Terbinafine DERMGEL
Active material: Terʙinafin
When ATH: D01AE15
CCF: Antifungal agents for external use
ICD-10 codes (testimony): B35.0, B35.2, B35.3, B35.4, B35.6, B36.0
When CSF: 08.02.02
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)
Pharmaceutical form, composition and packaging
◊ Gel for external use 1% brilliant, from white to almost white.
| 1 g | |
| terʙinafin | 10 mg |
Excipients: benzyl alcohol, carbomer 974R (Carbopol), isopropylammonium myristate, butylhydroksytoluol, sorbitan laurate, polysorbate 20, Sodium hydroxide, ethanol, Purified water, nitrogen.
5 g – aluminum tuba (1) – cardboard boxes.
15 g – aluminum tuba (1) – cardboard boxes.
30 g – aluminum tuba (1) – cardboard boxes.
Pharmacological action
Antifungal agent, allilamin. It has a wide range of antifungal activity. Terbinafine has fungicidal activity against dermatophytes, molds and certain dimorphic fungi. Activity against yeast, depending on the species, It may be fungicidal or fungistatic.
Terbinafine gives derived ergosterol biosynthesis in fungi in the early stages. This leads to a deficiency in ergosterol and intracellular accumulation of squalene, causing cell death fungus. Step terbinafine accomplished by inhibition of the enzyme squalene epoxidase, located on the cell membrane of the fungus.
This enzyme does not belong to the cytochrome R450i, thus, terbinafine has no effect on the metabolism of hormones or other drugs.
Pharmacokinetics
When applied topically absorbed less 5% dose, so terbinafine absorption into the systemic circulation is extremely low.
Testimony
- Fungal infections of the skin, incl. foot mycoses (foot moth), jock itch (moth leg), fungal infections of the skin smooth body (moth body), caused by dermatophytes, such as Trichophyton (incl. Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violet), Microsporum canis и Epidermophyton floccosum;
- Multi-colored shingles (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).
Dosage regimen
Lamizil® Dermgel used externally at adults and children 12 years 1 time / day for any of the indications. Before using the product, thoroughly clean and dry the affected areas. The drug is slightly rubbed into the affected areas as a, and the adjacent intact skin. In the case of infections, accompanied by a diaper rash (under the breasts, between fingers, in the gluteal and inguinal folds), the area of application of the gel can be covered with gauze, especially at night.
The duration and frequency of application of Lamisil® Dermgelya at ringworm of the body, goleneй – 1 Sunday, 1 time / day; at Tinea pedis – 1 Sunday, 1 time / day; at pityriasis versicolor – 1 Sunday, 1 time / day.
Before the first application of Lamisil® Dermgelya should pierce the sealing membrane with a sharp, screw cap disposed outside.
In the application of Lamisil® Dermgelya reduction in the severity of clinical manifestations are usually noted in the first days of treatment. If irregular or premature treatment termination there is a risk of recurrence of infection. In that case, If after a week of treatment is not showing signs of improvement, should verify the diagnosis.
To elderly patients It does not require correction dosing regimen.
Side effect
Local reactions: rarely – redness, itching or burning. These phenomena have rarely led to the need to stop treatment.
Allergic reactions: rarely – generalized rash and / or redness, hives, angioedema. With the development of these effects, treatment should be discontinued.
Contraindications
- Children up to age 12 years;
- Lactation;
- Hypersensitivity to terbinafine or to any other component of the drug.
Pregnancy and lactation
Clinical experience with Lamisil® Dermgelya during pregnancy is limited, so the product can be used only on strict conditions.
Known, that terbinafine is excreted in breast milk. Lamizil ®Dermgel should not be given a nursing mother during lactation.
Cautions
The drug is intended for external use only.
The caution should be applied Lamisil® Dermgel on damaged skin, tk. Alcohol can irritate.
Avoid contact with the eyes, tk. may develop irritation. In case of contact with the eyes should be immediately rinsed with running water, and in the case of persistent irritation phenomena of the patient should seek medical advice.
In the case of any side effects the patient should inform the doctor.
Overdose
No cases of overdose were reported.
Symptoms: Accidental admission into possible drug headache, nausea, epigastric pain and dizziness.
Treatment: symptomatic therapy.
Drug Interactions
Currently, drug interactions Lamisil® Dermgelya not known.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children at or above 30 ° C. Shelf life – 3 year.
