ABACAVIR AND LAMIVUDINE- abacavir sulfate and lamivudine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Available from:

Prasco Laboratories

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir and Lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and Lamivudine tablets are contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Abacavir and Lamivudine tablets 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 or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) . The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for b

Product summary:

Each Abacavir and Lamivudine 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 packaged as follows: Bottles of 30 tablets (NDC 66993-482-30). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

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

Summary of Product characteristics

ABACAVIR AND LAMIVUDINE- ABACAVIR SULFATE AND LAMIVUDINE TABLET, FILM
COATED
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR AND LAMIVUDINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR AND
LAMIVUDINE TABLETS.
ABACAVIR AND LAMIVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
•
•
•
•
•
•
EXACERBATIONS OF HEPATITIS B
•
INDICATIONS AND USAGE
Abacavir and Lamivudine tablets, containing two nucleoside analogue
HIV-1 reverse transcriptase inhibitors, are indicated
in combination with other antiretroviral agents for the treatment of
HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg of abacavir and 300 mg of lamivudine. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ABACAVIR-CONTAINING
PRODUCTS. (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 AND LAMIVUDINE TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A
PRIOR HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR AND LAMIVUDINE TABLETS AS SOON AS A
HYPERSENSITIVITY REACTION IS SUSPECTED.
REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR AND
LAMIVUDINE TABLETS IF
HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE
POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE
TABLETS, NEVER RESTART ABACAVIR
AND LAMIVUDINE TABLETS OR ANY OTHER ABACAVIR-CONTAINING PRODUCT. (5.1)
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE CO-INFECTED WITH
HEP