ACYCLOVIR tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Preferred Pharmaceuticals Inc.

Designación común internacional (DCI):

ACYCLOVIR

Composición:

ACYCLOVIR 400 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella). Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Resumen del producto:

Acyclovir Tablets USP, 400 mg are white to off-white colored, round shaped, biconvex, uncoated tablets, debossed with "791" on one side and plain on the other side and are supplied as follows: NDC 68788-7382-2 in bottles of 21 tablets NDC 68788-7382-7 in bottles of 28 tablets NDC 68788-7382-3 in bottles of 30 tablets NDC 68788-7382-8 in bottles of 35 tablets NDC 68788-7382-4 in bottles of 40 tablets NDC 68788-7382-5 in bottles of 50 tablets NDC 68788-7382-6 in bottles of 60 tablets NDC 68382-792-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Manufactured by: Cadila Healthcare Ltd. Baddi, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534                                                                                                                    Rev.: 05/13 Repackaged By: Preferred Pharmaceuticals Inc.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ACYCLOVIR- ACYCLOVIR TABLET
PREFERRED PHARMACEUTICALS INC.
----------
ACYCLOVIR TABLETS, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
tablets are formulations for oral administration.
Acyclovir is a white or almost white, crystalline powder with the
molecular formula
C H
N O and a molecular weight of 225.20. It is soluble in diluted
hydrochloric acid;
slightly soluble in water and insoluble in alcohol. 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]-_6H-_purin-6-one; it has the following
structural formula:
Each acyclovir tablet intended for oral administration contains 400 mg
and 800 mg of
acyclovir. In addition, each tablet contains the following inactive
ingredients: colloidal
silicon dioxide, magnesium stearate, microcrystalline cellulose,
pregelatinized starch and
sodium starch glycolate.
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
8
11
5
3
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