Sertaconazole

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SERTACONAZOLE (SERTACONAZOLE)

Composition:

Active substance: sertaconazole;

1 g of the preparation contains 20 mg of sertaconazole nitrate;

Excipients: polyethylene glycol stearate, cetostearyl alcohol, oleoyl polyoxylglycerides, glycerol monostearate, mineral oil, benzyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: semi-solid cream of fluid consistency, white in color, odorless or with a specific odor.

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01A C14.

Pharmacological properties.

Pharmacodynamics.

Sertaconazole – the active substance of this medicinal product – is an imidazole derivative with high fungicidal activity. Its mechanism of action involves inhibition of ergosterol synthesis and increased cell membrane permeability, leading to destruction of pathogens. It is effective against pathogenic yeast fungi (Candida albicans, Candida spp. and Malassezia furfur), dermatophytes (Trichophyton, Epidermophyton and Microsporum spp.), and pathogens causing infectious diseases of the skin and mucous membranes, including gram-positive strains (Staphylococcus, Streptococcus).

Pharmacokinetics.

No systemic absorption occurs.

Clinical characteristics.

Indications.

For local treatment of fungal skin infections caused by dermatophytes and yeast fungi: tinea pedis, tinea cruris, dermatomycosis of smooth skin, tinea barbae, tinea manuum, candidiasis, pityriasis versicolor.

Contraindications.

Hypersensitivity to any imidazole-derived antifungal agents in the past or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not established. If concomitant use of any other medicinal products is necessary, consult a physician.

Special precautions for use

The medicinal product must not be used in ophthalmology. It must not be administered orally. If irritation or hypersensitivity reactions occur during use of the medicinal product, treatment should be discontinued and appropriate therapy initiated. The drug is contraindicated in patients with hypersensitivity to sertaconazole or to any other imidazole-derived antifungal agents due to possible cross-sensitivity.

Hands should be washed before applying the cream to affected skin areas. The skin should be dry prior to cream application.

Patients should use acidic cleansing agents with caution, as an acidic environment promotes the proliferation of Candida spp.

Use during pregnancy or breastfeeding

After topical application of the medicinal product in large amounts, the drug was not detected in blood plasma. Since the potential harmful effects of the drug on newborns or pregnant women have not been studied, the benefit-risk ratio for the woman and fetus/infant should be carefully evaluated before prescribing the drug during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery

No effect.

Dosage and Administration.

Apply the cream once or twice daily (preferably at night or in the morning and evening), in a thin layer, gently and evenly to the affected area of skin, making an effort to include approximately 1 cm of healthy skin surrounding the affected area.

The duration of treatment depends on the etiology of the causative agent and the location of the infection. Treatment is usually recommended for approximately 4 weeks to achieve clinical remission with a negative result in microbiological follow-up testing to prevent recurrence; however, in many cases, clinical improvement occurs earlier—between 2 and 4 weeks.

Children. There is no data available regarding use in pediatric patients.

Overdose.

Considering the concentration of the active ingredient and the recommended route of administration, intoxication is unlikely. However, in case of accidental ingestion of the medicinal product, appropriate symptomatic therapy should be administered.

Side effects.

The product has shown good tolerability when applied to both intact and damaged skin.

Local reactions may include contact dermatitis (skin dryness, burning, itching, urticaria). Hypersensitivity reactions and transient local erythematous reactions are possible, which do not require discontinuation of the product.

The product contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 20 g of the product in a tube, 1 tube per box.

Supply category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovye"".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.