PODOFILOX solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

PODOFILOX (UNII: L36H50F353) (PODOFILOX - UNII:L36H50F353)

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

PODOFILOX

Composição:

PODOFILOX 5 mg in 1 mL

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Podofilox 0.5% Solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS). Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called “Bowenoid papulosis”) is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Podofilox 0.5% Solution. Podofilox 0.5% Solution is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.

Resumo do produto:

3.5 mL of Podofilox 0.5% Solution (NDC 54868-6198-0) is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. Store at controlled room temperature between 15° - 30°C (59° - 86°F). Avoid excessive heat. Do not freeze.

Status de autorização:

New Drug Application Authorized Generic

Características técnicas

PODOFILOX - PODOFILOX SOLUTION
PHYSICIANS TOTAL CARE, INC.
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PODOFILOX
0.5% TOPICAL SOLUTION
RX ONLY
DESCRIPTION
Podofilox is an antimitotic drug which can be chemically synthesized
or purified from the plant families
_Coniferae _and_ Berberidaceae_ (e.g. species of _Juniperus_ and
_Podophyllum_). Podofilox 0.5% Solution is
formulated for topical administration. Each milliliter of solution
contains 5 mg of podofilox, in a
vehicle containing lactic acid and sodium lactate in alcohol 95%, USP.
Podofilox has a molecular weight of 414.4 daltons, and is soluble in
alcohol and sparingly soluble in
water. Its chemical name is
5,8,8a,9-Tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7]
naphtho[2,3,_d_]-1, 3-dioxol-6(5a_H_)-one. Podofilox has the following
structural formula:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Treatment of genital warts with podofilox results in necrosis of
visible wart tissue. The exact
mechanism of action is unknown.
PHARMACOKINETICS
In systemic absorption studies in 52 patients, topical application of
0.05 mL of 0.5% podofilox solution
to external genitalia did not result in detectable serum levels.
Applications of 0.1 to 1.5 mL resulted in
peak serum levels of 1 to 17 ng/mL one to two hours after application.
The elimination half-life ranged
from 1 to 4.5 hours. The drug was not found to accumulate after
multiple treatments.
CLINICAL STUDIES
In clinical studies with Podofilox 0.5% Solution, the test product and
its vehicle were applied in a
double-blind fashion to comparable patient groups. Patients were
treated for two to four weeks, and
reevaluated at a two-week follow-up examination. Although the number
of patients and warts evaluated
at each time period varied, the results among investigators were
relatively consistent.
The following table represents the responses noted in terms of
frequency of response by lesions
treated and the overall response by patients. Data are presented for
the 2-week follow-up only for those
patients evaluated at that time point.
RESPONSES IN T