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.^{a b}

Uses for Benzonatate

Cough

Used for symptomatic relief of cough.^{100 101 106 108}

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.^b

Has been shown to be more effective than codeine in reducing the frequency of experimentally induced cough,¹⁰¹ and may be effective in providing symptomatic relief in patients with opiate-resistant cough.¹⁰⁸

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]}.¹⁰⁷

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.^{100 101 102 104} (See Sensitivity Reactions under Cautions and also Oral Administration under Dosage and Administration.)

Related/similar drugs

diphenhydramine, Benadryl, guaifenesin, dextromethorphan, Mucinex, codeine

Benzonatate Dosage and Administration

Administration

Oral Administration

Swallow the liquid-filled capsules whole.^{100 101 102}

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.^{100 101 102}

Local administration^{† [off-label]} (chewing the capsules or allowing to dissolve in mouth) can be employed to facilitate conscious intubation^{† [off-label]}.^{103 107} (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]},¹⁰⁶ although safety and efficacy have not been established in this age group.¹⁰⁰ (See Pediatric Use under Cautions.)

Children >10 years of age: 100 or 200 mg 3 times daily.^{100 101 106}

Adults

Cough

Oral

100 or 200 mg 3 times daily;^{100 101 106} doses up to 600 mg daily may be given in divided doses if necessary.^{100 101 106}

Prescribing Limits

Pediatric Patients

Cough

Oral

Children >10 years of age: Maximum 600 mg daily in divided doses.^{100 101 106}

Adults

Cough

Oral

Maximum 600 mg daily in divided doses.^{100 101 106}

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.^{a b}

Renal Impairment

No specific dosage recommendations for renal impairment.^{a b}

Geriatric Patients

No specific geriatric dosage recommendations.^a

Cautions for Benzonatate

Contraindications

• Known hypersensitivity to the drug or related compounds.¹⁰⁰

Warnings/Precautions

Sensitivity Reactions

Severe hypersensitivity reactions, including bronchospasm, laryngospasm, and cardiovascular collapse, have been reported with benzonatate.^{100 101 102}

Such reactions may have resulted from local anesthesia secondary to sucking or chewing the liquid-filled capsules rather than swallowing them whole.^{100 101}

Severe reactions have required medical intervention with vasopressor therapy and supportive measures.¹⁰⁰

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.^{100 103 104 105} (See Pediatric Use under Cautions.)

Dizziness,¹⁰⁴ disorientation,¹⁰³ drunken feeling,¹⁰⁴ unresponsiveness,¹⁰⁴ pulmonary congestion,¹⁰⁴ ventricular tachycardia,¹⁰³ cardiac arrest,¹⁰³ and nausea¹⁰⁴ 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.¹⁰⁰

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.¹⁰⁰

Specific Populations

Pregnancy

Category C.^a

Lactation

Not known whether benzonatate is distributed into milk.¹⁰⁰ Caution if used in nursing women.¹⁰⁰

Pediatric Use

Safety and effectiveness of benzonatate in children <10 years of age have not been established.¹¹¹

FDA has warned that accidental ingestion by children <10 years of age can result in death from overdose.¹¹¹ 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.¹¹¹

Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest.¹¹¹ Signs and symptoms of overdose can occur rapidly after ingestion (within 15–20 minutes).¹¹¹ (See Overdosage under Cautions.)

Deaths in children have been reported within hours of the accidental ingestion.¹¹¹

Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children.¹¹¹ If a child accidentally ingests benzonatate, caregivers should seek medical attention immediately.¹¹¹

Common Adverse Effects

Generally well tolerated when the liquid-filled capsules are swallowed intact.^{100 101 106}

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).^{100 103 106} (See Sensitivity Reactions under Cautions.)

Benzonatate Pharmacokinetics

Absorption

Onset

Usually within 15–20 minutes after swallowing capsules intact.^{100 103 104 106}

Oropharyngeal anesthesia: Develops rapidly when applied locally (e.g., by chewing or dissolving the liquid-filled capsules in the mouth),^{100 101 102 104 107} with complete anesthesia occurring within about 1 minute.¹⁰⁷

Duration

Approximately 3–8 hours following a single oral dose.^{100 101 103 104 106}

Stability

Storage

Oral

Liquid-filled Capsules

Tight, light-resistant containers at 15–30°C.¹⁰⁰

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.^b

• Does not depress respiration at recommended dosages^{100 104 106} ; in patients with bronchial asthma, the drug has been reported to increase the rate and depth of respiration, minute volume, and vital capacity.^b

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.^b (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.¹⁰⁰

• Importance of informing patients of other important precautionary information.¹⁰⁰ (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

Frequently asked questions

• Can benzonatate be used for a sore throat?

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