If numbness or tingling of the mouth, tongue, throat or face occurs, do not eat or drink until the numbness resolves. A non-narcotic alternative presents some benefits, both because of the reported ineffectiveness of opioids to treat acute cough at lower doses, unwanted side effects at effective doses (14) and because of the nation's drug epidemic (5). Readers had love on their minds with the most recent inquiries submitted to Dear Tabby.. Benzonatate is used to relieve coughs due to colds or influenza (flu). (. Version: 9.01. All possible dosages and drug forms may not be included here. RSV is a contagious virus. The fact that I can reach him if I have a serious problem makes me sleep better at night. This medication is sometimes used in dogs for chronic cough. 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. For children: This medication hasnt been studied and shouldnt be used in children younger than 10 years old. FDA Drug Safety Communication: target=_blank>Benzonatate Warning. Is benzonatate dangerous? 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. Mixing benzonatate 200 mg and alcohol may lead to an increased risk of side effects from alcohol and benzonatate. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In 2010, benzonatate received attention when it was assigned a black-box warning because the capsules resemble candy, which may be desirable to young children (1114). totallyforgiven 22 Jan 2012. Benzonatate belongs to a class of drugs called antitussive agents. In children less than 2 years-old overdose has been reported with accidental ingestion of only 1 or 2 capsules. Keep out of reach of children. Benzonatate may cause various side . To help prevent interactions, your doctor should manage all of your medications carefully. McLawhorn et al. Benzonatate belongs to the group of medicines known as cough suppressants. Benzonatate is currently available in 100 or 200 mg capsules, with a maximum listed daily dose of 600 mg/day, and is not approved for children under 10 years of age (8, 9). information submitted for this request. Still looking for answers? Last updated on May 26, 2022. It is usually taken three times a day as needed. North Carolina Office of the Chief Medical Examiner, Raleigh, NC. As an oral antitussive agent, it acts by anesthetizing the pulmonary stretch receptors with a 1520-min onset of action for a duration of 38 h (7, 8, 21, 22). Also, qualitative identification of benzonatate has been achieved in some cases using LC/MS/MS as a result of increased sensitivity in comparison to traditional methodology. Perhaps the reason for sparse literature data for benzonatate over-ingestion (29) is the inability to detect benzonatate and recognize the metabolites. Symptoms can appear as soon as 15 to 20 minutes after taking too much. +0. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Never suck or chew on a benzonatate capsule. They should not take 2 doses of benzonatate at one time. Benzonatate (Tessalon Perles) was approved in 1958 as a peripherally-acting antitussive for its ability to inhibit cough before its mechanism of action was completely understood. Food and Drug Administration. Some of these side effects may result from chewing or sucking on a capsule. 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). It may also act on the cough center in the brain. Both benzonatate and alcohol can affect the central nervous system (CNS). Do not give this medication to a child younger than 10 years old without medical advice. Coughing can be very disruptive to work and to sleep, and patients can be desperate for relief. It works by reducing the cough reflex in the lungs and air passages. It acts peripherally on stretch receptors in the lower respiratory tract to suppress the cough reflex. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. Unusual reactions to p-aminobenzoic acid (PABA)-derived ester-based LAs have been associated with these underlying allergies; however, the incidence of true IgE-mediated reactions is unknown and presumed to be rare (1518). [12-14-2010] The U.S. Food and Drug Administration (FDA) is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. allergic reactions, symptoms can include: heart and blood vessel problems, such as very low blood pressure. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Tessalon [Package Insert]. An overdose can be fatal, especially to a young child who has accidentally swallowed the medicine. Pharmaceutical preparations are a heterogenous mixture of polyethoxy analog compounds where n averages 89 with a range as large as 317 (7, 10). Comments: This drug should be swallowed whole. It is chemically related to medicines used as local anesthetics and works by numbing the nerves in the lungs which trigger a cough reflex. The old adage, when in doubt, throw it out, really applies here! Keep it in your carry-on bag. (Links to The Medical Letter review and the FDA warning are below.). Use: Symptomatic relief of cough, Children older than 10 years: Benzonatate, sold by the brand name Tessalon is prescribed to treat coughs caused by colds or the flu. Sandra C. Bishop-Freeman, Erin M. Shonsey, Laura W. Friederich, Michael C. Beuhler, Ruth E. Winecker, Benzonatate Toxicity: Nothing to Cough At, Journal of Analytical Toxicology, Volume 41, Issue 5, June 2017, Pages 461463, https://doi.org/10.1093/jat/bkx021. Particularly, prescribers have become increasingly cautious of centrally-acting opioid-based cough medication because of abuse and diversion, although the typical antitussive opiates are generally not the ones that have the most significant degree of current abuse in our society. Im certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. An official website of the United States government, : Do not suck, chew, crush, cut, or break open as this can cause overdosage. Copyright 1996-2023 Cerner Multum, Inc. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. 