Ciclopirox Olamine description, usages, side effects, indications, overdosage, supplying and lots more!

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Ciclopirox Olamine

G & W LABORATORIES, INC.

Ciclopirox Olamine Cream, 0.77%(Ciclopirox Cream)FOR DERMATOLOGIC USE ONLY.NOT FOR USE IN EYES. Rx Only


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

Ciclopirox Olamine Cream, 0.77% is for topical use.

Each gram of Ciclopirox Olamine cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of purified water USP, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, cocamide DEA, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative.

Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2.
The chemical structure is:

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 tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 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.

Penetration studies in human cadaverous skin from the back, with Ciclopirox Cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentration.

Autoradiographic studies with human cadaverous 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.

Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.

INDICATIONS AND USAGE

Ciclopirox Cream 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; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) vesicolor due to Malassezia furfur.

CONTRAINDICATIONS

Ciclopirox Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS

Ciclopirox Cream is not for ophthalmic use.

Keep out of the reach of children.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Cream, treatment should be discontinued and appropriate therapy instituted.

The patient should be told to:

  • Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
  • Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization.
  • Avoid the use of occlusive wrappings or dressings.

A carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site.

The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative).

The following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT – test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5000 mg/kg.

Reproduction studies have been performed in the mouse, rat, rabbit, and monkey (via various routes of administration) at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant woman. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Cream is administered to a nursing woman.

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

ADVERSE REACTIONS

In all controlled clinical studies with 514 patients using Ciclopirox Cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

DOSAGE AND ADMINISTRATION

Gently massage Ciclopirox Olamine Cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with Ciclopirox Olamine Cream, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

Ciclopirox Olamine Cream USP, 0.77% is supplied in:
 
15-g tubes (NDC 0713-0638-15)30-g tubes (NDC 0713-0638-31)90-g tubes (NDC 0713-0638-18)

Store at 20-25oC (68-77oF)
[see USP Controlled Room Temperature].

Manufactured by:

G&W Laboritories, Inc.
South Plainfield, NJ 07780

8-0638GW1
Issued 7/10

Principal Display Panel

NDC 0713-0638-31

G&W®

Ciclopirox Olamine Cream, 0.77%
(Ciclopirox Cream)

FOR DERMATOLOGIC USE ONLY - NOT FOR USE IN EYES.
Rx Only

30 g

Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube. Push cap until tube end is punctured. Screw cap back on to reseal tube.

Usual Dosage: Gently massage into the affected and surrounding skin areas twice daily, in the morning and evening. See insert for full prescribing information.

Each gram contains: 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of purified water USP, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, cocamide DEA, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative.

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Lot No. and Exp. Date on carton and crimp of tube.

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080
www.gwlabs.com

Ciclopirox Olamine

Ciclopirox Olamine CREAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0713-0638
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CICLOPIROX OLAMINE Ciclopirox 7.7 mg

Inactive Ingredients

Ingredient Name Strength
CETYL ALCOHOL
Mineral Oil
OCTYLDODECANOL
stearyl alcohol
POLYSORBATE 60
MYRISTYL ALCOHOL
SORBITAN MONOSTEARATE
Coco Diethanolamide
BENZYL ALCOHOL
water
LACTIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 30 in 1 TUBE
3 90 in 1 TUBE
4 NDC:0713-0638-18 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078463 2007-05-22


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