ACYCLOVIR tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Direct RX

INN (Alþjóðlegt nafn):

ACYCLOVIR

Samsetning:

ACYCLOVIR 400 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Acyclovir Tablets, 800 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100          (NDC 61442-113-01) Bottle of 500          (NDC 61442-113-05) Acyclovir Tablets, 400 mg (white to off-white, unscored, oval and engraved with “ ”) are supplied in bottles of 100 and 500. Bottle of 100          (NDC 61442-112-01) Bottle of 500          (NDC 61442-112-05) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Keep this and all medication out of the reach of children. Manufactured and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA OR Manufactured by: Yung Shin Pharm. Ind. (KS) Co., Ltd. No.191 Jin Yang West Road, Lujia, Kunshan, Jiangsu, China Packaged and distributed by: Carlsbad Technology, Inc. 5923 Balfour Ct. Carlsbad, CA 92008 USA CTI-10 REV. C REVISED: APRIL 2013

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

ACYCLOVIR- ACYCLOVIR TABLET
DIRECT RX
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ACYCLOVIR
DESCRIPTION SECTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
tablets are formulations of an antiviral drug for oral administration.
Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the
inactive
ingredients corn starch, microcrystalline cellulose, magnesium
stearate, and sodium
starch glycolate.
Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the
inactive
ingredients corn starch, microcrystalline cellulose, magnesium
stearate, and sodium
starch glycolate.
Acyclovir is a white, crystalline powder with the molecular formula C
8H 11N 5O 3 and a
molecular weight of 225. 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 6 H-purin-6-one,
2-amino-1,9-dihydro-9-[(2-
hydroxyethoxy)methyl]; it has the following structural formula:
CLINICAL PHARMACOLOGY SECTION
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.
Antiviral Activities
The quantitative relationship between the in vitro susc