ACYCLOVIR tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Acyclovir (UNII: X4HES1O11F) (Acyclovir - UNII:X4HES1O11F)

Commercializzato da:

RedPharm Drug Inc.

INN (Nome Internazionale):

Acyclovir

Composizione:

Acyclovir 400 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Acyclovir is indicated for the treatment of chickenpox (varicella).

Dettagli prodotto:

Acyclovir tablets, USP (white, oval-shaped, unscored) containing 400 mg acyclovir, USP and debossed with “RX 504 ” on one side. Bottle of 20 (NDC 67296-0375-1) Bottle of 30 (NDC 67296-0375-2) Bottle of 70 (NDC 67296-0375-3) 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 by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA April 2009

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ACYCLOVIR - ACYCLOVIR TABLET
REDPHARM DRUG INC.
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ACYCLOVIR TABLETS
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 ways: 1) competitive
inhibition of