ZIDOVUDINE- zidovudine tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

제공처:

Camber Pharmaceuticals, Inc.

INN (국제 이름):

ZIDOVUDINE

구성:

ZIDOVUDINE 300 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration ( 2.3)]. The indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of HIV-1-infected mothers 2. intrapartum therapy of HIV-1-infected mothers 3. post-partum therapy of HIV-1-exposed neonate Points to consider prior to initiating zidovudine in pregnant women for the prevention of maternal-fetal HIV-1 transmission include: • In most cases, zidovudine for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs. • Prevention of HIV-1 transmission in women who have received zidovudine for a prolonged period before pregnancy has not been evaluated.

제품 요약:

Zidovudine Tablets USP, 300 mg are white to off white colored, biconvex, round film coated tablets debossed with 'H' on one side and '1' on other side.               Bottle of 60 (NDC 31722-509-60).                Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ZIDOVUDINE - ZIDOVUDINE TABLET
CAMBER PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIDOVUDINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZIDOVUDINE TABLETS.
ZIDOVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND
SEVERE HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA HAVE
BEEN ASSOCIATED
WITH THE USE OF ZIDOVUDINE. ( 5.1)
• SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
( 5.3)
• LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE
BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES INCLUDING
ZIDOVUDINE. SUSPEND
TREATMENT IF CLINICAL OR LABORATORY FINDINGS SUGGESTIVE OF LACTIC
ACIDOSIS OR PRONOUNCED
HEPATOTOXICITY OCCUR. ( 5.4)
RECENT MAJOR CHANGES
Dosage and Administration, Prevention of Maternal-Fetal HIV-1
Transmission ( 2.3)
09/2018
Warnings and Precautions, Lactic Acidosis and Severe Hepatomegaly with
Steatosis ( 5.4)
11/2017
Warnings and Precautions, Lipoatrophy (
5.7) 11/2017
INDICATIONS AND USAGE
Zidovudine tablets are a nucleoside analogue reverse transcriptase
inhibitor indicated for:
•Treatment of Human Immunodeficiency Virus (HIV-1) infection in
combination with other antiretroviral
agents. ( 1.1)
• Prevention of maternal-fetal HIV-1 transmission. ( 1.2)
DOSAGE AND ADMINISTRATION
• Treatment of HIV-1 infection:
Adults: Recommended oral dosage is 300 mg twice a day with other
antiretroviral agents. ( 2.1)
Pediatric patients (aged 4 weeks to less than 18 years): Dosage should
be calculated based on body
weight not to exceed adult dose. ( 2.2)
• Prevention of maternal-fetal HIV-1 transmission:
Specific dosage instructions for mother and infant. ( 2.3)
• Patients with severe anemia and/or neutropenia:
Dosage interruption may be necessary. ( 2.4)
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