Benzonatate, a nonnarcotic oral antitussive agent, is 2,5,8,11,14,17,20, 23,26- nonaoxaoctacosan-28-yl-p-(butylamino) benzoate; with an average molecular weight of 603.7. The chemical formula is C₃₀H₅₃NO₁₁, structural formula is:

Each softgel (soft gelatin capsule), for oral administration, contains 100 mg benzonatate. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, methylparaben, propylparaben and purified water.

Last updated on RxList: 12/8/2004

Benzonatate is indicated for the symptomatic relief of cough.

Adults and children over 10 years of age: Usual dose is one 100 mg softgel t.i.d. as required. If necessary, up to 6 softgels daily may be given.

Each yellow softgel contains 100 mg of benzonatate and is available in bottles of 100's and 500's.

The softgels should be protected from light, moisture and humidity, and stored at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in USP/NF.

Caution: Federal law prohibits dispensing without prescription.

Last updated on RxList: 12/8/2004

Potential Adverse Reactions to benzonatate may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the softgel.

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. Rare instances of deliberate or accidental overdose have resulted in death.

No information provided.

Last updated on RxList: 12/8/2004

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the softgel instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.

Benzonatate is chemically related to anesthetic agents of the para-aminobenzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Usage in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate. 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.

Nursing Mothers

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

Pediatric Use

Safety and effectiveness in children below the age of 10 has not been established.

Last updated on RxList: 12/8/2004

Overdose may result in death. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms

If softgels are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.

Treatment

Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular- renal function is an essential feature of the treatment of severe intoxication from overdose.

Do not use CNS stimulants.

Hypersensitivity to benzonatate or related compounds.

Last updated on RxList: 12/8/2004

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. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

Last updated on RxList: 12/8/2004

Release of benzonatate from the softgel in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the softgels should be swallowed without chewing.

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

BENZONATATE- ORAL

(ben-ZO-nat-ate)

COMMON BRAND NAME(S): Tessalon Perle

USES: This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough.

Do not use this medication in children younger than 2 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).

HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily as needed or as directed by your doctor.

Swallow this medication whole. Do not chew, suck, or dissolve this medication in your mouth. Doing so will cause a loss of feeling in your mouth/throat and may cause choking or a severe allergic reaction. (See also Side Effects section.)

Dosage is based on your medical condition and response to therapy.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, headache, stomach upset, constipation, and stuffy nose may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, loss of feeling in the chest, burning in the eyes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. The possibility of an allergic reaction may increase if you chew, suck, or dissolve this medication in your mouth. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing, fainting.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking benzonatate, tell your doctor or pharmacist if you are allergic to it; or to certain anesthetic agents (e.g., procaine, tetracaine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Tell your doctor or pharmacist if you take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: restlessness, shaking (tremors), seizures.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.