Country: United States
Language: English
Source: NLM (National Library of Medicine)
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S), ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
Lupin Pharmaceuticals, Inc.
LAMIVUDINE
LAMIVUDINE 150 mg
ORAL
PRESCRIPTION DRUG
Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: - Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see CLINICAL STUDIES (14)] . Abacavir, lamivudine and zidovudine tablets are contraindicated in patients: - who have the HLA-B*5701 allele [see WARNINGS AND PRECAUTIONS (5.1)]. - with prior hypersensitivity reaction to abacavir [see WARNINGS AND PRECAUTIONS (5.1)], lamivudine, or zidovudine. - with moderate or severe hepatic impairment [see USE IN SPECIFIC POPULATIONS (8.7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir, lamivudine and zidovudine tablets during pregnancy. Healthcare providers are encouraged to register patients
Abacavir, lamivudine and zidovudine 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 colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows: Bottles of 60 Tablets NDC 68180-286-07 Bottles of 100 Tablets NDC 68180-286-01 Bottles of 500 Tablets NDC 68180-286-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE- ABACAVIR , LAMIVUDINE AND ZIDOVUDINE TABLET Lupin Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Abacavir, Lamivudine and Zidovudine Tablets (a-BAK-a-vir , la-MIV-ue-deen, zye-DOE-vue-deen) What is the most important information I should know about abacavir, lamivudine and zidovudine tablets? Abacavir, lamivudine and zidovudine tablets can cause serious side effects, including: • Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir, lamivudine and zidovudine tablets and other abacavir-containing products. 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 abacavir, lamivudine and zidovudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir, lamivudine and zidovudine tablets. 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 abacavir, lamivudine and zidovudine tablets because of an allergic reaction, never take abacavir, lamivudine and zidovudine tablets or any other abacavir-containing medicine (EPZICOM®, TRIUMEQ®, or ZIAGEN®) again. • If you have an allergic reaction, dispose of any unused abacavir, lamivudine and zidovudine tablets. Ask your pharmacist how to properly dispose of medicines. • If you take abacavir, lamivudine and zidovudine tablets 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 abacavir, lamivud Read the complete document
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE- ABACAVIR , LAMIVUDINE AND ZIDOVUDINE TABLET LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS. ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, AND EXACERBATIONS OF HEPATITIS B _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HYPERSENSITIVITY REACTIONS SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED 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 A HIGHER RISK OF EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1) ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4) DISCONTINUE ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. (5.1) FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS NEVER RESTART ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS OR ANY OTHER ABACAVIR- CONTAINING PRODUCT. (5.1) HEMATOLOGIC TOXICITY HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN ASSOCIATED WITH THE USE OF ZIDOVUDINE, A COMPONENT OF ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS. (5.2) MYOPATHY SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE. (5.3) LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEA Read the complete document