Sertaverin^® (Shampoo) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

D01AC14 (Sertaconazole)

Active Substance

Sertaconazole (Rec.INN registered by WHO)

Dosage Form

Sertaverin®

Medicated shampoo 2%: bottle 75 g, 100 g, or 150 g

Dosage Form, Packaging, and Composition

Medicated shampoo in the form of a transparent, colorless or light yellow liquid, with a slight characteristic odor; opalescence is allowed.

Excipients: sodium laureth sulfate (70% solution), propylene glycol, cocamide propyl betaine (cocamidopropyl betaine 30% solution), povidone K-17 (low molecular weight polyvinylpyrrolidone), sodium metabisulfite, imidurea, purified water.

75 g – bottles (1) – cardboard packs.
100 g – bottles (1) – cardboard packs.
150 g – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent, a derivative of imidazole and benzothiophene. It has a broad spectrum of activity against pathogenic fungi ( Candida albicans, Candida tropicalis, Candida spp., Pityrosporum orbiculare), dermatophytes ( Trichophyton and Microsporum) and pathogens of skin and mucous membrane infections (strains of staphylococci and streptococci).

In therapeutic doses, it has a fungistatic and fungicidal effect. The mechanism of action of sertaconazole is to inhibit the synthesis of ergosterol, the main sterol of fungal and yeast membranes, and to increase the permeability of the cell membrane, which leads to lysis of the fungal cell.

Pharmacokinetics

When applied topically, Sertaconazole is not detected in the blood and urine.

Indications

For application to the skin (in the appropriate dosage form): – treatment of superficial skin mycoses: dermatomycoses, Tinea pedis (“athlete’s foot”), Tinea cruris (dermatomycosis of the groin), Tinea corporis (mycosis of smooth skin), Tinea barbae (mycosis of the beard), Tinea manus (dermatophytosis of the hands), candidiasis (Moniliasis), as well as Pityriasis versicolor (Pityrosporum orbiculare) (tinea versicolor).

For application to the scalp (in the appropriate dosage form): treatment and prevention of infections caused by yeast-like microorganisms Malassezia spp. (Pityrosporum), such as tinea versicolor (local), seborrheic dermatitis and dandruff.

ICD codes

Dosage Regimen

Apply to the affected areas of the skin (in the appropriate dosage form) in a uniform thin layer twice a day, covering approximately 1 cm of the surface of healthy skin. The duration of treatment depends on the etiology of the pathogen and the location of the infection. The recommended duration of treatment is 4 weeks.

For the treatment and prevention of infections caused by yeast-like microorganisms Malassezia spp. (Pityrosporum), such as tinea versicolor (local), seborrheic dermatitis and dandruff, apply to the scalp in the appropriate dosage form; the regimen and duration of use depend on the indications. The dosage regimen for children from 12 to 18 years of age does not differ from the dosage regimen for adults.

Adverse Reactions

When applied to the skin

Skin and subcutaneous tissue disorders: contact dermatitis; transient local erythematous reactions are possible, which does not require discontinuation of sertaconazole.

When applied to the scalp (in the appropriate dosage form)

Eye disorders: uncommon – eye irritation, increased lacrimation.

Skin and subcutaneous tissue disorders: uncommon – dry skin, skin itching, skin rash; rare – contact dermatitis, skin peeling.

General disorders: uncommon – erythema, irritation at the application site.

Contraindications

Hypersensitivity to sertaconazole, imidazole derivatives, other components of the drug; depending on the dosage form used, Sertaconazole may be contraindicated in children under 12 years of age or in children and adolescents under 18 years of age.

With caution

Pregnancy, children aged 12 years and older (in the appropriate dosage form).

Use in Pregnancy and Lactation

The safety of sertaconazole in pregnant women has not been specifically studied. Therefore, use during pregnancy is possible only if the potential benefit to the mother outweighs the possible risk to the fetus.

During lactation, Sertaconazole in the dosage form for application to the skin should not be applied to the mammary glands. There are currently no data on the use of sertaconazole during breastfeeding, so if it is necessary to use it on the skin during this period, the issue of discontinuing breastfeeding should be discussed with a doctor.

Considering the absence of systemic absorption of sertaconazole when applied topically, this agent in the dosage form for application to the scalp can be used during pregnancy and breastfeeding only if the intended benefit to the mother outweighs the potential risk to the fetus and newborn.

Pediatric Use

Safety and effectiveness in children under 18 years of age have not been established.

Sertaconazole can be used with caution in children over 12 years of age in the dosage form intended for this age category.

Special Precautions

Do not use in ophthalmic practice. If this product accidentally gets into the eyes, rinse them with plenty of water.

After applying sertaconazole, the use of acidic detergents is not recommended (as the reproduction of Candida spp. increases in an acidic environment).

If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to confirm the diagnosis.

If side effects occur, the patient should stop using this product and consult a doctor.

Do not apply to the scalp if there are wounds, ulcers, or other damage to the skin in this area.

Drug Interactions

Not identified.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.