ACYCLOVIR tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Zydus Lifesciences Limited

INN (Mezinárodní Name):

ACYCLOVIR

Složení:

ACYCLOVIR 400 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Acyclovir Tablets USP, 400 mg are white to off-white colored, round shaped, biconvex, uncoated tablets, debossed with "791" on one side and plain on the other side and are supplied as follows: NDC 65841-802-06 in bottles of 30 tablets with child-resistant closure NDC 65841-802-16 in bottles of 90 tablets with child-resistant closure NDC 65841-802-01 in bottles of 100 tablets with child-resistant closure NDC 65841-802-05 in bottles of 500 tablets NDC 65841-802-10 in bottles of 1000 tablets NDC 65841-802-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Acyclovir Tablets USP, 800 mg are white to off-white colored, oval shaped, biconvex, uncoated tablets, debossed with "792" on one side and plain on the other side and are supplied as follows: NDC 65841-803-06 in bottles of 30 tablets with child-resistant closure NDC 65841-803-16 in bottles of 90 tablets with child-resistant closure NDC 65841-803-01 in bottles of 100 tablets NDC 65841-803-05 in bottles of 500 tablets NDC 65841-803-10 in bottles of 1000 tablets NDC 65841-803-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 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., Baddi, India Rev.: 10/23

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ACYCLOVIR- ACYCLOVIR TABLET
ZYDUS LIFESCIENCES LIMITED
----------
ACYCLOVIR TABLETS, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
tablets are formulations 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 tablet intended for oral administration contains 400 mg
and 800 mg of
acyclovir. In addition, each tablet contains the following inactive
ingredients: colloidal
silicon dioxide, magnesium stearate, microcrystalline cellulose,
pregelatinized starch and
sodium starch glycolate.
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
8
11
5
3
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 vir