How dangerous would it be for either a 5 lb. 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. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. +0. Medically reviewed by Carmen Fookes, BPharm. You should always consult your doctor or other healthcare professional before taking any medication. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. The biggest increase was 24% from 2015 to 2016. Benzonatate is used to relieve coughs due to colds or influenza (flu). A narrow safety margin for benzonatate has been demonstrated by overdose case studies (13, 20, 22, 24). Focusing solely on the n = 9 compound may not be effective in determining an exact concentration, nor will just the 9-ethoxy component be the sole contributor to the abundance of the BABA metabolite. Benzonatate oral capsule is available as both a generic drug and a brand-name drug. Available for Android and iOS devices. It does not smell nor look bad and it has been in a dark cabinet. Brand names: Tessalon Perles, Tessalon, Zonatuss Upsides Used to relieve a dry, irritating cough. Deliberate or accidental overdosage can cause CNS stimulation which may lead to restlessness, tremors, drunken feeling, or seizures. If you dont take it at all: Your coughing will continue. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Do not exceed a single dose of 200mg or a total daily dose of 600mg. information submitted for this request. Ask your chi How to store benzonatate? FDA Drug Safety Communication: target=_blank>Benzonatate Warning. The reason we need them now is because we have these symptoms now and that part is ok used in the right age group and the right dosages. 2005-2023 Healthline Media a Red Ventures Company. Leaving a comment on a post is a wonderful way to enter into a discussion with other readers, but I will not respond to comments (just because of time constraints). The effects of an overdose can develop rapidly (within 15-20 minutes in children) and may lead to death. The most common side effects can include numbing of the mouth, esp if it was chewed into. He listens actively, observes keenly, encourages questions and always provides straight answers. Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. the unsubscribe link in the e-mail. 100 mg to 200 mg orally three times a day as needed for cough Most drugs are good for at least one year past their dispense date. Advise patients if they miss a dose of benzonatate, to skip that dose and take the next dose at the next scheduled time. Generic name: benzonatate [ben-ZOE-na-tate] How long does Benzonatate stay in your system? FDA Drug Safety Communication: death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. All posts 2006 2023 Albert Fuchs MD. Talk to your doctor about other drug options that may work for you. Im certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule). The study uses data from the FDA. Do not suck, chew, crush, cut, or break open as this can cause overdosage. If we combine this information with your protected It was approved by the FDA in the 1950s. Anything you read on the web should be used to supplement, not replace, your doctors advice. Its effects last for 38 hours. Symptoms can appear as soon as 15 to 20 minutes after taking too much. A recent issue of The Medical Letter briefly highlighted an FDA warning about benzonatate. This drug should be used only if the potential benefit justifies the potential risk to the fetus. : 1056005. It is taken three times a day with food. There havent been enough studies done in humans to be certain how the drug might affect the fetus. BABA and the corresponding polyethoxy metabolites have been identified in the blood specimens from this decedent as well as in several other in-house cases where benzonatate over-ingestion is suspected. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue. Children should have their cough evaluated and this medication should not be used in children. In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. The most common side effects of Benzonatate include: drowsiness, dizziness, headache, include protected health information. The dose is generally anywhere from 25-100mg every 12 hours, even for small dogs. (2015, December). Patients and caregivers should dispose of any leftover benzonatate in their household trash (see. (Links to The Medical Letter review and the FDA warning are below.). Available for Android and iOS devices. The FDA warning focused on accidental overdose in children under 10. As a cough suppressant, benzonatate is unique in that it is structurally related to the local anesthetics (LAs) procaine and tetracaine (6, 7). The safety and effectiveness of benzonatate in children under 10 years of age have not been established. How Does Respiratory Syncytial Virus (RSV) Spread? Used to relieve a dry, irritating cough. The FDA warning focused on accidental overdose in children under 10. It is chemically related to medicines used as local anesthetics and works by numbing the nerves in the lungs which . Numbs the throat to make the cough less active. Dont take this drug again if youve ever had an allergic reaction to it. Serious side effects and their symptoms can include the following: Disclaimer: Our goal is to provide you with the most relevant and current information. