Terbin 1% cream 15 g

Terbin 1% cream 15 g

Composition:

Active Ingredient: Terbinafine hydrochloride — 10 mg (1.0%) per 1 gram of cream.
Excipients: Auxiliary cream base components.

Product Description:

• Topical antifungal agent belonging to the allylamine class with a broad spectrum of antimycotic activity.
• Even at low concentrations, terbinafine exerts a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold fungi, and the dimorphic fungus Pityrosporum orbiculare (Malassezia furfur).
• Against yeast fungi of the genus Candida (Candida albicans), its action may be fungicidal or fungistatic depending on the species. 
• Its mechanism involves inhibiting the enzyme squalene epoxidase in the fungal cell membrane, leading to ergosterol deficiency and intracellular accumulation of squalene, resulting in fungal cell death. 
• The drug does not influence the human cytochrome P450 system or hormone metabolism.

Indications for Use:

• Prevention and treatment of fungal skin infections caused by sensitive microorganisms:
• Fungal skin infections, including tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm);
• Cutaneous yeast infections, primarily caused by the genus Candida (e.g., intertrigo/chafing);
• Pityriasis versicolor (tinea versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

Method of Administration and Dosage:

• How to use: Topical application.
  Clean and dry the affected areas thoroughly prior to application.
• Adults and adolescents 12 years and older: Apply a thin layer of cream to the affected skin and surrounding areas once or twice daily and rub in gently.
• Infections in intertriginous areas (under breasts, between fingers/toes, between buttocks, in the groin), the application site may be covered with gauze, especially overnight.
• Average duration of treatment:
  Tinea corporis / tinea cruris / tinea pedis: 1 week (once daily).
  Cutaneous candidiasis: 1 to 2 weeks (once or twice daily).
  Pityriasis versicolor: 2 weeks (once or twice daily).

Contraindications:

Known hypersensitivity or allergy to terbinafine or any inactive cream excipients.
Children under 12 years of age (due to insufficient clinical trial experience).

Precautions:

• Use with caution in patients with hepatic and/or renal impairment, chronic alcoholism, bone marrow depression, tumors, metabolic disorders, occlusive vascular disease of the extremities.
• Relief of clinical symptoms is usually observed within the first few days of treatment.
  Irregular use or premature treatment discontinuation increases the risk of infection recurrence.
• Terbin cream is intended strictly for external/topical use.
  Avoid contact with eyes as it may cause irritation.
  In case of accidental eye contact, rinse thoroughly with running water immediately.
• Discontinue application if allergic reactions develop.

Adverse Reactions / Side Effects:

Local Reactions: Redness (erythema), itching (pruritus), peeling, burning, or pain may occur at the application site.
Allergic Reactions: Rarely — rash, urticaria, angioedema, contact dermatitis.

Pregnancy and Lactation:

Use during pregnancy is permissible only if the potential benefit to the mother outweighs the potential risk to the fetus.
Terbinafine is excreted in human breast milk; therefore, topical use during lactation is contraindicated (if treatment is required, breastfeeding should be discontinued).
Avoid infant contact with treated skin, including breasts.

Storage Conditions:

Store at a temperature not exceeding 25 °C in a dry place.
Keep out of reach of children.

Packaging:

Cardboard box containing a 15 g tube of cream.