Lamisil (Terbinafine) Contraindications and Precautions
- alcoholism
- breast-feeding
- hepatic disease
- hepatitis
- jaundice
- human immunodeficiency virus (HIV) infection
- immunosuppression
- neutropenia
- onychomycosis
- pregnancy
- renal failure
- renal impairment
Lamisil (Terbinafine) Contraindications and Precautions
Terbinafine is contraindicated in patients that have a known or suspected hypersensitivity to terbinafine or any of its components. Occasionally the use of terbinafine has been associated with serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If irritation, skin rash, or sensitivity occurs during use of terbinafine, treatment should be discontinued and appropriate therapy administered. Topical terbinafine formulations should be kept away from the eyes, nose, and mouth during treatment.
As with many other topical antifungal drugs, terbinafine cream is not effective for onychomycosis. This condition usually requires treatment with an oral (systemic) antifungal drug, like systemic (oral) terbinafine.
Transient lymphopenia and neutropenia have occurred with oral terbinafine therapy. In patients with known or suspected immunodeficiency syndromes (e.g., human immunodeficiency virus (HIV) infection), or immunosuppression, complete blood counts are recommended at baseline and with any treatment lasting greater than 6 weeks. If signs or symptoms of secondary infection occur, a complete blood count should be obtained to rule out lymphopenia or neutropenia. If the neutrophil count is < 1000/mm3, oral terbinafine should be discontinued.
Terbinafine, in both dermatologic and oral formulations, is rated FDA pregnancy risk category B. Studies in animals using large oral and topical dosages did not reveal teratogenic effects. Conclusive studies in humans, however, do not exist. Terbinafine should only be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus. The treatment of onychomycosis can be postponed until after pregnancy is completed; it is recommended that terbinafine not be initiated for this indication during pregnancy.
Oral terbinafine treatment is not recommended during breast-feeding. After oral administration, terbinafine is excreted into the breast milk of nursing mothers; the ratio of terbinafine in milk to plasma is 7:1. Nursing mothers should avoid using topical terbinafine formulations on the breast. A decision should be made whether to discontinue nursing or to discontinue terbinafine, taking into account the importance of the medication to the mother.
Oral terbinafine therapy is not recommended in patients with chronic or active hepatic disease (i.e., alcoholism, hepatitis). These conditions are unlikely to affect topical administration of terbinafine. Terbinafine systemic clearance is impaired in patients with hepatic disease. Dosage adjustments may be needed in some patients (see Dosage). Although the majority of cases of serious hepatotoxicity (i.e., hepatic failure, leading to death or liver transplant in some patients) have been reported in patients with serious underlying conditions, hepatotoxicity has been reported in patients with and without pre-existing hepatic disease. Patients who receive oral terbinafine treatment are recommended to have baseline evaluation of hepatic enzymes. If biochemical or clinical evidence of liver injury develops (e.g., jaundice), oral terbinafine treatment should be discontinued.
In patients with renal impairment or renal failure, the use of terbinafine tablets has not been studied, and therefore, is not recommended.
Changes in the ocular lens and retina have been reported following the use of oral terbinafine in controlled trials. The clinical significance of these changes is unknown.
[ Last revised: 5/7/2002 ]
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