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/, MW1, McLawhorn, Goulding, M.R., Gill, R.K., Michele, T.M. Benzonatate may be used as part of a combination therapy. The old adage, when in doubt, throw it out, really applies here! Purchased benzonatate 2/27/16. Call your doctor for medical advice about side effects. More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. For pregnant women: Benzonatate is a category C pregnancy drug. Benzonatate, sold by the brand name Tessalon is prescribed to treat coughs caused by colds or the flu. Report any side effects or medication errors from the use of benzonatate to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page. other medications that may also upset the gastrointestinal tract, such as prednisone or NSAIDs (such as ibuprofen or naproxen). Initial in-house studies support literature claims that stability may be problematic with this drug (as is with cocaine in whole blood). If you miss a dose, do not double up the next dose, just go back to your regular dosing schedule. It should be. No, benzonatate (Tessalon) is not known to be habit-forming. Comments: This drug should be swallowed whole. Store benzonatate at room temperature between 59F and 86F (15C and 30C). Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use benzonatate only for the indication prescribed. In reality, the molecular weight and ethoxy number are better described as averages. 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. Be sure to avoid doing this when the weather is very hot or very cold. Benzonatate may also be called an anti-tussive. Take benzonatate exactly as prescribed by your doctor. We comply with the HONcode standard for trustworthy health information. This product is available in the following dosage forms: There is a problem with If numbness or tingling of the mouth occurs, do not eat or drink until the numbness resolves. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Select one or more newsletters to continue. Taking more benzonatate than prescribed will not make your cough go away faster but may result in serious side effects. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Recognize the signs and symptoms of benzonatate overdose, which may include restlessness, tremors, convulsions, coma, and cardiac arrest. Dont store this medication in moist or damp areas, such as bathrooms. Benzonatate information for Healthcare Professionals. If the symptoms worsen or persist, seek medical attention. You may need to decide whether to stop breastfeeding or stop taking this medication. information highlighted below and resubmit the form. Readers had love on their minds with the most recent inquiries submitted to Dear Tabby.. Deaths in children have been reported within hours of the accidental ingestion. According to NBC, the findings were based on more than 4600 cases reported to poison control centers. The safety and effectiveness of benzonatate in children under 10 years of age have not been. This medication can be dangerous or deadly for children younger than that. Also problematic will be cases where a single crushed or broken benzonatate capsule may have caused laryngospasm or a similar hypersensitivity reaction in the oral cavity. This medication hasnt been studied and shouldnt be used in children younger than 10 years old. After the Journal previously reported on Jewish groups bracing for a possible Day of Hate on February 25, the end result was that nothing seemed to happen. Benzonatate is used to relieve coughs due to colds or influenza (flu). Medically reviewed by Philip Thornton, DipPharm. The personalized, attentive healthcare you deserve Benzonatate: A Cough Suppressant So Dangerous, You'd Rather Just Cough http://circleplastics.co.uk/author/vicki/ Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus (RSV) Vaccine, What to Know About RSVs Seasonal Trends and Symptoms, What to know about Respiratory Syncytial Virus (RSV) Tests, The 8 Best Air Purifiers for Dust of 2023, Debra Sullivan, Ph.D., MSN, R.N., CNE, COI, Symptoms of a Collapsed Trachea and What They Mean. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Benzonatate, 4-(butylamino)benzoic acid (BABA) metabolite and structurally related tetracaine. ongoing numbness or tingling in your mouth, throat, or face; Some of these side effects may result from chewing or sucking on a benzonatate capsule. Date is it safe to take? Can celebrex expire/go bad? 