DENAVIR- penciclovir cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENCICLOVIR (UNII: 359HUE8FJC) (PENCICLOVIR - UNII:359HUE8FJC)

Available from:

Physicians Total Care, Inc.

INN (International Name):

PENCICLOVIR

Composition:

PENCICLOVIR 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older. Denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.

Product summary:

Denavir is supplied in a 1.5 gram tube containing 10mg of penciclovir per gram. NDC 54868-4956-0 Store at controlled room temperature, 20°-25° C (68°-77°F) [see USP] QUESTIONS?   call 1-800-452-0051 24 hours a day, 7 days a week. October 2003 Manufactured by Novartis Pharma GmbH, Wehr, Germany for Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©2004 Novartis Consumer Health, Inc. Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

New Drug Application

Summary of Product characteristics

DENAVIR - PENCICLOVIR CREAM
PHYSICIANS TOTAL CARE, INC.
----------
DENAVIR
DENAVIR BRAND OFPENCICLOVIR CREAM, 1%
FOR DERMATOLOGIC USE ONLY
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
_Denavir _contains penciclovir, an antiviral agent active against
herpes viruses. _Denavir _is available for
topical administration as a 1% white cream. Each gram of _Denavir
_contains 10 mg of penciclovir and the
following inactive ingredients: cetomacrogol 1000 BP, cetostearyl
alcohol, mineral oil, propylene
glycol, purified water and white petrolatum. Chemically, penciclovir
is known as 9-[4-hydroxy-3-
(hydroxymethyl) butyl]guanine. Its molecular formula is C
H N O ; its molecular weight is 253.26. It
is a synthetic acyclic guanine derivative and has the following
structure:
Penciclovir is a white to pale yellow solid. At 20°C it has a
solubility of 0.2 mg/mL in methanol, 1.3
mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer
(pH 2) the solubility is 10.0
mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in
n-octanol/water at pH 7.5 is 0.024
(logP= -1.62).
CLINICAL PHARMACOLOGY
MICROBIOLOGY
MECHANISM OF ANTIVIRAL ACTIVITY: The antiviral compound penciclovir
has _in vitro _inhibitory activity
against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells
infected with HSV-1 or HSV-2,
viral thymidine kinase phosphorylates penciclovir to a monophosphate
form which, in turn, is converted
to penciclovir triphosphate by cellular kinases. _In vitro _studies
demonstrate that penciclovir triphosphate
inhibits HSV polymerase competitively with deoxyguanosine
triphosphate. Consequently, herpes
viral DNA synthesis and, therefore, replication are selectively
inhibited.
ANTIVIRAL ACTIVITY IN VITRO AND IN VIVO: In cell culture studies,
penciclovir has antiviral activity against
HSV-1 and HSV-2. Sensitivity test results, expressed as the
concentration of the drug required to inhibit
growth of the virus by 50% (IC
) or 99% (IC
) in cell culture, vary depending upon a number of
factors, including the assay pr