Lomexin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LOMEXIN® (LOMEXIN®)

Composition:

Active substance: fenticonazole nitrate;

1 g of cream contains 20 mg of fenticonazole nitrate;

Excipients: propylene glycol, hydrogenated lanolin, almond oil, polyglycolized fatty acid esters, cetyl alcohol, glycerol monostearate, sodium edetate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white-colored cream.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code D01A C12.

Pharmacological properties.

Pharmacodynamics. Lomexin® is a broad-spectrum antifungal agent.

The drug exhibits high fungistatic and fungicidal activity against dermatophytes (all species of Trichophyton, Microsporum, Epidermophyton), Candida albicans, and other fungal infections of the skin and mucous membranes. The drug inhibits acid proteinase of Candida albicans.

The drug also exerts antibacterial activity against Gram-positive microorganisms.

The mechanism of action of nitrofenticonazole is believed to involve inhibition of enzyme oxidation by accumulated peroxide and necrosis of fungal cells, manifested by a direct effect on membranes.

Pharmacokinetics. Pharmacokinetic studies have shown minimal absorption through the skin in animals and humans.

In preclinical studies, Lomexin® showed no mutagenic potential and did not increase sensitivity, phototoxicity, or photoallergy.

Animal studies did not reveal any effect of nitrofenticonazole on the functions of male or female sex glands or on the early phases of reproduction.

Clinical characteristics.

Indications.

• Dermatomycoses caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) of various locations: tinea capitis, tinea of smooth skin, tinea cruris, tinea pedis, tinea manuum, facial dermatomycoses, staphylococcal folliculitis, dermatophytic onychomycosis;
• Cutaneous candidiasis (intertriginous dermatitis, angular stomatitis, facial candidiasis, candidiasis of the groin and scrotum); balanitis, balanoposthitis, onychosis, paronychia;
• Pityriasis versicolor (caused by Pityrosporum orbiculare and P. ovale);
• Erythrasma;
• Mycoses with bacterial superinfection (caused by gram-positive bacteria);
• Scalp infections caused by the yeast-like fungus Pityrosporum, such as seborrheic dermatitis and dry dandruff.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

No pharmacokinetic interactions are expected.

Special precautions for use.

Avoid contact with the eyes; if the product gets into the eyes, they should be thoroughly rinsed with water.

Prolonged local use of the product may lead to increased sensitivity. If local hypersensitivity or allergic reactions occur, treatment should be discontinued.

Some of the excipients of the cream (hydrogenated lanolin, cetyl alcohol) may cause local skin reactions (e.g., contact dermatitis), and propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding.

Although absorption of fenticonazole nitrate through the skin is negligible, the product is not recommended during pregnancy.

Fenticonazole nitrate is excreted in small amounts in breast milk; therefore, the product is not recommended during breastfeeding.

Ability to influence the reaction rate while driving or operating machinery.

The product does not affect the reaction rate while driving or operating machinery.

Method of Administration and Dosage

Apply topically.

Lomexin® cream should be applied once or twice daily (depending on the severity of the condition), after washing, drying the affected area, and removing any remnants of damaged tissue (nails, hair, etc., as appropriate to the affected site). The cream is intended for application to smooth skin, skin folds, and mucous membranes by gentle rubbing or smearing onto the affected area.

The cream is primarily used for the treatment of superficial mycoses, such as pityriasis versicolor, erythrasma, and onychomycosis. When treating onychomycosis, the cream should be used with an occlusive dressing.

The cream may be used for the treatment of genital mycoses in men.

To prevent reinfection, the patient's sexual partner should simultaneously receive treatment with the same medicinal product.

The duration of treatment is determined by the physician according to the type and extent of the lesion.

Lomexin® cream does not leave greasy or colored stains and is easily washed off with water.

Children

The product is not intended for use in children.

Overdose

No cases of overdose have been reported.

Adverse reactions.

When used according to recommendations, Lomexin® is practically not absorbed, therefore systemic adverse reactions are not expected. A mild, transient burning sensation may occur after application. Prolonged use of the drug may lead to increased sensitivity.

The table below lists adverse reactions reported during clinical studies or in the post-marketing period, classified according to MedDRA organ system classes and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and frequency not known (when frequency cannot be estimated from available data).

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC. Keep out of the reach of children.

Packaging.

30 g of cream in a tube, 1 tube in a cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Recordati Industrie Chimiche e Farmaceutiche S.p.A.

WAMPHARMA S.r.l., Italy

Location of manufacturer and its registered office address.

Via M. Civitali 1, 20148, Milan, Italy.

Via Kennedy, 5, Comazzo (LO), 26833, Italy.

Marketing Authorization Holder.

Recordati Ireland Ltd.

Address of the Marketing Authorization Holder.

Raheny East, Ringsend, Co. Cork, Ireland.