ABACAVIR tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

AvPAK

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Abacavir tablets, 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 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 r

Ringkasan produk:

Abacavir tablets, USP containing abacavir sulfate, USP equivalent to 300 mg abacavir are yellow colored, biconvex, capsule shaped, film coated tablets debossed with 'H' on one side and '139' on other side separating 13 & 9 with score line. They are packaged as follows: NDC 50268-049-12 (10 tablets per card, 2 cards per carton). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

ABACAVIR- ABACAVIR TABLET
AvPAK
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MEDICATION GUIDE
Abacavir Tablets , USP
(ah-BAH-kah-veer)What is the mos t important information I s hould
know about abacavir
tablets ?
Abacavir can cause serious side effects, including:
•Serious allergic reaction (hypers ens itivity 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 s ymptom from 2 or more of the following groups while
taking abacavir tablets , call
your healthcare provider right away to find out if you s hould s top
taking abacavir tablets .
Symptom(s )
Group 1 Fever
Group 2 Ras h
Group 3 Naus ea, vomiting, diarrhea, abdominal (s tomach
area) pain
TM
Group 4 Generally ill feeling, extreme tirednes s , or
achines s
Group 5 Shortnes s of breath, cough, s ore 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 s top abacavir tablets becaus e 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 s ymptoms
that may include very low
blood pres s ure or death.
• If you stop abacavir tablets for any other reason, even for a few
days, and you are not allergic to
abacavir, 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 a

Ciri produk

ABACAVIR- ABACAVIR TABLET
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ABACAVIR TABLETS, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR
TABLETS.
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. ( 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 TABLETS ARE 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 TABLET OR
ANY OTHER ABACAVIR-CONTAINING PRODUCT. ( 5.1)
RECENT MAJOR CHANGES
Boxed Warning 05/2018
Warnings and Precautions, Lactic Acidosis and Severe 05/2018
Hepatomegaly with Steatosis ( 5.2)
Warnings and Precautions, Fat Redistribution (previous 5.4) Removed
05/2018
Warnings and Precautions, Myocardial Infarction ( 5.4) 05/2018
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, 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 b