ABACAVIR AND LAMIVUDINE- abacavir 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:

REMEDYREPACK INC.

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:   - 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)] or lamivudine. - with moderate or severe hepatic impairment [see USE IN SPECIFIC POPULATIONS ( 8.7)]. 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. 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

Product summary:

Abacavir and lamivudine tablets USP are available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange colored, oval shaped, biconvex, film-coated tablets debossed with "LU" on one side "C51" on the other side. They are packaged as follows: Bottles (120cc) of 30 Tablets (NDC 68180-288-06). Bottles (250cc) of 90 Tablets (NDC 68180-288-09). Pouches of 750 Tablets (NDC 68180-288-33). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Abacavir and Lamivudine (a-BAK-a-vir and la-MIV-ue-deen)
Tablets USP
Rx Only
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 (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 pressureordeath .
•
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
prov

Summary of Product characteristics

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
REMEDYREPACK INC.
----------
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
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)
EXACERBATIONS OF HEPATITIS B
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE CO-INFECTED WITH
HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) AND
HAVE DISCONTINUED
LAMIVUDINE, A COMPONENT OF ABACAVIR AND LAMIVUDINE TABLETS. MONITOR
HEPATIC FUNCTION CLOSELY IN THESE
PATIENTS AND, IF APPROPRIATE, INITIATE ANTI-HEPATITIS B TREATMENT. (
5.2)
RECENT MAJOR CHANGES
Boxed Warning 04/2018
Warnings and Precautions, Lactic Acidosis and 04/2018
Severe Hepatomegaly with Steatosis ( 5.3)
Warnings and Precautions, Fat Redistribution Remo