Indications

Terbinafine tablets: This tablet is suitable for the treatment of toenails or fingernail fungal diseases caused by dermatophytes (onychomycosis).

Terbinafine Cream: Trichophyton skin fungal infection (such as Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton) violaceus), Microsporum canis and Epidermophyton flocculus. Fungal skin infections are mainly caused by Candida species (such as Candida albicans). Tinea versicolor (ringworm) is caused by Pityrosporum vertica (also known as Malassezia pityriasis).

Pharmacology

Terbinafine, an allylamine antifungal agent, inhibits the biosynthesis of ergosterol (an essential component of fungal cell membranes) by inhibiting the enzyme squalene epoxidase. This leads to the death of fungal cells mainly due to the increase in membrane permeability mediated by the accumulation of high concentrations of squalene, but not due to a lack of ergosterol. Depending on the concentration of the drug and the fungal species tested in vitro, terbinafine hydrochloride can kill the fungus. However, the clinical significance of the in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections: Trichophyton Mentagrophyte, and Trichophyton rubrum.

Dosage & Administration

Terbinafine tablet:

• For the treatment of fingernail 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 the outgrowth of healthy nails.

Terbinafine cream: Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before the application of the terbinafine cream. Apply the cream to the affected skin and the surrounding area in a thin layer and rub it 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.

Interaction

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isoenzyme. Drugs primarily metabolized by the CYP450 2D6 isoenzyme include the following classes of drugs: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, class 1C antiarrhythmics (eg, flecainide) and propafenone) and monoamine oxidase inhibitors class B. advised. and may require a dose reduction of the 2D6 metabolite.

Contraindications

Terbinafine tablets and creams are contraindicated in people with known hypersensitivity to terbinafine.

Side Effects

Reported adverse reactions include gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), abnormal liver tests, rash, urticaria, pruritus, and taste disturbances. In general, adverse events were mild, and transient, and did not lead to discontinuation of treatment. A or liver transplantation, severe skin reactions, severe leukopenia, thrombocytopenia, angioedema, and allergic reactions (including anaphylaxis). Other side effects that have been reported include irritability, fatigue, vomiting, joint pain, muscle pain, and hair loss.

Pregnancy & Lactation

Terbinafine Tablets: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response and treatment of nail fungus may be delayed until late in pregnancy, terbinafine should not be started during pregnancy. pregnant. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended for nursing mothers.

Terbinafine Cream: Fetal toxicity and fertility studies in animals have not revealed any adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefit outweighs the potential risk, terbinafine should not be used. Terbinafine is excreted in human milk and therefore mothers should not be treated with terbinafine while breastfeeding.

Precautions & Warnings

Warning

• Terbinafine Tablets: Rare cases of liver failure, some leading to death or the need for a liver transplant, have occurred when terbinafine tablets were used to treat nail fungus in people with or without liver disease. before. In the majority of liver cases reported in association with terbinafine use, patients had serious underlying systemic conditions and an uncertain causal relationship with terbinafine. The severity of liver events and/or their outcomes may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there are biochemical or clinical signs of liver injury. Isolated cases of serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. In the event of a progressive rash, treatment with terbinafine should be discontinued.
• Terbinafine Cream: Terbinafine Cream is for external use only. Contact with eyes should be avoided.

Precautions for use: Terbinafine is not recommended in patients with chronic or active liver disease. Before prescribing Terbinafine, the pre-existing liver disease should be evaluated. Hepatotoxicity may occur in patients with or without pre-existing liver disease. Pretreatment of testes with serum transaminases (ALT and ASAT) is advised in all patients prior to administration of terbinafine tablets.

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Storage Conditions

Store in a cool and dry place, below 30°C, and protect from light.

Generic

Terbinafine Hydrochloride

Pharmaceutical Name

General Pharmaceuticals Ltd.