Properties
What is it?
EXODERIL® 1% Solution for external use Drug name EXODERIL® 1% Solution for external use International Nonproprietary Name Naftifine Dosage form Solution Description Clear, colorless or pale yellow solution with an ethanol odor. Composition 1 ml of solution contains the active substance Naftifine hydrochloride - 10 mg. Excipients: propylene glycol (50mg/ml), ethanol, purified water. See blog: Exoderil - a preparation for combating fungal infections Pharmacotherapeutic group Antifungal agents for dermatological use; Antifungal agents for external use; Other antifungal agents for external use, naftifine. ATC code: D01AE22. Pharmacological properties Pharmacodynamics Exoderil contains the active substance naftifine and is intended for external use in the treatment of fungal infections. Naftifine has a fungicidal effect against the following organisms: Trichophyton spp., Microsporon spp., Epidermophyton floccosum. It is moderately effective against yeasts (Candida spp.), molds (Aspergillus spp.), and other fungi (e.g., Sporothrix schenkii). Naftifine also has antibacterial and anti-inflammatory effects. Pharmacokinetics Systemic exposure is very low. When applied to the skin, absorption is approximately 4% of the dose. Naftifine is detected in trace amounts in plasma and blood. Indications for use Local treatment of fungal infections caused by pathogens sensitive to naftifine: - Fungal infections of the skin and skin folds, with or without itching; - Fungal infections of the nails; - Cutaneous candidiasis; - Pityriasis versicolor. Contraindications Hypersensitivity to naftifine, propylene glycol, or other excipients of the preparation. Method of administration and dosage For external use on skin or nails only. Use as directed. For the treatment of fungal skin infections, use once a day. Clean and dry the affected skin and surrounding area, then thoroughly moisten with the solution directly from the bottle or with a cotton swab. Do not allow contact with eyes or mucous membranes. For the treatment of fungal nail infections, use the preparation twice a day, applying the solution to the free edge of the nail. Before the first application of the solution, remove as much of the damaged nail as possible with scissors and nail clippers. Children and adolescents: The safety and efficacy of naftifine in children and adolescents under 18 years of age have not been established (insufficient experience with use). Patients with renal or hepatic insufficiency: Dose adjustment is not required. Elderly patients: Dose adjustment is not required. Duration of use Requires course-based treatment. To prevent recurrence of infection, continue treatment for at least two weeks after clinical recovery. For rapid recovery and prevention of re-infection, follow these rules: - Change clothes and underwear that come into contact with the affected skin or nails daily; - Do not wear stiff, airtight clothing and footwear (e.g., synthetic socks, narrow shoes). After bathing, the affected skin and nails should be thoroughly dried. Sponges and towels should be changed daily; - To prevent further spread of infection, and especially to prevent re-infection in your own home, bathroom, hotel, or pool, do not walk barefoot. - Saunas and baths can be visited only after recovery from the fungal disease. Clean, healthy, and dry skin is the best protection against fungal infections. If no improvement is observed after 4 weeks, consult a doctor. If a dose is missed, apply the solution as soon as you remember. Then continue using the solution as usual. Special instructions and precautions Exoderil solution is not intended for ophthalmic use. Avoid contact with eyes and mucous membranes. The solution should not be used on open wounds or cracks. The preparation contains propylene glycol (50 mg/ml), which may cause skin irritation. The preparation is applied undiluted and should not be mixed with other external preparations, as the effectiveness of the active substance may be insufficient due to reduced concentration. The drug is not phototoxic and does not cause photosensitization. Pregnancy and breastfeeding For safety reasons, the use of Exoderil should be avoided during pregnancy and lactation. Effect on ability to drive and operate machinery Does not affect the ability to drive vehicles and operate machinery. Overdose Acute overdose and life-threatening complications are unlikely with external use of naftifine. In case of accidental ingestion, consult a doctor. Appropriate symptomatic treatment is recommended. A specific antidote is unknown. Side effects In isolated cases, dryness, burning or redness, contact dermatitis, and erythema may occur. Interactions with other medicinal products and other types of interactions Interactions with other medicinal substances or alcohol have not been reported. Packaging 10ml or 20ml solution in dark glass bottles with a dropper and screw cap; 1 bottle with instructions for medical use in a cardboard box. Shelf life 3 years. Do not use after the expiry date indicated on the packaging. Storage conditions Store at a temperature not exceeding 30°C. Keep out of reach of children. Store opened bottle for no more than 6 months at a temperature not exceeding 25°C. Dispensing conditions from pharmacies: Pharmaceutical product group III, available without a prescription.
