ABACAVIR tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)

Available from:

Avera McKennan Hospital

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 300 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ABACAVIR- ABACAVIR TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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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, 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. (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 IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-
B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B 5701
STATUS, PERMANENTLY DISCONTINUE ABACAVIR IF HYPERSENSITIVITY CANNOT BE
RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
ABACAVIR 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 09/2015
Allele Prior to Starting Abacavir (2.1)
Dosage and Administration, Recommended Dosage for 03/2015
Pediatric Patients (2.3)
Contraindications (4) 09/2015
Warnings and Precautions, Hypersensitivity Reactions (5.1) 09/2015
Warnings and Precautions, Related Products that are Not 03/2015
Recommended (5.6)
INDICATIONS AND USAGE
Abacavir tablets, a nucleoside analogue human immunodeficiency virus
(HIV-1) reverse transcriptase inhibitor, are
ind