Benzonatate: Difference between revisions

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{{DrugProjectFormSinglePage
|authorTag={{SS}}
|genericName=Benzonatate
|drugClass=Antitussive
|indication=symptomatic relief of [[cough]]
|adverseReactions=[[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]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=<h4>[[Cough]]</h4>


* 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.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Benzonatate in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Benzonatate in adult patients.
|fdaLIADPed=<h4>[[Cough]]</h4>
* 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.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Benzonatate in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> 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
|clinicalTrials=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=FDA Package Insert for Benzonatate contains no information regarding Postmarkting experience.
|drugInteractions=FDA Package Insert for Benzonatate contains no information regarding Drug Interaction.
|FDAPregCat=C
|useInPregnancyFDA=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.
|useInNursing=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.
|useInGeri=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.
|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.
|IVCompat=There is limited information about the IV Compatibility.
|overdose=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.
|drugBox={{Drugbox2
| Verifiedfields = changed
| verifiedrevid = 459953703
| IUPAC_name = 2-[2-[2-[2-[2-[2-[2-[2- (2-methoxyethoxy) ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethoxy] ethyl4-butylaminobenzoate
| image = Benzonatate.png
| width = 250px
<!--Clinical data-->
| tradename = Tessalon
| Drugs.com = {{drugs.com|monograph|benzonatate}}
| MedlinePlus = a682640
| pregnancy_US = C
| pregnancy_category = 
| legal_status = 
| routes_of_administration = 
<!--Pharmacokinetic data-->
| bioavailability = 
| protein_bound = 
| metabolism = 
| elimination_half-life = 3-8 hours
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 104-31-4
| ATC_prefix = R05
| ATC_suffix = DB01
| ATC_supplemental = 
| PubChem = 7699
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00868
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 7413
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1374379
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 5P4DHS6ENR
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00242
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 3032
<!--Chemical data-->
| C=30 | H=53 | N=1 | O=11
| molecular_weight = 603.742 g/mol
| smiles = O=C(OCCOCCOCCOCCOCCOCCOCCOCCOCCOC)c1ccc(NCCCC)cc1
| InChI = 1/C30H53NO11/c1-3-4-9-31-29-7-5-28(6-8-29)30(32)42-27-26-41-25-24-40-23-22-39-21-20-38-19-18-37-17-16-36-15-14-35-13-12-34-11-10-33-2/h5-8,31H,3-4,9-27H2,1-2H3
| InChIKey = MAFMQEKGGFWBAB-UHFFFAOYAD
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C30H53NO11/c1-3-4-9-31-29-7-5-28(6-8-29)30(32)42-27-26-41-25-24-40-23-22-39-21-20-38-19-18-37-17-16-36-15-14-35-13-12-34-11-10-33-2/h5-8,31H,3-4,9-27H2,1-2H3
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = MAFMQEKGGFWBAB-UHFFFAOYSA-N
}}
|mechAction=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.
[[File:Benzonatate_structure_01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
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.
|nonClinToxic=Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with BENZONATATE.
|clinicalStudies=There is limited information about the clinical studies.
|howSupplied=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].
|fdaPatientInfo=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.
|alcohol=Alcohol-Benzonatate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* Tessalon Perles
* Zonatuss
|lookAlike=There is limited information about the look-alike drug names.
}}
{{PillImage
|fileName=Benzonatate_100 mg_NDC 50111-851.JPG
|drugName=Benzonatate 100 MG Oral Capsule
|NDC=50111-851
|drugAuthor=Pliva Inc.
|ingredients=d&c yellow no. 10, gelatin, glycerin, water
|pillImprint=PA46
|dosageValue=100
|dosageUnit=mg
|pillColor=Yellow
|pillShape=Oval
|pillSize=9.00
|pillScore=1
}}
{{LabelImage
|fileName=Benzonatate_label_01.jpg
}}
{{LabelImage
|fileName=Benzonatate_panel_01.png
}}

Revision as of 14:22, 25 September 2014

Benzonatate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Disclaimer

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Overview

Benzonatate is {{{aOrAn}}} 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

Template:Px
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 104-31-4
ATC code R05DB01
PubChem 7699
DrugBank DB00868
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 eMolecules & PubChem
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.

This image is provided by the National Library of Medicine.

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

{{#ask: Page Name::Benzonatate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Benzonatate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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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