Loprox Gel

Superficial Dermatophyte Infections

LOPROX® GeI is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.

Seborrheic Dermatitis

LOPROX® Gel (ciclopirox gel) is indicated for the topical treatment of seborrheic dermatitis of the scalp.

LOPROX® Gel (ciclopirox) 0.77% is supplied in 30 g tubes (NDC 99207-013-30), and 45 g tubes (NDC 99207-013-45).

Store at 15° - 30°C (59° - 86°F).

Prescribing Information as of September 2001. Manufactured for: MEDICIS, The Dermatology Company® Scottsdale, AZ 85258. By: Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main. Made in Germany. FDA Rev date: 3/26/2003

No information provided.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

In clinical trials, 140 (39%) of 359 subjects treated with LOPROX® Gel (ciclopirox gel) reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.

Read the entire FDA prescribing information for Loprox (Ciclopirox Gel)

FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.

Rx Only

Mechanism of Action

Ciclopirox acts by chelation of polyvalent cations (Fe3+ or Al3+) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

In vitro studies showed that ciclopirox inhibited the formation of 5-lipoxygenase inflammatory mediators (5-HETE and LTB4) and also inhibited PGE2 release in a cell culture model. In vivo, ciclopirox inhibited inflammation in an arachidonic acid-induced murine ear edema model. The clinical significance of these findings is unknown.

Pharmacokinetics

A comparative study of the pharmacokinetics of LOPROX® Gel, and LOPROX® Cream (ciclopirox olamine) 0.77% in 18 healthy males indicated that systemic absorption of ciclopirox from LOPROX® Gel was higher than that of LOPROX® Cream. A 5 gm dose of LOPROX® Gel produced a mean (±SD) peak serum concentration of 25.02 (±20.6) ng/mL total ciclopirox and 5 gm of LOPROX® Cream produced 18.62 (±13.56) ng/mL total ciclopirox. Approximately 3% of the applied ciclopirox was excreted in the urine within 48 hours after application, with a renal elimination half-life of about 5.5 hours.

In a study of LOPROX® Gel, 16 men with moderate to severe tinea cruris applied approximately 15 grams/day of the gel for 14.5 days. The mean (±SD) dose-normalized values of Cmax for total ciclopirox in serum were 100 (±42) ng/mL on Day 1 and 238 (±144) ng/mL on Day 15. During the 10 hours after dosing on Day 1, approximately 10% of the administered dose was excreted in the urine.

Microbiology

Ciclopirox is a hydroxypyridinone antifungal agent that inhibits the growth of pathogenic dermatophytes. Ciclopirox has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

NDC 99207-013-30

30g
Rx Only

LOPROX® GEL
(ciclopirox) 0.77%