Country: United States
Language: English
Source: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
State of Florida DOH Central Pharmacy
ABACAVIR SULFATE
ABACAVIR SULFATE 600 mg
ORAL
PRESCRIPTION DRUG
EPZICOM Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. Additional important information on the use of EPZICOM for treatment of HIV-1 infection: - EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir. - In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions compared with patients taking ZIAGEN 300 mg twice daily. - As part of a triple-drug regimen, EPZICOM Tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors. See WARNINGS, ADVERSE REACTIONS, and Description of Clinical Studies. There have been no clinical trials conducted with EPZICOM (see CLINICAL PHARMACOLOGY for informa
EPZICOM is available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 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
State of Florida DOH Central Pharmacy ---------- MEDICATION GUIDE EPZICOM® (ep' zih com) Tablets Generic name: abacavir (uH-BACK-ah-veer) sulfate and lamivudine (la-MIV-yoo-deen) Read the Medication Guide that comes with EPZICOM before you start taking it and each time you get a refill because there may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Be sure to carry your EPZICOM Warning Card with you at all times. What is the most important information I should know about EPZICOM? • Serious Allergic Reaction to Abacavir. EPZICOM contains abacavir (also contained in ZIAGEN® and TRIZIVIR®). Patients taking EPZICOM 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 than if you do not. Your doctor 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 EPZICOM, call your doctor right away to determine if you should stop taking this medicine. 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. If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM (abacavir sulfate and lamivudine) or any other abacavir-containing medicine (ZIAGEN and TRIZIVIR) again. If you take EPZICOM 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 EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your doctor before taking it again. Taking EPZICOM again can cause a Read the complete document
EPZICOM - ABACAVIR SULFATE AND LAMIVUDINE TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- EPZICOM (ABACAVIR SULFATE AND LAMIVUDINE) TABLETS WARNINGS EPZICOM CONTAINS 2 NUCLEOSIDE ANALOGUES (ABACAVIR SULFATE AND LAMIVUDINE) AND IS INTENDED ONLY FOR PATIENTS WHOSE REGIMEN WOULD OTHERWISE INCLUDE THESE 2 COMPONENTS. HYPERSENSITIVITY REACTIONS: SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH ABACAVIR SULFATE, A COMPONENT OF EPZICOM. HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME USUALLY CHARACTERIZED BY A SIGN OR SYMPTOM IN 2 OR MORE OF THE FOLLOWING GROUPS: (1) FEVER, (2) RASH, (3) GASTROINTESTINAL (INCLUDING NAUSEA, VOMITING, DIARRHEA, OR ABDOMINAL PAIN), (4) CONSTITUTIONAL (INCLUDING GENERALIZED MALAISE, FATIGUE, OR ACHINESS), AND (5) RESPIRATORY (INCLUDING DYSPNEA, COUGH, OR PHARYNGITIS). DISCONTINUE EPZICOM AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGH RISK FOR EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. PRIOR TO INITIATING THERAPY WITH ABACAVIR, SCREENING FOR THE HLA-B*5701 ALLELE IS RECOMMENDED; THIS APPROACH HAS BEEN FOUND TO DECREASE THE RISK OF HYPERSENSITIVITY REACTION. SCREENING IS ALSO RECOMMENDED PRIOR TO REINITIATION OF ABACAVIR IN PATIENTS OF UNKNOWN HLA-B*5701 STATUS WHO HAVE PREVIOUSLY TOLERATED ABACAVIR. HLA- B*5701-NEGATIVE PATIENTS MAY DEVELOP A SUSPECTED HYPERSENSITIVITY REACTION TO ABACAVIR; HOWEVER, THIS OCCURS SIGNIFICANTLY LESS FREQUENTLY THAN IN HLA-B*5701-POSITIVE PATIENTS. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE EPZICOM IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART EPZICOM OR ANY OTHER ABACAVIR-CONTAINING PRODUCT BECAUSE MORE SEVERE SYMPTOMS CAN OCCUR WITHIN HOURS AND MAY INCLUDE LIFE-THREATENING HYPOTENSION AND DEATH. REINTRODUCTION OF EPZICOM OR ANY OTHER ABACAVIR-CONTAINING PRODUCT, EVEN IN PATIENTS WHO HAVE NO IDENTIFIED HISTORY OR Read the complete document