ACYCLOVIR capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Zydus Lifesciences Limited

INN (الاسم الدولي):

ACYCLOVIR

تركيب:

ACYCLOVIR 200 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella). Acyclovir capsules are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

ملخص المنتج:

Acyclovir Capsules USP, 200 mg are white to off-white powder filled in size "1" empty hard gelatin capsules with blue opaque colored cap imprinted with '668' in black ink and white opaque colored body and are supplied as follows: NDC 65841-829-06 in bottles of 30 capsules NDC 65841-829-16 in bottles of 90 capsules NDC 65841-829-01 in bottles of 100 capsules NDC 65841-829-05 in bottles of 500 capsules NDC 65841-829-10 in bottles of 1000 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container (USP). Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088.   Manufactured  by: Zydus Lifesciences Ltd., Ahmedabad, India   Rev.: 10/23

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ACYCLOVIR- ACYCLOVIR CAPSULE
ZYDUS LIFESCIENCES LIMITED
----------
ACYCLOVIR CAPSULES, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
capsules are formulation for oral administration.
Acyclovir is a white or almost white, crystalline powder with the
molecular formula
C H
N O and a molecular weight of 225.20. It is soluble in diluted
hydrochloric acid;
slightly soluble in water and insoluble in alcohol. 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]-_6H-_purin-6-one; it has the following
structural formula:
Each acyclovir capsule intended for oral administration contains 200
mg of acyclovir. In
addition, each capsule contains the following inactive ingredients:
corn starch, FD & C
blue # 1, FD & C red # 3, gelatin, lactose monohydrate, magnesium
stearate, sodium
lauryl sulfate and titanium dioxide. Each capsule is printed with
black pharmaceutical ink
which contains black iron oxide, butyl alcohol, dehydrated alcohol,
isopropyl alcohol,
potassium hydroxide, propylene glycol, shellac and strong ammonia
solution.
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