Prescription Required
In stock
Manufacturer
ASCEND LABORATO
SKU
67877010501

benzonatate 100 mg capsule

Generic
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Uses

Cough

Benzonatate is used for symptomatic relief of cough. Benzonatate may be effective in suppressing cough in acute respiratory conditions such as pneumonia, bronchitis, pertussis, and the common cold; and in chronic diseases such as pulmonary emphysema, bronchial asthma, tuberculosis, and pulmonary tumor. Benzonatate has been shown to be more effective than codeine in reducing the frequency of experimentally induced cough, and may be effective in providing symptomatic relief in patients with opiate-resistant cough. Because of the drug's rapid, pronounced local anesthetic effect, benzonatate has been applied locally in the oral cavity in adults by releasing the drug from the liquid-filled capsules (e.g., by chewing or dissolving two 100-mg liquid-filled capsules in the mouth) to provide sufficient oropharyngeal anesthesia for conscious intubation. This method of administration must not be employed when the drug is used as an antitussive because of the risk of potentially life-threatening complications resulting from local effects of the drug on the oropharyngeal tract. (See Cautions: Precautions and Contraindications and also see Dosage and Administration: Administration.)

Dosage and Administration

Administration

Benzonatate is administered orally. Benzonatate liquid-filled capsules should be swallowed whole without chewing or dissolving in the mouth, since temporary local anesthesia of the oral mucosa, choking, or severe hypersensitivity reactions could occur; oropharyngeal anesthesia develops rapidly with such improper administration. However, such local administration has been employed to facilitate conscious intubation.(See Uses.)

Dosage

Cough

The usual dosage of benzonatate for adults and children older than 10 years of age is 100 or 200 mg 3 times daily. If necessary, doses up to 600 mg daily may be given in divided doses. Children 10 years of age or younger have been given 8 mg/kg daily in 3-6 divided doses, although safety and efficacy have not been established in this age group.(See Cautions: Pediatric Precautions.)

Cautions

Adverse Effects

Benzonatate generally is well tolerated when the liquid-filled capsules are swallowed intact. Adverse effects of benzonatate may include sedation, headache, mild dizziness, bizarre behavior (e.g., mental confusion, visual hallucinations), nasal congestion, nausea, GI upset, constipation, sensation of burning in the eyes, a vague ''chilly'' sensation, pruritus and skin eruptions, numbness in the chest, and hypersensitivity (e.g., bronchospasm, laryngospasm, cardiovascular collapse, possibly related to local anesthesia from chewing or sucking the liquid-filled capsules).

Deliberate or accidental overdosage of benzonatate can result in CNS stimulation which may lead to restlessness, tremors, and seizures; profound CNS depression and death can follow.(See Cautions: Pediatric Precautions.) Dizziness, disorientation, drunken feeling, unresponsiveness, pulmonary congestion, ventricular tachycardia, cardiac arrest, and nausea also have been reported with overdosage.

Acute benzonatate overdosage should be managed by evacuating the GI contents and administration of activated charcoal. Protection against aspiration of gastric contents and orally administered substances should be ensured even in conscious patients because cough and gag reflexes may be substantially depressed. Seizures can be managed with a short-acting barbiturate, and intensive measures should be undertaken to maintain respiration and cardiovascular and renal function. CNS stimulants should not be used.

Precautions and Contraindications

Severe hypersensitivity reactions, including bronchospasm, laryngospasm, and cardiovascular collapse, have been reported with benzonatate. Such reactions may have resulted from local anesthesia secondary to sucking or chewing the liquid-filled capsules rather than swallowing them whole. Severe reactions have required medical intervention with vasopressor therapy and supportive measures.

Bizarre behavior, including mental confusion and visual hallucinations, has been reported rarely in patients receiving benzonatate concomitantly with certain other drugs.

The possibility that adverse CNS effects associated with other p-aminobenzoic acid-derivative local anesthetics (e.g., procaine, tetracaine) could occur with benzonatate should be considered.

Benzonatate is contraindicated in patients with known hypersensitivity to the drug or related compounds.

Safe use of benzonatate during pregnancy or lactation has not been established.

Pediatric Precautions

The safety and effectiveness of benzonatate in children under 10 years of age have not been established.

The US FDA has warned the public that accidental ingestion of benzonatate (e.g., Tessalon) by children under the age of 10 years can result in death from overdose. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule).

Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes).(See Cautions: Adverse Effects.) Deaths in children have been reported within hours of the accidental ingestion.

Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. If a child accidentally ingests benzonatate, caregivers should immediately seek medical attention.

Pharmacokinetics

Benzonatate usually acts within 15-20 minutes after oral administration. The duration of action following a single oral dose is approximately 3-8 hours. Oropharyngeal anesthesia develops rapidly when the drug is applied locally (e.g., by chewing or dissolving the liquid-filled capsules in the mouth), with complete anesthesia occurring within about 1 minute.

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