ACYCLOVIR suspension

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Actavis Pharma, Inc.

DCI (Denominação Comum Internacional):

ACYCLOVIR

Composição:

ACYCLOVIR 200 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 oral suspension is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Resumo do produto:

Acyclovir oral suspension, USP (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL). Bottle of 1 pint (473 mL) NDC 0472-0082-16. Store between 15° to 25°C (59° to 77°F). Protect from light. Dispense in a tight container as defined in the USP. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 1/2020 3701602-1120 GW7331

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ACYCLOVIR- ACYCLOVIR SUSPENSION
ACTAVIS PHARMA, INC.
----------
ACYCLOVIR ORAL SUSPENSION, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against herpes
viruses. Acyclovir suspension is
formulated for oral administration.
Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200
mg of acyclovir and the
inactive ingredients carboxymethylcellulose sodium, flavor, glycerin,
methylparaben (0.1%),
microcrystalline cellulose, propylparaben (0.02%), purified water and
sorbitol.
Acyclovir is a white, crystalline powder with the molecular formula C
H N O , and a molecular
weight of 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine;
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 three 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 to VZV is due to its more efficient
phosphorylation by the viral TK.
ANTIVIRAL ACTIVITIES: The quantitative relationship between the _in
vitro_ susceptibility of herpes viruses
to antivirals and the clinical response to therapy has not been
established in humans,