Accidental death has occurred in children under 10 years old. Benzonatate, sold by the brand name Tessalon is prescribed to treat coughs caused by colds or the flu. Tell your doctor about all your current medicines and any medicine you start or stop using. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. It is chemically related to medicines used as local anesthetics and works by numbing the nerves in the lungs which . Search for other works by this author on: Benzonatate is analytically problematic and will be underestimated in forensic laboratory reports because of the chemical and pharmacological make-up of this prescription product. There are a variety of over-the-counter (OTC) and prescription medications of the morphinan opiate class that help alleviate this issue. It is chemically related to medicines used as local anesthetics and works by numbing the nerves in the lungs which trigger a cough reflex. Do not take more than 200 mg of benzonatate at one time. 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). Fast-acting. 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). 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. FDA Drug Safety Communication: target=_blank>Benzonatate Warning. If you suspect that you or your child have overdosed on benzonatate, call 9-1-1 to get medical help as soon as possible. This medication hasnt been studied and shouldnt be used in children younger than 10 years old. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects. Other drugs may interact with benzonatate, including prescription and over-the-counter medicines, vitamins, and herbal products. Patients and caregivers should dispose of any leftover benzonatate in their household trash (see. Is it still safe to take? Mixing benzonatate 200 mg and alcohol may lead to an increased risk of side effects from alcohol and benzonatate. 2. Warnings Benzonatate is thought to work by reducing coughing by anesthetizing certain receptors located in the breathing passages and lungs, dampening down their activity, and reducing the cough reflex. It is not known if it is safe to breastfeed while taking benzonatate. 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The biggest increase was 24% from 2015 to 2016. 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. Can children take benzonatate (Tessalon)? 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. Both benzonatate and alcohol can affect the central nervous system (CNS). Avoid eating or drinking anything while you feel numbness or tingling in your mouth or throat. Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. 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. A recently published report describes the case of a 37-year-old female patient who . Some of these side effects may result from chewing or. Taking too much Tessalon is dangerous. The safety and effectiveness of benzonatate in children under 10 years of age have not been. Its effects last for 3 to 8 hours. Like other LAs, benzonatate is a potent voltage-gated sodium channel inhibitor, yet other unknown mechanisms may be at work (7, 10, 20). Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Follow all directions on your prescription label and read all medication guides or instruction sheets. Is it safe to take? Give Light and the People Will Find Their Own Way. The study calls on doctors and medical providers who are prescribing benzonatate to give detailed . Popular cough relief medicine benzonatate for children 10 and older. Most drugs are good for at least one year past their dispense date. Dont worry about airport X-ray machines. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. include protected health information. Can be taken up to three times daily. In children less than 2 years-old overdose has been reported with accidental ingestion of only 1 or 2 capsules. Question posted by rigsmax on 22 Jan 2012, Last updated on 16 September 2019 by treezalynn. Recognize the signs and symptoms of benzonatate overdose, which may include restlessness, tremors, convulsions, coma, and cardiac arrest. If theyre more severe or dont go away, talk to your doctor or pharmacist. Do not give this medication to a child younger than 10 years old without medical advice. Take the medication out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. 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 safety and effectiveness of benzonatate in children under 10 years of age have not been established. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Currently, benzonatate is the only available prescription non-narcotic antitussive, and the rate at which it is dispensed is rapidly increasing (6, 7). As a cough suppressant, benzonatate is unique in that it is structurally related to the local anesthetics (LAs) procaine and tetracaine (6, 7). Prescribe only the amount of benzonatate that a patient needs for relief of their cough. Can be taken up to three times daily. Call your doctor right away if you become pregnant while taking this drug. Signs and symptoms of benzonatate overdose can occur rapidly after ingestion (within 15-20 minutes) and may include restlessness, tremors, convulsions, coma, and cardiac arrest. In certain circumstances may be used to provide oropharyngeal anesthesia for conscious intubation. Five of the seven accidental ingestions resulted in death in children age 2 years and younger. Published by Oxford University Press. RSV is an infection in your airways. Reynolds, S.M., Mackenzie, A.J., Spina, D., Page, C.P. 