Instructions Exoderil cream 1% tube 15 g
Composition
active ingredient: naftifine hydrochloride;
1 g of cream contains 10 mg of naftifine hydrochloride;
excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.
Dosage form
Cream.
Main physicochemical properties: white, soft or slightly cheesy shiny cream with a slight characteristic odor.
Pharmacotherapeutic group
Antifungal agents for use in dermatology. ATX code D01A E22.
Pharmacological properties
Pharmacodynamics.
Exoderil® is an antifungal agent of the allylamine class. Its active ingredient is naftifine hydrochloride, the mechanism of action of which is associated with the inhibition of the action of ergosterol.
Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeasts (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix schenckii). Naftifine has fungicidal activity against dermatophytes and Aspergillus in vitro, and fungicidal or fungistatic activity against yeasts, depending on the strain of the microorganism.
Exoderil® also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with mycotic lesions.
In addition, Exoderil® has powerful anti-inflammatory properties.
Pharmacokinetics.
Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in different layers of the skin. Approximately 4% of the dose applied to the skin is absorbed, so the systemic exposure of the active substance is very low. Only trace amounts of naftifine are found in blood plasma and urine. The active substance is almost completely metabolized; the metabolites have no antifungal activity and are excreted in feces and urine. The half-life is 2-4 days.
Indication
Topical treatment of fungal infections caused by pathogens sensitive to naftifine:
fungal and are accompanied by itching or without it.
Contraindication
Hypersensitivity to naftifine or to other components of the drug. The drug should not be applied to the wound surface. Do not use for the treatment of eyes.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
The drug should be used externally only for nail and skin diseases!
Use during pregnancy or breastfeeding
There are no or limited amount of data from the use of naftifine in pregnant women. Animal studies do not indicate direct or indirect harmful effects of the drug on reproductive function. The drug should be used during pregnancy or breastfeeding only if clearly needed after a careful benefit/risk assessment by a physician.
Breastfeeding mothers should prevent the drug from getting on the baby's skin and digestive tract.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Exoderil® cream should be applied to the affected skin surface and adjacent areas once a day after it has been thoroughly cleaned and dried, capturing approximately 1 cm of healthy skin around the edges of the affected area.
Duration of treatment: for dermatomycoses – 2-4 weeks (if necessary – up to 8 weeks); for candidiasis – 4 weeks; for nail infections – up to 6 months.
For fungal nail diseases, the drug is recommended to be used 2 times a day. Before the first use, it is necessary to remove as much of the affected part of the nail as possible with scissors or a nail file (to facilitate this procedure, on the recommendation of a doctor, the nails can be treated with a special softener).
To prevent relapse, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease have disappeared.
Children.
Data on the efficacy and safety of the drug in children are insufficient, therefore it is not recommended to prescribe Exoderil® to patients in this age category.
Overdose
Acute overdose with topical application of naftifine has not been observed.
Systemic intoxication with external use of the drug is unlikely due to the fact that a small amount of the active substance is absorbed through the skin.
In case of accidental ingestion of the drug, symptomatic treatment should be initiated.
Side effects
The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), frequency unknown (cannot be estimated from the available data).
General disorders: frequency unknown - in rare cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.
Expiration date
3 years.
The product is stable for 4 weeks at 25°C after first opening.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
15 g or 30 g of cream in a tube; 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Sandoz GmbH – TechOps (series release).
Location of the manufacturer and its business address.
Biochemiststrasse 10, 6250 Kundl, Austria.
or
Producer.
Salutas Pharma GmbH (bulk manufacturer, primary and secondary packaging, control, batch release).
Location of the manufacturer and its business address.
Production site in Osterwedingen, Lange Goeren 3, Sulzetal, OT Osterwedingen, Saxony-Anhalt, 39171, Germany.
