Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Colchicine (UNII: SML2Y3J35T) (Colchicine - UNII:SML2Y3J35T)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares. 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 Tablets, 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 toxicity has been reported with colchicine taken in therapeutic doses. Pregnancy Category C There are no adequate and well-controlled studies with colchicine in pregnant women. Colchicine crosses the human placenta. While not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth or teratogenic effects among pregnant women using colchicine to treat familial Mediterranean fever (FMF). Although animal reproductive and developmental stud
Colchicine Tablets, USP 0.6 mg are purple, film-coated, capsule-shaped tablets debossed with "AR 374" on one side and scored on the other side. Bottles of 30 71205-310-30 Bottles of 60 71205-310-60 Bottles of 90 71205-310-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
New Drug Application Authorized Generic
Proficient Rx LP ---------- MEDICATION GUIDE COLCHICINE TABLETS, USP Read the Medication Guide that comes with Colchicine Tablets, USP 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, USP when you start taking it and at regular checkups. What is the most important information that I should know about Colchicine Tablets, USP? Colchicine Tablets, USP can cause serious side effects or death if levels of colchicine are too high in your body. • Taking certain medicines with Colchicine Tablets, USP 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, USP 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, USP 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) clarithromycin (Biaxin) darunavir (Prezista) fosamprenavir (Lexiva) itraconazole (Sporanox) lopinavir/ritonavir (Kaletra) nelfinavir mesylate (Viracept) saquinavir mesylate (Invirase) ritonavir (Norvir) telithromycin (Ketek) tipranavir (Aptivus) Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the Perskaitykite visą dokumentą
COLCHICINE- COLCHICINE TABLET, FILM COATED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE COLCHICINE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COLCHICINE TABLETS, USP. COLCHICINE TABLETS, USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1961 INDICATIONS AND USAGE Colchicine Tablets, USP are an alkaloid indicated for: • • Colchicine Tablets, USP are not an analgesic medication and should not be used to treat pain from other causes. DOSAGE AND ADMINISTRATION • • Colchicine Tablets, USP are administered orally without regard to meals. See full prescribing information 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). DOSAGE FORMS AND STRENGTHS 0.6 mg tablets (3). CONTRAINDICATIONS Patients with renal or hepatic impairment should not be given Colchicine Tablets, USP 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 PROPHYLAXIS OF GOUT FLARES: The most commonly reported adverse reaction in clinical trials for the prophylaxis of gout was diarrhea. TREATMENT OF GOUT FLARES: The most common adverse reactions reported in the clinical trial for gout were diarrhea (23%) and pharyngolaryngeal pain (3%). FMF: Most common adverse reactions (up to 20%) are abdominal pain, diarrhea, nausea and vomiting. These effects are usually mild, transient and reversible upon lowering the dose (6). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TAKEDA PHARMACEUTICALS AT 1-877-825- 3327 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS 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 O Perskaitykite visą dokumentą