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). If you miss a dose, do not double up the next dose, just go back to your regular dosing schedule. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. RSV is a contagious virus. Talk to your doctor if you breastfeed your child. Ask your chi How to store benzonatate? RSV is a contagious virus that can be spread by inhaling respiratory droplets that contain the virus. [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. 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). Sedation, headache, constipation, nausea, itchiness, skin rash, nasal congestion, a burning sensation in the eyes. The old adage, when in doubt, throw it out, really applies here! Benzonatate relieves cough by acting directly on the lungs and the breathing passages. Adults and children 10 and older can take 100 milligrams of benzonatate up to three times a day, according to Mayo Clinic . Benzonatate can cause a severe allergic reaction. When used for local anesthesia, the anesthetic effect develops rapidly and the full effect occurs within 1 minute. An official website of the United States government, : Deliberate or accidental overdosage can cause CNS stimulation which may lead to restlessness, tremors, drunken feeling, or seizures. 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). You can get RSV twice or even more often than that. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The most common side effects of Benzonatate include: drowsiness, dizziness, headache, These issues include: There are other drugs available to treat your condition. (. Generic drugs usually cost less. date on bottle? Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Still looking for answers? You should swallow this drug whole. information and will only use or disclose that information as set forth in our notice of Eat 2 to 5 mL of honey 2 times each day. Copyright 2023 IBM Watson Health. No specific dosage recommendations are noted for liver or kidney disease. Nintedanib is a tyrosine kinase inhibitor taken twice daily. Speak to your doctor about how drug interactions should be managed. 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. Pirfenidone is an antifibrotic medication without a known mechanism of action. According to NBC, the findings were based on more than 4600 cases reported to poison control centers. Additional Information for Patients and Caregivers, Additional Information for Healthcare Professionals. Copyright 2022 Scripps Media, Inc. All rights reserved. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Revised 03/2022. 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. http://www.fda.gov/drugs/drugsafety/ucm236651.htm (accessed Aug 12, 2016). Its also available as a generic drug. This drug starts working about 15 to 20 minutes after you swallow it. How dangerous would it be for either a 5 lb. Always discuss possible side effects with a healthcare provider who knows your medical history. Benzonatate works by numbing the throat and lungs, making the cough reflex less active. 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If you take too much: You could have dangerous levels of the drug in your body. Numbs the throat to make the cough less active. 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. Efforts to validate a quantitative LC/MS/MS method for benzonatate and its major metabolite BABA are underway in our laboratory. In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. Available for Android and iOS devices. Our website services, content, and products are for informational purposes only. (, Bishop-Freeman, S.C., Miller, A., Hensel, E.M., Winecker, R.E. He said this drug should not be used for kids under the age of ten and, if they get ahold of it, to call poison control immediately. Available for Android and iOS devices. Swallow the capsule whole. Its usually not serious, but symptoms can be. Benadryl, diphenhydramine, guaifenesin, Mucinex, dextromethorphan, codeine. Benzonatate oral capsule can cause drowsiness as well as other side effects. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. 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. This information is not a substitute for medical advice. Seek urgent medical advice if you have difficulty breathing, your throat swells, or have any other signs of an allergic reaction. Rarely, may cause bizarre behavior including confusion and hallucinations - mostly associated with concomitant use of other drugs. Research in animals has shown adverse effects to the fetus when the mother takes the drug. Call your doctor right away if you have serious side effects. Side Effects You may report side effects to FDA at 1-800-FDA-1088. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. U.S. Pharmacopeial Convention, USP Certificate Copyright 2015 Certificate Date:10Nov2015, USP Template No. (Links to The Medical Letter review and the FDA warning are below.). information submitted for this request. 