Product image of Lamisilate Monodose (Terbinafine Hydrochloride) supplied by GNH India

Lamisilate Monodose

Active Ingredient:
Terbinafine Hydrochloride
Origin:
EU

Lamisilate Monodose (Terbinafine Hydrochloride)

Terbinafine Hydrochloride, the active ingredient in Lamisilate Monodose, is an allylamine presented as a topical formulation for skin application. It is indicated for the treatment of superficial fungal infections of the skin and nails in both adults and children, acting by disrupting fungal cell membrane synthesis.

GNH India supplies Lamisilate Monodose as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing consistent quality and regulatory adherence for global distribution and supporting timely delivery to meet patient care needs.

Manufacturer / TM Owner

Karo Healthcare Ab

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Indications & Clinical Uses

Terbinafine Hydrochloride is an allylamine antifungal used to treat dermatophyte and yeast infections of the skin and nails.

  • Tinea pedis: relief of itching and eradication of the causative dermatophyte on the feet.
  • Tinea corporis: clearance of ring‑shaped lesions on the body.
  • Tinea cruris: treatment of fungal infection in the groin area.
  • Tinea versicolor: reduction of discolored patches caused by Malassezia species.
  • Onychomycosis (topical): improvement of fungal nail infection when applied to the affected nail surface.

How It Works

  • Terbinafine Hydrochloride inhibits the fungal enzyme squalene epoxidase, a key step in the biosynthesis of ergosterol, an essential component of the fungal cell membrane. By blocking ergosterol production, the drug causes accumulation of toxic squalene and destabilizes the membrane, leading to fungal cell death and resolution of the infection.

Side Effects

Terbinafine Hydrochloride may cause local skin reactions when applied topically.

Common Side Effects

  • Itching: mild to moderate sensation at the application site.
  • Burning: transient heat sensation during or after application.
  • Redness: localized erythema around the treated area.
  • Scaling: flaking of skin as the infection resolves.
  • Dryness: temporary loss of skin moisture.
  • Irritation: mild discomfort or stinging.

Serious or Rare Side Effects

  • Allergic reaction: hives, swelling, or difficulty breathing.
  • Severe skin rash: widespread redness or blistering.
  • Contact dermatitis: persistent inflammation at the site.
  • Swelling: localized edema beyond normal irritation.
  • Urticaria: raised, itchy welts on the skin.
  • Rare systemic effects: liver enzyme abnormalities with extensive use.

Precautions & Warnings

Before using Lamisilate Monodose, consider the following precautions.

  • Avoid use on broken skin: do not apply to open wounds or erosions.
  • Do not apply to mucous membranes: keep away from eyes, mouth and genital mucosa.
  • Check for hypersensitivity: discontinue if signs of allergic reaction appear.
  • Consult healthcare professional if using other topical agents: avoid overlapping applications that may increase irritation.
  • Store at room temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Terbinafine Hydrochloride may interact with other medications or products.

Major Interactions (Avoid)

  • Systemic terbinafine: concurrent use may increase overall exposure and risk of systemic side effects.
  • Known hypersensitivity to allylamines: avoid to prevent severe allergic reactions.

Moderate Interactions (Monitor Closely)

  • Other topical antifungals: may increase local irritation.
  • Corticosteroid creams: can mask infection signs and delay healing.
  • Alcohol‑based skin products: may enhance skin dryness and irritation.
  • Phototoxic agents: increase risk of photosensitivity when exposed to sunlight.

Frequently Asked Questions

Lamisilate Monodose contains terbinafine hydrochloride and is applied topically to treat superficial fungal infections such as athlete's foot (tinea pedis), ringworm of the body (tinea corporis), groin infection (tinea cruris), fungal discoloration of the skin (tinea versicolor), and mild cases of nail fungus when used on the nail surface.

Terbinafine hydrochloride blocks the fungal enzyme squalene epoxidase, which is essential for producing ergosterol, a key component of the fungal cell membrane. Inhibiting this pathway leads to toxic buildup of squalene and loss of membrane integrity, causing fungal cell death and clearing the infection.

The specific dosage and frequency of Lamisilate Monodose are determined by the prescribing healthcare professional based on the type and severity of the infection, the patient’s age, and other clinical factors. Patients should follow the prescriber’s instructions and the product label.

Safety data for topical terbinafine during pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before using Lamisilate Monodose.

To request Lamisilate Monodose, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Lamisilate Monodose delivers terbinafine, an allylamine that targets squalene epoxidase, offering a different mechanism than azole antifungals which inhibit lanosterol 14‑α‑demethylase. This can result in faster symptom relief and lower rates of resistance for certain dermatophyte infections, making it a valuable alternative when azoles are ineffective or not tolerated.

Store Lamisilate Monodose at room temperature, below 25 °C, in its original packaging. Keep the container tightly closed, protect it from moisture, excessive heat and direct sunlight to maintain product stability.

Apply a thin layer of the cream or gel to the affected skin area once or twice daily as directed by the prescriber. Clean and dry the skin before application, and wash hands after use to avoid accidental contact with eyes or mucous membranes.

While generally well tolerated, serious adverse reactions can include severe allergic responses such as hives, swelling, difficulty breathing, or a widespread rash. If any of these occur, discontinue use immediately and seek medical attention.

Individuals with a known hypersensitivity to terbinafine, other allylamines, or any component of the formulation should avoid using Lamisilate Monodose. It is also contraindicated on broken skin, mucous membranes, or in patients where a systemic antifungal is already being administered.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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