Composition
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of 1 g of cream contains:
Active ingredient: Terbinafine hydrochloride-10.0 mg
Auxiliary substances: cetyl alcohol and stearyl alcohol or cetostearyl alcohol – 80.0 mg, benzyl alcohol-10.0 mg, cetyl palmitate-20.0 mg, polysorbate 60-61.0 mg, isopropyl myristate-80.0 mg, sorbitan stearate-19.0 mg, sodium hydroxide-1.2 mg, purified water – up to 1000.0 mg.
Pharmacological action
Antifungal drug for external use, which has a wide spectrum of antifungal activity. In low concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), molds (for example, Aspergillus, Cladosporium, Scorpulariopsis brevicalius), certain dimorphic (Pityrosporum orbiculare) and yeast fungi (mainly Candida albicans). Activity against other yeast fungi Candida spp., depending on their type, can be fungicidal or fungistatic. Terbinafine specifically alters the early stage of sterol biosynthesis that occurs in fungi. This leads to ergosterol deficiency and intracellular squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the squalene oxidase enzyme located on the cell membrane of the fungus. Terbinafine has no effect on the cytochrome P 450 system in humans and, accordingly, on the metabolism of hormones or other drugs. Pharmacokinetics. When applied topically, the absorption is less than 5%, it has a slight systemic effect.
Indications
Prevention and treatment of fungal skin infections, including:
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mycoses of the feet (“fungus” of the foot);
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inguinal epidermophytosis;
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fungal lesions of the smooth skin of the body;
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Infections caused by yeast-like fungi of the genus Candida (candidiasis), in particular diaper rash;
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Multicolored (pityriasis) lichen.
Use during pregnancy and lactation
No teratogenic properties of terbinafine have been identified in experimental studies. To date, no malformations have been reported with terbinafine cream.
However, since the clinical experience of using terbinafine as a cream in pregnant women is very limited, it should not be used unless absolutely necessary. During pregnancy, it is used only if the intended benefit to the mother exceeds the potential risk to the fetus. You should consult your doctor.
Terbinafine is excreted in breast milk, so the drug should not be used by nursing mothers. Do not allow the baby to come into contact with any surface of the skin treated with the cream.
Contraindications
Hypersensitivity to terbinafine or to any component of the drug; breast-feeding period; children under 12 years of age (for this dosage form).
With caution: hepatic and / or renal insufficiency, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.
Side effects
Local reactions: Â in places where the cream is applied, redness, itching or burning sensation, allergic reactions are possible.
Interaction
There are no data on the drug interaction of Thermicon.
How to take, course of use and dosage
Thermicon® is prescribed externally for adults and children over 12 years of age.
Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied 1-2 times / day in a thin layer on the affected skin and adjacent areas, lightly rubbed.
For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night.
The average duration of treatment for dermatomycosis of the trunk, legs, feet – 1 time/day for 1 week; for candidiasis of the skin-1-2 times/day for 1-2 weeks; for multi-colored lichen-1-2 times/day for 2 weeks.
A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or premature discontinuation, there is a risk of recurrent infection. If there are no signs of improvement after 1-2 weeks of treatment, the diagnosis should be verified.
The dosage regimen of the drug for elderly patients is the same as for patients of other age groups.
Overdose
No overdose cases have been reported. If Termicon® is accidentally ingested, you can expect to develop the same symptoms as with an overdose of tablets: headache, nausea, epigastric pain and dizziness.
Treatment: Â activated charcoal, if necessary – symptomatic maintenance therapy.
Description
Cream for external use 1% white, homogeneous, with a weak specific smell.
Special instructions
A decrease in the severity of clinical manifestations is usually noted in the first days of treatment.
In case of irregular treatment or its premature termination, there is a risk of recurrence of infection.
Thermicon® is intended for external use only.
Avoid getting it in your eyes, as it can cause irritation.
If the drug accidentally gets into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor.
If allergic reactions develop, the drug should be discontinued.
Form of production
Cream for external use 1% in aluminum tubes of 10 g or 15 g. Each tube with instructions for use is placed in a pack of cardboard.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of reach of children.
Shelf
life is 3 years.
Active ingredient
Terbinafine
Dosage form
cream
Description
Nursing mothers as prescribed by a doctor, For adults, Children over 2 years of age, Pregnant women as prescribed by a doctor
Indications
Fungus, Diaper Rash, Skin Fungus
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Side effects of Termicon, cream 1%, 15g.
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