ACYCLOVIR- acyclovir suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
13-09-2019

Aktiv ingrediens:

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

Tilgjengelig fra:

Atlantic Biologicals Corps

INN (International Name):

ACYCLOVIR

Sammensetning:

ACYCLOVIR 200 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

NDC:17856-0082-1 in a CUP of 5 SUSPENSIONS NDC:17856-0082-5 in a CUP of 5 SUSPENSIONS

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                ACYCLOVIR- ACYCLOVIR SUSPENSION
ATLANTIC BIOLOGICALS CORPS
----------
ACYCLOVIR ORAL SUSPENSION, USP
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses.
Each teaspoonful (5 mL) of acyclovir oral suspension, USP, for oral
administration, contains 200 mg of
acyclovir and the inactive ingredients artificial banana flavor,
carboxymethylcellulose sodium, glycerin,
methylparaben 0.1% (added as a preservative), microcrystalline
cellulose, propylparaben 0.02% (added
as a preservative), purified water, and sorbitol.
Acyclovir is a white, crystalline powder with the molecular formula C
H N O 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
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 and
inhibitory activity against herpes simplex
virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV).
_in vitroin vivo_
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. , 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 with VZV is due to its more efficient phosphorylation by the
viral TK. _In vitro_
Antiviral Activities:
The quantitative relationship between the susceptibility of herpes
viruses to antivirals and the clinical
response to t
                                
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