Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
REMEDYREPACK INC.
ABACAVIR SULFATE
ABACAVIR 300 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ABACAVIR- ABACAVIR TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ABACAVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR TABLETS. ABACAVIR TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: HYPERSENSITIVITY REACTIONS, AND LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HYPERSENSITIVITY REACTIONS • SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED WITH ABACAVIR TABLETS. ( 5.1) • HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. ( 5.1) • PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE A HIGHER RISK OF EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. ( 5.1) • ABACAVIR TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. ( 4) • DISCONTINUE ABACAVIR TABLETS AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA- B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR TABLETS IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. ( 5.1) • FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART ABACAVIR TABLET OR ANY OTHER ABACAVIR- CONTAINING PRODUCT. ( 5.1) LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS • LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES. ( 5.2) RECENT MAJOR CHANGES Boxed Warning 09/2015 Indications and Usage ( 1) 09/2015 Dosage and Administration, Screening for HLA-B*5701 Allele prior to Starting abacavir ( 2.1) 09/2015 Dosage and Administration, Recommended Dosage for Pediatric Patients ( 2.3) 03/2015 Contraindications ( 4) 09/2015 Warnings and Precautions, Hypersensitivity Reactions ( 5.1) 09/2015 Warnings and Precautions, Related Products that are Not Recommended ( 5.6) 03/2015 INDICATIONS AND USAGE Abacavir tablet, USP a nucleoside analogue human immu Olvassa el a teljes dokumentumot