Benzonatate

What is Benzonatate?

• Benzonatate (Tessalon; Zonatuss) is a non-narcotic antitussive agent, used for the symptomatic relief of cough.

Benzonatate

Benzonatate 3d-model-bonds

What are the uses of this medicine?

• Benzonatate (Tessalon; Zonatuss) is used to relieve cough.

How does this medicine work?

• Benzonatate is in a class of medications called antitussives (cough suppressants).
• Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source.
• It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to benzonatate or related compounds.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Benzonatate was approved for medical use in the United States in 1958.
• It is available as a generic medication.

How should this medicine be used?

Recommended dosage: Adults and Children over 10 years of age:

• Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough.
• If necessary to control cough, up to 600 mg daily in three divided doses may be given.

Administration:

• Benzonatate comes as a liquid-filled capsule and a capsule to take by mouth.
• It is usually taken three times a day as needed.
• Benzonatate should be swallowed whole.
• Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
• If the medication is released in the mouth, it may make the mouth numb and cause choking.
• Do not eat or drink if you feel numbness or tingling of your mouth, tongue, throat, or face.
• If feelings of numbness or tingling continue or get worse, get medical help right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP.

This medicine is available in fallowing brand namesː

• Tessalon; Zonatuss

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse
• sedation
• headache
• dizziness
• mental confusion
• visual hallucinations
• constipation
• nausea
• GI upset
• pruritus
• skin eruptions
• nasal congestion
• sensation of burning in the eyes
• vague “chilly” sensation
• numbness of the chest
• hypersensitivity

What special precautions should I follow?

• Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules.
• Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.
• Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzonatate is administered to a nursing woman
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking benzonatate.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• restlessness, tremors, convulsions, coma and cardiac arrest.
• Accidental ingestion resulting in death has been reported in children.
• Overdosage resulting in death may occur in adults.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Benzonatate should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in children below the age of 10 has not been established.
• Accidental ingestion resulting in death has been reported in children below age 10.
• Keep out of reach of children.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BENZONATATE

Inactive ingredients (intravenous):

• D&C YELLOW NO. 10
• GELATIN, UNSPECIFIED
• GLYCERIN
• METHYLPARABEN SODIUM
• PROPYLPARABEN SODIUM

Who manufactures and distributes this medicine?

Manufactured by:

• Swiss Caps AG
• Kirchberg, Switzerland

Manufactured for:

• Alembic Pharmaceuticals, Inc.
• Bedminster, NJ, USA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Dispense in tight, light-resistant container as defined in the USP.

• Dailymed label info on Benzonatate
• FDA Benzonatate