Xfin

Generic

Terbinafine Hydrochloride

 

Indications

Terbinafine tablet: This tablet is used to treat dermatophytes-caused onychomycosis of the toenail or fingernail (tinea unguium).

Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, and Epidermophyton floccosum cause fungal infections of the skin. Yeast infections of the skin, mostly caused by the Candida genus (e.g. C. albicans). Due to Pityrosporum orbiculare, pityriasis (tinea) versicolor develops (also known as Malassezia furfur).

 

Pharmacology

Terbinafine, an antifungal Allylamine, inhibits the formation of Ergosterol (an important component of fungi cell membranes) by inhibiting the Squalene Epoxidase enzyme. This causes fungal cell death mostly due to increased membrane permeability caused by high levels of Squalene buildup, rather than Ergosterol insufficiency. Terbinafine hydrochloride may be fungicidal depending on the medication concentration and the fungus species tested in vitro. The clinical value of in vitro data, on the other hand, remains unknown. Terbinafine has been proven to be effective in vitro and in clinical infections against the majority of strains of the following microorganisms: Tricophyton Menta Tricophyton Menta Tricophyton Menta.                                                                                                                      

 

Dosage & Administration

Terbinafine tablet:

• For the treatment of finger nail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
• For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
• The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Terbinafine granules:

• Body Weight: <25 kg: 125 mg/day up to 6 weeks
• Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
• Body Weight: >35 kg: 250 mg/day up to 6 weeks

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. The likely durations of treatment are as follows:

• Tinea corporis, cruris: 1 to 2 weeks
• Tinea pedis: 1 week
• Cutaneous candidiasis: 2 weeks
• Pityriasis versicolor: 2 weeks

Relief of the clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

 

Contraindications

Terbinafine tablets and cream are not recommended for people who are hypersensitive to terbinafine.

 

Side Effects

Gastrointestinal symptoms (including diarrhea, dyspepsia, and stomach discomfort), liver test abnormalities, rashes, urticaria, itching, and taste alterations are among the side effects recorded. In general, the side effects were minor and temporary, and they did not necessitate stopping the medication. Idiosyncratic and symptomatic hepatic injury, and more rarely, cases of liver failure, some resulting to death or liver transplant, serious skin responses, severe neutropenia, thrombocytopenia, angioedema, and allergic reactions, according to worldwide experience with terbinafine use (including anaphylaxis). Malaise, weariness, vomiting, and arthralgia are some of the other side effects that have been documented.

 

Pregnancy & Lactation

Terbinafine cream has been shown to have no negative effects on foetal toxicity and fertility in animals. There is no clinical experience with terbinafine in pregnant women; consequently, terbinafine should not be used unless the possible benefits outweigh the potential risks. Terbinafine is secreted in breast milk, so mothers who are breastfeeding should avoid terbinafine medication.

 

Precautions & Warnings

Terbinafine pills: The use of terbinafine tablets for the treatment of onychomycosis in patients with and without preexisting liver disease has resulted in rare occurrences of liver failure, some of which have resulted in death or liver transplantation. Patients with substantial underlying systemic illnesses and an unknown causal relationship with terbinafine were seen in the majority of liver cases reported in connection with terbinafine use. In patients with current or chronic liver disease, the severity of hepatic events and/or their outcome may be worse. If you have biochemical or clinical indications of liver injury, you should stop using terbinafine tablets.

 

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

 

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 25°C. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.