ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 71209-005-05) Bottle of 500 (NDC 71209-005-10) 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 71209-006-05) Bottle of 500 (NDC 71209-006-10) 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. Made in India by: Cadila Pharmaceuticals Limited,  1389, Dholka, District - Ahmedabad, Gujarat State, INDIA Revised: November 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR - ACYCLOVIR TABLET
CADILA PHARMACEUTICALS LIMITED
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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 of
acyclovir. 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. 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
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 has not been
established in humans, and
virus sensitivity te