ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 66267-007-30 Bottles of 30 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.: 09/12 Revision Date: 14/09/2012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR TABLET
NUCARE 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 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
8
11
5
3
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 _suscepti