Micofin (terbinafine) skin spray 1% 30 ml. vial

Description

Micofin composition
active substance: terbinafine hydrochloride;
1 g of spray contains terbinafine hydrochloride 10 mg;
excipients: ethanol 96%, polyethylene glycol cetostearyl ether, propylene glycol, purified water.

Dosage form
Skin spray.

Pharmacological properties
Terbinafine is an allylamine that has a broad spectrum of antifungal activity. Terbinafine in the appropriate concentration has a fungicidal effect on dermatophytes, molds and some dimorphic fungi. Activity against yeast fungi, depending on their species can be fungicidal or fungistatic.
Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell membrane. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes fungal cell death. Terbinafine acts by inhibiting the enzyme squalene epoxidase in the fungal cell membrane. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.

Indication
Fungal skin infections caused by dermatophytes such as Trichophyton (eg T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, eg interdigital epidermophytia of the feet (“athlete’s foot”), inguinal dermatophytes itching jockey “), dermatophytosis of the torso (” ringworm “). Variegated herpes caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindication
Hypersensitivity to terbinafine or any component of the drug Micofin.

Use during pregnancy or breastfeeding
No effect of terbinafine on fertility and embryotoxic effects of terbinafine was observed. Use in pregnant women is limited, so during pregnancy Micofin spray can be used only if the expected benefit to the pregnant woman outweighs the potential risk to the fetus. Terbinafine passes into breast milk in small amounts, so the drug should not be used in women during breastfeeding.
Infants should avoid contact with any area of ​​skin on which the drug has been applied.

Method of application and dosage
Micofin, a skin spray, is intended for external use only.
The duration of treatment depends on the severity of the disease.
Before using the drug it is necessary to thoroughly clean and dry the affected areas of skin. The drug is sprayed on the affected areas in an amount sufficient for their thorough moisturizing, and, in addition, applied to adjacent areas of both affected and intact skin.
The duration of treatment and frequency of use is set depending on the indications:

• epidermophytia of the feet and trichophytia of smooth skin – once a day for a week;
• herpes zoster – 2 times a day for a week.

No dose adjustment is required for elderly patients.
Relief of symptoms is usually expected within a few days. Unsystematic use or premature discontinuation of treatment leads to recurrence of the disease. If there are no signs of improvement after a week of treatment, you should see a doctor.

Children
Safety and effectiveness in children have not been established, so it is not recommended to use the drug in children (under 18 years).

Overdose
Low systemic absorption of terbinafine when applied topically causes an extremely low probability of overdose. If you accidentally swallow more Micofin, a dermal spray, the side effects should be similar (headache, nausea, epigastric pain and dizziness). In case of accidental ingestion, the ethanol content of the medicinal product should be taken into account.
Treatment of overdose in case of accidental ingestion is to remove the active substance, primarily by taking activated charcoal and symptomatic therapy if necessary.

Side effects
Local symptoms such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentation disorders, erythema, crusting may be observed at the application site. These minor symptoms should be distinguished from hypersensitivity reactions, including rash, which have been reported in isolated cases and require discontinuation of treatment. Accidental eye contact with terbinafine hydrochloride may cause eye irritation. In rare cases, latent fungal infection may worsen.

• Immune system disorders: Hypersensitivity reactions, including urticaria.
• From the eyes: eye irritation.
• From the skin and connective tissues: peeling skin, itching; skin damage, crust formation, skin lesions, pigmentation disorders, erythema, burning sensation of the skin. Feeling of dry skin, contact dermatitis, eczema, rash.
• General disorders and administration site conditions: pain, application site pain, application site irritation; exacerbation of symptoms.

Expiration date
2 years.

Storage conditions
Store in a dry, protected from light place at a temperature not exceeding 25 ºC.
Keep out of reach of children.