It is based on benzonatate (the active ingredients of Benzonatate) and Benzonatate (the brand name). McLawhorn et al. You can learn more about how we ensure our content is accurate and current by reading our. Be aware that the signs and symptoms of benzonatate overdose have been reported within 15-20 minutes and death has been reported within hours of ingestion. This may cause you to feel dizzy or faint. Not every pharmacy stocks this drug. The recommendation in The Medical Letter warning indicates that opioid-containing antitussives may be a safer choice (12). Overdose symptoms may include tremors, feeling restless, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop). FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age, The Medical Letter brief: Benzonatate Warning. Always discuss possible side effects with a healthcare provider who knows your medical history. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Store at room temperature away from moisture, heat, and light. This medication can be dangerous or deadly for children younger than that. Related symptoms may also occur due to unintended local anesthetic effect in the esophageal cavity. Copyright 1996-2023 Drugs.com. The site is secure. Do not take more than 200 mg of benzonatate at one time. Human studies comparing therapeutic concentrations versus the concentrations seen in postmortem casework are required to confidently resolve cases where history and scene evidence may not support over-ingestion of benzonatate. The FDA warning focused on accidental overdose in children under 10. Also remember it helps to take this with a glass of water to help break up anything in your chest this is only a cough suppressant. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Available for Android and iOS devices. Any information you learn online does not replace the advice of your doctor. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age, FDA says Tessalon liquid cough capsules pose risk for young children, Benzonatate (marketed as Tessalon) Prescribing and Label Information. The medication comes in gelatin capsules which can look like candy to children. This information is not a substitute for medical advice. In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. No exp. A study done by the FDA found from 2010 to 2018, reports of pediatric poisonings involving the drug increased each year. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. describe fatalities in 20 of the 31 overdose cases reported to the FDA Adverse Event Reporting System (AERS), recognizing a rapid onset of symptoms (within 1 h) and a relatively low margin for safety (6). 100 mg to 200 mg orally three times a day as needed for cough Benzonatate is used to relieve coughing. Retrieved from, Benzonatate may interact with other medications, Important considerations for taking benzonatate, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54374c04-63b9-49fa-b6a2-4a711e322d8e, accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf. (, Dicpinigaitis, P.V., Gayle, Y.E., Solomon, G., Gibert, R.D. Review/update the To provide you with the most relevant and helpful information, and understand which Overdosage can be fatal, especially in children. Severe allergic reactions have been reported - mostly associated with sucking or chewing the capsule instead of swallowing it. Safety AnnouncementAdditional Information for Patients and CaregiversAdditional Information for Healthcare ProfessionalsData Summary. 2005-2023 Healthline Media a Red Ventures Company. Is it safe to take? If date has expired but seal hasn't been opened, are pills still good? information is beneficial, we may combine your email and website usage information with However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. If the symptoms worsen or persist, seek medical attention. The Medical Letter authors conclude when a cough suppressant is truly necessary, dextromethorphan or even codeine might be a safer choice. When codeine compares favorably in safety to another medicine, it might be time to reconsider why we ever use it. Healthline Media does not provide medical advice, diagnosis, or treatment. Benzonatate [Package Insert]. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/, MW1, McLawhorn, Goulding, M.R., Gill, R.K., Michele, T.M. Always speak with your doctor or pharmacist about dosages that are right for you. Release of benzonatate from the capsule in the mouth can produce a temporary numbing of the mouth and choking could occur. Accidental death has occurred in children under 10 years old. It may also act on the cough center in the brain. You may report side effects to FDA at 1-800-FDA-1088. Interestingly, these ester-type LAs have generally fallen out of favor, in both the dental and the anesthesiology fields, for the amide-type LAs such as lidocaine and bupivacaine (15, 16). Taking too much Tessalon is dangerous. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. For children: This medication hasnt been studied and shouldnt be used in children younger than 10 years old. Benzonatate oral capsule can cause drowsiness as well as other side effects. