ACYCLOVIR tablet

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 400 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Acyclovir Tablets, USP 400 mg are available for oral administration as white to off-white, oval, unscored tablets imprinted "Apotex Logo 5306" on one side and plain on the other side. They are supplied as follows: Bottles of 30 (60505-5306-3) Bottles of 100 (60505-5306-1)  Bottles of 500 (60505-5306-5) Bottles of 1000 (60505-5306-8) Acyclovir Tablets, USP 800 mg are available for oral administration as white to off-white, oval, unscored tablets imprinted "Apotex Logo 5307" on one side and plain on the other side.  They are supplied as follows: Bottles of 30 (60505-5307-3) Bottles of 100 (60505-5307-1) Bottles of 500 (60505-5307-5) Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture. APOTEX INC. ACYCLOVIR TABLETS, USP 400 MG & 800 MG Revised: February 2016 Rev. 3

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACYCLOVIR- ACYCLOVIR TABLET
APOTEX CORP.
----------
ACYCLOVIR TABLETS, USP
400 MG AND 800 MG
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against herpes
viruses. Acyclovir
tablets are a formulation for oral administration. Each 800 mg tablet
of acyclovir
contains 800 mg of acyclovir and the inactive ingredients colloidal
silicon dioxide,
croscarmellose sodium, magnesium stearate and microcrystalline
cellulose. Each 400
mg tablet of acyclovir contains 400 mg of acyclovir and the inactive
ingredients colloidal
silicon dioxide, croscarmellose sodium, magnesium stearate and
microcrystalline
cellulose.
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
8
11
5
3
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 betw