MYCOSTER

Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses.

In particular, the agent is especially effective in treating Tinea versicolor.

Used as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.

Ciclopirox is a broad-spectrum antifungal medication that also has antibacterial and anti-inflammatory properties.

Its main mode of action is thought to be its high affinity for trivalent cations, which inhibit essential co-factors in enzymes.

Ciclopirox exhibits either fungistatic or fungicidal activity in vitro against a broad spectrum of fungal organisms, such as dermatophytes, yeasts, dimorphic fungi, eumycetes, and actinomycetes.

In addition to its broad spectrum of action, ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria.

Furthermore, the anti-inflammatory effects of ciclopirox have been demonstrated in human polymorphonuclear cells, where ciclopirox has inhibited the synthesis of prostaglandin and leukotriene.

Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.

Rapidly absorbed after oral administration.

Mean absorption of ciclopirox after application to nails of all twenty digits and adjacent 5 millimeters of skin once daily for 6 months in patients with dermatophytic onychomycoses was less than 5% of the applied dose.

Ciclopirox olamine also penetrates into hair and through the epidermis and hair follicles into sebaceous glands and dermis.

Glucuronidation is the main metabolic pathway of ciclopirox.

Most of the compound is excreted either unchanged or as glucuronide.

After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration.

Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides.

hours for 1% topical solution.

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Solution, 8% is not for ophthalmic, oral, or intravaginal use.

It is for use on nails and immediately adjacent skin only.

Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Solution, 8% should be used as a component of a comprehensive management program for onychomycosis.

Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy.

Careful consideration of the appropriate nail management program should be given to patients with diabetes.

• Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Patient – Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox Topical Solution, 8% is removed with alcohol.

Solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.

Solution, 8% should be applied evenly over the entire nail plate.

If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Solution, 8% should not be removed on a daily basis.

Daily applications should be made over the previous coat and removed with alcohol every seven days.

This cycle should be repeated throughout the duration of therapy.

Solution, 8% is available as follows: 6.6 mL glass bottle with a screw cap fitted with a brush (NDC 45802 - 141 -67) Protect from light (store bottle in the carton after every use).

Store at 20-25°C (68-77°F) .

Keep away from heat and flame.

Protect from light (store bottle in the carton after every use).

Store at 20-25°C (68-77°F) .

Keep away from heat and flame.

• Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women.

Solution, 8% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk.

Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% is administered to a nursing woman.

Based on the safety profile in adults, Ciclopirox Topical Solution, 8% is considered safe for use in children 12 years and older.

No clinical trials have been conducted in the pediatric population.

Clinical studies of ciclopirox topical solution, 8% did not include sufficient numbers of subjects aged and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between elderly and younger patients.