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Benzonatate

Medically reviewed by Drugs.com. Last updated on Oct 17, 2020.

Pronunciation

(ben ZOE na tate)

Index Terms

  • Tessalon Perles

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Tessalon Perles: 100 mg

Generic: 100 mg, 150 mg, 200 mg

Brand Names: U.S.

  • Tessalon Perles

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: Oral: 100 to 200 mg 3 times daily as needed for cough; maximum dose: 200 mg/dose; maximum daily dose: 600 mg/day

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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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. Information related to use in pregnancy is limited (Heinonen 1977).

Patient Education

What is this drug used for?

• It is used to relieve coughing.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation

• Dizziness

• Fatigue

• Stuffy nose

• Nausea

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Behavioral changes

• Confusion

• Sensing things that seem real but are not

• Numbness and tingling of mouth, throat, tongue, and face

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.