ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S), ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)

Available from:

LUPIN LIMITED

INN (International Name):

LAMIVUDINE

Composition:

LAMIVUDINE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: - Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL) [see CLINICAL STUDIES (14)] . Abacavir, lamivudine and zidovudine 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)], lamivudine, or zidovudine. - with moderate or severe hepatic impairment [see USE IN SPECIFIC POPULATIONS (8.7)] . Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of abacavir, lamivudine and zidovudine tablets in pregnant women. Reproduction studies with abacavir, lamivudine, and zidovudine have been p

Product summary:

Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows: Bottles of 60 Tablets                           NDC 68180-286-07 Bottles of 100 Tablets                         NDC 68180-286-01 Bottles of 500 Tablets                         NDC 68180-286-02 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 SULFATE, LAMIVUDINE AND ZIDOVUDINE- ABACAVIR SULFATE,
LAMIVUDINE AND
ZIDOVUDINE TABLET
LUPIN LIMITED
----------
MEDICATION GUIDE
Abacavir, Lamivudine and Zidovudine Tablets
(a-BAK-a-vir , la-MIV-ue-deen, zye-DOE-vue-deen)
What is the most important information I should know about abacavir,
lamivudine and zidovudine
tablets?
Abacavir, lamivudine and zidovudine tablets can cause serious side
effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
abacavir, lamivudine and zidovudine 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, lamivudine and
zidovudine tablets, call your healthcare provider right away to find
out if you should stop taking abacavir,
lamivudine and zidovudine 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, lamivudine and zidovudine tablets because of an
allergic reaction, never take
abacavir, lamivudine and zidovudine tablets or any other
abacavir-containing medicine (EPZICOM®,
TRIUMEQ®, or ZIAGEN®) again.
•
If you take abacavir, lamivudine and zidovudine tablets or any other
abacavir-containing medicine
again after you have had an allergic reaction, within hours you may
get life-threateningsymptoms
that may include very low blood pressure or death .
•
If you stop abacavir, lamivudine and zidovudine tablets for any other
reason, even for a few days,
and you are not allergic to abacavir, lamivudine and zidovudine
tablets, talk with your healt

Summary of Product characteristics

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE- ABACAVIR SULFATE,
LAMIVUDINE AND
ZIDOVUDINE TABLET
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR, LAMIVUDINE AND
ZIDOVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ABACAVIR, LAMIVUDINE
AND ZIDOVUDINE TABLETS.
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY,
MYOPATHY,
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, 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, LAMIVUDINE AND ZIDOVUDINE TABLETS ARE CONTRAINDICATED IN
PATIENTS WITH A PRIOR
HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE
PATIENTS. (4)
DISCONTINUE ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS AS SOON AS A
HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR, LAMIVUDINE AND
ZIDOVUDINE TABLETS IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN
OTHER DIAGNOSES ARE POSSIBLE.
(5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, LAMIVUDINE AND
ZIDOVUDINE TABLETS NEVER RESTART
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
HEMATOLOGIC TOXICITY
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE, A COMPONENT OF ABACAVIR, LAMIVUDINE AND ZIDOVUDINE
TABLETS. (5.2)
MYO PATHY
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.3)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCL