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:

State of Florida DOH Central Pharmacy

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. Additional important information on the use of abacavir tablets for treatment of HIV-1 infection: - Abacavir tablets are one of multiple products containing abacavir. Before starting abacavir tablets, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir [see Warnings and Precautions (5.1), Adverse Reactions (6)]. Abacavir tablets are contraindicated in patients with: - previously demonstrated hypersensitivity to abacavir or any other component of the products. NEVER restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status [see Warnings and Precautions (5.1), Adverse Reactions (6)]. - moderate or severe hepatic impairment [see Dosage and Administration (2.3)

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 supplied by State of Florida DOH Central Pharmacy as follows: 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

State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
ABACAVIR TABLETS, USP
(a bak′ a vir sul′ fate)
300 mg
Read this Medication Guide before you start taking abacavir tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or your treatment. Be sure to carry your
Abacavir Tablets Warning Card
with you at all times.
What is the most important information I should know about abacavir
tablets?
1. Serious allergic reaction (hypersensitivity reaction). Abacavir
tablets contain abacavir (also contained
in EPZICOM®** and TRIZIVIR®**). Patients taking abacavir tablets may
have a serious allergic
reaction (hypersensitivity reaction) that can cause death. 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 two 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 (abacavir sulfate)
or any other abacavir-containing medicine (EPZICOM®** and
TRIZIVIR®**) again. 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 hea

Caracteristicilor produsului

ABACAVIR SULFATE - ABACAVIR SULFATE TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE
HEPATOMEGALY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN
ASSOCIATED WITH ABACAVIR (ABACAVIR
SULFATE). (5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1)
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGH RISK FOR
EXPERIENCING A HYPERSENSITIVITY REACTION
TO ABACAVIR. (5.1)
DISCONTINUE ABACAVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701
STATUS, PERMANENTLY DISCONTINUE ABACAVIR 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)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGUES. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2) 05/2012
Warnings and Precautions, Hypersensitivity Reaction (5.1) 05/2012
Warnings and Precautions, Immune Reconstitution Syndrome (5.3) 11/2011
INDICATIONS AND USAGE
Abacavir, a nucleoside analogue, is indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection. (1)
DOSAGE AND ADMINISTRATION
A medication guide and warning card should be dispensed with each new
prescription and refill. (2)
Adults: 600 mg daily, administered as either 300 mg twice daily or 600
mg once daily. (2.1)
Pediatric Patients Aged 3 Months and Older: Dose should be calculated
on body weight (kg) and should not exceed 300
mg twice daily. (2.2)
Patients with Hepatic