CICLOPIROX suspension

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

Ciclopirox Olamine (UNII: 50MD4SB4AP) (Ciclopirox - UNII:19W019ZDRJ)

Հասանելի է:

Taro Pharmaceuticals U.S.A., Inc.

INN (Միջազգային անվանումը):

Ciclopirox Olamine

Կազմը:

Ciclopirox 7.7 mg in 1 mL

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Ciclopirox Topical Suspension USP is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum , Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis ; cutaneous candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur . Ciclopirox Topical Suspension USP is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ապրանքի ամփոփագիր:

Ciclopirox Topical Suspension USP, 0.77% is supplied in 30 mL (NDC 51672-1323-3) and 60 mL (NDC 51672-1323-4) bottles. Bottle space provided to allow for vigorous shaking before each use. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CICLOPIROX- CICLOPIROX SUSPENSION
TARO PHARMACEUTICALS U.S.A., INC.
----------
CICLOPIROX
TOPICAL SUSPENSION USP, 0.77% W/W
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Ciclopirox Topical Suspension USP, 0.77% is for topical use.
Each gram of Ciclopirox Topical Suspension USP contains 7.70 mg of
ciclopirox (as ciclopirox
olamine) in a water miscible suspension base consisting of cetyl
alcohol, cocamide DEA, lactic acid,
mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60,
purified water, sorbitan monostearate,
stearyl alcohol, and benzyl alcohol (1%) as preservative.
Ciclopirox Topical Suspension USP contains a synthetic,
broad-spectrum, antifungal agent ciclopirox
(as ciclopirox olamine). The chemical name is
6-cyclohexyl-1-hydroxy-4-methyl-2(1_H_)-pyridone, 2-
aminoethanol salt.
The CAS Registry Number is 41621-49-2.
The chemical structure is:
Ciclopirox Topical Suspension USP has a pH of 7.
CLINICAL PHARMACOLOGY
Ciclopirox is a broad-spectrum, antifungal agent that inhibits the
growth of pathogenic dermatophytes,
yeasts, and _Malassezia furfur_. Ciclopirox exhibits fungicidal
activity _in vitro_ against isolates of
_Trichophyton rubrum_, _Trichophyton mentagrophytes_, _Epidermophyton
floccosum_, _Microsporum canis_, and
_Candida albicans_.
Pharmacokinetic studies in men with radiolabeled ciclopirox solution
in polyethylene glycol 400
showed an average of 1.3% absorption of the dose when it was applied
topically to 750 cm on the back
followed by occlusion for 6 hours. The biological half-life was 1.7
hours and excretion occurred via
the kidney. Two days after application only 0.01% of the dose applied
could be found in the urine.
Fecal excretion was negligible. Autoradiographic studies with human
cadaver skin showed that
ciclopirox penetrates into the hair and through the epidermis and hair
follicles into the sebaceous
glands and dermis, while a portion of the drug remains in the stratum
corneum.
2
_In vitro_ penetration studies in frozen or fresh excised human
cadaver and pig