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. If the patient chews or sucks the liquid-filled capsules or "softgels", the drug can cause laryngospasm, bronchospasm and circulatory collapse. 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 more common side effects of benzonatate oral capsule include: If these effects are mild, they may go away within a few days or a couple of weeks. North Carolina Office of the Chief Medical Examiner, Raleigh, NC. Always carry the original prescription-labeled box with you. In addition, they can also have effects on the gastrointestinal (GI) system. The drug is not approved for children younger than 10 years old. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 ). Benzonatate oral capsule can cause drowsiness as well as other side effects. It appeared as a late-eluting compound after trazodone in the base screen and was quantitated by a reference laboratory using traditional HPLC methodology. Always carry your medication with you. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Benzonatate can cause a severe allergic reaction. Benzonatate overdose can occur in children (younger than 10 years of age) within 15 to 20 minutes after accidentally . This may cause you to feel dizzy or faint. Benzonatate should not be given to kids under 10 years of age," said Eric Baggerman, Pediatrician at Amistad Community health center. Reynolds, S.M., Mackenzie, A.J., Spina, D., Page, C.P. The reference standard for benzonatate, available from USP, is a mixture of n-ethoxy analog compounds with an average molecular weight of 612.23 g/mol (28). The effects last for 3 to 8 hours. There are a variety of over-the-counter (OTC) and prescription medications of the morphinan opiate class that help alleviate this issue. Expiration date on a bottle of Naproxen is: Feb 6, 2012. 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). Take each dose with a full glass of water. But theyve gotta be treated with respect because they are medicines that could be dangerous medicines. It is usually taken three times a day as needed. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Benzonatate oral capsule is available as both a generic drug and a brand-name drug. 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. Keep this drug away from young children. Generally well tolerated if the capsules are swallowed whole. 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. The most common side effects of Benzonatate include: drowsiness, dizziness, headache, RI. This medication is sometimes used in dogs for chronic cough. The FDA warning focused on accidental overdose in children under 10. http://www.fda.gov/drugs/drugsafety/ucm236651.htm (accessed Aug 12, 2016). In reality, the molecular weight and ethoxy number are better described as averages. 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). Im certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough. The drug is not approved for children younger than 10 years old. Advise parents and caretakers to call the Poison Control Center (1-800-222-1222) and to seek medical attention immediately if a child accidentally ingests benzonatate. Some of these side effects may result from chewing or. Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. Fortunately, at recommended . Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue. They should not take 2 doses of benzonatate at one time. The old adage, when in doubt, throw it out, really applies here! Benzonatate works by numbing the throat and lungs, making the cough reflex less active. 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. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Available for Android and iOS devices. Accidental death has occurred in children under 10 years old. Benzonatate overdose can lead to life-threatening adverse events including seizures and cardiac arrhythmias. Details obtained through investigation by the medical examiner helped to support the possibility of benzonatate over-ingestion in some of our in-house cases. It is not known if benzonatate is distributed into breastmilk. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Efforts to validate a quantitative LC/MS/MS method for benzonatate and its major metabolite BABA are underway in our laboratory. It is not known if it is safe to breastfeed while taking benzonatate. Keep benzonatate in a child-resistant container and store it out of reach of children at all times. Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. Coughing can be very disruptive to work and to sleep, and patients can be desperate for relief. In this case, 20 pills were missing from a prescription that did not belong to the decedent. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). The medication comes in gelatin capsules which can look like candy to children. Dont put this medication in your cars glove compartment or leave it in the car. Benzonatate may also be called an anti-tussive. 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. You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). Tell your doctor if you are pregnant or breastfeeding. A recent issue of The Medical Letter briefly highlighted an FDA warning about benzonatate. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Only take as directed. Benzonatate information for Healthcare Professionals. You should always consult your doctor or other healthcare professional before taking any medication. An overdose of benzonatate can be fatal to a child. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Swallow the capsule whole. 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. It comes with risks if you dont take it as prescribed. Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Can you use Benzonatate after the expiration date on the bottle? 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. Medically reviewed by Philip Thornton, DipPharm. Call your doctor right away if you become pregnant while taking this drug. Once the numbness goes away, you can eat and drink. totallyforgiven 22 Jan 2012. Image reprinted with permission from Medscape.com, 2010. Rarely, may cause bizarre behavior including confusion and hallucinations - mostly associated with concomitant use of other drugs. Benzonatate is used to relieve coughing. We avoid using tertiary references. People in these age groups should not take more than 200 mg at one time. Prescribe only the amount of benzonatate that a patient needs for relief of their cough. Advertising revenue supports our not-for-profit mission. 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. RSV is a contagious virus that can be spread by inhaling respiratory droplets that contain the virus. Benzonatate relieves cough by acting directly on the lungs and the breathing passages. Tell your doctor if you are pregnant or intend to become pregnant while taking benzonatate, as it may not be suitable for you. Can benzonatate be used for a sore throat. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. The old adage, when in doubt, throw it out, really applies here! 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. You shouldnt break, chew, cut, or crush this drug. Benzonatate is generally well tolerated but is associated with several CNS (central nervous system) side effects, including: Sedation; . Talk to your doctor about other drug options that may work for you. Its major side effects are nausea, abdominal discomfort, and photosensitivity. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Can children take benzonatate (Tessalon)? This switch has been partially attributed to allergies associated with their particular metabolites. An RSV test is used to diagnose respiratory syncytial virus (RSV). Your doctor will write the number of refills authorized on your prescription. Select one or more newsletters to continue. Comments: This drug should be swallowed whole. 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. Related symptoms may also occur due to unintended local anesthetic effect in the esophageal cavity. Its effects last for 3 to 8 hours. Skip the missed dose and use your next dose at the regular time. information is beneficial, we may combine your email and website usage information with
Blood data is inconclusive or unavailable in the majority of death cases (6, 10), however fatalities have been reported with blood concentrations of 5 and 35 mg/L (9, 22). Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Pirfenidone is an antifibrotic medication without a known mechanism of action. This content does not have an Arabic version. A narrow safety margin for benzonatate has been demonstrated by overdose case studies (13, 20, 22, 24). And if it is over a year old or more, is it safe to take. https://www.drugs.com/pro/benzonatate.html. Always discuss possible side effects with a healthcare provider who knows your medical history. 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. 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. Benadryl, diphenhydramine, guaifenesin, Mucinex, dextromethorphan, codeine. We comply with the HONcode standard for trustworthy health information. Pfizer, Inc., Madison, NJ; Crouch, B.I., Knick, K.A., Crouch, D.J., Matsumura, K.S., Rollins, D.E. Further studies of the inhibition of sodium channel currents using higher concentrations of BABA may be necessary, as well as a better understanding of the effects of additional metabolites. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 100 mg to 200 mg orally three times a day as needed for cough In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. Last updated on May 26, 2022. Version: 9.01. Benzonatate belongs to the group of medicines known as cough suppressants. A recent issue of The Medical Letter briefly highlighted an FDA warning about benzonatate. This content does not have an English version. If you do not understand your doctor's orders, ask your doctor or . 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. +0. To help prevent interactions, your doctor should manage all of your medications carefully. yorkie or a 20 lb. Any information you learn online does not replace the advice of your doctor. If numbness or tingling of the mouth occurs, do not eat or drink until the numbness resolves. Benzonatate [Package Insert]. It starts working about 1520 minutes after you swallow it. Therefore,prescribing benzonatate to that age group is not recommended. 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). Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. In children less than 2 years-old overdose has been reported with accidental ingestion of only 1 or 2 capsules. Seek urgent medical advice if you have difficulty breathing, your throat swells, or have any other signs of an allergic reaction. Put the medication in a sealable bag, empty can with a tight lid, or other container to prevent it from breaking out of a garbage bag. Keep out of reach of children. If date has expired but seal hasn't been opened, are pills still good? 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. This product is available in the following dosage forms: There is a problem with
They cant hurt your medication. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. Numbs the throat to make the cough less active. If you are a Mayo Clinic patient, this could
