ZOVIRAX- acyclovir suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles). ZOVIRAX is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. ZOVIRAX is indicated for the treatment of chickenpox (varicella). ZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Product summary:

ZOVIRAX (acyclovir) Oral Suspension contains 200 mg of acyclovir, USP in each teaspoonful (5 mL). The off-white, banana-flavored suspension is available as follows: NDC 0378-9735-73 1 pint bottle (473 mL) Store at 15° to 25°C (59° to 77°F). Protect from light. ZOVIRAX® , a registered trademark of GlaxoSmithKline LLC, is licensed (limited) to Delcor Asset Corp., a Mylan company. © 2018 Delcor Asset Corporation, a Mylan Company Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Confab Laboratories Inc. St-Hubert, Canada J3Y 3X3 301791-02 Revised: 4/2018 CON:ACYCZOS:R1

Authorization status:

New Drug Application

Summary of Product characteristics

ZOVIRAX- ACYCLOVIR SUSPENSION
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside
analogue active against herpes
viruses. ZOVIRAX Oral Suspension is a formulation for oral
administration.
Each teaspoonful (5 mL) of ZOVIRAX Oral Suspension contains 200 mg of
acyclovir and the inactive
ingredients methylparaben 0.1% and propylparaben 0.02% (added as
preservatives),
carboxymethylcellulose sodium, flavor, glycerin, microcrystalline
cellulose, and sorbitol.
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 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 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