Terbinafine Tablets USP 250 mg_

Terbinafine tablets, USP 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). ( 1 )

• Prior to administering, evaluate patients for evidence of chronic or active liver disease
• Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks
• Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks
• Assessment Prior to Initiation Before administering terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications and Warnings and Precautions ]
• 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

Terbinafine tablets, 250 mg are supplied as white, round, flat faced beveled edge tablets debossed with IG on one side and 209 on the other. Tablet, 250 mg ( 3 )

• The safety and efficacy of terbinafine tablets have not been established
• Pediatric patients with onychomycosis

Clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise the patient to read the FDA-Approved Medication Guide
• Patients taking terbinafine tablets should receive the following information and instructions: Advise patients to immediately report to their physician or get emergency help if they experience any of the following symptoms: hives, mouth sores, blistering and peeling of skin, swelling of face, lips, tongue, or throat, difficulty swallowing or breathing
• Terbinafine tablets treatment should be discontinued
• Advise patients to immediately report to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or pale stools. …

• Terbinafine tablets are contraindicated in patients with: • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions ] • Chronic or active liver disease [see Warnings and Precautions ] Chronic or active liver disease
• History of allergic reaction to oral terbinafine because of the risk of anaphylaxis

Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on metabolism of desipramine. Drug interactions have also been noted with cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. ( 7.1 ) 7.1 Drug-Drug Interactions In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. …

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. ( 5.1 ) 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. ( 5.2 ) Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. …

Common (greater than 2% of patients treated with terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 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. …

Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.