"The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of codeine for cough and cold in children because there is a risk for serious adverse effects, including respiratory"...
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule 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 (benzonatate) in combination with other prescribed drugs.
Accidental Ingestion and Death in Children
Keep TESSALON (benzonatate) out of reach of children. Accidental ingestion of TESSALON (benzonatate) resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
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.
Usage in Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with TESSALON (benzonatate). It is also not known whether TESSALON (benzonatate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON (benzonatate) should be given to a pregnant woman only if clearly needed.
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 (benzonatate) is administered to a nursing woman.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON (benzonatate).
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
Prescribing Document Revised: January 2011This monograph has been modified to include the generic and brand name in many instances.
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