ACYCLOVIR ointment

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mylan Pharmaceuticals Inc.

INN (Международно Name):

ACYCLOVIR

Композиция:

ACYCLOVIR 50 mg in 1 g

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients. Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

Каталог на резюме:

Each gram of Acyclovir Ointment USP, 5% contains acyclovir USP, 50 mg in a polyethylene glycol base. Acyclovir Ointment USP, 5% is an opaque white to off-white ointment available as follows: 0378-8700-06 carton of one 15 g tube 0378-8700-49 carton of one 30 g tube Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Inc. Sugar Land, TX 77478 U.S.A. Revised: 7/2018 ACYCO:R4 1193.4 [pharmacode 1934]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ACYCLOVIR- ACYCLOVIR OINTMENT
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Acyclovir ointment, USP is a synthetic nucleoside analogue active
against herpes viruses. Acyclovir
ointment 5% is a formulation for topical administration. Each gram of
acyclovir ointment 5% contains 50
mg of acyclovir in a polyethylene glycol (PEG) base.
Acyclovir, USP is a white to off-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
9-[(2-Hydroxyethoxy)methyl]guanine; 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 to 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 humans, and
virus sensitivity testing has not been
standardized. Sensitivity testing results, expressed as the
concentration of drug required to inhibit by
50% the growth of virus