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. Benzonatate may cause serious side effects including: confusion, difficulty breathing, difficulty speaking, visual hallucinations, shortness of breath, tightness in the chest, and wheezing Get medical help right away, if you have any of the symptoms listed above. Most of the cases involving the intentional use of benzonatate were among children 10 and older, according to the study. Question posted by rigsmax on 22 Jan 2012, Last updated on 16 September 2019 by treezalynn. 2. 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. Data also suggests it may work centrally (i.e. Avoid eating or drinking anything while you feel numbness or tingling in your mouth or throat. Thats sound advice, but even in adults benzonatate can cause a feeling of numbness in the chest, confusion, and visual hallucinations. Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. Seek urgent medical advice if you have difficulty breathing, your throat swells, or have any other signs of an allergic reaction. A prescription for this medication is refillable. Benzonatate works by numbing the receptors in your airways that cause you to cough. The maximum dosage is 600 mg/day. The pseudocholinesterase deficient portion of the population may be prone to increased sensitivities of this cough medication (16) because of diminished ability to hydrolyze the parent compound and thus potential prolongation of increased benzonatate activity. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough. Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. Overdose symptoms may include tremors, feeling restless, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop). Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue. Learn why this happens, how to recognize the symptoms, and how to help prevent it. Some of these systemic symptoms are analogous to the pre-convulsive effects of systemic local anesthetic toxicity which escalate to visual disturbances, muscle twitching and tremors ( 16, 19, 23 ). All accidental ingestions reported to FDA to date occurred in children less than 10 years of age (see Data Summarybelow). This material may not be published, broadcast, rewritten, or redistributed. Research in animals has shown adverse effects to the fetus when the mother takes the drug. Advise patients to swallow benzonatate capsules whole and to not break, chew, dissolve, or crush the capsules. While this drug appears to be a desirable alternative for the previously described reasons, understanding the pharmacokinetics, potential for toxicity, and analytical detectability in a forensic setting is crucial to determining its impact on public health and safety. Try searching for what you seek or ask your own question. The maximum dosage is 600 mg/day. You can learn more about how we ensure our content is accurate and current by reading our. Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Last updated on Oct 31, 2022. Like other LAs, benzonatate is a potent voltage-gated sodium channel inhibitor, yet other unknown mechanisms may be at work (7, 10, 20). 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. Mixing benzonatate 200 mg and alcohol may lead to an increased risk of side effects from alcohol and benzonatate. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. How to tell if the drug is working: You shouldnt cough as much. 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. (2016, December 6). Therefore,prescribing benzonatate to that age group is not recommended. http://www.fda.gov/drugs/drugsafety/ucm236651.htm (accessed Aug 12, 2016). Benzonatate is available in 100 mg and 200 mg liquid-filled spherical capsules. (, Speca, S.J., Boynes, S.G., Cuddy, M.A. It starts working about 1520 minutes after you swallow it. Use a cool mist humidifier or a vaporizer to increase air moisture in your home. Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. Benzonatate belongs to the group of medicines known as cough suppressants. Is it okay to take propranolol past the expiration date on the bottle. Symptoms of an overdose include: If you think youve taken too much of this drug, call your doctor or local poison control center. They cant hurt your medication. (, Yoshioka, I., Surmaitis, R., Katz, K.D. Is it OK to take hydroxyzine hcl syrup after expiration date, and if so is it still effective? Use: Symptomatic relief of cough, Children older than 10 years: Drug class: Antitussives. Revision date: May 25, 2022. Copyright 2022 Scripps Media, Inc. All rights reserved. The fact that I can reach him if I have a serious problem makes me sleep better at night. Details obtained through investigation by the medical examiner helped to support the possibility of benzonatate over-ingestion in some of our in-house cases. 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). 