ACYCLOVIR- acyclovir capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

Acyclovir

Composition:

Acyclovir 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Acyclovir Capsules, 200 mg Oval capsule, opaque light blue cap imprinted with a mark "200" and opaque white body imprinted with . NDC 50268-060-15 10 capsules per card, 5 cards per carton Dispensed in blister punch material. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 11/14 AV Rev. 03/16 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
AVPAK
----------
ACYCLOVIR CAPSULES USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir capsules are
formulations for oral administration.
Each capsule contains 200 mg of acyclovir and the inactive
ingredients: lactose monohydrate, sodium
lauryl sulfate, sodium starch glycolate, and magnesium stearate. The
capsule shell consists of FD&C
Blue #1, gelatin, and titanium dioxide. The imprinting ink contains,
alcohol, FD&C Blue #2, FD&C Red
#40, FD&C Yellow #10, iron oxide black, shellac Glaze.
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: 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_ susceptibility of herpes viruses