ZIAGEN- abacavir sulfate tablet, film coated ZIAGEN- abacavir sulfate solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

ViiV Healthcare Company

INN (International ime):

ABACAVIR SULFATE

Sastav:

ABACAVIR 300 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZIAGEN 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 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 misca

Proizvod sažetak:

ZIAGEN tablets, containing abacavir sulfate equivalent to 300 mg abacavir are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides. They are packaged as follows: Bottles of 60 tablets (NDC 49702-221-18) with child-resistant closure. Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP). ZIAGEN oral solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid, which may turn brown over time. Each mL of the solution contains abacavir sulfate equivalent to 20 mg of abacavir. It is packaged in plastic bottles as follows: Bottles of 240 mL (NDC 49702-222-48) with child-resistant closure. This product does not require reconstitution. Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP). DO NOT FREEZE. May be refrigerated.

Status autorizacije:

New Drug Application

Uputa o lijeku

ZIAGEN- ABACAVIR SULFATE SOLUTION
ViiV Healthcare Company
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MEDICATION GUIDE
ZIAGEN (ZY-uh-jen) ZIAGEN (ZY-uh-jen)
(abacavir) (abacavir)
tablets oral solution
What is the most important information I should know about ZIAGEN?
ZIAGEN can cause serious side effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
ZIAGEN 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 ZIAGEN, call your
healthcare provider right away to find out if you should stop taking
ZIAGEN.
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 ZIAGEN because of an allergic reaction, never take ZIAGEN
(abacavir) or any other
abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.
•
If you have an allergic reaction, dispose of any unused ZIAGEN. Ask
your pharmacist how to
properly dispose of medicines.
•
If you take ZIAGEN 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 ZIAGEN for any other reason, even for a few days, and you
are not allergic to
ZIAGEN, talk with your healthcare provider before taking it again.
Taking ZIAGEN 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 ZIAGEN again,
start taking it when you are
around medical help or peo

Svojstava lijeka

ZIAGEN- ABACAVIR SULFATE TABLET, FILM COATED
ZIAGEN- ABACAVIR SULFATE SOLUTION
VIIV HEALTHCARE COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIAGEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIAGEN.
ZIAGEN (ABACAVIR) TABLETS, FOR ORAL USE
ZIAGEN (ABACAVIR) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
ZIAGEN, 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
•
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
•
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WARNINGS AND PRECAUTIONS
•
•
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ZIAGEN
(ABACAVIR). (5.1)
HYPERSENSITIVITY TO ZIAGEN 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)
ZIAGEN IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO
ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ZIAGEN AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED.
REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ZIAGEN IF
HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE
POSSIBLE.
(5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ZIAGEN, NEVER RESTART ZIAGEN
OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
Before initiating ZIAGEN, 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
tw