ACYCLOVIR tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Liberty Pharmaceuticals, Inc.

INN (International Adı):

ACYCLOVIR

Kompozisyon:

ACYCLOVIR 800 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

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: 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. ACYCLOVIR TABLETS, USP 400 MG & 800 MG PACKAGED BY AIDAREX PHARMACEUTICALS LLC. CORONA CA, 92880 Rev. 08/16

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ACYCLOVIR- ACYCLOVIR TABLET
LIBERTY PHARMACEUTICALS, INC.
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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 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.
8
11
5
3
ANTIVIRAL ACTIVITIES
The quantitative r