Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)
State of Florida DOH Central Pharmacy
ABACAVIR SULFATE
ABACAVIR 300 mg
ORAL
PRESCRIPTION DRUG
TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection. Additional important information on the use of TRIZIVIR for treatment of HIV-1 infection: TRIZIVIR Tablets are contraindicated in patients with: TRIZIVIR: Pregnancy Category C. There are no adequate and well-controlled studies of TRIZIVIR in pregnant women. Reproduction studies with abacavir, lamivudine, and zidovudine have been performed in animals (see Abacavir, Lamivudine, and Zidovudine sections below). TRIZIVIR should be used during pregnancy only if the potential benefits outweigh the risks. Abacavir: Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) and developmental toxicity (depressed fetal body weight and reduced crown-rump length) were observed in rats at a dose which produced 35 times the human exposure, based on AUC. Embryonic and fetal toxicities (incre
TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
New Drug Application
TRIZIVIR - ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLET, FILM COATED State of Florida DOH Central Pharmacy ---------- MEDICATION GUIDE TRIZIVIR® (TRY-zih-veer) (abacavir sulfate, lamivudine, and zidovudine Tablets Read this Medication Guide before you start taking TRIZIVIR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to carry your TRIZIVIR Warning Card with you at all times. What is the most important information I should know about TRIZIVIR? 1.Serious allergic reaction (hypersensitivity reaction). TRIZIVIR contains abacavir (also contained in ZIAGEN® and EPZICOM®). Patients taking TRIZIVIR may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking TRIZIVIR, call your healthcare provider right away to find out if you should stop taking TRIZIVIR. Symptom( s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop TRIZIVIR because of an allergic reaction, never take TRIZIVIR(abacavir sulfate, lamivudine, and zidovudine)or any other abacavir-containing medicine (ZIAGEN and EPZICOM) again. If you take TRIZIVIR or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. If you stop TRIZIVIR, for any other reason, even for a few days, and you are not allergic to TRIZIVIR Прочитајте комплетан документ
TRIZIVIR - ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRIZIVIR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIZIVIR. TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: RISK OF HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • • • • • • • • INDICATIONS AND USAGE TRIZIVIR, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Tablets contain 300 mg abacavir, 150 mg of lamivudine, and 300 mg of zidovudine. (3) (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH ABACAVIR- CONTAINING PRODUCTS. (5.1) HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1) PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGH RISK FOR EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1) DISCONTINUE TRIZIVIR AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA- B*5701 STATUS, PERMANENTLY DISCONTINUE TRIZIVIR IF HYPERSENSITIVITY CANNOT BE RULED OUT. (5.1) FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART TRIZIVIR OR ANY OTHER ABACAVIR- CONTAINING PRODUCT. (5.1) HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN ASSOCIATED WITH THE USE OF ZIDOVUDINE, A COMPONENT OF TRIZIVIR. (5.2) SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE. (5.3) LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAV Прочитајте комплетан документ