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. Generic name: benzonatate [ben-ZOE-na-tate] Can ChatGPT write a Jewish Journal column. The old adage, when in doubt, throw it out, really applies here! You and your doctor should monitor certain health issues. Image reprinted with permission from Medscape.com, 2010. Select one or more newsletters to continue. Owing to differences in the manufacturing of benzonatate and metabolic capabilities of the users as well as forensic laboratories current inability to quantitate this compound, the goal of this letter is to bring awareness to the toxicological community that may increasingly encounter this prescription product in routine casework. Benzonatate also comes as an oral perle (smaller capsule). If children accidentally take benzonatate seek medical attention immediately. Try searching for what you seek or ask your own question. More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. Benzonatate information for Healthcare Professionals. Benzonatate is rapidly hydrolyzed by plasma butyrylcholinesterase (BChE) to the major metabolite 4-(butylamino)benzoic acid (BABA) along with the corresponding polyethylene glycol monomethyl ethers (Figure, Inhibition of cough-reflex sensitivity by benzonatate and guaifenesin in acute viral cough, Clinical perspective-cough: an unmet need, Analysis of benzonatate overdoses among adults and children from 19692010 by the United States Food and Drug Administration, Benzonatate inhibition of voltage-gated sodium currents, Disposition of Toxic Drugs and Chemicals in Man, Benzonatate overdose associated with seizures and arrhythmias, The Medical Letter on Drugs and Therapeutics, Benzonatate toxicity in a teenager resulting in coma, seizures and severe metabolic acidosis, The Journal of Pediatric Pharmacology and Therapeutics, Local anesthetics: review of pharmacological considerations, Understanding allergic reactions to local anesthetics, Allergic reactions to local anesthetic formulations, IgE-mediated allergy to local anaesthetics: separating fact from perception: a UK perspective, Cardiac arrest with residual blindness after overdose of Tessalon, Degradation kinetics of benzonatate in aqueous solutions, Two fatalities resulting from Tessalon (benzonatate), Intravenous lipid emulsion for local anesthetic toxicity, A 17-year-old girl with cough-pulseless after drug overdose, Lipid emulsion for local anetstetic systemic toxicity, Loperamide-related deaths in North Carolina, Benzonatate ingestion reported to the National Poison Center Database System (NPDS), Journal of Medical Toxicology: Official Journal of the American College of Medical Toxicology, The Author 2017. Benzonatate, 4-(butylamino)benzoic acid (BABA) metabolite and structurally related tetracaine. You should swallow this drug whole. Its also available as a generic drug. Take benzonatate exactly as prescribed by your doctor. Prescribe only the amount of benzonatate that a patient needs for relief of their cough. Store benzonatate at room temperature between 59F and 86F (15C and 30C). A search of FDA's Adverse Event Reporting System (AERS) database through May 19, 2010 identified 31 cases of overdose associated with benzonatate (median age 18 years, range 1 to 66 years). Overdose of benzonatate has been reported in adults and adolescents. Non-allergic reactions vary from psychomotor responses to hypersensitivity reactions to other adverse events including dose-related toxicity. 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Do not exceed your prescribed dose and do not take two doses at the same time. Use: Symptomatic relief of cough. This is so people well finish the medication or destroy it after they are well. Tell your doctor if you are pregnant or breastfeeding. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. This can be harmful or prevent the drug from working well. U.S. Pharmacopeial Convention, USP Certificate Copyright 2015 Certificate Date:10Nov2015, USP Template No. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Drug Overdose deaths in the United States hit record numbers in 2014. This means you may need to take it with other medications. Serious adverse outcomes reported to the National Poison Center between 2000 and 2006 occurred in 116 patients (41 in children <6 years old), with 4 deaths. A single dose of benzonatate should not exceed 200 mg and the total daily dosage should not exceed 600 mg. Report adverse events and medication errors involving benzonatate to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page. Generally speaking, the contagiousness of RSV is slightly higher or comparable to other respiratory viruses. In several of the published over-ingestion cases, as well as those observed in our office, only a small handful of pills was enough to cause seizures, a cardiac event and death. Interestingly, the product insert directs one to not double up a missed dose of benzonatate and only take a maximum of 200 mg at a time. Benzonatate relieves a dry cough; however, the capsules must be swallowed whole because the risk of a fatal overdosage is increased if the capsules are opened in any way. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/, MW1, McLawhorn, Goulding, M.R., Gill, R.K., Michele, T.M. Only take as directed. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. https://www.drugs.com/pro/benzonatate.html. Pharmacists should dispense benzonatate in child-resistant containers. Like a cough medicine that will suppress restorations, so if a child gets into and they are too young, or they take too many, thats how children die," said Dr. Baggerman. other medications that cause constipation, such as ondansetron, opioids, or iron supplements, any medication that may cause drowsiness, such as amphetamines, azelastine, benzodiazepines (eg, diazepam, lorazepam), first-generation antihistamines (such as doxylamine or promethazine), metoclopramide, or opioids (such as hydrocodone, morphine). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. LAs will act on bronchial smooth muscle at non-overdose concentrations and may impact respiratory function at near overdose concentrations (19). Reynolds, S.M., Mackenzie, A.J., Spina, D., Page, C.P. Taking it again could be fatal (cause death). Your risk may be higher if you chew or suck this drug instead of swallowing it whole. Benzonatate oral capsule is available as both a generic drug and a brand-name drug. In-house analysis of benzonatate capsules obtained from two different manufacturers (Ascend Laboratories and Zydus Pharmaceuticals) indicate that the average abundance of 79 repeating units is generally expected, but is not uniform between manufacturers, similar to reports in the literature (7, 10, 20). 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. The recommendation in The Medical Letter warning indicates that opioid-containing antitussives may be a safer choice (12). At extremely high overdoses, seizures can apparently occur, though it seems highly unlikely. It is not known if benzonatate is distributed into breastmilk. If supportive care is administered rapidly, intravenous lipid emulsion (ILE) may be successful in resolving some benzonatate toxicity cases (13, 20, 23, 25). Major Pharmaceuticals. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. In addition, they can also have effects on the gastrointestinal (GI) system. But caution that this is dangerous for children less than 2 years old due to botulism risk. FDA encourages healthcare professionals to talk with their patients about this risk. Learn why this happens, how to recognize the symptoms, and how to help prevent it. Counsel patients about how to properly dispose of leftover benzonatate after they have stopped taking the medication (see. This site complies with the HONcode standard for trustworthy health information: verify here. Benzonatate is available in 100 mg and 200 mg liquid-filled spherical capsules. Benzonatate benzonatate capsule. 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