ACYCLOVIR ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NorthStar Rx LLC

INN (International Name):

ACYCLOVIR

Sammensetning:

ACYCLOVIR 50 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients. Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

Produkt oppsummering:

Acyclovir Ointment, USP 5% is supplied as a white color ointment.  Each gram of acyclovir ointment, USP 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 15 g tubes (NDC  16714-668-01) 30 g tubes (NDC  16714-668-02) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place.   Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Amneal Pharmaceuticals LLC Piscataway, NJ  08854. Iss. 05-2017-00

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ACYCLOVIR- ACYCLOVIR OINTMENT
NORTHSTAR RX LLC
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ACYCLOVIR OINTMENT, USP 5%
DESCRIPTION
Acyclovir, USP, is a synthetic nucleoside analogue active against
herpes viruses. Acyclovir ointment,
USP 5% is a formulation for topical administration. Each gram of
acyclovir ointment, USP 5% contains
50 mg of acyclovir, USP in a polyethylene glycol (PEG) base.
Acyclovir, USP 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, USP are
2.27 and 9.25.
The chemical name of acyclovir, USP 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.
ANTIVIRAL ACTIVITIES: The quantitative relationship between the _in
vitro_ susceptibility of herpes viruses
to antivirals and the clinical response to therapy has not been
established in humans, and virus sensitivity
testing has not been standardized. Sensitivity testing results,
expressed as the concentration o