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Special Alerts
Benzonatate: Accidental Ingestion and Fatal Overdose In Children; FDA Issues Warning
December 2010
The U.S. Food and Drug Administration (FDA) has issued a warning in regards to accidental ingestion and potentially fatal overdose of benzonatate (Tessalon®) in children <10 years of age. Though benzonatate overdose has been reported in adults and adolescents, all accidental ingestions reported to the FDA to date, have occurred in children <10 years, and in some cases, have been reported following ingestion of as few as 1 or 2 capsules in children <2 years. Signs and symptoms of overdose (restlessness, tremors, convulsion, coma, cardiac arrest) may occur within 15-20 minutes after ingestion. Fatalities in children have been reported within hours of accidental ingestion. Benzonatate is not approved for use in children <10 years of age.
Healthcare providers are advised to:
- Prescribe benzonatate only in sufficient quantities for relief of cough.
- Dispense the drug in child resistant containers.
- Be aware of the signs/symptoms of overdose and of their potentially rapid onset.
Healthcare professionals should advise patients on or how to:
- Proper storage (child-resistant container kept away out of children's reach) and disposal of any unused drug upon discontinuation of therapy.
- Contact the Poison Control Center at 1-800-222-1222 and seek immediate medical attention following accidental ingestion by a child.
- Proper dosage and administration including instructions regarding missed doses.
The product labeling is being revised by the FDA. Further information is available at http://www.fda.gov/Drugs/DrugSafety/ucm236651.htm.
Pronunciation
(ben ZOE na tate)
Generic Available
Yes: Capsule (softgel)
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Symptomatic relief of nonproductive cough
Pregnancy Risk Factor
C
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to benzonatate, related compounds (such as tetracaine), or any component of the formulation
Adverse Reactions
1% to 10%:
Central nervous system: Sedation, headache, dizziness
Dermatologic: Rash
Gastrointestinal: GI upset
Neuromuscular & skeletal: Chest numbness
Ocular: Burning sensation in eyes
Respiratory: Nasal congestion
Drug Interactions
There are no known significant interactions.
Mechanism of Action
Tetracaine congener with antitussive properties; suppresses cough by topical anesthetic action on the respiratory stretch receptors
Pharmacodynamics/Kinetics
Onset of action: Therapeutic: 15-20 minutes
Duration: 3-8 hours
Dosage
Children >10 years and Adults: Oral: 100 mg 3 times/day or every 4 hours up to 600 mg/day
Administration: Oral
Swallow capsule whole (do not break or chew).
Monitoring Parameters
Monitor patient's chest sounds and respiratory pattern
Patient Education
Do not break or chew capsule. Maintain adequate hydration, unless instructed to restrict fluid intake. You may experience drowsiness, impaired coordination, blurred vision, increased anxiety, upset stomach, or nausea. Report persistent CNS changes (dizziness, sedation, tremor, or agitation), numbness in chest or feeling of chill, visual changes or burning in eyes, numbness of mouth or difficulty swallowing, or lack of improvement or worsening or condition.
Geriatric Considerations
No specific geriatric information is available about benzonatate. Avoid use in patients with impaired gag reflex or who cannot swallow the capsule whole.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness
Mental Health: Effects on Psychiatric Treatment
May potentiate sedative effects of sedating psychotropics
Nursing: Physical Assessment/Monitoring
Assess effectiveness of therapy (relief of cough, lung sounds, and respiratory pattern). Monitor for CNS changes at beginning of therapy and periodically throughout.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, oral:
Zonatuss™: 150 mg
Capsule, softgel, oral: 100 mg, 200 mg
Tessalon®: 100 mg, 200 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Benzonatate)
100 mg (30): $19.99
200 mg (30): $33.99
Capsules (Tessalon Perles)
100 mg (30): $49.99
References
Mongan PD and Culling RD, “Rapid Oral Anesthesia for Awake Intubation,” J Clin Anesth, 1992, 4(2):101-5.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2011
Content last modified March 2011
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