Benzonatate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Overview
Benzonatate is an antitussive that is FDA approved for the {{{indicationType}}} of symptomatic relief of cough. Common adverse reactions include nausea, numbness of tongue, if capsules are broken or chewed, Oral hypoesthesia, throat symptom, numbness if capsules are broken or chewed, dizziness, headache, sedated, somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Cough
- Dosing information
- Usual dose is: 100 mg or 200 mg PO tid.
- If necessary to control cough, up to 600 mg PO tid divided doses may be given.
- Benzonatate should be swallowed whole.Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of benzonatate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of benzonatate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Cough
- Dosing information (for children over 10 years of age)
- Usual dose is: 100 mg or 200 mg PO tid.
- If necessary to control cough, up to 600 mg PO tid divided doses may be given.
- Benzonatate should be swallowed whole.Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of benzonatate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of benzonatate in pediatric patients.
Contraindications
Hypersensitivity to benzonatate or related compounds.
Warnings
Hypersensitivity
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Psychiatric Effects
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.
Accidental Ingestion and Death in Children
Keep benzonatate out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately
Adverse Reactions
Clinical Trials Experience
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.
Postmarketing Experience
FDA package insert for benzonatate contains no information regarding postmarkting experience.
Drug Interactions
FDA Package Insert for benzonatate contains no information regarding drug interaction.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): 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.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzonatate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Benzonatate during labor and delivery.
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.
Pediatric Use
There is no FDA guidance on the use of Benzonatate in pediatric settings.
Geriatic Use
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
Gender
There is no FDA guidance on the use of Benzonatate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Benzonatate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Benzonatate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Benzonatate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Benzonatate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Benzonatate in patients who are immunocompromised.
Administration and Monitoring
Administration
Benzonatate should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
Monitoring
FDA package insert for benzonatate contains no information regarding drug monitoring.
IV Compatibility
There is limited information about the IV compatibility.
Overdosage
Intentional and unintentional overdose may result in death, particularly in children.
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:
The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.
CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.
Treatment:
In case of overdose, seek medical attention immediately. 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 overdosage.
Do not use CNS stimulants.
Pharmacology
| |
Benzonatate
| |
| Systematic (IUPAC) name | |
| 2-[2-[2-[2-[2-[2-[2-[2- (2-methoxyethoxy) ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethyl4-butylaminobenzoate | |
| Identifiers | |
| CAS number | |
| ATC code | R05 |
| PubChem | |
| DrugBank | |
| Chemical data | |
| Formula | Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox |
| Mol. mass | 603.742 g/mol |
| SMILES | & |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | 3-8 hours |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
C(US) |
| Legal status | |
| Routes | ? |
Mechanism of Action
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.
Structure
Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7.
Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.
Pharmacodynamics
There is limited information regarding Benzonatate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Benzonatate Pharmacokinetics in the drug label.
Nonclinical Toxicology
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Benzonatate.
Clinical Studies
There is limited information about the clinical studies.
How Supplied
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with “PA46”, available in bottles of 100’s and 500’s.
Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in bottles of 100’s.
Storage
The capsules should be protected from light, moisture and humidity, and stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
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. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time.
Precautions with Alcohol
Alcohol-Benzonatate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Tessalon Perles
- Zonatuss
Look-Alike Drug Names
There is limited information about the look-alike drug names.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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