Instructions for use Terbinorm spray cutaneous solution 10 mg/g bottle 20 ml
Composition
active ingredient: terbinafine;
1 ml of the drug contains terbinafine hydrochloride 10.08 mg;
excipients: propylene glycol, macrogol 300, ethanol 96%, purified water.
Dosage form
Skin spray, solution.
Main physicochemical properties: transparent or slightly opalescent solution, colorless or with a yellowish tinge.
Pharmacotherapeutic group
Antifungal agents for topical use. ATX code D01A E15.
Pharmacological properties
Pharmacodynamics
Terbinafine is an allylamine with a broad spectrum of antifungal activity. At appropriate concentrations, it has fungicidal activity against dermatophytes, molds and some dimorphic fungi. Its 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.
When applied topically, the drug is almost not absorbed, begins to act quickly, and is effective for short-term treatment (7 days).
Pharmacokinetics
After topical application, less than 5% of the applied dose is absorbed, so systemic exposure to terbinafine is very insignificant.
Indication
Fungal skin infections caused by dermatophytes such as Trichophyton (e.g. Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum, e.g. interdigital tinea pedis ("athlete's foot"), inguinal tinea ("jock itch"), truncal tinea ("ringworm").
Tinea versicolor, caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
The drug is intended for external use.
The drug should be used with caution in patients with skin lesions, as the ethanol contained in it may cause irritation.
Do not inhale. In case of accidental inhalation, consult a doctor if any adverse symptoms worsen or persist.
Avoid contact with eyes and do not apply to face. If the spray accidentally gets into eyes or face, rinse immediately with running water.
The product contains propylene glycol, which may cause skin irritation.
In animal studies, no effect of terbinafine on fertility was observed.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
In animal studies, no embryotoxic effects of terbinafine were observed. Clinical experience in pregnant women is limited, therefore, the drug can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Terbinafine passes into breast milk in small amounts, so the drug should not be used 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
The drug is intended for external use only.
Before using it, the affected areas of the skin should be thoroughly cleaned and dried. Spray the spray onto the affected areas in an amount sufficient to thoroughly moisten them, and, in addition, apply to the adjacent areas of both the affected and intact skin.
The duration of treatment and frequency of use depends on the indications:
athlete's foot and smooth skin trachophytosis - once a day for a week; multi-colored lichen - twice a day for a week.
Elderly patients do not require dose adjustment.
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
The safety and effectiveness of terbinafine 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.
In case of accidental ingestion, the ethyl alcohol content in the medicinal product (4032.8 mg/vial) should be taken into account.
Treatment of overdose consists of removing the active substance primarily by administering 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 and others 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. In case of accidental contact with the eyes, the drug may cause eye irritation. In rare cases, exacerbation of latent fungal infections is possible.
The adverse reactions listed below are classified by system organ class and frequency (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10000 to <1/1000; very rare: <1/10000), not known (frequency cannot be estimated from the available data).
On the part of the immune system:
not known – hypersensitivity reactions, including urticaria.
On the part of the organs of vision:
rarely - eye irritation.
Skin and subcutaneous tissue disorders:
common – skin peeling, itching; uncommon – skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rare – dry skin, contact dermatitis, eczema; unknown – rash.
General disorders and administration site reactions:
uncommon – pain, application site pain, application site irritation; rare – worsening of symptoms.
Expiration date
3 years. Do not use after the expiration date.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
20 ml of the drug in a polymer bottle with a sprayer and a cap-lid. 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
K.O. Rompharm Company S.R.L.
Location of the manufacturer and its business address
Otopeni, Eroilor Street No. 1A, 075100, Ilfov County, Romania.
