Terbinafine Hydrochloride

What it is and how it works

Mechanism of Action Terbinafine is an allylamine antifungal .

Indications

1. INDICATIONS AND USAGE Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

Dosage and administration (summary)

2. DOSAGE AND ADMINISTRATION Prior to administering, evaluate patients for evidence of chronic or active liver disease. Fingernail onychomycosis: One tablet, once daily for 6 weeks. Toenail onychomycosis: One tablet, once daily for 12 weeks. Assessment Prior to Initiation Before administering Terbinafine tablets, evaluate patients for evidence of chronic or active liver disease . Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks. Toenail onychomycosis: One 250 mg 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.

Contraindications

4. CONTRAINDICATIONS Terbinafine tablets are contraindicated in patients with: Chronic or active liver disease History of allergic reaction to oral terbinafine because of the risk of anaphylaxis Chronic or active liver disease. History of allergic reaction to oral terbinafine because of the risk of anaphylaxis.

Warnings and precautions

5. WARNINGS AND PRECAUTIONS Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases. Prior to initiating treatment and periodically during therapy, assess liver function tests. Discontinue Terbinafine tablets if liver injury develops. Taste disturbance, including taste loss, has been reported with the use of Terbinafine tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue Terbinafine tablets if taste disturbance occurs.

Pregnancy

Pregnancy Risk Summary Available data from postmarketing cases on the use of Terbinafine Tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Terbinafine Tablets, USP are supplied as white, oblong, unscored tablets debossed "B" and "526" on one side and plain on the other side. NDC: 71335-0918-1: 30 Tablets in a BOTTLE NDC: 71335-0918-2: 60 Tablets in a BOTTLE NDC: 71335-0918-3: 90 Tablets in a BOTTLE NDC: 71335-0918-4: 100 Tablets in a BOTTLE NDC: 71335-0918-5: 7 Tablets in a BOTTLE NDC…

Source: Terbinafine Hydrochloride (Terbinafine Hydrochloride) — US FDA prescribing information, 2024-08-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.