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Benzonatate

Pronunciation

Pronunciation

(ben ZOE na tate)

Index Terms

  • Tessalon Perles

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Tessalon: 200 mg [DSC] [contains fd&c yellow #10 (quinoline yellow), methylparaben, propylparaben]

Tessalon Perles: 100 mg

Zonatuss: 150 mg [contains brilliant blue fcf (fd&c blue #1)]

Generic: 100 mg, 150 mg, 200 mg

Brand Names: U.S.

  • Tessalon Perles
  • Tessalon [DSC]
  • Zonatuss

Pharmacologic Category

  • Antitussive

Pharmacology

Tetracaine congener with antitussive properties; suppresses cough by topical anesthetic action on the respiratory stretch receptors

Onset of Action

Therapeutic: 15-20 minutes

Duration of Action

3-8 hours

Use: Labeled Indications

Symptomatic relief of nonproductive cough

Contraindications

Hypersensitivity to benzonatate, related compounds (such as tetracaine), or any component of the formulation

Dosing: Adult

Cough: Oral: 100-200 mg 3 times/day as needed; maximum dose: 600 mg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children >10 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Administration

Swallow capsule whole (do not break. chew, dissolve, cut, or crush).

Storage

Store at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Cardiovascular: Chest numbness

Central nervous system: Chills, confusion, dizziness, hallucination, headache, sedation

Dermatologic: Pruritus, skin rash

Gastrointestinal: Constipation, gastrointestinal distress, nausea

Hypersensitivity: Hypersensitivity reaction (bronchospasm, laryngospasm, cardiovascular collapse)

Ophthalmic: Burning sensation of eyes

Respiratory: Nasal congestion

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe reactions, including bronchospasm, cardiovascular collapse and laryngospasm have been reported. May be related to localized anesthetic effects due to sucking or chewing the capsule.

• Psychiatric effects: Isolated cases of abnormal behavior including mental confusion and visual hallucinations have been reported; may be related to prior sensitivity to related agents (eg, tetracaine, procaine) or interaction with concurrent medications.

Special populations:

• Pediatric: Accidental ingestion and potentially fatal overdose of benzonatate has been reported in children <10 years of age. Signs and symptoms of overdose (restlessness, tremors, convulsion, coma, cardiac arrest) may occur within 15-20 minutes after ingestion. Death has been reported within 1 hour. Not approved for use in children <10 years of age.

Monitoring Parameters

Monitor patient's chest sounds and respiratory pattern

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience constipation, dizziness, fatigue, rhinitis, nausea, or headache. Have patient report immediately to prescriber behavioral changes, confusion, hallucinations, or numbness and tingling of mouth, throat, tongue, and face (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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