ABACAVIR tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

REMEDYREPACK INC.

INN (nume internaţional):

ABACAVIR SULFATE

Compoziție:

ABACAVIR 300 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

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