ACYCLOVIR capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

American Health Packaging

INN（国際名）:

ACYCLOVIR

構図:

ACYCLOVIR 200 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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.

製品概要:

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:Unit dose packages of 100 (10 x 10) NDC 68084-107-01 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. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Apotex Corp. as follows: (200 mg / 100 UD) NDC 68084-107-01 packaged from NDC 60505-0042 Distributed by: American Health Packaging Columbus, OH 43217 8210701/0813A

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ACYCLOVIR- ACYCLOVIR CAPSULE
AMERICAN HEALTH PACKAGING
----------
ACYCLOVIR CAPSULES USP
8210701/0813A
RX ONLY
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). 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
8
11
5
3
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