Lamiderm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LAMIDERM (LAMIDERM)

Composition:

Active substance: terbinafine;

1 g of cream contains terbinafine hydrochloride 10 mg;

Excipients: emulsifying wax; cetylstearyl alcohol; mineral oil; white soft paraffin; benzyl alcohol; propylene glycol; Cremophor EL; disodium hydrogen phosphate dihydrate; triethanolamine; purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white or almost white cream.

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01AE15.

Pharmacological properties.

Pharmacodynamics.

Terbinafine is an allylamine with a broad spectrum of antifungal activity. Terbinafine exhibits fungicidal activity against dermatophytes, molds, and some dimorphic fungi at low concentrations. Activity against yeasts may be either fungicidal or fungistatic, depending on the species. The drug has a prolonged effect, enabling therapeutic efficacy to be achieved within a short treatment period.

Terbinafine specifically inhibits an early stage of sterol biosynthesis in the fungal cell membrane. This leads to ergosterol deficiency and intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibiting the enzyme squalene epoxidase in the fungal cell membrane. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormonal agents or other medicinal drugs.

Pharmacokinetics.

When applied topically, less than 5% of the dose is absorbed, so systemic absorption of terbinafine into the bloodstream is negligible.

After 7 days of treatment with Lamiderm, concentrations of terbinafine exceeding those required for fungicidal activity remain present in the stratum corneum of the epidermis for at least 7 days after discontinuation of treatment.

Clinical characteristics.

Indications.

Fungal skin infections caused by dermatophytes such as Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum, for example: tinea pedis (athlete's foot); tinea cruris (jock itch); tinea corporis (ringworm); cutaneous candidiasis caused by Candida species, usually Candida albicans; pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications.

Hypersensitivity to terbinafine or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

Lamiderm is intended for topical use only. Contact of the cream with the eyes should be avoided, as the medicinal product may cause eye irritation. In case of accidental contact with the eyes, they should be thoroughly rinsed with running water. Lamiderm contains cetostearyl alcohol, which may cause local skin irritation (e.g., contact dermatitis).

Contact between infants and skin areas treated with the medicinal product should be avoided, including the mammary glands.

If irritation or hypersensitivity reactions occur, or if the condition worsens, application of the cream should be discontinued and appropriate treatment initiated.

Do not apply to facial skin.

To prevent skin mycosis, the following rules should be observed: change underwear daily, as microorganisms may be present on clothing parts that have been in contact with infected skin surfaces; avoid wearing clothes that are too tight or poorly breathable; thoroughly dry affected skin areas after washing; use a personal towel, which should be changed daily. In case of tinea pedis (athlete's foot), walking barefoot should be avoided. In addition to topical treatment once daily, socks or footwear should be treated once daily with an antifungal powder.

Use during pregnancy or breastfeeding.

Studies in animals have not shown embryotoxic effects of terbinafine. Since clinical experience with the use of this medicinal product in pregnant women is limited, Lamiderm should not be used during pregnancy unless, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the fetus. Terbinafine passes into breast milk; therefore, the product should not be used during breastfeeding. Contact between infants and skin areas treated with the cream should be avoided, including the mammary glands.

In animal studies, no effect of terbinafine on fertility was observed.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

The cream is intended for topical use only.

Adults and children aged 12 years and older.

Apply Lamiderm cream to the skin once or twice daily, depending on the condition. Before application, thoroughly clean and dry the affected areas. Apply a thin layer of cream to the affected skin and surrounding areas, gently rubbing it in. For infections accompanied by maceration (under the breasts, in the interdigital areas, groin, and between the buttocks), the treated areas may be covered with gauze, especially at night.

Duration and frequency of use.

The duration of treatment depends on the severity of the disease:

• Interdigital tinea pedis, tinea cruris, and tinea corporis: once daily for 1 week;
• Scaled-hyperkeratotic tinea pedis ("moccasin-type" athlete's foot): twice daily for 2 weeks;
• Cutaneous candidiasis: once or twice daily for 1–2 weeks;
• Pityriasis versicolor: once or twice daily for 2 weeks.

Dosage adjustment is not required for elderly patients.

Symptom relief usually occurs within a few days. Irregular use or premature discontinuation of treatment may lead to recurrence.

If there is no sign of improvement after 2 weeks of treatment, consult a physician.

Children.

Experience with the use of the drug in children under 12 years of age is limited; therefore, the medicinal product should not be used in this age group.

Overdose.

The low systemic absorption of terbinafine from the topical cream formulation results in an extremely low risk of overdose. Accidental ingestion of 30 g of cream (corresponding to 300 mg of terbinafine hydrochloride) is comparable to taking one 250 mg terbinafine tablet (an oral dosage form). In cases of overdose due to accidental ingestion of a large amount of cream, adverse effects would be expected to be similar to those seen with an overdose of terbinafine tablets (e.g., headache, nausea, epigastric pain, and dizziness).

Management of overdose following accidental ingestion includes removal of the active substance, primarily by administering activated charcoal, and symptomatic treatment as necessary.

Side effects.

Local reactions such as itching, peeling or burning of the skin, pain and irritation at the application site, pigment disturbances, erythema, crusting and others may occur at the site of application. These mild reactions should be differentiated from hypersensitivity reactions, including rash, which have been reported in isolated cases and require discontinuation of treatment. Accidental contact with eyes may cause irritation due to terbinafine hydrochloride. In rare cases, latent fungal infection may worsen.

Immune system disorders.

Frequency unknown (cannot be estimated from available data): hypersensitivity reactions, including urticaria.

In isolated cases: angioedema and anaphylactic shock.

Eye disorders.

Rare (≥ 1/10,000, < 1/1,000): eye irritation.

Skin and subcutaneous tissue disorders.

Common (≥ 1/100, < 1/10): skin peeling, itching.

Uncommon (≥ 1/1,000, < 1/100): skin injury, crusting, skin lesions, pigment disturbances, erythema, skin burning sensation.

Rare (≥ 1/10,000, < 1/1,000): skin dryness sensation, contact dermatitis (including bullous dermatitis), eczema.

Frequency unknown (cannot be estimated from available data): rash, blister formation.

General disorders and administration site conditions.

Uncommon (≥ 1/1,000, < 1/100): pain, pain at application site, irritation at application site.

Rare (≥ 1/10,000, < 1/1,000): worsening of symptoms.

Note: adverse reaction data obtained from post-marketing use are reported voluntarily; therefore, their frequency cannot be determined and is designated as "unknown". However, these cases are most likely rare (≥ 1/10,000, < 1/1,000) or very rare (< 1/10,000).

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

15 g in a tube. 1 tube per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer: Indoce Remedies Limited.

Manufacturer's address and place of business.

L-14, Verna Industrial Estate, Verna, Goa IN-403 722, India.