ACYCLOVIR tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

Acyclovir

Sammensetning:

Acyclovir 400.00 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Acyclovir Tablets, 800 mg (white to off-white, unscored, oval and engraved with “”) are supplied in bottles of 35. Bottle of 21          (NDC 42254-198-21) Bottle of 25          (NDC 42254-198-25) Bottle of 30 (NDC 42254-198-30) Bottle of 35 (NDC 42254-198-35) Bottle of 50 (NDC 42254-198-50) Acyclovir Tablets, 400 mg (white to off-white, unscored, oval and engraved with “”) are supplied in bottles of 30. Bottle of 15          (NDC 42254-133-15) Bottle of 20          (NDC 42254-133-20) Bottle of 21          (NDC 42254-133-21) Bottle of 25          (NDC 42254-133-25) Bottle of 30          (NDC 42254-133-30) Bottle of 60          (NDC 42254-133-60) Bottle of 90          (NDC 42254-133-90) 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 BY: Carslbad Technology, Inc Carlsbad, CA USA Repackaged By: Rebel Distributors Corp Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ACYCLOVIR- ACYCLOVIR TABLET
REBEL DISTRIBUTORS CORP
----------
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 ways: 1) competitive
inhibition