Brand name: Tessalon
Drug class: Antitussives
ATC class: R05DB01
VA class: RE302
CAS number: 104-31-4

Medically reviewed by Drugs.com on Mar 5, 2024. Written by ASHP.

Introduction

Local anesthetic antitussive agent.

Uses for Benzonatate

Cough

Used for symptomatic relief of cough.

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.

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.

Conscious Intubation

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^{† [off-label]}.

Do not employ this method of administration^{† [off-label]} when the drug is used as an antitussive because of the risk of potentially life-threatening complications resulting from local effects on the oropharyngeal tract. (See Sensitivity Reactions under Cautions and also Oral Administration under Dosage and Administration.)

Benzonatate Dosage and Administration

Administration

Oral Administration

Swallow the liquid-filled capsules whole.

Do not chew or dissolve in the mouth when used as an antitussive, since temporary, potentially life-threatening local anesthesia of the oral mucosa, choking, or severe hypersensitivity reactions could occur; oropharyngeal anesthesia develops rapidly with such improper administration.

Local administration^{† [off-label]} (chewing the capsules or allowing to dissolve in mouth) can be employed to facilitate conscious intubation^{† [off-label]}. (See Conscious Intubation under Uses.)

Dosage

Pediatric Patients

Cough

Oral

Children ≤10 years of age: 8 mg/kg daily in 3–6 divided doses^{† [off-label]}, although safety and efficacy have not been established in this age group. (See Pediatric Use under Cautions.)

Children >10 years of age: 100 or 200 mg 3 times daily.

Adults

Cough

Oral

100 or 200 mg 3 times daily; doses up to 600 mg daily may be given in divided doses if necessary.

Prescribing Limits

Pediatric Patients

Cough

Oral

Children >10 years of age: Maximum 600 mg daily in divided doses.

Adults

Cough

Oral

Maximum 600 mg daily in divided doses.

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.

Renal Impairment

No specific dosage recommendations for renal impairment.

Geriatric Patients

No specific geriatric dosage recommendations.

Cautions for Benzonatate

Contraindications

• Known hypersensitivity to the drug or related compounds.

Warnings/Precautions

Sensitivity Reactions

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.

Major Toxicities

Overdosage

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 Pediatric Use under Cautions.)

Dizziness, disorientation, drunken feeling, unresponsiveness, pulmonary congestion, ventricular tachycardia, cardiac arrest, and nausea also have been reported with overdosage.

General Precautions

CNS Effects

Rarely, bizarre behavior, including mental confusion and visual hallucinations, when used concomitantly with certain other drugs.

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.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether benzonatate is distributed into milk. Caution if used in nursing women.

Pediatric Use

Safety and effectiveness of benzonatate in children <10 years of age have not been established.

FDA has warned that accidental ingestion by children <10 years of age can result in death from overdose. Overdose in children <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 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 Overdosage under Cautions.)

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 seek medical attention immediately.

Common Adverse Effects

Generally well tolerated when the liquid-filled capsules are swallowed intact.

Adverse effects 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). (See Sensitivity Reactions under Cautions.)

Benzonatate Pharmacokinetics

Absorption

Onset

Usually within 15–20 minutes after swallowing capsules intact.

Oropharyngeal anesthesia: Develops rapidly when applied locally (e.g., by chewing or dissolving the liquid-filled capsules in the mouth), with complete anesthesia occurring within about 1 minute.

Duration

Approximately 3–8 hours following a single oral dose.

Stability

Storage

Oral

Liquid-filled Capsules

Tight, light-resistant containers at 15–30°C.

Actions

• Inhibits cough production by anesthetizing stretch receptors of vagal afferent fibers in the bronchi, alveoli, and pleura that mediate the cough reflex; also suppresses transmission of the cough reflex at the level of the medulla where the afferent impulse is transmitted to the motor nerves.

• Does not depress respiration at recommended dosages ; in patients with bronchial asthma, the drug has been reported to increase the rate and depth of respiration, minute volume, and vital capacity.

Advice to Patients

• Importance of warning patients using benzonatate as an antitussive to swallow the liquid-filled capsules whole without chewing or dissolving in the mouth because of risk of potentially life-threatening local anesthesia. (See Oral Administration under Dosage and Administration and also Sensitivity Reactions under Cautions.)

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• Can benzonatate be used for a sore throat?

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