ZOVIRAX- acyclovir cream

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)

Доступна с:

Rebel Distributors Corp

ИНН (Международная Имя):

ACYCLOVIR

состав:

ACYCLOVIR 50 mg in 1 g

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older). ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.

Обзор продуктов:

Each gram of ZOVIRAX Cream 5% contains 50 mg acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows: 5-g tubes (NDC 42254-149-05). Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Manufactured by GlaxoSmithKline Research Triangle Park, NC 27709 for BTA Pharmaceuticals, Inc. (subsidiary of Biovail Corporation) Bridgewater, NJ 08807 ©2009, GlaxoSmithKline. All rights reserved. July 2009         ZVC:2PI Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Статус Авторизация:

New Drug Application

Характеристики продукта

ZOVIRAX- ACYCLOVIR CREAM
REBEL DISTRIBUTORS CORP
----------
ZOVIRAX
(ACYCLOVIR)
CREAM 5%
USE ONLY FOR COLD SORES
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside
analogue active against
herpesviruses. ZOVIRAX Cream 5% is a formulation for topical
administration. Each gram of
ZOVIRAX Cream 5% contains 50 mg of acyclovir and the following
inactive ingredients: cetostearyl
alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl
sulfate, water, and white
petrolatum.
Acyclovir is a white, crystalline powder with the molecular formula C
H N O and a molecular
weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL.
The pKa’s of acyclovir are 2.27
and 9.25.
The chemical name of acyclovir is
2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6_H_-purin-6-one;
it has the following structural formula:
VIROLOGY
MECHANISM OF ANTIVIRAL ACTION:
Acyclovir is a synthetic purine nucleoside analogue with in vitro and
in vivo inhibitory activity against
herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster
virus (VZV).
The inhibitory activity of acyclovir is highly selective due to its
affinity for the enzyme thymidine
kinase (TK) encoded by HSV and VZV. This viral enzyme converts
acyclovir into acyclovir
monophosphate, a nucleotide analogue. The monophosphate is further
converted into diphosphate by
cellular guanylate kinase and into triphosphate by a number of
cellular enzymes. In vitro, acyclovir
triphosphate stops replication of herpes viral DNA. This is
accomplished in 3 ways: 1) competitive
inhibition of viral DNA polymerase, 2) incorporation into and
termination of the growing viral DNA
chain, and 3) inactivation of the viral DNA polymerase. The greater
antiviral activity of acyclovir
against HSV compared with VZV is due to its more efficient
phosphorylation by the viral TK.
ANTIVIRAL ACTIVITIES:
The quantitative relationship between the in vitro susceptibility of
herpes viruses to antivirals and the
clinical response to therapy has not been established in hu