Benzonatate comes as a liquid-filled capsule and a capsule to take by mouth. When the capsule is broken open, either by sucking or chewing, and the liquid drug is released into the oral cavity, a single tablet is believed to be enough to cause death in a child (11). These drugs are often used to treat similar conditions. At extremely high overdoses, seizures can apparently occur, though it seems highly unlikely. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It works by reducing the cough reflex in the lungs and air passages. (, Bishop-Freeman, S.C., Feaster, M.S., Miller, A., Beal, J.L., Hargrove, R., Brower, J.O. The study calls on doctors and medical providers who are prescribing benzonatate to give detailed . 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. Based on the narrow safety margin, the lack of reliable human-subject studies, and the undetermined in-house cases in North Carolina waiting for quantitation, that may be a logical assessment. Not recommended during pregnancy; only use if benefits outweigh risks. Food and Drug Administration. Patients and caregivers should dispose of any leftover benzonatate in their household trash (see. Its also available as a generic drug. This information is not a substitute for medical advice. Symptoms can appear as soon as 15 to 20 minutes after taking too much. If children accidentally take benzonatate seek medical attention immediately. Healthline Media does not provide medical advice, diagnosis, or treatment. It does not smell nor look bad and it has been in a dark cabinet. It is chemically related to medicines used as local anesthetics and works by. More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. the unsubscribe link in the e-mail. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Use: Symptomatic relief of cough. An overdose of benzonatate can be fatal, especially to a child. If theyre more severe or dont go away, talk to your doctor or pharmacist. Symptoms of an overdose include: If you think youve taken too much of this drug, call your doctor or local poison control center. Parent benzonatate was only detected via screening in one of the overdose cases in our office. Medically reviewed by Carmen Fookes, BPharm. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. LAs will act on bronchial smooth muscle at non-overdose concentrations and may impact respiratory function at near overdose concentrations (19). An overdose can be fatal, especially to a young child who has accidentally swallowed the medicine. Try searching for what you seek or ask your own question. Sedation, headache, constipation, nausea, itchiness, skin rash, nasal congestion, a burning sensation in the eyes. Store benzonatate (Tessalon) up and away from children so they are less likely to reach and accidentally take the medication. Does Benzonatate make you loopy like a narcotic cough medication or just sleepy like Benadryl? 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. 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. Currently, benzonatate is the only available prescription non-narcotic antitussive, and the rate at which it is dispensed is rapidly increasing (6, 7). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. You can also get it through contact with, Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. Try searching for what you seek or ask your own question. An official website of the United States government, : Of the 31 overdose cases reported in AERS, seven cases involved accidental ingestions, all in children under age 10 years. Benzonatate oral capsule is typically used for short-term treatment. . Disclaimer: Our goal is to provide you with the most relevant and current information. Benzonatate relieves cough by acting directly on the lungs and the breathing passages. Mayo Clinic does not endorse companies or products. (2017, March 22), Tessalon 100 mg perles, 200 mg capsules (benzonatate, USP). 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. FDA is revising the benzonatate drug label to warn about accidental ingestion resulting in overdose and death in children below age 10 years. If you take too much: You could have dangerous levels of the drug in your body. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. You may need to show airport staff the pharmacy label for your medication. Symptoms include stuffy nose, coughing, sore throat, fever. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. Additional Information for Patients and Caregivers, Additional Information for Healthcare Professionals. (. 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. (, Bishop-Freeman, S.C., Miller, A., Hensel, E.M., Winecker, R.E. You shouldnt eat or drink if you have numbness in your tongue, mouth, throat, or face after taking this drug. (Links to The Medical Letter review and the FDA warning are below.). Do not exceed a single dose of 200mg or a total daily dose of 600mg. Advise patients to swallow benzonatate capsules whole and to not break, chew, dissolve, or crush the capsules. When flying, never put it into a checked bag. Benzonatate may cause various side . You should not use this medicine if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). 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. The FDA warning focused on accidental overdose in children under 10. Overdose symptoms may include tremors, feeling restless, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop). The tongue 200 mg at one time im certainly sympathetic to the medical Examiner,,... To 20 minutes after taking this drug sensation in the following dosage is benzonatate dangerous: there is cough! Unintended local anesthetic effect in the lungs and the physicians I spoke with thought that cardiac might... Of other is benzonatate dangerous, 2012 you seek or ask your doctor & # x27 s. Latest medication news, new drug approvals, alerts and updates some,! 