Onabet

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ONABET (ONABET)

Composition:

Active substance: sertaconazole;

1 g of cream contains 20 mg of sertaconazole nitrate;

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

Pharmaceutical form. Cream.

Main physicochemical characteristics: semi-solid white cream.

Pharmacotherapeutic group.

Antifungal agents for topical use.

ATC code D01A C14.

Pharmacological properties.

Pharmacodynamics.

Sertaconazole is a topical antifungal agent, an imidazole derivative, exerting a potent fungicidal effect and having a broad spectrum of activity against pathogenic fungal infections: dermatophytes (Trichophyton, Epidermophyton floccosum, Microsporum spp.), yeasts (Candida albicans, Candida subspecies, Malassezia furfur), as well as infections caused by gram-positive pathogens (Staphylococcus and Streptococcus). The mechanism of action of sertaconazole is due to inhibition of ergosterol synthesis and increased fungal cell membrane permeability, leading to fungal cell death.

Pharmacokinetics.

After topical application, it is not detected in blood or urine.

Clinical characteristics.

Indications.

Topical treatment of fungal skin infections caused by dermatophytes and yeast fungi: tinea pedis, tinea cruris, dermatomycosis of smooth skin, trichophytia of the beard and mustache area, dermatomycosis of hands, candidiasis, pityriasis versicolor.

Contraindications.

Hypersensitivity to sertaconazole or to any other imidazole-derived antifungal agents in medical history, or to any other component of the drug.

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.

Instructions for Use

The drug must not be used in ophthalmology. It must not be administered orally or intravaginally. The cream is intended for topical application only. If irritation or hypersensitivity reactions occur during use of the drug, it should be discontinued and appropriate treatment initiated. The drug is contraindicated in patients hypersensitive to sertaconazole or to any other antifungal agents of the imidazole derivatives due to the possibility of cross-sensitivity.

Hands should be washed before applying the cream to affected skin areas. Contact of the drug with eyes, nose, mouth, and other mucous membranes should be avoided. The skin should be dry before application of the cream.

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

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

Use during pregnancy or breastfeeding.

The effects of sertaconazole on newborns or pregnant women have not been studied. Therefore, the benefit-risk ratio for the woman and fetus/child should be carefully evaluated before prescribing the drug during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Dosage and Administration.

The cream should be applied 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.

Generally, approximately 4 weeks of treatment is recommended to achieve clinical remission with negative microbiological findings and to prevent relapse; however, in many cases, clinical improvement occurs earlier—between the 2nd and 4th week.

Children.

There is no data available regarding the use of the drug 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, appropriate symptomatic treatment should be administered.

Adverse Reactions.

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.

Shelf Life.

2 years.

Storage Conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not freeze.

Packaging.

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

Availability.

Over-the-counter (without prescription).

Manufacturer.

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Manufacturer's Address and Place of Business.

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