Intentional and unintentional overdose may result in death, particularly in children.
The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.
Signs And SymptomsThe signs and symptoms of overdose of benzonatate have been reported within 15–20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.
CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.
TreatmentIn case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.
Do not use CNS stimulants.
Hypersensitivity to benzonatate or related compounds.
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; nausea; GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.
Deliberate or accidental overdose has resulted in death, particularly in children.
TESSALON is indicated for the symptomatic relief of cough.
Perles, 100 mg (yellow);
bottles of 100
NDC 0069 0122 01
Imprint: T.
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).
PROTECT FROM LIGHT
Dispense in tight (USP), child-resistant containers.
Mfd. by: Catalent Pharma Solutions, St. Petersburg, Florida 33716. Dist. by: Pfizer, Madison, New Jersey 07940. Revised: May 2016
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.
Psychiatric EffectsIsolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON in combination with other prescribed drugs.
Accidental Ingestion And Death In ChildrenKeep TESSALON out of reach of children. Accidental ingestion of TESSALON 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).
PRECAUTIONSBenzonatate 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 PregnancyPregnancy 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 MothersIt 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 FertilityCarcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.
Pediatric UseSafety 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.
Adults and Children over 10 years of age: Usual dose is one 100 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. TESSALON should be swallowed whole. TESSALON Perles are not to be broken, chewed, dissolved, cut or crushed.
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; nausea; GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.
Deliberate or accidental overdose has resulted in death, particularly in children.
DRUG INTERACTIONSNo information provided.
