ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 800 mg

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, 800 mg white to off-white, unscored, oval NDC: 63629-1678-1: 25 Tablets in a BOTTLE NDC: 63629-1678-2: 35 Tablets in a BOTTLE NDC: 63629-1678-3: 30 Tablets in a BOTTLE NDC: 63629-1678-4: 60 Tablets in a BOTTLE NDC: 63629-1678-5: 50 Tablets in a BOTTLE NDC: 63629-1678-6: 10 Tablets in a BOTTLE NDC: 63629-1678-7: 40 Tablets in a BOTTLE NDC: 63629-1678-8: 21 Tablets in a BOTTLE NDC: 63629-1678-9: 90 Tablets in a BOTTLE NDC: 63629-1678-0: 500 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR TABLET
BRYANT RANCH PREPACK
----------
ACYCLOVIR TABLETS USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
tablets are formulations of an antiviral drug for oral administration.
Each 800-mg tablet
of acyclovir contains 800 mg of acyclovir and the inactive ingredients
corn starch,
microcrystalline cellulose, magnesium stearate, and sodium starch
glycolate. Each 400-
mg tablet of acyclovir contains 400 mg of acyclovir and the inactive
ingredients corn
starch, microcrystalline cellulose, magnesium stearate, and sodium
starch glycolate.
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 6H-purin-6-one,
2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; 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 to VZV is due to its more efficient phosphorylation by
the viral TK.
ANTIVIRAL ACTIVITIES
The quantitative relationship between the _in vitro_ s