ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Acyclovir Tablets, USP 400 mg are available for oral administration as white round tablets, engraved Y212 on one side and plain on other. They are supplied as follows: Bottle of 6 (NDC 82804-005-06) Bottle of 15 (NDC 82804-005-15) Bottle of 20 (NDC 82804-005-20) Bottle of 21 (NDC 82804-005-21) Bottle of 30 (NDC 82804-005-30) Bottle of 35 (NDC 82804-005-35) Bottle of 60 (NDC 82804-005-60) Bottle of 90 (NDC 82804-005-90) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR TABLET
PROFICIENT RX LP
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ACYCLOVIR TABLETS, USP
400 MG
DESCRIPTION
Acyclovir, USP is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
Capsules, USP and Acyclovir Tablets, USP are formulations for oral
administration.
Each capsule contains 200 mg of acyclovir, USP and the inactive
ingredients corn
starch, lactose monohydrate, magnesium stearate, and sodium lauryl
sulfate. The
capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3,
FD&C Yellow No. 6
and titanium dioxide. Printed with edible black ink.
Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and
the inactive
ingredients magnesium stearate, microcrystalline cellulose PH101,
povidone K30, and
sodium starch glycolate (Type A) (Starch from Non GMO potatoes).
Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and
the inactive
ingredients magnesium stearate, microcrystalline cellulose PH101,
povidone K30, and
sodium starch glycolate (Type A) (Starch from Non GMO potatoes).
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
2.5mg/mL. The
pka's of acyclovir are 2.27 and 9.25.
The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-
hydroxyethoxy)methyl]-6H-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).
8
11
5
3
The inhibitory activity of acyclovir is highly selective due to its
affinity for the enzyme
thymidine kinase (TK) enclosed 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