Universal reference book for medicines
Product name: LAMIZIL ® DERMGEL (LAMISIL ® DERMGEL)

Active substance: terbinafine

Type: Antifungal medication for external use

Manufacturer: GlaxoSmithKline Helsker (Russia) manufactured by NOVARTIS CONSUMER HEALTH (Switzerland)
Composition, form of production and packaging

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Gel for external use 1% shiny, from white to almost white.
100 g

terbinafine 1 g

Auxiliary substances: benzyl alcohol - 0.5 g, carbomer - 1 g, isopropyl myristate - 10 g, butyl hydroxytoluene - 0.02 g, sorbitan laurate - 1 g, polysorbate 20 - 5 g, sodium hydroxide (in the form of sodium hydroxide solution 30% m / m) - 0.1 g, ethanol 96% (by volume) - 10 g, water - 71.38 g.

15 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Antifungal drug for external use, which has a wide range of antifungal activity.
In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), moldy (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.
Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi.
This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.
Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other medications.

PHARMACOKINETICS

With external application, the absorption of terbinafine is less than 5%.
The systemic action is not very pronounced.
INDICATIONS

- fungal infections of the skin, incl.
mycosis of the feet (tinea pedis), inguinal epidermophytia (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum;
- Multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

DOSING MODE

Outwardly.

Before the first use of the drug Lamisil® Dermgel, it is necessary to pierce the sealing membrane with a tip on the outside of the cap.

Lamisil ® Dermgel is used in adults 1 time / day for any of the indications.
Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is lightly rubbed into the areas of both affected and adjacent intact skin. In the case of infections accompanied by intertrigo (under the mammary glands, between the fingers, in the gluteal and groin folds), the gel application area can be covered with gauze, especially at night.
Duration and frequency of application of the drug Lamisil ® Dermgel with trunk tummy tibia, shins - 1 week, 1 time / day;
with dermatomycosis stop - 1 week, 1 time / day; with multi-colored lichen - 1 week, 1 time / day.
Reducing the severity of clinical manifestations is usually noted in the first days of treatment.
In case of irregular treatment or premature termination, there is a risk of recurrence of the infection. In the event that after a week of treatment there are no signs of improvement, the diagnosis should be verified.
For elderly patients, dosage adjustment is not required.

SIDE EFFECT

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1 / 1000), very rarely (<1/10 000), including individual messages.

From the side of the immune system: separate messages - hypersensitivity reactions (rash).

From the side of the organ of vision: rarely - irritation of the eyes.

From the skin: often - skin peeling, itching;
infrequently - skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin; rarely - dry skin sensation, contact dermatitis, eczema; individual messages - a rash.
Local reactions: infrequent pain, pain in the application site, irritation at the site of application;
rarely - exacerbation of the symptoms of the disease. In places where the drug is applied, itching, skin flaking, pain, irritation, skin pigmentation change, burning, erythema, and cortex can be observed. These minor symptoms should be distinguished from hypersensitivity reactions such as rashes that occur in rare cases and require the withdrawal of therapy. In rare cases, the course of the fungal infection may worsen.
CONTRAINDICATIONS

- hypersensitivity to terbinafine or to any component of the drug.

- the period of breastfeeding;

- Children under 18 years.

Caution: use caution when applying the product to damaged areas of the skin.
The alcohol contained in the preparation may cause irritation.
PREGNANCY AND LACTATION

The clinical experience of using the drug Lamisil ® Dermgel for external use during pregnancy is very limited, its use is possible if the intended benefit for the mother exceeds the potential risk to the fetus.

Terbinafine excreted in breast milk, so it should not be prescribed to nursing mothers.

In experimental studies teratogenic properties of terbinafine have not been revealed.
To date, no developmental defects have been reported with the use of Lamisil ®Dermgel.
APPLICATION IN ELDERLY PATIENTS

For elderly patients, dosage adjustment is not required.

SPECIAL INSTRUCTIONS

Lamisil® Dermgel is for external use only.

The drug should not be applied to the face.

Avoid contact with eyes.
it can cause irritation. In case of accidental contact, the eye should be rinsed immediately with running water, and in case of persistent irritation, consult a physician.
The drug contains butylhydroxytoluene, which can cause local allergic reactions (contact dermatitis) in the areas of application, as well as irritation of the eyes and mucous membranes.

Please note that the preparation contains ethanol 96%.

Caution should be exercised when applying Lamisil ® Dermgel to damaged areas of the skin.
The alcohol included in its composition can cause irritation.
Impact on the ability to drive vehicles and mechanisms

Does not affect.

OVERDOSE

No cases of overdose of Lamisil ® Dermgel were reported.

Symptoms: random ingestion of a 30 g drug containing 300 mg of terbinafine base into the tube is comparable to taking 1 tablet of Lamisil ® with a dosage of 250 mg (single dose for an adult).
If you randomly take more Lamisil ® Dermgel inside, you can expect the development of the same side effects as with an overdose of Lamisil ® tablets (headache, nausea, epigastric pain and dizziness). It should also be noted that the spray contains ethyl alcohol (9.4% (v / v).
Treatment: activated charcoal, if necessary, perform symptomatic therapy.

DRUG INTERACTION

Currently, the drug interaction of the drug Lamisil ® Dermgel is not described.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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