ACYCLOVIR ointment

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Amneal Pharmaceuticals LLC

DCI (Denominação Comum Internacional):

ACYCLOVIR

Composição:

ACYCLOVIR 50 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Acyclovir Ointment, USP 5% is supplied as a white color ointment.  Each gram of acyclovir ointment, USP 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 15-g tubes (NDC 65162-835-94) 30-g tubes (NDC 65162-835-96) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place.   Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 02-2016-01

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ACYCLOVIR- ACYCLOVIR OINTMENT
AMNEAL PHARMACEUTICALS LLC
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ACYCLOVIR OINTMENT, USP 5%
DESCRIPTION
Acyclovir, USP, is a synthetic nucleoside analogue active against
herpes viruses.
Acyclovir ointment, USP 5% is a formulation for topical
administration. Each gram of
acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a
polyethylene glycol
(PEG) base.
Acyclovir, USP 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, USP are 2.27 and 9.25.
The chemical name of acyclovir, USP 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 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 conce