Instructions for Mikofin spray 10 mg/g 30 ml bottle with sprayer No. 1
Composition
active ingredient: 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.
Main physicochemical properties: transparent, colorless solution.
Pharmacotherapeutic group
Antifungal drugs for topical use. ATX code D01A E15.
Pharmacological properties
Pharmacodynamics
Terbinafine is an allylamine with a broad spectrum of antifungal activity. Terbinafine, at appropriate concentrations, has fungicidal activity against dermatophytes, molds and some dimorphic fungi. Activity against yeasts, 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.
Pharmacokinetics
When applied topically, the drug is almost not absorbed, begins to act quickly, and is effective with short-term treatment (7 days).
When applied topically, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is very low.
Indication
Fungal skin infections caused by dermatophytes such as Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, e.g. tinea pedis, so-called "athlete's foot"; inguinal tinea ("jock itch"); tinea corporis ("ringworm"); candidiasis of the skin caused by fungi of the genus Candida, usually Candida albicans; tinea versicolor (pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindication
Hypersensitivity to terbinafine or any component of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
The drug is for external use. It should be used with caution in patients with damaged skin, as ethanol, which is part of the drug, can cause irritation. Do not inhale. In case of accidental inhalation, consult a doctor if any adverse symptoms worsen or persist. Avoid contact with the eyes. Do not apply to the face. In case of accidental contact of the spray with the eyes or face, rinse them immediately with running water.
Mycofin®, a cutaneous spray, contains propylene glycol, which may cause skin irritation.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
No effect of terbinafine on fertility and embryotoxic effects of terbinafine have been observed. Use in pregnant women is limited, therefore, during pregnancy, Mycofin® spray can be used only if the expected benefit to the pregnant woman outweighs the potential risk to the fetus. Terbinafine penetrates into breast milk in small quantities, therefore, the drug should not be used in women during breastfeeding.
Infants should be avoided from coming into contact with any area of skin to which the drug has been applied.
Method of administration and doses
Mycofin®, a cutaneous spray, is 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 the skin. The drug should be sprayed onto the affected areas in an amount sufficient to thoroughly moisten them, and, in addition, applied to the adjacent areas of both the affected and intact skin.
The duration of treatment and frequency of application are determined depending on the indications:
athlete's foot and trichophytosis of smooth skin – once a day for a week; lichen planus – twice a day for a week.
No dose adjustment is necessary for elderly patients.
Relief of symptoms is usually expected within a few days. Irregular use or premature discontinuation of treatment leads to relapses of the disease. If there are no signs of improvement after a week of treatment, you should consult a doctor.
Children
Safety and efficacy in children have not been established, therefore the drug is not recommended for use in children (under 18 years of age).
Overdose
The low systemic absorption of terbinafine when applied topically makes overdose extremely unlikely. Accidental ingestion of the contents of one bottle of Mycofin® cutaneous spray, 30 ml (containing 300 mg of terbinafine hydrochloride) is comparable to ingestion of one Mycofin® 250 mg tablet (oral dosage form). In case of accidental ingestion of a larger amount of Mycofin® cutaneous spray, side effects should be similar to those seen with an overdose of Mycofin® tablets (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 consists of removing the active substance, primarily by taking activated charcoal, and providing symptomatic therapy if necessary.
Adverse reactions
Local symptoms such as itching, peeling or burning of the skin, pain and irritation at the application site, pigmentation disorders, erythema, crusting may occur 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. In case of accidental contact with the eyes, terbinafine hydrochloride may cause eye irritation. In rare cases, latent fungal infections may be exacerbated.
Immune system disorders: hypersensitivity reactions, including urticaria.
From the organs of vision: eye irritation.
Skin and connective tissue disorders: skin peeling, itching; skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin. 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 place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 ml of the drug in a bottle with a sprayer. 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
NOBEL ILACH SANAI VE TJARET A.Sh.
Location of the manufacturer and its business address
Sankaklar Quarter, Eski Akcakoca Ave., No. 299, 81100 Duzce, Turkey
