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Loprox

Loprox is essentially a regional brand with a modest international footprint. Its marketing authorisation extends to eight countries spread across the Americas, Europe, and Southeast Asia, and its active ingredient is ciclopirox. A traveller or expatriate familiar with the brand from one market may or may not encounter the same name elsewhere, even where the underlying molecule is widely stocked.

Ciclopirox is most commonly used in topical preparations indicated for dermatological conditions including dermatitis and seborrheic dermatitis, as well as certain skin and mucosal infections and vaginitis. The structured indication list further down this page details the registered uses for Loprox in the markets where it is sold, and these can vary modestly from one regulatory jurisdiction to another.

Although the Loprox brand itself is registered in only a handful of countries — among them Brazil, Indonesia, Canada, the Netherlands, and Thailand — ciclopirox as an active ingredient is available far more broadly under different brand names. Travellers who have been using Loprox at home will usually find a ciclopirox-containing product, or a comparable topical antifungal in the same therapeutic category, available in their destination country. A local pharmacist is well placed to act as translator between brand names and identify the appropriate regional equivalent.

Other topical antifungal products based on different active ingredients are also widely sold internationally and may be appropriate substitutes in certain situations, although they are not freely interchangeable with ciclopirox. Any decision to start, continue, switch, or substitute a topical therapy of this kind belongs with a healthcare provider familiar with the patient's situation rather than being made at the pharmacy counter.

Countries
Argentina Brazil Canada Indonesia Mexico Netherlands Thailand USA
Diseases
Dermatitis Infection Vaginitis Seborrheic Dermatitis Shingles
Ingredients
Ciclopirox

Drugs with the same active ingredients

Micopirox Micopirox laca Piroctol Batrafen Ciclocutan Kitonail Stieprox 1,5% Obytin Sai jie Myconail Mycosten Mycosten (ciclopirox) Fungirox Gino loprox Micolamina Polinail Flucort-c Flucort-c (ciclopirox,fluocinolone) Mycoster 1% Mycoster 8%

Overdose

No information provided.

Contraindications

LOPROX® Gel (ciclopirox gel) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Undesirable effects

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.

Therapeutic indications

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.

Pharmacokinetic properties

A comparative study of the pharmacokinetics of LOPROX® GeI and LOPROX® Cream (ciclopirox olamine) 0.77% in 18 healthy males indicated that systemic absorption of ciclopirox from LOPROX® Gel (ciclopirox gel) was higher than that of LOPROX® Cream. A 5 gm dose of LOPROX® Gel (ciclopirox 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 (ciclopirox 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.

Fertility, pregnancy and lactation

Teratogenic effects: Pregnancy Category B

Reproduction studies of ciclopirox revealed no significant evidence of impaired fertility in rats exposed orally up to 5 mg/kg body weight (approximately 5 times the maximum recommended topical human dose based on surface area). No fetotoxicity was shown due to ciclopirox in the mouse, rat, rabbit, and monkey at oral doses up to 100, 30, 30, and 50 mg/kg body weight, respectively (approximately 37.5, 30, 44, and 77 times the maximum recommended topical human dose based on surface area). By the dermal route of administration, no fetotoxicity was shown due to ciclopirox in the rat and rabbit at doses up to 120 and 100 mg/kg body weight, respectively (approximately 121 and 147 times, respectively, the maximum recommended topical human dose based on surface area).

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. LOPROX® Gel (ciclopirox gel) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Qualitative and quantitative composition

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

Special warnings and precautions for use

WARNINGS

LOPROX® Gel (ciclopirox gel) is not for ophthalmic, oral, or intravaginal use.

Keep out of reach of children.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of LOPROX® Gel (ciclopirox gel) , treatment should be discontinued and appropriate therapy instituted. A transient burning sensation may occur, especially after application to sensitive areas. Avoid contact with eyes. Efficacy of LOPROX® Gel in immunosuppressed individuals has not been studied. Seborrheic dermatitis in association with acne, atopic dermatitis, Parkinsonism, psoriasis and rosacea has not been studied with LOPROX® Gel (ciclopirox gel). Efficacy in the treatment of plantar and vesicular types of tinea pedis has not been established.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) 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 battery of in vitro genotoxicity tests was conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster cells, with and without metabolic activation (positive); gene mutation assays 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/c 3T3 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.

Pregnancy Teratogenic effects: Pregnancy Category B

Reproduction studies of ciclopirox revealed no significant evidence of impaired fertility in rats exposed orally up to 5 mg/kg body weight (approximately 5 times the maximum recommended topical human dose based on surface area). No fetotoxicity was shown due to ciclopirox in the mouse, rat, rabbit, and monkey at oral doses up to 100, 30, 30, and 50 mg/kg body weight, respectively (approximately 37.5, 30, 44, and 77 times the maximum recommended topical human dose based on surface area). By the dermal route of administration, no fetotoxicity was shown due to ciclopirox in the rat and rabbit at doses up to 120 and 100 mg/kg body weight, respectively (approximately 121 and 147 times, respectively, the maximum recommended topical human dose based on surface area).

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. LOPROX® Gel (ciclopirox gel) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

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 LOPROX® Gel (ciclopirox gel) is administered to a nursing woman.

Pediatric Use

The efficacy and safety of LOPROX® Gel (ciclopirox gel) in pediatric patients below the age of 16 years have not been established.

Dosage (Posology) and method of administration

Superficial Dermatophyte Infections

Gently massage LOPROX® Gel (ciclopirox gel) into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

Seborrheic Dermatitis of the Scalp

Apply LOPROX Gel (ciclopirox gel) to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

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.

DRUG INTERACTIONS

No information provided.

Frequently asked questions

What conditions does Loprox treat?

Loprox is prescribed for a range of dermatological and related conditions, including dermatitis, seborrheic dermatitis, certain skin and mucosal infections, and vaginitis. The active ingredient belongs to the broad category of topical antifungal agents, which is the therapeutic role most commonly associated with ciclopirox preparations. The structured indication block further down this page lists each registered use as recognised by national regulators in the markets where Loprox is sold.

What is the active ingredient in Loprox?

Loprox contains ciclopirox, an active substance widely used in topical antifungal therapy. Ciclopirox is the same molecule whether sold under the Loprox brand or under one of the other brand names used in different regions. Internationally, the same active ingredient circulates under multiple commercial names, depending on the manufacturer and the regulatory jurisdiction in which the product is authorised.

In how many countries is Loprox available?

Loprox is registered in eight countries, spanning North and South America, Europe, and Southeast Asia. Examples include Brazil, Canada, Indonesia, the Netherlands, Mexico, Thailand, and the United States. If your country is not represented on this list, a local pharmacist can usually confirm whether ciclopirox is available in that market under a different brand name or as a generic preparation.

Are there other medications with the same active ingredient as Loprox?

Ciclopirox is sold under several brand names worldwide, particularly in markets where multiple manufacturers produce topical preparations in parallel. Other medications within the broader topical antifungal category also exist, although they are not freely interchangeable — different molecules within the category can have meaningfully different profiles. To identify a local ciclopirox-containing product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.

Should I consult a doctor before taking Loprox?

Yes. Loprox is generally a prescription medication, although regulatory status can differ between countries. Skin and mucosal conditions often look similar to one another while requiring quite different treatments, so a clinician's assessment matters before starting therapy. This is especially relevant for travellers and people relocating between countries, since prescription requirements, branded packaging, and available generics can differ across regulatory regimes.

Loprox

Available in 8 countries