ACYCLOVIR tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Acyclovir (UNII: X4HES1O11F) (Acyclovir - UNII:X4HES1O11F)

Disponível em:

Nivagen Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

Acyclovir

Composição:

Acyclovir 400 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Acyclovir Tablets is indicated for the acute treatment of herpes zoster (shingles). Acyclovir Tablets is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Acyclovir Tablets are indicated for the treatment of chickenpox (varicella). Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Resumo do produto:

Acyclovir Tablets, USP 400 mg is White to off white, oval, biconvex, uncoated tablets, debossed with 'CP114' on one side and '400' on other side. It is available as follows: Bottle of 100 (NDC 75834-122-01) Bottle of 500 (NDC 75834-122-05) Acyclovir Tablets, USP 800 mg is Light blue to blue, oval, biconvex, uncoated tablets, debossed with 'CP113' on one side and '800' on the other side. It is available as follows: Bottle of 100 (NDC 75834-123-01) Bottle of 500 (NDC 75834-123-05) Store at 15° to 25°C (59° to 77°F) and protect from light and moisture. Dispense in tight light resistant container as defined in the USP.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ACYCLOVIR- ACYCLOVIR TABLET
NIVAGEN PHARMACEUTICALS, INC.
----------
ACYCLOVIR TABLETS, USP
NIVAGEN PHARMACEUTICALS, INC.
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
Tablets are for oral administration. Each Acyclovir Tablet contains
400 mg or 800-mg. In
addition, each tablet contains the inactive ingredients: magnesium
stearate,
microcrystalline cellulose, povidone, sodium starch glycolate and
talc. The 800mg tablet
also contains FD&C Blue No. 2 Lake.
Acyclovir is a white, crystalline powder with the molecular formula C
H
N O and a
molecular weight of 225.20. 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
8
11
5
3
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 ha