Terbinox 250mg 10pcs

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 is an allylamine antifungal agent that inhibits the biosynthesis of ergosterol (an important component of fungal cell membranes) by inhibiting squalene epoxidase. This is mainly due to increased membrane permeability mediated by accumulation of high concentrations of squalene rather than lack of ergosterol leading to fungal cell death. Depending on the drug concentration and the in vitro fungal species test, terbinafine hydrochloride may have a bactericidal effect. However, the clinical significance of the in vitro data is unclear. In vitro and clinical infections, terbinafine has been shown to be active against most strains of the following microorganisms: Trichophyton mentagrophytes, Trichophyton rubrum.

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 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.

Interaction

Terbinafine inhibits the CYP450 2D6 isozyme in vivo, according to research. Tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone), and monoamine oxidase inhibitors Type B are among the drugs processed mostly by the CYP450 2D6 isozyme. Co-administration of terbinafine should be done with caution, and the dose of the 2D6-metabolized medication may need to be reduced.

Contraindications

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

Side Effect

The reported adverse events included gastrointestinal symptoms (including diarrhea, indigestion, and abdominal pain), abnormal liver tests, skin rash, urticaria, itching, and dysgeusia. Generally speaking, adverse events are mild and short-lived and will not lead to treatment interruption. According to the world experience of using terbinafine, adverse events include: terbinafine and symptomatic liver damage, as well as more rare cases of liver failure, some leading to death or liver transplantation, severe skin reactions, severe neutral Granulocytopenia, thrombocytopenia, angioedema, and allergic reactions (including allergic reactions). Other adverse reactions that have been reported include discomfort, fatigue, vomiting, arthralgia, myalgia, and hair loss.

Pregnancy & Lactation

Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.

Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Precautions & Warnings

Warning

Terbinafine tablets: When using terbinafine tablets to treat onychomycosis in people with or without pre-existing liver disease, rare liver failure occurred, some leading to death or liver transplantation. In most reported liver cases related to terbinafine use, patients have serious underlying systemic disease, and the causal relationship with terbinafine is uncertain. In patients with active or chronic liver disease, the severity of the liver event and/or its outcome may be worse. If there is biochemical or clinical evidence of liver injury, terbinafine tablets should be discontinued. Individual cases of severe skin reactions (eg Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. If a progressive rash occurs, terbinafine treatment should be discontinued.

Terbinafine Cream: Terbinafine Cream is for external use only. Avoid contact with eyes.

Note: Terbinafine is not recommended for patients with chronic or active liver disease. Before prescribing terbinafine, the pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with or without pre-existing liver disease. It is recommended that all patients precondition the testes with serum transaminases (ALT and AST) before taking terbinafine tablets.

Storage Conditions

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