ZIDOVUDINE syrup

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Cipla Ltd.

INN (Mezinárodní Name):

ZIDOVUDINE

Složení:

ZIDOVUDINE 50 mg in 5 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Zidovudine Syrup (Zidovudine oral solution), a nucleoside reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Zidovudine Syrup (Zidovudine oral solution) is 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: - antepartum therapy of HIV-1 infected mothers - intrapartum therapy of HIV-1 infected mothers - 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. -   Because the fetus is most susceptible to

Přehled produktů:

Zidovudine Syrup (Zidovudine oral solution USP) (colorless to pale yellow strawberry flavored clear solution) containing 50mg of Zidovudine in each teaspoon (5mL) in plastic bottles of 240 mL [NDC no. 53104-0105-9]. Store at 20° to 25°C (68° to 77 °F). (see USP Controlled Room Temperature). Preserve in tight, light-resistant container.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ZIDOVUDINE- ZIDOVUDINE SYRUP
CIPLA LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIDOVUDINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZIDOVUDINE.
ZIDOVUDINE SYRUP [ZIDOVUDINE ORAL SOLUTION] 50MG/5ML, FOR ORAL USE
RX ONLY
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, Allergic Reaction to Latex 11/2017 (5.2)
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 is 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 interrupt