During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Ternafin tablets. Ternafin tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.
Lamisil Tablets are contraindicated in individuals with a history of allergic reaction to oral Ternafin because of the risk of anaphylaxis.
Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Lamisil Tablets in individuals with and without preexisting liver disease.
In the majority of liver cases reported in association with use of Lamisil Tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Lamisil Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.
Lamisil Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Lamisil should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Lamisil Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral Ternafin, and the patientâ€™s liver function should be immediately evaluated.
Lamisil Tablets contain the synthetic allylamine antifungal compound Ternafin hydrochloride. Chemically, Ternafin hydrochloride is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90, and the following structural formula:
Ternafin hydrochloride is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
Each tablet contains:
Active Ingredients: Ternafin hydrochloride (equivalent to 250 mg base)
Inactive Ingredients: colloidal silicon dioxide NF, hydroxypropyl methylcellulose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.
Is Ternafin safe to take if I'm pregnant or breastfeeding?
There are no adequate studies in pregnant women. Since nail fungus treatment can be delayed until after pregnancy there is no reason to use oral Ternafin during pregnancy.
Breastfeeding mothers should not use oral Ternafin because Ternafin passes into breast milk.
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Lamisil (Ternafin hydrochloride) is an antifungal antibiotic used to treat infections caused by fungus that affect the fingernails or toenails (onychomycosis). Oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old. Lamisil is available in generic form. Common side effects of Lamisil include
- stomach upset,
- stomach pain,
- spinning sensation,
- mild skin rash,
- itching, or
- temporary unusual or unpleasant taste or loss of taste in your mouth.
To treat fingernail onychomycosis the dose of Lamisil is one 250 mg tablet once daily for 6 weeks. For toenail onychomycosis, take one 250 mg tablet once daily for 12 weeks. Lamisil may interact with cimetidine, rifampin, other antifungal antibiotics, blood thinners, heart rhythm medications, antidepressants, MAO inhibitors (MAOIs), or beta-blockers. Tell your doctor all medications you use. During pregnancy, Lamisil should be used only when prescribed. Fungal nail infection treatment can usually wait until after you have had your baby. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.
Our Lamisil (Ternafin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the metabolism of Ternafin?
Ternafin is absorbed well when taken orally, with or without food. It is bound to proteins such as albumin in the circulating blood and becomes concentrated in fat cells and within skin and nails . It is slowly eliminated in faeces and urine mostly after conversion by the liver into inactive compounds. It is a moderate CYP2D6 inhibitor. Doses may need to be reduced in the presence of kidney disease.
Skin concentrations may be up to 75-fold higher than those in the blood. It may persist in the skin for up to 8 weeks after the drug has been discontinued and in the nails for up to a year.
Ternafin tablets are contraindicated in patients with:
- Chronic or active liver disease
- History of allergic reaction to oral Ternafin because of the risk of anaphylaxis
An evaluation of the effect of food on Ternafin tablets was conducted. An increase of less than 20% of the AUC of Ternafin was observed when Ternafin tablets were administered with food. Ternafin tablets can be taken with or without food.
Clinical experience regarding overdose with oral Ternafin 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.