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Benzonatate: Pediatric drug information

Benzonatate: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Benzonatate: Drug information" and "Benzonatate: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Tessalon Perles [DSC]
Therapeutic Category
  • Antitussive
Dosing: Pediatric

Dosage guidance:

Safety: Should only be used in patients who can swallow capsules whole; if capsules are chewed, sucked on, or allowed to dissolve in the mouth, local anesthesia of mouth and choking can result.

Cough

Cough: Children ≥10 years and Adolescents: Oral: 100 to 200 mg 3 times daily as needed for cough; maximum dose: 200 mg/dose; maximum daily dose: 600 mg/day.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Benzonatate: Drug information")

Cough

Cough: Oral: 100 to 200 mg 3 times/day as needed for cough (maximum single dose: 200 mg; maximum dose: 600 mg/day).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Limited pharmacokinetic data are available describing the disposition of benzonatate and its metabolites.

Altered kidney function: No dosage adjustment likely to be necessary for any degree of kidney dysfunction (rapidly hydrolyzed by plasma enzymes) (Ref).

Hemodialysis, intermittent (thrice weekly): Not likely to be significantly dialyzed (rapidly metabolized): No supplemental dose or dosage adjustment likely to be necessary (Ref).

Peritoneal dialysis: Not likely to be significantly dialyzed (rapidly metabolized): No dosage adjustment likely to be necessary (Ref).

CRRT: No dosage adjustment likely to be necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment likely to be necessary (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Chest numbness

Dermatologic: Pruritus, skin rash

Gastrointestinal: Constipation, gastrointestinal distress, nausea (Ref)

Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reaction)

Nervous system: Chills, confusion, dizziness (Ref), drowsiness (Ref), hallucination, headache (Ref), numbness of tongue (Ref), sedated state (Ref)

Ophthalmic: Burning sensation of eyes

Respiratory: Nasal congestion

Contraindications

Hypersensitivity to benzonatate, related compounds, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including bronchospasm, cardiovascular collapse and laryngospasm have been reported. May be related to localized anesthetic effects due to sucking or chewing the capsule instead of swallowing it.

• Psychiatric effects: Isolated cases of bizarre behavior, including mental confusion and visual hallucinations have been reported during concurrent use with other prescribed drugs.

Special populations:

• Pediatric: Benzonatate has a narrow therapeutic index; intentional overdose or accidental ingestion has resulted in cardiac dysrhythmias, seizures, and death. In pediatric patients, onset of symptoms can be <5 minutes and with as few as 1 to 2 capsules (Bishop-Freeman 2017; Constantino 2023; Crouch 1998; Kim 2022; Minhaj 2021; Stephens 2022; Winter 2010). Not approved for use in children <10 years of age.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Tessalon Perles: 100 mg [DSC]

Generic: 100 mg, 150 mg, 200 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Benzonatate Oral)

100 mg (per each): $0.12 - $2.50

150 mg (per each): $2.12

200 mg (per each): $0.19 - $4.77

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Oral: Swallow capsule whole (do not break, chew, dissolve, cut, or crush). If capsules are chewed or dissolved in the mouth, oral mucosa anesthesia may occur and could lead to choking. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquid until numbness has resolved.

Administration: Adult

Oral: Swallow capsule whole (do not break, chew, dissolve, cut, or crush). If capsules are chewed or dissolved in the mouth, oral mucosa anesthesia may occur and could lead to choking. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquid until numbness has resolved.

Storage/Stability

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

Use

Symptomatic relief of cough (FDA approved in ages ≥10 years and adults).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Information related to use in pregnancy is limited (Heinonen 1977).

Monitoring Parameters

Monitor for symptoms of overdose or hypersensitivity.

Mechanism of Action

Tetracaine congener with antitussive properties; suppresses cough by topical anesthetic action on the respiratory stretch receptors

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Therapeutic: 15 to 20 minutes.

Duration: 3 to 8 hours.

Metabolism: Rapidly hydrolyzed by plasma butyrylcholinesterase (BChE) to the major metabolite 4-(butylamino) benzoic acid (BABA) along with the corresponding polyethylene glycol monomethyl ethers; activity of metabolites (ie, active versus inactive) is unknown (has not been studied) (Bishop-Freeman 2017).

Excretion: Unknown (has not been studied).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IN) India: Benz | Benz pearls;
  • (KR) Korea, Republic of: Zicol;
  • (MX) Mexico: Benzonal | Benzonatato | Benzonatato g.i.no | Benzonatato gi | Benzonatato gi ken | Benzonatato gi ser | Benzonatato le g.i | Bronpax | Capsicof | D-tato | Lemtosid | Pebegal | Pharben | Progelben | Tesalon | Tesaperl | Tesopen | Texoven | Tukaliv | Tusitato | Tuzzil | Velpro;
  • (PR) Puerto Rico: Tessalon | Zonatuss;
  • (SE) Sweden: Tessalon;
  • (TW) Taiwan: Bensau
  1. Benzonatate [prescribing information]. Alpharetta, GA: Acella Pharmaceuticals, LLC; October 2020.
  2. Benzonatate [prescribing information]. Central Islip, NY: Ascent Pharmaceuticals Inc; October 2019.
  3. Bishop-Freeman SC, Shonsey EM, Friederich LW, Beuhler MC, Winecker RE. Benzonatate toxicity: nothing to cough at. J Anal Toxicol. 2017;41(5):461-463. doi:10.1093/jat/bkx021 [PubMed 28334901]
  4. Costantino RC, Leonard J, Gorman EF, Ventura D, Baltz A, Gressler LE. Benzonatate safety and effectiveness: a systematic review of the literature. Ann Pharmacother. 2023;57(10):1221-1236. doi:10.1177/10600280221135750 [PubMed 36688284]
  5. Crouch BI, Knick KA, Crouch DJ, Matsumura KS, Rollins DE. Benzonatate overdose associated with seizures and arrhythmias. J Toxicol Clin Toxicol. 1998;36(7):713-718. doi:10.3109/15563659809162620 [PubMed 9865240]
  6. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  7. Heinonen OP, Slone D, Shapiro S, eds. Birth defects and drugs in pregnancy. Littleton, MA: Publishing Sciences Group, Inc.; 1977.
  8. Kim I, Goulding M, Tian F, et al. Benzonatate exposure trends and adverse events. Pediatrics. 2022;150(6):e2022057779. doi:10.1542/peds.2022-057779 [PubMed 36377394]
  9. Minhaj FS, Leonard JB. A description of the clinical course of severe benzonatate poisonings reported in the literature and to NPDS: a systematic review supplemented with NPDS cases. Hum Exp Toxicol. 2021;40(12_suppl):S39-S48. doi:10.1177/09603271211030560 [PubMed 34219543]
  10. Stephens RJ, Filip AB, Baumgartner KT, Schwarz ES, Liss DB. Benzonatate overdose presenting as cardiac arrest with rapidly narrowing QRS interval. J Med Toxicol. 2022;18(4):344-349. doi:10.1007/s13181-022-00904-4 [PubMed 35790679]
  11. Tessalon (benzonatate) [prescribing information]. Madison, NJ: Pfizer; November 2019.
  12. Winter ML, Spiller HA, Griffith JR. Benzonatate ingestion reported to the National Poison Center Database System (NPDS). J Med Toxicol. 2010;6(4):398-402. doi:10.1007/s13181-010-0086-6 [PubMed 20490746]
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