From the FDA Drug Label
DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. The recommended dose and frequency of Tessalon (Benzonatate) Perles is:
- 100 mg or 200 mg capsule
- Three times a day as needed for cough
- Up to 600 mg daily in three divided doses may be given if necessary to control cough 1
From the Research
Recommended Dose and Frequency of Tessalon (Benzonatate) Perles
- The recommended dose and frequency of Tessalon (Benzonatate) Perles are not explicitly stated in the provided studies 2, 3, 4, 5, 6.
- However, the studies report on the pharmacokinetics and toxicity of benzonatate, which may provide some insight into its dosing.
- One study reports that healthy Chinese volunteers were administered a single dose of 100 mg benzonatate soft capsule, and the results showed that benzonatate was rapidly absorbed and reached a maximum concentration (Cmax) of 1063 ± 460 ng/mL 4.
- Another study reports on the overdose of benzonatate, where a 17-year-old woman ingested at least 10 200-mg Tessalon capsules, and a 14-year-old female ingested 14 capsules containing 200 mg benzonatate 3, 5.
- The studies suggest that benzonatate can be toxic in high doses, and its use should be monitored closely to avoid adverse events.
Pharmacokinetics of Benzonatate
- The pharmacokinetics of benzonatate have been studied in healthy Chinese volunteers, where a single dose of 100 mg benzonatate soft capsule was administered 4.
- The results showed that benzonatate was rapidly absorbed and reached a maximum concentration (Cmax) of 1063 ± 460 ng/mL, with a half-life (t1/2) of 1.01 ± 0.41 h.
- The area under the curve from 0 h to 10 h (AUC0-10) for benzonatate was 1097 ± 559 ng/mL·h.
Toxicity of Benzonatate
- The studies report on the toxicity of benzonatate, including cardiac arrest, torsades de pointes, and complete recovery without neurologic deficits 2, 3, 5.
- The toxicity of benzonatate is a concern, and its use should be monitored closely to avoid adverse events.
- The genotoxicity of benzonatate and its major metabolite has been assessed, and the results showed that they were not mutagenic and did not cause numerical or structural chromosome alterations 6.