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

Active substance: terbinafine

Type: Antifungal medication for external use

Manufacturer: GlaxoSmithKline Helsker (Russia) manufactured by NOVARTIS PHARMA PRODUCTIONS (Germany)
Composition, form of production and packaging

?
The cream for external use is white, homogeneous, with a weak characteristic odor.
1 g

terbinafine hydrochloride 10 mg

Excipients: benzyl alcohol, sodium hydroxide, sorbitan stearate, cetyl palmitate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water.

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

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

?
Spray for external use in the form of a transparent colorless or light yellow liquid with a characteristic odor.
1 g

terbinafine hydrochloride 10 mg

Excipients: water - 670 mg, ethanol 96% - 250 mg, propylene glycol - 50 mg, macrogol cetostearate - 20 mg.

15 ml - bottles of high-density polyethylene with a spray tip (1) - packs of cardboard.

30 ml - bottles of high-density polyethylene with a spray tip (1) - packs of cardboard.

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 topical application, absorption is less than 5%, has a minor systemic effect.

INDICATIONS

Prevention and treatment of fungal infections of the skin:

- foot mycoses (tinea pedis);
horniness, cracks, itching and flaking of the skin caused by foot fungus; inguinal epidermophytia (tinea craris), fungal lesions 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 (eg, Candida albicans), in particular, diaper rash;

- Multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

DOSING MODE

Lamisil ® Cream

In adults and children over 12 years, the Lamisil ® cream can be applied 1 or 2 times / day, depending on the indications.
Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The cream is applied a thin layer on the affected skin and adjacent areas and lightly rubbed. In infections accompanied by intertrigo (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.
In case of extensive fungal lesions of the body, it is recommended to use a cream in tubes of 30 g.

The average duration of treatment and the frequency of application of the drug for dermatomycosis of the trunk, shins is 1 week 1 time / day;
with dermatomycosis stop - 1 week 1 time / day; with keratinization, cracks, itching and flaking of the skin caused by the fungus of the foot - 2 weeks 1-2 times / day; with candidiasis of the skin - 1-2 weeks 1-2 times / day; with colored lichen - 2 weeks 1-2 times / day.
Reducing the severity of clinical manifestations is usually noted in the first days of treatment.
If there is an irregular application or premature discontinuation of treatment, there is a risk of renewal of the infection. If there are no signs of improvement, the diagnosis should be verified after 1-2 weeks of therapy.
Correction of the dosage regimen of Lamisil ® cream in elderly patients is not required.

Lamisil ® Spray

In adults, Lamisil ® can be applied 1 or 2 times / day, depending on the indications.
Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is sprayed on the affected areas in an amount sufficient to thoroughly moisturize them, and, in addition, applied to adjacent areas of both affected and intact skin.
With extensive fungal lesions of the body, it is recommended to use a spray in 30 ml vials.

Multiplicity of the drug and duration of treatment: dermatomycosis of the trunk, shins - 1 time / day for 1 week;
dermatomycosis stop - 1 time / day for 1 week; multi-colored lichen - 2 times / day for 1 week; inguinal epidermophytia, diaper rash - 1 time / day for 1 week.
SIDE EFFECT

Determination of the frequency of adverse events (WHO): 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.
If any of these side effects are aggravated, or the patient has noticed any other side effects, you should inform your doctor.

CONTRAINDICATIONS

- hypersensitivity to terbinafine or to any of the inactive ingredients that make up the drug;

- the period of breastfeeding;

- Children under 12 years of age (Lamisil ® cream);

- Children under 18 years of age (Lamisil ® spray).

With caution appoint the drug to patients with hepatic and / or renal insufficiency, patients with chronic alcoholism, with oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

PREGNANCY AND LACTATION

Since the clinical experience of using Lamisil ® cream in pregnant women is very limited, it should not be used, except in cases of extreme necessity.
In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus. It is necessary to consult a doctor.
In experimental studies teratogenic properties of terbinafine were not revealed.
To date, no developmental defects have been reported with the use of Lamisil ® .
Terbinafine is excreted in breast milk, so the drug should not be given to nursing mothers.
Do not allow the baby to contact any skin surface treated with Lamisil ® .
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution appoint the drug to patients with kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint the drug to patients with hepatic insufficiency.

APPLICATION FOR CHILDREN

Lamisil ® is contraindicated in children under 12 years old .

Lamisil ® is contraindicated in children under the age of 18 years .

APPLICATION IN ELDERLY PATIENTS

Correction of the dosage regimen of Lamisil ® cream in elderly patients is not required.

SPECIAL INSTRUCTIONS

Reducing the severity of clinical manifestations is usually noted in the first days of treatment.
In case of irregular application or premature termination, there is a risk of recurrence of the infection.
The drug is intended for external use only.

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.
When developing allergic reactions, it is necessary to cancel the drug.

Lamisil ® Cream for external use contains cetyl and stearyl alcohols, which can cause local allergic reactions (contact dermatitis) in the places of application.

Caution should be exercised when applying Lamisil ® spray to damaged areas of the skin.
Ethanol included in its composition can cause irritation. Lamisil ® isintended for external use only. Do not use Lamisil ® spray to apply to the face. If the Lamisil ® spray was accidentally injected into the respiratory tract by inhalation, then if any symptoms occur, and especially when they persist, you should consult your doctor. Spray Lamisil ® contains propylene glycol, which in some cases can cause skin irritation. It should also be taken into account that the preparation contains ethanol 96%.
OVERDOSE

No cases of overdose of Lamisil ® were reported.

Symptoms: accidental ingestion of 30 ml of Lamizil ® spray with 300 mg of terbinafine hydrochloride is comparable to taking 1 tablet of Lamisil ® with a dosage of 250 mg (single dose for an adult).
If you randomly take more Lamizil ® spray 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 (28.87% (v / v).
Treatment: activated charcoal, if necessary, perform symptomatic therapy.

DRUG INTERACTION

Currently, the drug interaction of the drug Lamisil ® is unknown.

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 - 5 years.
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