ZIAGEN- abacavir sulfate tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

State of Florida DOH Central Pharmacy

INN (Kansainvälinen yleisnimi):

ABACAVIR SULFATE

Koostumus:

ABACAVIR SULFATE 300 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

ZIAGEN Tablets and Oral Solution, 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 ZIAGEN for treatment of HIV-1 infection: - ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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. ZIAGEN is contraindicated in patients with previously demonstrated hypersensitivity to abacavir or any other component of the products. NEVER restart ZIAGEN 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)] . ZIAGEN is contraindicated in patients with moderate or severe hepatic impairment. Pregnancy Category C. Studies in pregnant rats showed that abacavir is transferred to the fe

Tuoteyhteenveto:

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 supplied by State of Florida DOH Central Pharmacy as follows: 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. 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 0173-0664-00) 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.

Valtuutuksen tilan:

New Drug Application

Pakkausseloste

ZIAGEN - ABACAVIR SULFATE TABLET, FILM COATED
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
ZIAGEN® (ZY-uh-jen) Tablets
ZIAGEN® Oral Solution
Generic name: abacavir (uh-BACK-ah-veer) sulfate tablets and oral
solution
Read the Medication Guide that comes with ZIAGEN before you start
taking it and each time you get a
refill because there may be new information. This information does not
take the place of talking to your
doctor about your medical condition or your treatment. Be sure to
carry your ZIAGEN Warning Card
with you at all times.
What is the most important information I should know about ZIAGEN?
•
Serious Allergic Reaction to Abacavir. ZIAGEN contains abacavir (also
contained in EPZICOM®
and TRIZIVIR®). Patients taking ZIAGEN 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 than if you do not. Your doctor 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 doctor right away to determine if you should
stop taking this medicine.
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.
If you stop ZIAGEN because of an allergic reaction, NEVER take ZIAGEN
(abacavir sulfate) or any
other abacavir-containing medicine (EPZICOM and TRIZIVIR) again. 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 doctor before taking it again

Valmisteyhteenveto

ZIAGEN - 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
ZIAGEN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZIAGEN.
ZIAGEN (ABACAVIR SULFATE) TABLETS AND ORAL SOLUTION
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 ZIAGEN (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 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 ABACAVIR, NEVER RESTART
ZIAGEN 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
Boxed Warning July 2008
Dosage and Administration (2.2) December 2008
Warnings and Precautions (5.1, 5.5) July 2008
INDICATIONS AND USAGE
ZIAGEN, a nucleoside analogue, is indicated in combination with other
antiretroviral agents for the treatment of HIV-1
infection. (1) (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 Impairment: Mild hepatic impairment – 200 mg
twice daily; moderate/severe hepatic imp