ABACAVIR tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Cipla USA Inc.

INN (International namn):

ABACAVIR SULFATE

Sammansättning:

ABACAVIR 300 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Abacavir tablets USP 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablet is 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)] . - with moderate or severe hepatic impairment [see Use in Specific Populations (8.6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir sulfate during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Dat

Produktsammanfattning:

Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are yellow coloured, capsule shaped, biconvex, film coated tablets, having scoreline on both sides with "5" and "14" debossed on either side of scoreline on one side. They are packaged as follows: Bottles of 60 tablets (NDC 69097-514-03). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

ABACAVIR- ABACAVIR TABLET, FILM COATED
Cipla USA Inc.
----------
MEDICATION GUIDE
Abacavir (a-BAK-a-vir) Tablets
What is the most important information I should know about abacavir
tablets?
Abacavir tablets can cause serious side effects, including:
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with abacavir
tablet 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 tablets, call your
healthcare provider right away to find out if you should stop taking
abacavir 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 tablets because of an allergic reaction, never
take abacavir tablets or any other
abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.
•
If you have an allergic reaction, dispose of any unused abacavir
tablets. Ask your pharmacist
how to properly dispose of medicines.
•
If you take abacavir 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 tablets for any other reason, even for a few
days, and you are not allergic to
abacavir tablets, talk with your healthcare provider before taking it
again. Taking abacavir tablets
again can cause a serious allergic or life-threatening reaction, even
if you never had an allergic
reaction to it before.
If your healthcare provider tells you that you can take abacavir
tablets aga

Produktens egenskaper

ABACAVIR- ABACAVIR TABLET, FILM COATED
CIPLA USA 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE
OCCURREDWITH ABACAVIR SULFATE. (5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1)
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGHER RISK OF
EXPERIENCING A HYPERSENSITIVITY REACTION
TO ABACAVIR. (5.1)
ABACAVIR TABLETIS 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 TABLETS OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
INDICATIONS AND USAGE
Abacavir tablet, a nucleoside analogue human immunodeficiency virus
(HIV-1) reverse transcriptase inhibitor, is indicated
in combination with other antiretroviral agents for the treatment of
HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
Before initiating abacavir tablets, screen for the HLA-B*5701 allele.
(2.1)
Adults: 600 mg daily, administered as either 300 mg twice daily or 600
mg once daily. (2.2)
Pediatric Patients Aged 3 Months and Older: Administered either once
or twice daily. Dose should be calculated on
body weight (kg) and should not exceed 600 mg daily. (2.3)
Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg
twice daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg scored (3)
CONTRAINDICATIONS
Presence of HLA-B*5701 allele. (4)
Prior hypersensitivity rea