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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 [DSC] [contains brilliant blue fcf (fd&c blue #1)]

Generic: 100 mg, 150 mg, 200 mg

Brand Names: U.S.

  • Tessalon Perles
  • Tessalon [DSC]
  • Zonatuss [DSC]

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 to 20 minutes

Duration of Action

3 to 8 hours

Use: Labeled Indications

Cough: Symptomatic relief of cough

Contraindications

Hypersensitivity to benzonatate, related compounds, or any component of the formulation

Dosing: Adult

Cough: Oral: 100 to 200 mg 3 times/day as needed for cough (maximum single dose: 200 mg; maximum dose: 600 mg/day)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Cough: Children >10 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Oral: Swallow capsule whole (do not break, chew, dissolve, cut, or crush). If capsules are chewed or dissolved in the mouth, oral mucosa anesthesia may occur and could lead to choking. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquid until numbness has resolved.

Storage

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

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 hypersensitivity reactions, including bronchospasm, cardiovascular collapse and laryngospasm have been reported. May be related to localized anesthetic effects due to sucking or chewing the capsule instead of swallowing it.

• Psychiatric effects: Isolated cases of bizarre behavior, including mental confusion and visual hallucinations have been reported during concurrent use with other prescribed drugs.

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 to 20 minutes and death has been reported within 1 hour of ingestion. Not approved for use in children <10 years of age.

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 health care 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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