ZOVIRAX- acyclovir capsule ZOVIRAX- acyclovir tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prestium Pharma, Inc.

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 200 mg

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 Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200” Bottle of 100 (NDC 40076-991-55) Store at 15° to 25°C (59° to 77°F) and protect from moisture. ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800” Bottle of 100 (NDC 40076-945-55) Store at 15° to 25°C (59° to 77°F) and protect from moisture. ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side. Bottle of 100 (NDC 40076-949-55) Store at 15° to 25°C (59° to 77°F) and protect from moisture. ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL). Bottle of 1 pint (473 mL) (NDC 40076-953-96) Store at 15° to 25°C (59° to 77°F). ZOVIRAX is a registered trademark of GlaxoSmithKline. Manufactured for: Prestium Pharma, Inc. Newtown, PA 18940 By GlaxoSmithKline Mississauga, ON, CANADA Manufactured for: Prestium Pharma, Inc. Newtown, PA 18940 By GlaxoSmithKline Research Triangle Park, NC 27709 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

ZOVIRAX- ACYCLOVIR CAPSULE
ZOVIRAX- ACYCLOVIR TABLET
ZOVIRAX- ACYCLOVIR SUSPENSION
PRESTIUM PHARMA, INC.
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ZOVIRAX
(ACYCLOVIR)
CAPSULES
ZOVIRAX
(ACYCLOVIR)
TABLETS
ZOVIRAX
(ACYCLOVIR)
SUS PENS ION
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside
analogue active against
herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are
formulations for oral administration.
Each capsule of ZOVIRAX contains 200 mg of acyclovir and the inactive
ingredients corn starch,
lactose, magnesium stearate, and sodium lauryl sulfate. The capsule
shell consists of gelatin, FD&C
Blue No. 2, and titanium dioxide. May contain one or more parabens.
Printed with edible black ink.
Each 800-mg tablet of ZOVIRAX contains 800 mg of acyclovir and the
inactive ingredients FD&C
Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone,
and sodium starch glycolate.
Each 400-mg tablet of ZOVIRAX contains 400 mg of acyclovir and the
inactive ingredients magnesium
stearate, microcrystalline cellulose, povidone, and sodium starch
glycolate.
Each teaspoonful (5 mL) of ZOVIRAX 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 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:
®
®
®
8
11
5
3
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