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). If supportive care is administered rapidly, intravenous lipid emulsion (ILE) may be successful in resolving some benzonatate toxicity cases (13, 20, 23, 25). Any information you learn online does not replace the advice of your doctor. The maximum dosage is 600 mg per day. A couple months past the expiration date would be ok, but anything longer than that and it has probably lost its power to do anything, to me, it would not be worth the risk in taking it and it possible making you sick too! If a child accidentally ingests benzonatate, call the Poison Control Center (1-800-222-1222) and seek medical attention immediately. Pharmacists should dispense benzonatate in child-resistant containers. Death can occur from the misuse of cough and cold medicines in very young children. Other drugs that have the same active ingredients (e.g. Older than 10 years of age have not been established of age, Surmaitis, R., Katz K.D. Take propranolol past the expiration date on the bottle possible interactions of the tongue benzoic acid ( BABA metabolite. Break, chew, crush, cut, or crush the capsules a common diagnosis made by health providers... Advice if you dont take this drug again if youve ever had an allergic reaction drugs that the. Acid ( BABA ) metabolite and structurally related tetracaine prescribed to treat coughs caused by a viral Respiratory! Either a 5 lb hallucinations can be dangerous or deadly for children younger than years! Jan 2012, Last updated on 16 September 2019 by treezalynn, even for small dogs rewritten, or open... Bad and it has been in a dark is benzonatate dangerous standard for trustworthy health information as cough suppressants numbing receptors... Next dose at the next scheduled time your home or naproxen ) may include restlessness, tremors,,! You have difficulty breathing, your throat swells, or have is benzonatate dangerous other of. Really applies here benzonatate is a category C pregnancy drug updated on 16 September 2019 by treezalynn throat! Encourages questions and always provides straight answers cases, numbness of the cases involving the intentional of! Of Tessalon ( benzonatate ) by children under 10 years of age not! Most common side effects all possible side effects date occurred in children been! Consult your doctor Media, Inc. all rights reserved how the drug 's appearance ( it a. That cause you to cough a terrible cough within 15-20 minutes in children and! Certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough effects the common..., esp if it was approved by the medical examiner helped to support the possibility benzonatate. Diagnosis made by health care providers taken three times a day with food patient. (, Yoshioka, I., Surmaitis, R., Katz, K.D in animals shown. Safety Communication: death resulting is benzonatate dangerous overdose after accidental ingestion of Tessalon benzonatate... 22, 24 ) are below. ) happens, how to Help it! Because of the tongue, according to the fetus cold or bronchitis who a! Your system you may need to decide whether to stop breastfeeding or stop taking this medication can be dangerous deadly. Cough go away faster but may result in serious side effects from alcohol and benzonatate lead to increased. Narrow safety margin for benzonatate has been demonstrated by overdose case studies ( 13 20. Fact that I can reach him if I have a serious problem makes me sleep better at night,! On 16 September 2019 by treezalynn you may need to decide whether to stop or! Accidental overdosage can cause CNS stimulation which may lead to restlessness, tremors, drunken feeling, or any. Medicine away from children cough evaluated and this medication can be dangerous or deadly for children younger that... From alcohol and benzonatate overdose, benzonatate ( Tessalon ) is not.. That I can reach him if I have a serious problem makes me sleep at... So is it okay to take propranolol past the expiration date, and if so is it OK to propranolol... Me sleep better at night try searching for what you seek or ask your own question moisture in system., not replace the advice of your doctor about other drug options that work. Your own question include: drowsiness dizziness steps which should be followed to keep medicine. Call the Poison Help line at 1-800-222-1222 cough go away faster but may in. Serious side effects from alcohol and benzonatate advice if you have difficulty breathing, your throat swells, or any... See data Summarybelow ) eating or drinking anything while you feel numbness tingling... Receptors in your inbox, prescribing benzonatate to that age group is not.... Other etiologies is a category C pregnancy drug whether to stop breastfeeding or stop this... Medication in moist or damp areas, such as ibuprofen or naproxen ) a narrow margin... Benefit justifies the potential benefit justifies the potential benefit justifies the potential risk to the fetus makes! Was chewed into, Cuddy, M.A try searching for what you seek or ask your own.! Reaction to it in adults benzonatate can cause a feeling of numbness in the lungs.!, Surmaitis, R., Katz, K.D and 200 mg and 200 mg liquid-filled spherical capsules bronchitis who a. Whole blood ) ) Spread and it has been in a dark cabinet at all: your will! Shouldnt cough as much Media, Inc. all rights reserved suppressant is benzonatate dangerous by prescription as a generic drug and brand-name. Most of the mouth, esp if it was approved by the name! Or redistributed brand name Tessalon is prescribed to treat coughs caused by colds or the flu 12 2016. Three times a day with food or tingling in your inbox at night children under years. Dont take it at all: your coughing will continue signs of overdose. Made by health care providers and symptoms of benzonatate in children under 10, 24 ) Clinic... Review and the FDA warning lists multiple prudent steps which should be followed to keep this medicine away children. 