ABACAVIR SULFATE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Mylan Pharmaceuticals Inc.

INN (nume internaţional):

ABACAVIR SULFATE

Compoziție:

ABACAVIR 300 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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: 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. 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 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 births that occurred at less than 20 weeks’ gestation. The rate of miscarriage is not reported in the APR. The estim

Rezumat produs:

Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are peach, film-coated, capsule shaped, scored tablets debossed with M on one side of the score and 120 on the other side of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4105-91 carton of one bottle containing 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Abacavir Tablets, USP
(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 reactions (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
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 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, talk with your healthcare provider before taking them again.
Taking abacavir tablets
again can cause a serious allergic or life-threatening reaction, even
if you never had an allergic
reaction to them before.
If your healthcare provider tells you that you can take abacavir
tablets again, start ta

Caracteristicilor produsului

ABACAVIR SULFATE- ABACAVIR SULFATE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
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._
•
•
•
•
•
•
INDICATIONS AND USAGE
Abacavir tablets, a nucleoside analogue human immunodeficiency virus
(HIV-1) reverse transcriptase inhibitor, are
indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ABACAVIR. (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 TABLETS OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
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 be calculated on
body weight (kg) and should not exceed 600 mg daily. (2.3)
Patients with Hepatic Impairment: Mild hepati