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Active ingredients
Terbinafin
Release form
Cream
Composition
1 g krem contains: Active substance: terbinafine hydrochloride 10 mg. Auxiliary substances: cetyl alcohol - 40 mg, stearyl alcohol - 40 mg, cetyl palmitate - 20 mg, benzyl alcohol - 10 mg, sorbitan stearate - 19 mg, isopropyl myristate - 80 mg, sodium hydroxide - 2 mg, polysorbate 60 - 61 mg, purified water - 718 mg.
Pharmacological effect
Terbinafine belongs to the group of allylamines, has a broad spectrum of antifungal action. In low concentrations, it has a fungicidal effect on dermatophytes Trychophyton (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (eg. Aspergillus, Cladosporium, Scopulariophoraphiophorathiophora, pyropycosis, mold fungi (for example Aspergillus, Cladosporium, Scopulariomerosis Mushrooms, mold fungi (eg Aspergillus, Cladosporium, Scopulariophorathiophorathiophorathis, Otiscerans, T. violaceumum) fungi, mainly Candida albicans, and some dimorphic fungi. Depending on the species of fungus, Candida fungi and its mycelial forms have a fungicidal or fungistatic effect. Terbinafine violates the early stage of the biosynthesis of the main component of the cell membrane of the fungus ergosterol by inhibiting the enzyme squalene epoxidase. Squalene epoxidase is not associated with the cytochrome P450 (CYP450) system, therefore, terbinafine does not affect the metabolism of hormones and drugs, the metabolism of which is associated with CYP450. When used orally, it accumulates in the skin, nails and hair in an amount that has fungicidal action. Systemic treatment of multi-colored lichen caused by Malassezia furfur is ineffective.
Pharmacokinetics
When applied topically - absorption of less than 5%, has a slight systemic effect.
Indications
- prevention and treatment of fungal infections of the skin, including foot mycoses (foot fungus), inguinal athlete (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum; - yeast infections of the skin, mainly those caused by fungi of the genus Candida (for example, Candida albicans), in particular diaper rash; - versicolor versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindications
liver and / or kidney failure, less alcohol, less tumor, less metabolic disease, less bone marrow hematopoiesis, less limb vascular disease, less childhood age up to 12 years (no clinical experience).
Use during pregnancy and lactation
Contraindicated
Dosage and administration
Outwardly. Before applying the drug Exifin it is necessary to clean and dry the affected areas. The cream is applied with a thin layer on the affected skin and surrounding areas and lightly rubbed. For infections with diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region), the places of application of the cream can be covered with gauze, especially overnight. The average duration and frequency of application is smaller than the torso and tibia: 1 time per day for 1 weeks. smaller more Larger athlete's foot: 1 time per week for 1–2 weeks. fewer more. Foot rheumatic fever (“foot fungus”): 1 time per day for 1 week. less than more Candidiasis of the skin: 1 or 2 times a day for 1– 2 weeks.me shebrbolshe Pityriasis versicolor 1 or 2 times a day for 2 nedel.Dlitelnost of treatment depends on the indication and the severity of the disease. Reducing the severity of clinical manifestations is usually observed in the first days of treatment. To prevent recurrence of mycoses of the feet: 2-3 courses for 2 weeks with a break of 7 days. The dosage regimen Exifin cream in the elderly does not differ from the above.
Side effects
On the part of the digestive system: often - a feeling of full stomach, dyspepsia, nausea, loss of appetite, abdominal pain, diarrhea; not often - a violation of taste perception, incl. loss of taste, which is restored within a few weeks after cessation of treatment; rarely - cholestasis, jaundice, hepatitis, asymptomatic increase in liver transaminase levels. Despite the unproven causation of these disorders with the use of terbinafine, in the case of hepatobiliary dysfunction, treatment with Exifin should be stopped. On the CNS side: rarely - paresthesia, hypesthesia, dizziness; very rarely - depression, a feeling of increased anxiety. From the side of the musculoskeletal system: often - arthralgia, myalgia. From the hematopoietic system: very rarely - neutropenia, agranulocytosis, thrombocytopenia. From the immune system: often - urticaria, erythema multiforme; rarely, systemic allergic reactions (reactions like serum sickness, angioedema); very rarely, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity).With the progression of skin rashes, treatment with terbinafine should be stopped. Others: often - headache, feeling unwell, feeling tired; very rarely - exacerbation of psoriasis, increased hair loss.
Overdose
Symptoms: nausea, vomiting, pain in the lower abdomen, in the epigastric region. Treatment: gastric lavage followed by the appointment of activated charcoal and / or symptomatic therapy.
Interaction with other drugs
Practically does not affect the clearance of drugs metabolized with cytochrome P450 (for example, cyclosporine, terfenadine, tolbutamide, triazoles, oral contraceptives). Inhibits CYP2D6 isoenzyme and interferes with the metabolism of drugs such as tricyclic antidepressants and selective blockers, tricyclic antidepressants and selective blockers, tricyclic antidepressants and selective blockers, tricyclic antidepressants and selective blockers, tricyclic antidepressants, and tacrolimus. beta-blockers (metoprolol, propranolol), antiarrhythmic drugs (flekainid, propafenone), MAO-B inhibitors (for example, selegilin) and antipsychotics (for example, chlorpromazi Haloperidol) funds. Drug enzyme inducers CYP450 (such as rifampicin) can accelerate the excretion of terbinafine from the body. Medicinal preparations-inhibitors of CYP450 (such as cimetidine) can slow the metabolism and excretion of terbinafine from the body. With the simultaneous use of these drugs, you may need a dose adjustment of terbinafine. Possible menstrual disturbance while taking terbinafine and oral contraceptives. Reduces caffeine clearance by 21% and prolongs its half-life by 31%. It does not affect the clearance of antipyrine, digoxin, warfarin. Ethanol and other hepatotoxic drugs increase the risk of a hepatotoxic effect.
special instructions
Irregular use of terbinafine or premature termination of treatment leads to a relapse of the disease. Factors such as, for example, the presence of concomitant diseases, the condition of the nails at the beginning of the course of treatment, can also affect the duration of therapy. If there is no improvement in the skin infection after 2 weeks of treatment, you must reapply determine the causative agent of the disease and its sensitivity to the drug. Systemic use in onychomycosis is justified only in the case of total damage to most nails, the presence of nnogo subungual hyperkeratosis, inefficiency prior local therapy.In the treatment of onychomycosis, the clinical response is usually observed several months after mycological cure and cessation of treatment, due to the rate of growth of a healthy nail. Removal of nail plates in the treatment of onychomycosis of the hands for 3 weeks and onychomycosis of the feet for 6 weeks is not required. In the presence of severe renal failure (Cl creatinine 300 μmol / l), if there is an abnormal liver function, the dose of terbinafine should be halved. may be reduced. With reduced liver function, half of the adult dose is prescribed. During treatment, it is necessary to control the level of liver transaminases in the serum. In rare cases, after 3 months of treatment, cholestasis and hepatitis occur. If there are signs of abnormal liver function (weakness, persistent nausea, loss of appetite, abdominal pain, jaundice, dark urine or colorless stools), the drug should be discontinued. The appointment of terbinafine to patients with psoriasis requires increased caution, because in very rare cases, terbinafine can provoke an outbreak of psoriasis. When treating with terbinafine, the general rules of hygiene should be followed to prevent the possibility of re-infection through underwear and shoes. In the process of treatment (every 2 weeks) and at the end it is necessary to produce antifungal treatment of shoes, socks and stockings. Influence on the ability to drive and work mechanisms: terbinafine does not affect the ability to drive and perform work requiring increased concentration.