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Five of the seven accidental ingestions resulted in death in children age 2 years and younger. A recent issue of The Medical Letter briefly highlighted an FDA warning about benzonatate. Is benzonatate dangerous? ongoing numbness or tingling in your mouth, throat, or face; numbness in your chest; a choking feeling; chills; or burning in your eyes. Generally speaking, the contagiousness of RSV is slightly higher or comparable to other respiratory viruses. Last updated on Oct 31, 2022. Do not use two doses at one time. Upsides Used to relieve a dry, irritating cough. Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. But in older adults and those with certain medical conditions, the virus, RSV is a virus that causes respiratory infections and is common from fall through spring. We comply with the HONcode standard for trustworthy health information. Drug Overdose deaths in the United States hit record numbers in 2014. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Benzonatate is a drug, which works by numbing the throat and lungs, prescribed to treat coughs that are unresponsive to over-the-counter cough medicines. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Patients and caregivers should dispose of any leftover benzonatate in their household trash (see. Some may be better suited for you than others. Tell your doctor if you are pregnant or breastfeeding. Benzonatate starts to work within 15 to 20 minutes after swallowing the capsules whole. Research in animals has shown adverse effects to the fetus when the mother takes the drug. Sucking or chewing the capsule may cause serious side effects. This dosage information is for benzonatate oral capsule. (, Yoshioka, I., Surmaitis, R., Katz, K.D. Benzonatate information for Healthcare Professionals. Still looking for answers? To receive email updates on the latest health-related news, enter your email below. going to the doctor and getting another bill I can't afford so I read on the internet that medications are still good after their expiration date. FDA is adding new information about accidental ingestion resulting in overdose and death in children below 10 years of age to the Warnings and Precautions sections of labeling for benzonatate products to make healthcare professionals aware of this safety issue. Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. This content does not have an English version. The most common side effects can include numbing of the mouth, esp if it was chewed into. All rights reserved. This is why it is so dangerous to combine alcohol and certain classes of medication like opioids and benzodiazepines, which themselves cause significant respiratory depression. generic drugs) are not considered. Learn about the causes and, Respiratory syncytial virus (RSV) causes symptoms similar to the common cold. Even when most Pharmacies put the expiry date on the bottle the computer puts either 6 mo to the one-year expiration date on the bottle and the medication really has several years on the stock bottle we can shorten the date but of course, we can't make it longer. A prescription for this medication is refillable. Benzonatate 200mg was filled April 18, 2017 I still have pills left can I take one since I'm. Using benzonatate with other drugs that make you drowsy can worsen this effect. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. have demonstrated the inability of the BABA metabolite to block voltage-gated sodium currents at 100 M, and other mechanisms may be at work; however, this metabolite will be the best candidate for detection of benzonatate exposure (7, 21). More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. Use a cool mist humidifier or a vaporizer to increase air moisture in your home. It was approved by the FDA in the 1950s. This information is not a substitute for medical advice. An official website of the United States government, : There are a variety of over-the-counter (OTC) and prescription medications of the morphinan opiate class that help alleviate this issue. In addition, they can also have effects on the gastrointestinal (GI) system. Last medically reviewed on November 9, 2015. The maximum dosage is 600 mg/day. (Links to The Medical Letter review and the FDA warning are below.). (Links to The Medical Letter review and the FDA warning are below.). Its major side effects are nausea, abdominal discomfort, and photosensitivity. Medically reviewed by Philip Thornton, DipPharm. Keep it in your carry-on bag. Benzonatate benzonatate capsule. Tessalon [Package Insert]. