TRIZIVIR- abacavir sulfate, lamivudine, and zidovudine tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

から入手可能:

State of Florida DOH Central Pharmacy

INN（国際名）:

ABACAVIR SULFATE

構図:

ABACAVIR 300 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection. Additional important information on the use of TRIZIVIR for treatment of HIV-1 infection: TRIZIVIR Tablets are contraindicated in patients with: TRIZIVIR: Pregnancy Category C. There are no adequate and well-controlled studies of TRIZIVIR in pregnant women. Reproduction studies with abacavir, lamivudine, and zidovudine have been performed in animals (see Abacavir, Lamivudine, and Zidovudine sections below). TRIZIVIR should be used during pregnancy only if the potential benefits outweigh the risks. Abacavir: Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) and developmental toxicity (depressed fetal body weight and reduced crown-rump length) were observed in rats at a dose which produced 35 times the human exposure, based on AUC. Embryonic and fetal toxicities (incre

製品概要:

TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

認証ステータス:

New Drug Application

情報リーフレット

TRIZIVIR - ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLET, FILM
COATED
State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
TRIZIVIR® (TRY-zih-veer)
(abacavir sulfate, lamivudine, and zidovudine
Tablets
Read this Medication Guide before you start taking TRIZIVIR 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
TRIZIVIR Warning Card with you at all
times.
What is the most important information I should know about TRIZIVIR?
1.Serious allergic reaction (hypersensitivity reaction). TRIZIVIR
contains abacavir (also contained in
ZIAGEN® and EPZICOM®). Patients taking TRIZIVIR 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 2 or more of the following groups while
taking TRIZIVIR, call your
healthcare provider right away to find out if you should stop taking
TRIZIVIR.
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 TRIZIVIR because of an allergic reaction, never take
TRIZIVIR(abacavir sulfate, lamivudine,
and zidovudine)or any other abacavir-containing medicine (ZIAGEN and
EPZICOM) again. If you take
TRIZIVIR 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 TRIZIVIR, for any other reason, even for a few days, and you are
not allergic to TRIZIVIR

製品の特徴

TRIZIVIR - ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLET, FILM
COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIZIVIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRIZIVIR.
TRIZIVIR (ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE) TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY,
MYOPATHY,
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
TRIZIVIR, a combination of abacavir, lamivudine, and zidovudine, each
nucleoside analogue HIV-1 reverse transcriptase
inhibitors, is indicated in combination with other antiretroviral
agents for the treatment of HIV-1 infection. (1) (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets contain 300 mg abacavir, 150 mg of lamivudine, and 300 mg of
zidovudine. (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN
ASSOCIATED WITH ABACAVIR-
CONTAINING PRODUCTS. (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 TRIZIVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-
B*5701 STATUS, PERMANENTLY DISCONTINUE TRIZIVIR IF HYPERSENSITIVITY
CANNOT BE RULED OUT. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
TRIZIVIR OR ANY OTHER ABACAVIR-
CONTAINING PRODUCT. (5.1)
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN
ASSOCIATED WITH THE USE OF
ZIDOVUDINE, A COMPONENT OF TRIZIVIR. (5.2)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.3)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAV