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:

Rebel Distributors Corp

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 21695-009-25) Bottle of 30 (NDC 21695-009-30) Acyclovir tablets, USP (white, oval-shaped, unscored) containing 800 mg acyclovir, USP and debossed with “RX 505 ” on one side. Bottle of 21 (NDC 21695-011-21) Bottle of 25 (NDC 21695-011-25) Bottle of 30 (NDC 21695-011-30) Bottle of 35 (NDC 21695-011-35) Bottle of 40 (NDC 21695-011-40) Acyclovir tablets, USP (white, oval-shaped, unscored) containing 400 mg acyclovir, USP and debossed with “RX 504 ” on one side. Bottle of 20 (NDC 21695-010-20) Bottle of 25 (NDC 21695-010-25) Bottle of 30 (NDC 21695-010-30) Bottle of 60 (NDC 21695-010-60) Bottle of 90 (NDC 21695-010-90) Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from moisture. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA April 2009 Repackaged By: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
ACYCLOVIR- ACYCLOVIR TABLET
REBEL DISTRIBUTORS CORP
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ACYCLOVIR
RXONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. 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 black iron
oxide, edible printing ink, gelatin, and titanium dioxide.
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 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 wa