LOPROX- ciclopirox olamine suspension LOPROX- ciclopirox olamine kit

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ciclopirox olamine (UNII: 50MD4SB4AP) (ciclopirox - UNII:19W019ZDRJ)

थमां उपलब्ध:

Medimetriks Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

ciclopirox olamine

रचना:

ciclopirox 7.7 mg in 1 mL

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

LOPROX® Topical Suspension 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. LOPROX® Topical Suspension is contraindicated in individuals who have shown hypersensitivity to any of its components.

उत्पाद समीक्षा:

LOPROX® (ciclopirox) Topical Suspension, 0.77% is supplied in 60 mL bottles (NDC 43538-550-60) Bottle space provided to allow for vigorous shaking before each use. Store between 5° - 25°C (41° - 77°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

LOPROX- CICLOPIROX OLAMINE SUSPENSION
LOPROX- CICLOPIROX OLAMINE
MEDIMETRIKS PHARMACEUTICALS, INC.
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LOPROX (CICLOPIROX)
TOPICAL SUSPENSION, 0.77%
FOR TOPICAL USE ONLY
Not for use in eyes
RX ONLY
DESCRIPTION
LOPROX (ciclopirox) Topical Suspension, 0.77% is for topical use.
Each gram of LOPROX Topical Suspension contains 7.70 mg of ciclopirox
(as ciclopirox olamine) in
a water miscible suspension base consisting of purified water USP,
cocamide DEA, octyldodecanol
NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate
60 NF, myristyl alcohol NF,
lactic acid USP, sorbitan monostearate NF, and benzyl alcohol NF (1%)
as preservative.
LOPROX Topical Suspension 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.
LOPROX Topical Suspension has a pH of 7.
The chemical structure is:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ciclopirox is a hydroxypyridone antifungal agent that acts by
chelation of polyvalent cations (Fe
or
Al
), resulting in the inhibition of the metal-dependent enzymes that are
responsible for the degradation
of peroxides within the fungal cell.
PHARMACOKINETICS
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
®
®
®
®
®
3+
3+
2
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.
_In vitro_ penetration studies in frozen or fresh excised human
cadaver an