ACYCLOVIR capsule ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Acyclovir capsules, USP (white, opaque cap and body) containing 200 mg acyclovir, USP and printed with “RX 652 ” on both the cap and the body. Bottle of 25 (NDC 10544-089-25) Acyclovir tablets, USP (white, oval-shaped, unscored) containing 400 mg acyclovir, USP and debossed with “RX 504 ” on one side. Bottle of 25 (NDC 10544-039-25) Bottle of 40 (NDC 10544-039-40) Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from moisture. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA Manufactured by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA Marketed/ Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131, (USA) July 2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
ACYCLOVIR- ACYCLOVIR TABLET
BLENHEIM PHARMACAL, INC.
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ACYCLOVIR CAPSULES, USP AND ACYCLOVIR TABLETS, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against herpes
viruses. Acyclovir capsules, USP
and acyclovir tablets, USP are formulations for oral administration.
Each capsule of acyclovir contains 200 mg of acyclovir, USP and the
inactive ingredients lactose
monohydrate, magnesium stearate, and pregelatinized starch. The
capsule shell consists of gelatin and
titanium dioxide, printed with edible printing ink that contains black
iron oxide, and propylene glycol.
Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and
the inactive ingredients
colloidal silicone dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinized starch, and
sodium starch glycolate.
Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and
the inactive ingredients
colloidal silicone dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinized starch, and
sodium starch glycolate.
Acyclovir, USP is a white to off-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
8
11
5
3
monophosphate, a nucleotide analogue. The monophosphate is further
converted into diphosphate by
cellular guanylate kinase and into triphosphate by a number of
cellula