ACYCLOVIR capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Apotex Corp.

INN (Isem Internazzjonali):

Acyclovir

Kompożizzjoni:

Acyclovir 200 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Acyclovir Capsules USP 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and an aqua blue opaque cap. “APO 042” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 100 (60505-0042-6) Bottles of 500 (60505-0042-5) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture. Manufactured by:                                    Manufactured for: Apotex Inc.                                             Apotex Corp. Toronto, Ontario                                      Weston, Florida Canada M9L 1T9                                     33326 Revised: December 2005 Rev. 4

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACYCLOVIR- ACYCLOVIR CAPSULE
APOTEX CORP.
----------
ACYCLOVIR CAPSULES USP
200 MG
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against herpes
viruses. Acyclovir
capsule is a formulation for oral administration. Each capsule of
acyclovir contains 200
mg of acyclovir and the inactive ingredients colloidal silicon
dioxide, croscarmellose
sodium, magnesium stearate and microcrystalline cellulose. The capsule
shell consists of
FD&C blue #1, gelatin and titanium dioxide. The capsule black
imprinting ink contains the
following inactive ingredients: ammonium hydroxide, black iron oxide,
n-butyl, ethyl
alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and
shellac.
Acyclovir is a white, crystalline powder with the molecular formula C
H
N O and a
molecular weight of 225.2. 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).
8
11
5
3
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