ABACAVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Strides Pharma Science Limited

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 300

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir tablets in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir 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)]. - 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 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 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

Product summary:

Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are dark yellow coloured, biconvex, capsule shaped, film coated tablets with "AB" debossed on one side and break line on other side. They are packaged as follows: Bottles of 60 tablets (NDC 64380-717-03). Unit dose blister packs of 60 tablets (NDC 64380-717-01). Each pack contains 6 blister cards of 10 tablets each. Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ABACAVIR - ABACAVIR TABLET
Strides Pharma Science Limited
----------
MEDICATION GUIDE
Abacavir tablets USP 300 mg
(A bak′ a vir)
What is the most important information I should know about abacavir
tablets?
Abacavir tablets can cause serious side effects, including:
•
Serious allergic reaction (hypersensitivity reaction) that can cause
death have happened with
abacavir 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 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. 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 getlife-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 a

Summary of Product characteristics

ABACAVIR - ABACAVIR TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
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 OCCURRED
WITH ABACAVIR
TABLETS 300 MG. (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 FOR
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1)
ABACAVIR IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO
ABACAVIR AND IN HLA-B*5701- POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR TABLETS 300 MG AS SOON AS A HYPERSENSITIVITY
REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR
TABLETS 300 MG IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN
OTHER DIAGNOSES
ARE POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
ABACAVIR TABLETS 300
MG OR ANY OTHER ABACAVIR-CONTAINING PRODUCT. (5.1)
INDICATIONS AND USAGE
Abacavir tablets, 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) (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 alle