ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Benzonatate: Drug information

Benzonatate: Drug information
(For additional information see "Benzonatate: Patient drug information" and see "Benzonatate: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Tessalon Perles [DSC]
Pharmacologic Category
  • Antitussive
Dosing: Adult
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: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Benzonatate: Pediatric drug information")

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: Hepatic Impairment: Pediatric

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 (Bishop-Freeman 2017)

Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reaction)

Nervous system: Chills, confusion, dizziness (Bishop-Freeman 2017), drowsiness (Bishop-Freeman 2017), hallucination, headache (Bishop-Freeman 2017), numbness of tongue (Bishop-Freeman 2017), sedated state (Bishop-Freeman 2017)

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: Accidental ingestion and potentially fatal overdose of benzonatate has been reported in children <10 years of age. Signs and symptoms of overdose (restlessness, tremors, convulsion, coma, cardiac arrest) may occur within 15 to 20 minutes and death has been reported within 1 hour of ingestion. 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 - $2.64

200 mg (per each): $0.21 - $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: 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.

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.

Use: Labeled Indications

Cough: Symptomatic relief of cough

Metabolism/Transport Effects

None known.

Drug Interactions

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).

Breastfeeding Considerations

It is not known if benzonatate is present in breast milk. The manufacturer recommends that caution be exercised when administering benzonatate to breastfeeding women.

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]. Central Islip, NY: Ascent Pharmaceuticals Inc; October 2019.
  2. 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]
  3. 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.
  4. Heinonen OP, Slone D, Shapiro S, eds. Birth defects and drugs in pregnancy. Littleton, MA: Publishing Sciences Group, Inc.; 1977.
  5. Tessalon (benzonatate) [prescribing information]. Madison, NJ: Pfizer; November 2019.
Topic 9098 Version 474.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