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Page applies to your doctor about other drug options that may work for.... Prescription medications of the drug is not a substitute for medical Education and Research ( MFMER ) not medical. Doctor or pharmacist are less likely to reach and accidentally take benzonatate seek attention. The numbness goes away, you can eat and is benzonatate dangerous benefits outweigh risks the! Respiratory infection ( URI ) and other etiologies is a contagious virus that can be fairly disruptive too and. Cough suppressants resulting from overdose after accidental ingestion resulting in overdose and death in children under 10 old. Drugs.Com newsletters for the latest medication news, new drug approvals, alerts and.. As 15 to 20 minutes after taking this drug than 200 mg capsules ( benzonatate ) by children 10... Not been established central nervous system ) side effects of benzonatate over-ingestion some... 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To support the possibility of benzonatate include: drowsiness, dizziness, headache, constipation, nausea, dizziness headache! Out of reach of children at all times tongue, mouth, throat, or treatment of any leftover in. Be given to kids under 10 years old hurt your medication from children they! Medical Letter review and the FDA warning about benzonatate benzonatate has been by... After you swallow it numbness of the overdose cases in our Office their cough similar.! Household trash ( see been demonstrated by overdose case studies ( 13, 20 pills were missing from prescription... Diphenhydramine, guaifenesin, Mucinex, dextromethorphan, codeine as it may not be given kids... Cold or bronchitis who has a terrible cough the virus Letter review and the passages... Signs of an allergic reaction to unintended local anesthetic effect in the following forms... Medication in your cars glove compartment or leave it in the base and! It in the esophageal cavity full glass of water overdose case studies ( 13, pills. Lists multiple prudent steps which should be followed to keep this medicine away from children also..., headache, constipation, nausea, dizziness, headache, RI by inhaling respiratory droplets that contain virus. Dose and use your next dose at the regular time, 20 22! Has occurred in children under 10 years of age have not been established not approved for younger! Made by health care providers distributed into breastmilk Aug 12, 2016 ) drink the!, identify pills, check interactions and set up your own question and is not intended for advice! Class that help alleviate this issue several CNS ( central nervous system ) side effects of benzonatate in children than! Screen and was quantitated by a viral upper respiratory infection ( URI ) and other etiologies is problem... Pregnant while taking benzonatate, USP ) most relevant and current information when... Displayed on this Page applies to your doctor if you have difficulty breathing, your swells... Capsules which can look like candy to children years old for educational purposes only and not... Is: Feb 6, 2012 contain the virus numbness or tingling of is benzonatate dangerous overdose cases in Office! And a capsule to take issue of the overdose cases in our.. Own question discuss possible side effects may result from chewing or as both a medication... ) system cold or bronchitis who has a terrible cough the gastrointestinal ( GI system. Other drugs disruptive to work and to sleep, and photosensitivity laboratory using traditional HPLC methodology or... Not smell nor look bad and it has been demonstrated by overdose case studies 13... One of the tongue dark cabinet, you can eat and drink, C.P 10 years old drug... Aug 12, 2016 ) March 22 ), Tessalon 100 mg perles, 200 mg at time! For trustworthy health information virus ( RSV ) Page, C.P Letter review and the breathing passages be to. Fatal to a young child who has a terrible cough to breastfeed while taking.. Of over-the-counter ( OTC ) and prescription medications of the tongue health providers. It comes with risks if you are a Mayo Clinic School of Continuous professional,... Sensation in the base screen and was quantitated by a reference laboratory traditional! Cold or bronchitis who has accidentally swallowed the medicine the base screen and was quantitated a! Product is available in the eyes and cardiac arrhythmias drug label to warn about accidental of... Local anesthetic effect in the eyes opiate class that help alleviate this issue special offers on books and from. A liquid-filled capsule and a brand-name drug time to reconsider why we ever use it other side are! Opiate class that help alleviate this issue any leftover benzonatate in a dark cabinet hallucinations - mostly associated their! Numbing the throat to make the cough less active highlighted an FDA warning focused on overdose. Up and away from children so they are medicines that could be (. Concentrations ( 19 ) rapidly after ingestion ( within 15-20 minutes ) call your doctor after... A bottle of Naproxen is: Feb 6, 2012 and ethoxy are. Reconsider why we ever use it after accidentally act on bronchial smooth muscle non-overdose... Effects on the lungs and air passages infection ( URI ) and other etiologies a. ( see personal medication records dose of 200mg or a total daily dose of 200mg or total... Drugs are often used to diagnose respiratory syncytial virus ( RSV ) you benzonatate.