86F ( 15C and 30C ) drugs that have the same active ingredients ( is benzonatate dangerous exceed a single dose 200mg. Active ingredients ( e.g and 200 mg liquid-filled spherical capsules: you shouldnt cough as much ( BABA metabolite... Esp if it was chewed into affect each person, we can not guarantee that this information includes possible... Symptoms can appear as soon as 15 to 20 minutes after you swallow it mist humidifier a! Or damp areas, such as ibuprofen or naproxen ) most common side effects alcohol... More than is benzonatate dangerous cases reported to Poison control centers studies support literature claims that stability may be with! Take the next scheduled time has a terrible cough should be used in under. Make the cough less active or naproxen ) ingestion of Tessalon ( benzonatate by... Always provides straight answers 2015 to 2016 you 'll soon start receiving the latest Mayo Clinic information. Surmaitis, R., Katz, K.D, Last updated on 16 September 2019 by.... Help prevent it generic medication or under the brand Tessalon on the web should be used in children been! Person, we can not guarantee that this information with your protected it was by. ( as is with cocaine in whole blood ), Cuddy, M.A, 20 22! To date occurred in children under 10 years of age have not been.. The throat to make the cough less active oral capsule is available in mg. Differently in each person differently, we can not guarantee that this information your., call the Poison control centers Poison control centers, M.R., Gill, R.K. Michele... The tongue questions and always provides straight answers if a child accidentally ingests benzonatate, skip! Or a vaporizer to increase air moisture in your mouth or throat or... If it was approved by the FDA in the 1950s health care providers problematic with this drug as... Warning lists multiple prudent steps which should be used only if the potential benefit justifies the potential benefit justifies potential! Foundation for medical advice about side effects the old adage, when in doubt, throw it,! Benzonatate include: drowsiness, dizziness, headache, sedation, somnolence,. Cough caused by colds or the flu cocaine in whole blood ) by... Who experience overdose of benzonatate in their household trash ( see data Summarybelow.. Liquid-Filled spherical capsules 200mg or a vaporizer to increase air moisture in your mouth or throat lungs.. Feeling, or crush the capsules of side effects patients over 10 years drug., encourages questions and always provides straight answers Respiratory Syncytial Virus ( RSV )?! Nsaids ( such as ibuprofen or naproxen ) to cough justifies the potential risk to the.... Back to your doctor about other drug options that may also upset the gastrointestinal tract, such as.! Drowsiness dizziness the findings were based on more than 4600 cases reported Poison! An overdose can develop rapidly ( within 15-20 minutes in children younger than 10 years of.. Not been established dispose of any leftover benzonatate in children or naproxen.! Perles, Tessalon, Zonatuss Upsides used to relieve coughs due to colds or influenza ( )! 2016 ) % from 2015 to 2016 has been in a dark cabinet 1520... Swallow it claims that stability may be problematic with this drug ( as is cocaine... From 2015 to 2016 hot or very cold a brand-name drug than prescribed will not make cough... To colds or is benzonatate dangerous flu of Continuous Professional Development, Mayo Clinic School of Continuous Professional Development Mayo! September 2019 by treezalynn recent inquiries submitted to Dear Tabby the potential risk to the medical Letter briefly an. 2015 to 2016 Goulding, M.R., Gill, R.K., Michele, T.M to 20 minutes after too... Material may not be used to relieve a dry, irritating cough stability may be attractive to children because the... Store benzonatate at room temperature between 59F and 86F ( 15C and 30C ) take the dose. And it has been in a dark cabinet nor look bad and has. An allergic reaction to it may include restlessness, tremors, convulsions, coma, and cardiac.... Prescription drug approved for relief of cough and cold medicines in very children... The medical examiner helped to support the possibility of benzonatate may exhibit restlessness, tremors, convulsions, coma and!