Lamisil Dermgel gel 1%, 15 g (Terbinafine)

Description

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

Release form

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

Pharmacological action

Antifungal drug for external use with a wide spectrum 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), mold (mainly Candida albicoricum fungi) and fungi.

Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically modifies the early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell.

The action of terbinafine is carried out by inhibiting the squalene epoxidase enzyme located on the cell membrane of the fungus.

Terbinafine does not affect the human cytochrome P450 system and, accordingly, the metabolism of hormones or other drugs.

Indications

Prevention and treatment of fungal infections of the skin, including foot mycoses (tinea pedis), inguinal epidermophytosis (tinea cruris), fungal infections of smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton canis and Epidermophyton floccosum versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

Contraindications

Hypersensitivity to terbinafine or to any component of the drug.

breastfeeding period

children under 18 years of age.

Recommendations for the use of

Caution should be exercised when applying the drug to damaged skin, as alcohol, contained in the preparation may cause irritation.

Use during pregnancy and lactation

Clinical experience with the use of Lamisil® Dermgel for external use during pregnancy is very limited, its use is possible if the intended benefit to the mother outweighs the potential risk to the fetus.

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

In experimental studies of teratogenic properties of terbinafine not detected.

To date, no malformations have been reported with the use of Lamisil® Dermgel.

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 with eyes, rinse immediately with running water, and if persistent irritation develops, consult a doctor.

The drug contains butylhydroxytoluene, which can cause local allergic reactions (contact dermatitis) at the application site, as well as irritation of the eyes and mucous membranes.

It should be borne in mind that the drug contains 96% ethanol.

Caution should be exercised when applying Lamisil® Dermgel to damaged skin, as the alcohol in its composition can cause irritation.

Impact on ability to drive vehicles and mechanisms

Not affected.

Composition of

1 g of gel contains:

Active ingredient:

terbinafine (base form) 10 mg

Excipients:

benzyl alcohol

carbomer (carbopol 974 R)

isopropyl myristate

butylhydroxytoluene

sorbitan laurate

polysorbate 20

sodium hydroxide

ethanol

purified water.

Dosage and Administration

Externally.

Before using Lamisil® Dermgel for the first time, pierce the sealing membrane with a tip on the outside of the cap.

Lamisil® Dermgel is used in adults 1 time / day according to any indication. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is gently rubbed into areas of both affected and adjacent intact skin. In case of infections accompanied by diaper rash (under the mammary glands, between the fingers, in the gluteal and inguinal folds), the area of ​​application of the gel can be covered with gauze, especially at night.

Duration and frequency of use of the drug Lamisil® Dermgel for dermatomycosis of the trunk, legs - 1 week, 1 time / day for dermatomycosis of the feet - 1 week, 1 time / day for multi-colored lichen - 1 week, 1 time / day.

A decrease in the severity of clinical manifestations is usually observed in the early days of treatment. In the case of irregular treatment or its premature termination, there is a risk of infection recurrence. 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 effects

Determination of frequency of side effects: very common ( 1/10), often ( 1/100 and <1/10), infrequent ( 1/1000 and <1/100), rare ( 1 / 10,000 and <1/1000), very rare (<1 / 10,000), including individual messages.

From the immune system: separate reports - hypersensitivity reactions (rash).

From the eye: Rare - eye irritation.

From the skin: often - skin peeling, itching infrequently - skin damage, crust formation, skin damage, pigmentation disorder, erythema, skin burning sensation rarely - skin dryness, contact dermatitis, eczema separate messages - rash.

Local reactions: infrequently - pain, pain at application site, irritation at application site rarely - exacerbation of disease symptoms. In places of application of the drug itching can be observed, peeling of the skin, pain, irritation, change of skin pigmentation, burning, erythema, crust.

These minor symptoms should be distinguished from hypersensitivity reactions such as a rash, occurring in rare cases and requiring cancellation of therapy. In rare cases, the course of the fungal infection can be exacerbated.

Lekarstvennoe interaction

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

Overdose

No cases of overdose of Lamisil® Dermgel have been reported.

Symptoms: accidental ingestion of a tube of a drug weighing 30 g, containing 300 mg of terbinafine base, comparable to taking 1 tablet of Lamisil® with a dosage of 250 mg (single dose for an adult).

If you accidentally 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 borne in mind that the spray contains ethyl alcohol (9.4% (v / v).

Treatment: activated charcoal, symptomatic therapy is necessary if necessary.

Storage conditions

The product should be stored out of the reach of children at a temperature not exceeding 30 ° C.

Term hodnosty

3 years

active substance

Terbinafine

Terms

pharmacy leave

pharmacy leave terms without a prescription

Novartis Farma Stein AG, Switzerland



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