Instructions for Lomexin cream 2% tube 30 g
Composition
active ingredient: fenticonazole nitrate;
1 g of cream contains fenticonazole nitrate 20 mg;
excipients: propylene glycol, hydrogenated lanolin, almond oil, polyglycol esters of fatty acids, cetyl alcohol, glycerol monostearate, sodium edetate, purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous white cream.
Pharmacotherapeutic group
Antifungal agents for topical use. Imidazole and triazole derivatives.
ATX code D01A C12.
Pharmacological properties
Pharmacodynamics. Lomexin® is a broad-spectrum antifungal agent.
The drug has 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 the acid proteinase of Candida albicans.
The drug has an antibacterial effect against gram-positive microorganisms.
It is assumed that the mechanism of action of fenticonazole nitrate is inhibition of enzyme oxidation by accumulated peroxide and necrosis of fungal cells, which is manifested by a direct effect on membranes.
Pharmacokinetics: Pharmacokinetic studies have shown negligible absorption through the skin in animals and humans.
In preclinical studies, Lomexin® did not show mutagenic potential, did not contribute to increased sensitivity, phototoxicity, and photoallergy.
Animal studies have not shown any effect of fenticonazole nitrate on the functions of male or female gonads and on the early stages of reproduction.
Indication
Dermatomycoses caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) of various locations: ringworm, trichophytosis of smooth skin, trichophytosis of the perineum, athlete's foot, dermatomycoses of the hands, dermatomycoses of the face, staphylococcal folliculitis, dermatophytic onychomycosis;
skin candidiasis (intertriginous dermatitis, angular stomatitis, facial candidiasis, perineal and scrotal candidiasis); balanitis, balanoposthitis, onychosis, paronychia;
colored tinea versicolor (caused by Pityrosporum orbiculare and P. Ovale);
erythrasma;
mycoses with bacterial superinfection (caused by gram-positive bacteria);
Scalp infections caused by the yeast Pityrosporum, such as seborrheic dermatitis and dry dandruff.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug.
Interaction with other medicinal products and other types of interactions
No pharmacokinetic interaction is expected.
Application features
Avoid contact with eyes; if the drug does get into the eyes, they should be rinsed thoroughly with water.
Prolonged topical use of the drug may cause hypersensitivity. In the event of local hypersensitivity or allergic reaction, treatment should be discontinued.
Some excipients of the cream (hydrogenated lanolin, cetyl alcohol) may cause local skin reactions (e.g. contact dermatitis), propylene glycol may cause skin irritation.
Use during pregnancy or breastfeeding
Although the absorption of fenticonazole nitrate through the skin is insignificant, it is not recommended to use the drug during pregnancy.
Fenticonazole nitrate is excreted in small amounts into breast milk, so it is not recommended to use the drug during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Method of administration and doses
Apply locally.
Lomexin®, cream, should be applied 1–2 times a day (depending on the severity of the disease), after washing and drying the affected area and removing the remains of damaged tissue (nails, hair, etc., depending on the affected area). The cream is intended for application to smooth skin, skin folds and mucous membranes by lightly rubbing or lubricating the affected area.
The cream is mainly used to treat dry mycoses, for example, colored tinea versicolor, erythrasma, onychomycosis. When treating onychomycosis, the cream should be used with an occlusive dressing.
The cream can be used to treat genital mycoses in men.
In order to avoid re-infection, the patient's sexual partner should also use the drug at the same time.
The doctor determines the duration of treatment depending on the type of lesion and the size of the affected area.
Lomexin®, a cream, does not leave greasy or colored stains and is easily washed off with water.
Children.
The drug is not used in children.
Overdose
There have been no reports of overdose.
Side effects
The table below lists the adverse reactions reported during clinical trials or during post-marketing use of the drug, according to the MedDRA system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); rare (<1/10,000) and frequency unknown (in cases where the frequency of the reaction cannot be estimated from the available data).
| Organ or system | Frequency of occurrence | Adverse reactions |
| Skin and subcutaneous tissue disorders | Rare | Redness, itching, rash, erythematous rash, skin irritation, skin burning sensation |
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
30 g of cream in a tube, 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Records of Industria Chimica e Farmaceutica S.p.A.
VAMPHARMA S.R.L., Italy
Address
via M. Civitali 1, 20148, Milan, Italy.
VIA KENNEDY, 5, COMAZZO (LO), 26833, Italy.
Applicant
Recordate Island Ltd.
