ACYCLOVIR- acyclovir suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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04-09-2014

Ingredientes activos:

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

Disponible desde:

Renaissance Pharma, Inc.

Designación común internacional (DCI):

ACYCLOVIR

Composición:

ACYCLOVIR 200 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Acyclovir Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL). Bottle of 1 pint (473 mL) (NDC 40085-842-96). Store at 15° to 25°C (59° to 77°F). Manufactured for: Renaissance Pharma, Inc. Newtown, PA 18940 by Glaxosmithkline Mississauga, ON, CANADA March 2014

Estado de Autorización:

New Drug Application Authorized Generic

Ficha técnica

                                ACYCLOVIR- ACYCLOVIR SUSPENSION
RENAISSANCE PHARMA, INC.
----------
ACYCLOVIR SUSPENSION
PRESCRIBING INFORMATION
ACYCLOVIR SUSPENSION
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir Suspension is a
formulation for oral administration.
Each teaspoonful (5 mL) of Acyclovir Suspension contains 200 mg of
acyclovir and the inactive
ingredients methylparaben 0.1% and propylparaben 0.02% (added as
preservatives),
carboxymethylcellulose sodium, avor, glycerin, microcrystalline
cellulose, and sorbitol.
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
afnity 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 efcient
phosphorylation by the viral TK.
ANTIVIRAL ACTIVITIES:
The quantitative relationship between the in vitro susceptibility of
herpes viruses to antivirals and the
clinical re
                                
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