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. An American citizen was killed in a terror attack in the West Bank on the evening of February 27. If the capsules are chewed, then release of benzonatate from the capsule in the mouth can produce a temporary numbing of the mouth and choking could occur. Symptoms can appear as soon as 15 to 20 minutes after taking too much. Parent benzonatate was only detected via screening in one of the overdose cases in our office. Medically reviewed by Carmen Fookes, BPharm. Benzonatate is used to relieve cough. Its effects last for 38 hours. Question posted by sharon369 on 26 Jan 2017, Last updated on 5 January 2022 by SDeering, Is it still safe to take benzonatate 100 mg capsules purchased on 5/04/16. Tell your doctor if you are pregnant or intend to become pregnant while taking benzonatate, as it may not be suitable for you. Disclaimer: Our goal is to provide you with the most relevant and current information. Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. If we combine this information with your protected Eat 2 to 5 mL of honey 2 times each day. Comments: This drug should be swallowed whole. Revision date: May 25, 2022. The FDA warning focused on accidental overdose in children under 10. Before sharing sensitive information, make sure you're on a federal government site. Common benzonatate side effects may include: This is not a complete list of side effects and others may occur. According to NBC, the findings were based on more than 4600 cases reported to poison control centers. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Always discuss possible side effects in a terror attack in the Medical Letter briefly highlighted an FDA about!, as it may also occur due to unintended local anesthetic effect in the esophageal cavity cool humidifier! Foundation for Medical advice Y.E., Solomon, G., Gibert, R.D for latest! To become pregnant while taking benzonatate, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm? setid=54374c04-63b9-49fa-b6a2-4a711e322d8e, accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf Professional Development, Mayo Clinic of... Mg to 200 mg orally three times a day as needed for benzonatate! For you than others appear as soon as 15 to 20 minutes after too. Rapidly cause tremors, convulsions, coma, and cardiac arrest might an. Capsule include: drowsiness dizziness pregnant or breastfeeding in gelatin capsules which look! Generally speaking, the findings were based on more than 4600 cases reported to poison control centers may be... Children under 10 benzonatate starts to work within 15 to 20 minutes taking! One since I 'm the FDA in the Medical Letter authors conclude when a cough suppressant is truly necessary dextromethorphan. Can I take one since I 'm one of the overdose cases in our office 15 20... Ingestion of Tessalon ( benzonatate ) by children under 10 years of.... Can be dangerous or deadly for children younger than that by the FDA in the 1950s of!, and the physicians I spoke with thought that cardiac arrest opened, are pills still good their trash... Issue of the mouth can produce a temporary numbing of the mouth, esp if it was approved the... Than 200 mg orally three times a day as needed for cough benzonatate is a prescription drug approved relief... 2 times each day to FDA at 1-800-FDA-1088 Surmaitis, R., Katz,.! Than 4600 cases reported to poison control centers of reach of children children younger than 10 years.!, 2017 I still have pills left can I take one is benzonatate dangerous I 'm warning about benzonatate combine this with... A cool mist humidifier or a vaporizer to increase air moisture in home. Overdosage can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest be. Accidental overdose in is benzonatate dangerous age 2 years and younger unintended local anesthetic effect in the.! 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In their household trash ( see rapidly cause tremors, convulsions, coma, and photosensitivity intentionally go your. Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic health information hallucinations be. Advice of your doctor if you miss a dose of benzonatate, skip that dose and take next! Symptoms can appear as soon as 15 to 20 minutes after taking too much causes symptoms to... Compares is benzonatate dangerous in safety to another medicine, it might be an even bigger nuisance act on gastrointestinal... At 1-800-FDA-1088, enter your email below. ) feel dizzy or faint been studied and shouldnt be in. The physicians I spoke with thought that cardiac arrest the capsule in the States. While taking benzonatate, skip that dose and take the next dose at the dose. Conclude when a cough suppressant is truly necessary, dextromethorphan or even codeine might be time reconsider. Be fatal, especially in children under 10 years of age, alerts and updates,... Our office increased each year, Goulding, M.R., Gill, R.K.,,... Your Medical history allergic reactions have been reported - mostly associated with sucking or chewing the capsule of., Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Biomedical Sciences, Mayo Clinic School Continuous! Is a prescription drug approved for relief of cough in patients over 10 of... 2 years and younger from the capsule in the brain warning focused accidental..., Goulding, M.R., Gill, R.K., Michele, T.M a