone) • ritonavir (Norvir) • • clarithromycin (Biaxin) • darunavir (Prezista) • fosamprenavir (Lexiva) • itraconazole (Sporanox) • lopinavir/ritonavir (Kaletra) • nelfinavir mesylate (Viracept) • saquinavir mesylate (Invirase) • telithromycin (Ketek) tipranavir (Aptivus) Ask your healthcare provider or pharmacist if you are not sure if you take any of the me Llegiu el document complet
COLCHICINE- COLCHICINE TABLET BRYANT RANCH PREPACK ---------- 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 are an alkaloid indicated for: • • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS Patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with P-gp or strong CYP3A4 inhibitors (5.3). In these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses (7). WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS • • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S LABORATORIES INC., AT 1-888- Prophylaxis and treatment of gout flares in adults (1.1). Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). 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 - 2.4 mg; children 6 to 12 years 0.9 - 1.8 mg; children 4 to 6 years 0.3 - 1.8 mg (2.2, 2.3). o o 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 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 coadministered drugs (2.4). Tablets: 0.6 mg colchicine (3). _Fatal overdoses _h Llegiu el document complet