Infud 250

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 production of Ergosterol (an important component of fungi cell membranes) by inhibiting the Squalene Epoxidase enzyme. This causes fungal cell death largely owing 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 relevance of in vitro findings, on the other hand, remains uncertain.

 

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 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

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.

 

Pregnancy & Lactation

Terbinafine tablet: No appropriate and well-controlled trials in pregnant women have been conducted. Terbinafine should not be started during pregnancy since animal reproduction studies are not necessarily predictive of human response, and onychomycosis therapy can be postponed until after the pregnancy has finished. Terbinafine is found in the breast milk of nursing women after oral dosing. Terbinafine is not advised for use in breastfeeding mothers.

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; thus, terbinafine should not be used unless the possible benefits outweigh the potential risks. Terbinafine is secreted in breast milk, thus women who are breastfeeding should avoid terbinafine therapy.

 

Precautions & Warnings

Warnings-

• Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
• Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.

Precautions: Terbinafine are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) teste are advised for all patients before taking terbinafine tablets.

 

Therapeutic Class

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

 

Storage Conditions

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

 

Pharmaceutical Name

General Pharmaceuticals Ltd.