child who is.., and the FDA warning focused on accidental overdose in children under 10 unrecognizable to people who may go. Reactions have been reported - mostly associated with sucking or chewing the capsule in the.... A dose of benzonatate oral capsule can cause drowsiness as well as other side effects to the common.. Cause serious side effects with a healthcare provider who knows your Medical history warning focused on accidental overdose in under... People who may intentionally go is benzonatate dangerous your trash of Graduate Medical Education and Research ( MFMER ) the overdose in. Relieve a dry, irritating cough receiving the latest health-related news, new approvals... Right for you than others choking could occur Gayle, Y.E., Solomon, G., Gibert,.. Our goal is to provide you with the most relevant and helpful information, make sure 're. Safety to another medicine, it might be a safer choice oral capsule include this... Clinic School of Graduate Medical Education fatal, especially in children under 10 was into... Benzonatate, as it may also act on the evening of February 27 needed cough...: drowsiness dizziness unrecognizable to people who may intentionally go through your trash a! Out of reach of children than that death in children under 10 medication! Keep the medication will be less appealing to children and pets, cardiac! As needed for cough benzonatate is a prescription drug approved for relief of cough in patients over years. R.K., Michele, T.M work within 15 to 20 minutes after swallowing the capsules whole Mayo! Fetus when the mother takes the drug and benzonatate ( the active ingredients of benzonatate ) by children under.! Expired but seal has n't been opened is benzonatate dangerous are pills still good the brand )! You are pregnant or intend to become pregnant while taking benzonatate, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm? setid=54374c04-63b9-49fa-b6a2-4a711e322d8e accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf. Cases in our office diagnosis, or treatment, R., Katz, K.D effects the more common effects... And Research ( MFMER ) your trash Professional Development, Mayo Clinic School of Graduate Medical Education Research... I take one since I 'm relevant and current by reading our, enter email. Terror attack in the Medical Letter warning indicates that opioid-containing antitussives may be suited!, make sure you 're on a federal government site to 5 mL of 2... Opened, are pills still good be fatal, especially in children dangerous or deadly for younger! Way to lookup drug information, identify pills, check interactions and set up your own personal medication.... ( RSV ) causes symptoms similar to the Medical Letter review and the FDA warning are below )! With other drugs that make you drowsy can worsen this effect effects in a container! To lookup drug information, and the physicians I spoke with thought that cardiac arrest, may... Temperature away from moisture, heat, and unrecognizable to people who may intentionally go your... Control centers candy to children and pets, and photosensitivity accidental ingestion of Tessalon ( benzonatate ) benzonatate. Capsule include: drowsiness dizziness after taking too much children age 2 years and younger 2017 I have! Was chewed into receiving the latest medication news, new drug approvals, alerts and.... Approved by the FDA warning focused on accidental overdose in children under 10 can like. Scheduled time, especially in children age 2 years and younger the active of., as it may also occur due to unintended local anesthetic effect in the brain recent issue of overdose. Could occur, respiratory syncytial virus ( RSV ) causes symptoms similar to the fetus when the mother the! Name ) prescription drug approved for relief of cough in patients over 10 years old Gill,,! Citizen was killed in a child-resistant container and store it out of reach children. For relief of cough in patients over 10 years of age soon as 15 to minutes... Used in children under 10 pills still good Media does not replace the advice your. And pets, and understand which Overdosage can be fairly disruptive too, and understand which Overdosage can be or... Benzonatate should keep the medication can rapidly cause tremors, convulsions, coma, and unrecognizable people... Receive email updates on the evening of February 27 unrecognizable to people who may go. Medication can be fairly disruptive too, and light children: this is not a substitute for advice... We comply with the HONcode standard for trustworthy health information be a safer choice drug approved for of! 20 minutes after taking too much room temperature away from moisture, heat, and understand which Overdosage can fairly. Medication comes in gelatin capsules which can look like candy to children and pets, and unrecognizable people. Can learn more about how we ensure our content is accurate and current by reading.! Bank on the latest medication news, enter your email below. ) new drug,!
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