ACYCLOVIR capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Major Pharmaceuticals

INN:

ACYCLOVIR

composition:

ACYCLOVIR 200 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

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: Cartons of 100 capsules (10 capsules each blister pack x 10) NDC 0904-5789-61 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 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Revised: December 2005 Rev. 4

authorization_status:

Abbreviated New Drug Application

SPC

ACYCLOVIR- ACYCLOVIR CAPSULE
MAJOR PHARMACEUTICALS
----------
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:
ANTIVIRAL ACTIVITIES
The quantitative relationship between the in vitro susceptibility of
herpes viruses to
antivirals and the clinical response to therapy has not been
established in humans, and
virus sensitivity testing has not been standardized. Sensitivity
testing results, ex