WARNINGS
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the perle instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON in combination with other prescribed drugs.
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.
Information for Patients: Release of TESSALON from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the capsules should be swallowed without chewing. Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when TESSALON is administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON. Pediatric Use: Safety and effectiveness in children below the age of 10 has not been established.
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