Recommended Dose for Tessalon (Benzonatate)
Standard Dosing
The recommended dose of Tessalon (benzonatate) for adults and children over 10 years old is 100-200 mg three times daily as needed, with a maximum daily dose of 600 mg.
Unfortunately, none of the provided evidence documents contain FDA labeling or guideline information specifically for benzonatate (Tessalon). The evidence provided focuses on influenza antivirals, tuberculosis medications, and other unrelated drugs. However, based on standard medical knowledge and the safety concerns highlighted in the research evidence, the following applies:
Dosing by Age and Weight
Adults and Children ≥10 Years
- Usual dose: 100 mg three times daily (TID)
- Range: 100-200 mg TID as needed for cough
- Maximum daily dose: 600 mg total
Children <10 Years
- Benzonatate is not recommended for children under 10 years of age due to significant safety concerns, including risk of fatal overdose even with small amounts 1, 2
Critical Safety Considerations
Overdose Risk
- Benzonatate poses serious overdose risk with rapid development of life-threatening complications including cardiac arrest, seizures, and death 1, 3
- Ingestion of as few as 10 capsules (2000 mg) has resulted in cardiac arrest with permanent neurological sequelae including blindness 1
- Fatal cases have been reported in both children and adults, with death occurring within 1 hour of ingestion 2, 3
Administration Warnings
- Capsules must be swallowed whole - never chewed, dissolved, or opened
- Chewing or sucking the capsule can cause local anesthesia of the oral mucosa and potential choking
- The medication is structurally similar to local anesthetics (tetracaine, procaine), which explains its toxicity profile 1, 3
Patient Education Requirements
- Emphasize the importance of keeping medication out of reach of children
- Warn about the rapid onset of severe toxicity in overdose
- Instruct patients to swallow capsules intact without chewing
- Counsel on maximum daily dosing limits
Clinical Context
While benzonatate remains widely prescribed as a nonnarcotic antitussive, its risk profile is not fully appreciated by many prescribers 1, 3. The limited treatment options available in overdose situations and the potential for rapid deterioration necessitate careful patient selection and thorough counseling before prescribing.