ACYCLOVIR capsule

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 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Acyclovir Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “ “CP115” and “200” Bottle of 100 (NDC 71209-004-05). Bottle of 500 (NDC 71209-004-10). Store at 15° to 25°C (59° to 77°F) and protect from moisture. Manufactured 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 CAPSULE
CADILA PHARMACEUTICALS LIMITED
----------
DESCRIPTION
Acyclovir, a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
Capsules, is a formulation for oral administration. Each Acyclovir
Capsule contains
200 mg of acyclovir and the inactive ingredients corn starch, lactose
monohydrate,
magnesium stearate, and sodium lauryl sulfate. The capsule shell
consists of gelatin,
FD&C Blue No. 2, and titanium dioxide. Printed with edible black ink.
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:
8
11
5
3
The quantitative relationship between the _in vitro_ susceptibility of
herpes viruses to
antivirals and the clinical response to therapy has not been
established in h