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Lamisil Oral Granules

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Lamisil Oral Granules

Lamisil Oral Granules

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hepatotoxicity

Cases of liver failure, some leading to death or liver transplant, have occurred with the use of oral terbinafine during postmarketing experience in individuals with and without pre-existing liver disease. In the majority of liver cases reported, 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 Oral Granules (terbinafine hydrochloride) should be discontinued if biochemical or clinical evidence of liver injury develops.

Lamisil Oral Granules (terbinafine hydrochloride) is not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Oral Granules (terbinafine hydrochloride) , 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) tests are advised for all patients before taking Lamisil Oral Granules (terbinafine hydrochloride) . Patients prescribed Lamisil Oral Granules (terbinafine hydrochloride) and/or their guardians 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 Lamisil Oral Granules (terbinafine hydrochloride) , and the patient's liver function should be immediately evaluated.

Monitoring Laboratory Tests

Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking Lamisil Oral Granules (terbinafine hydrochloride) .

Hematological

Transient decreases in absolute lymphocyte counts (ALC) have been observed in clinical trials. In placebo-controlled trials, 8/465 subjects receiving Lamisil Tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mm3 on two or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment will exceed six weeks. Cases of severe neutropenia have been reported; these were reversible upon discontinuation of terbinafine, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is ≤ 1,000 cells/mm3, Lamisil Oral Granules (terbinafine hydrochloride) should be discontinued and supportive management started.

Skin Reactions

There have been post marketing reports of serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis) with oral terbinafine. If progressive skin rash occurs, treatment with Lamisil Oral Granules (terbinafine hydrochloride) should be discontinued.

Renal Function

In patients with renal impairment (creatinine clearance < 50 mL/ min), the use of Lamisil Oral Granules has not been adequately studied [see CLINICAL PHARMACOLOGY].

Lupus Erythenatosus

During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking oral terbinafine. Therapy should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

Nonclinical Toxicology

Carcinogenesis, Mutugenesis, Impairment of Fertility

In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2x the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.

The results of a variety of in vitro (mutations in >E. coli and S. typhimurium, DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential. Oral reproduction studies in rats at doses up to 300 mg/kg/day (approximately 12x the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.

Use In Specific Populations

Pregnancy

Pregnancy Category B.

Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the Maximum Recommended Human Dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine. There are, however, 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 Lamisil (terbinafine hydrochloride) Oral Granules not be initiated during pregnancy.

Nursing Mothers

After oral administration, terbinafine is present in breast milk of nursing mothers. The ratio of terbinafine in milk to plasma is 7:1. Treatment with Lamisil Oral Granules (terbinafine hydrochloride) is not recommended in nursing mothers.

Pediatric Use

Lamisil Oral Granules (terbinafine hydrochloride) was studied in two randomized, active-controlled trials in which 1021 subjects having a clinical diagnosis of tinea capitis confirmed by KOH microscopy were treated with Lamisil Oral Granules (terbinafine hydrochloride) at the labeled dose for up to 6 weeks. The most common adverse events were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection [see ADVERSE REACTIONS].

Geriatric Use

Lamisil Oral Granules (terbinafine hydrochloride) has not been studied in geriatric patients.

Last reviewed on RxList: 7/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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