LAMIZIL (Cream)

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, B37.2
When CSF: 08.02.02
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

Pharmaceutical form, composition and packaging

◊ Cream for external application 1% white, uniform, with low specific smell.

Excipients: benzyl alcohol, Sodium hydroxide, sorbitan stearate, tsetyla palmitat, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropylammonium myristate, Purified water.

15 g – aluminum tuba (1) – packs cardboard.
30 g – aluminum tuba (1) – packs cardboard.

Pharmacological action

Antifungal agents for external use, with a wide spectrum antifungal activity. In small concentrations of terbinafine has fungicidal effect for dermophytes (Red Trychophyton, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violet, Trychophyton tonsurans, Microspores dog, Epidermophyton floccosum), mold (mostly Candida albicans) and certain dimorphic fungi (Orbicular Pityrospores). Activity against yeast, depending on the species, It may be fungicidal or fungistatic.

Terbinafine specific changes the early stage of the biosynthesis of sterols, what is happening in mushrooms. This leads to a deficiency of ergosterol and to an 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.

Terbinafine has no effect on the cytochrome P450 system in humans and, respectively, 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

Prophylaxis and treatment of fungal skin infections:

- Tinea pedis (foot moth), jock itch (Tinea craris), fungal skin smooth body (moth body), caused by dermatophytes such, as Trichophyton (incl. T. red, T. mentagrophytes, T. verrucosum, T. purple), Microsporum canis и Epidermophyton floccosum;

- Yeast infections of the skin, basically the, originally called Candida (eg, Candida albicans), in particular, diaper rash;

- Multi-colored shingles (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

Dosage regimen

In Adult Lamizil^® It may be used 1 or 2 times / day, depending on the evidence. Before using the product, thoroughly clean and dry the affected areas. Cream are thin in the affected skin and surrounding areas and lightly scrub. When infections, accompanied intertrigo (under the breasts, interdigital spaces, between the buttocks, groin) place applying the cream you can cover the gauze, especially at night.

At extensive fungal body We recommend that you apply the cream in the box on 30 g.

Average duration of treatment and the multiplicity of drugs in ringworm of the body, goleneй is 1 week 1 time / day; at Tinea pedis – 1 week 1 time / day; at orogovenii, cracks, itching and desquamation, caused by a fungus of the foot – 2 of the week 1-2 times / day; at pityriasis versicolor – 1-2 of the week 1-2 times / day; at candidiasis skin 1-2 of the week 1-2 times / day.

Reducing the severity of the clinical manifestations are usually noted in the first days of treatment. The irregular use or premature termination of treatment, there is a risk of re-infecting. In the absence of signs of improvement through 1-2 weeks of therapy should verify the diagnosis.

Lamizil^® cream is not recommended for use in children under the age of 12 years.

Side effect

Local reactions: redness, itching or burning.

Other: allergic reactions.

Contraindications

- Hypersensitivity to terbinafine or any of the inactive ingredients, members of the drug.

FROM caution shall mean patients with hepatic and/or renal failure, patients with chronic alcoholism, the oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of extremities, as well as in childhood (lack of sufficient clinical experience).

Pregnancy and lactation

Clinical experience with Lamisil^® for external use during pregnancy is limited, so the product can be used only on strict conditions.

Known, that terbinafine is excreted in breast milk. However, when the application in nursing Lamizila^® any negative effect on the baby is unlikely, Since the absorption terbinafina system through the skin when applied externally slightly.

IN experimental studies teratogenic properties of terbinafine is not revealed. So far, no reports of any malformation when using Lamisil^®.

Cautions

The drug is intended for external use only.

Avoid contact with the eyes, because it may cause irritation. In the event of accidental ingestion eye should be immediately rinsed with running water, and in the case of persistent phenomena irritation you need to see a specialist.

With the development of allergic reactions need to stop the drug.

Overdose

The overdose cases Lamizila^® not reported.

Symptoms: Accidental admission into possible drug headache, nausea, epigastric pain and dizziness. It should also take into account the content of the spray ethanol 23.5%.

Treatment: Activated carbon, if necessary, symptomatic therapy.

Drug Interactions

Currently, drug interactions Lamisil^® unknown.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored at a temperature no higher than 30 ° C; Do not freeze. Shelf life – 5 years.