Onabet cream 20 mg/g tube 20 g

Instructions Onabet cream 20 mg/g tube 20 g

Composition

active ingredient: sertaconazole;

1 g of cream contains sertaconazole nitrate 20 mg;

excipients: cetyl alcohol, stearyl alcohol, myristyl alcohol, glycerol monostearate, sorbitan stearate, polysorbate 60, octyldodecanol, light mineral oil, benzyl alcohol, purified water.

Dosage form

Cream.

Main physicochemical properties: semi-solid, homogeneous white cream.

Pharmacotherapeutic group

Antifungal drugs for topical use.

ATX code D01A C14.

Pharmacological properties

Pharmacodynamics

Sertaconazole is an antifungal agent for topical treatment, an imidazole derivative, which has a strong fungicidal effect and a wide spectrum of activity against pathogenic fungal infections: dermatophytes (Trichophytop, Epidermophytop floccosum, Mycosis fungoides spp.), yeast fungi (Candida albicans, Candida subspecies, Malassezza furfur), as well as infections caused by gram-positive pathogens (Staphylococcus and Streptococcus). The mechanism of action of sertaconazole is due to the inhibition of ergosterol synthesis and increased permeability of the fungal cell membrane, which leads to the death of the fungi.

Pharmacokinetics

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

Indication

Topical treatment of fungal skin infections caused by dermatophytes and yeasts: athlete's foot, inguinal athlete's foot, smooth skin dermatomycosis, trichophytosis of the beard and mustache area, dermatomycosis of the hands, candidiasis, lichen planus.

Contraindication

History of hypersensitivity to sertaconazole or to any antifungal derivatives of the imidazole group or to any other component of the drug.

Interaction with other medicinal products and other types of interactions

Not established. If it is necessary to use any other medicines at the same time, you should consult a doctor.

Application features

The drug cannot be used in ophthalmology. It cannot be used orally and intravaginally. The cream should only be used topically. If irritation or hypersensitivity reactions occur during the use of the drug, the drug should be discontinued and the necessary treatment should be prescribed. The drug is contraindicated in patients with hypersensitivity to sertaconazole or any antifungal derivatives of the imidazole group due to possible cross-sensitivity.

Before applying the cream to the affected areas of the skin, wash your hands. Avoid contact with the eyes, nose, mouth, and other mucous membranes. The skin should be dry before applying the cream.

Patients should use acidic detergents with caution, as the spread of Candida spp. increases in an acidic environment.

The content of cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

The effect of sertaconazole on newborns or pregnant women has not been studied, therefore, before prescribing the drug during pregnancy or breastfeeding, the benefit-risk ratio for the woman and the fetus/child must be assessed.

Method of administration and doses

The cream should be applied 1 or 2 times a day (preferably at night or in the morning and evening) in a thin layer gently and evenly to the affected area of skin, trying to capture approximately 1 cm of healthy skin around the affected area.

The duration of treatment depends on the etiology of the pathogen and the location of the infection.

Typically, approximately 4 weeks of treatment are recommended to achieve clinical remission with negative microbiological detection and to prevent relapse, but in many cases clinical recovery occurs earlier, between 2 and 4 weeks.

Children

There are no data on the use of the drug in pediatrics.

Overdose

Taking into account the concentration of the active substance and the recommended route of administration, intoxication is unlikely. However, in case of accidental ingestion of the drug, appropriate symptomatic therapy should be applied.

Adverse reactions

The drug showed good tolerability when applied to both intact and damaged skin.

Local contact dermatitis (dry skin, burning, itching, urticaria) may occur. Hypersensitivity reactions, local transient erythematous reactions that do not require discontinuation of the drug are possible.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Do not freeze.

Packaging

20 g of cream in a tube, each tube in a cardboard box.

Vacation category

Without a prescription.

Producer

Glenmark Pharmaceuticals Ltd.

Location of the manufacturer and its business address

Precinct No. E-37/39, M.I.D.C., Satpur, Nasik – 422 007, India.