ACYCLOVIR capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
05-01-2011

Aktiv ingrediens:

Acyclovir (UNII: X4HES1O11F) (Acyclovir - UNII:X4HES1O11F)

Tilgjengelig fra:

Boscogen, Inc.

INN (International Name):

Acyclovir

Sammensetning:

Acyclovir 200 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Acyclovir Capsules USP, 200 mg Oval capsule, light blue opaque cap and aqua blue opaque body imprinted with "HP146" are supplied in bottles of 100s (NDC 62033-0204-0) and 400s (NDC 62033-0204-4). Store at 150 to 250C (590 to 770F) and protect from moisture.  Call you doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: BOSCOGEN, INC. 11 Morgan Irvine, CA  92618 Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA  92618

Autorisasjon status:

Export only

Preparatomtale

                                ACYCLOVIR - ACYCLOVIR CAPSULE
BOSCOGEN, INC.
----------
ACYCLOVIR CAPSULES
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir capsules are
formulations for oral administration.
Each capsule contains 200mg of acyclovir and the inactive ingredients:
lactose monohydrate, sodium
lauryl sulfate, sodium starch glycolate, and magnesium stearate. The
capsule shell consists of FDandC
Blue #1, FDandC Blue #2, FDandC Red #40, DandC Yellow #10, iron oxide
black, pharmaceutical
shellac glaze and propylene glycol.
Acyclovir is a white, crystalline powder with the molecular formula
C8H11N5O3 and a molecular
weight of 225. The maximum solubility in water at 37 degree C is
2.5mg/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]-6H-purin-6-one;
it has the following structural formula
VIROLOGY
MECHANISM OF ANTIVIRAL ACTION: Acyclovir is a synthetic purine
nucleoside analogue with in vitro in in
vivo inhibitory activity against herpes simples virus types 1 (HSV-1),
2 (HSV-2), and varicella-zoster
virus (VZV). The inihibitory 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 nucleoside 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 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 susceptibility of herpes viruses
to antivirals and the clinical response 
                                
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