Benzonatate

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Serious side effects have been reported with benzonatate including the following:

• Severe allergic reactions such as difficulty swallowing, breathing and heart problems, possibly resulting from sucking or chewing the capsule instead of swallowing it.
• Bizarre behavior, mental confusion and visual hallucinations, usually when taken in combination with other drugs.

Benzonatate can cause drowsiness, dizziness, and visual side effects. Do not drive or operate heavy machinery until you know how benzonatate affects you.

Do not take benzonatate if you are allergic to benzonatate or any of this medication’s ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of benzonatate, there are no specific foods that you must exclude from your diet when receiving this medication.

• Store benzonatate at controlled room temperature ( 68-77 degrees F).
• Keep benzonatate capsules in a tight, light resistant container.
• Keep this and all medicines out of the reach of children.

Usual Adult Dose for Cough:

100 mg to 200 mg orally three times a day as needed for cough

Comments: This drug should be swallowed whole.

Use: Symptomatic relief of cough

Usual Pediatric Dose for Cough:

Children older than 10 years:
100 mg to 200 mg orally three times a day as needed for cough

Comments: This drug should be swallowed whole.

Use: Symptomatic relief of cough

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† (chewing the capsules or allowing to dissolve in mouth) can be employed to facilitate conscious intubation†.103 107 (See Conscious Intubation under Uses.)

Dosage

Pediatric Patients

Children ≤10 years of age: 8 mg/kg daily in 3–6 divided doses†,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

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

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

Adults

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

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

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

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

Category C.a

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

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.)

In the U.S.

• Tessalon Perles
• Zonatuss

Available Dosage Forms:

• Capsule
• Capsule, Liquid Filled

Therapeutic Class: Antitussive

Take benzonatate exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Swallow the capsules whole. Do not break, crush, or chew them. If the capsules come in contact with the mouth, it may cause the mouth and throat to become numb (loss of feeling) and choking may occur.

If numbness or tingling of the mouth, tongue, throat, or face occurs, do not eat or drink until these symptoms disappear. Check with your doctor right away if these symptoms persist or become worse.

Dosing

The dose of benzonatate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of benzonatate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For cough:
    • Adults and children 10 years of age and older—100 milligrams (mg) three times a day. Do not take more than 200 mg at one time or more than 600 mg per day.
    • Children younger than 10 years of age—Use is not recommended.

Missed Dose

If you miss a dose of benzonatate, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the capsules in a child-resistant container and store it out of reach of children at all times.

Throw any unused medicine by mixing it with used coffee grounds or kitty litter and place it in a sealable bag, empty can, or container.

• If you have an allergy to benzonatate or any other part of benzonatate.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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:

• 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in the way you act.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Numbness and tingling of the mouth, tongue, throat, and face have happened when this medicine was broken, crushed, chewed, melted, or sucked before taking. Choking and very bad allergic reactions have also happened. If numbness or tingling happens, do not eat or drink until it goes away. If you have an allergic reaction or if numbness or tingling lasts or gets worse, call your doctor right away.

Potential Adverse Reactions to Benzonatate may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.

3 to 8 hours

Animal reproduction studies have not been conducted.

Children older than 10 years:
100 mg to 200 mg orally three times a day as needed for cough

Comments: This drug should be swallowed whole.

Use: Symptomatic relief of cough

Data not available