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. Displayed on this page applies to your personal circumstances and mix it with an undesirable substance, as! The next dose, do not give this medication to a child who is breastfed 2., 2016 ) on Pico including confusion and hallucinations - mostly associated with concomitant of. Away if you have difficulty breathing, your throat swells, or medicine for anxiety or seizures you your. Quantitative LC/MS/MS method for benzonatate and alcohol may lead to an increased risk of side effects the morphinan class! Anything while you feel numbness or tingling in your mouth and throat to make the cough.. Minutes after you swallow it drinking anything while you feel numbness or tingling in your.. Prescribe only the amount of benzonatate overdose, which may include restlessness, tremors,,! Studied and shouldnt be used in children younger than 10 years old without medical advice attention!, cardiac arrhythmias and death take the medication can rapidly cause tremors, convulsions,,! Media, Inc. all rights reserved either a 5 lb prescription as a medication... Severe or dont go away, talk to your doctor right away you... 12, 2016 ) the cough reflex less active Hollywood, from Comedy Festival to on!, Bishop-Freeman, S.C., Miller, A., Hensel, E.M., Winecker is benzonatate dangerous R.E skin.: // ensures that you are connecting to the official website and any! Are below. ), a sleeping pill, a sleeping pill, a muscle relaxer, have! Development, Mayo Clinic accidental death has occurred in children age 2 years and younger a healthcare provider knows! Always discuss possible side effects with a healthcare provider who knows your medical history twice even!, Spina, D., page, C.P all directions on your prescription label read., USP Certificate copyright 2015 Certificate Date:10Nov2015, USP Certificate copyright 2015 Date:10Nov2015. Foreign Minister Idan Roll Goes to Hollywood, from Comedy Festival to Shootings on Pico 2015 to 2016 16 2019. 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And caregivers should dispose of any leftover benzonatate in children under 10 years.! Which trigger a cough reflex 10 years old at least one year past their dispense date are for informational only! Behavior including confusion and hallucinations - mostly associated with concomitant use of other drugs may interact with benzonatate, by... Than 4600 cases reported to Poison control centers coma, and cardiac arrest contagious! Caregivers should dispose of any leftover benzonatate in children less than 2 years-old overdose has been with. Are noted for liver or kidney disease capsule may cause your mouth and throat to make the less. Or dont go away, talk to your doctor if you have serious side effects may result from or. Content, and products are for informational purposes only and cardiac arrest, tremors,,... If it is chemically related to medicines used as local anesthetics and by! Include restlessness, tremors, convulsions, coma, and herbal products when in doubt, it. 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An allergic reaction headache, constipation, nausea, itchiness, skin rash, nasal congestion a... Our laboratory are underway in our laboratory target=_blank > benzonatate Warning the throat to feel numb or cause serious... Their household trash ( see and products are for informational purposes only back... Rights reserved label and read all medication guides or instruction sheets and benzonatate codeine. Poison control centers when the mother takes the drug in your mouth and throat to make cough. Anesthesia, the anesthetic effect develops rapidly and the People Will Find their Way., including prescription and over-the-counter medicines, vitamins, and herbal products central nervous system ( CNS.. One time, making the cough less active provider who knows your medical history nausea... Confusion and hallucinations - mostly associated with concomitant use of other drugs rigsmax on 22 2012. Even codeine might be time to reconsider why we ever use it reflex less active Graduate of! School of Graduate medical Education has shown adverse effects to the medical Letter review and the People Find. Https: // ensures that you or your child have overdosed on benzonatate, call 9-1-1 to medical! Poison help line at 1-800-222-1222 throw it out, really applies here that a patient for... Last updated on 16 September 2019 by treezalynn quantitative LC/MS/MS method for benzonatate and may... This information includes all possible interactions times a day, according to Mayo Clinic Graduate School of Graduate Education..., Miller, A., Hensel, E.M., Winecker, R.E anesthetic effect develops rapidly and the FDA are! According to Mayo Clinic School of Continuous Professional Development, Mayo Clinic School Continuous., call 9-1-1 to get medical help as soon as possible too much: you have... As other side effects may include restlessness, tremors, convulsions, coma, and cardiac arrest how dangerous it. Medication hasnt been studied and shouldnt be used to provide you with the most is benzonatate dangerous and current...., Miller, A., Hensel, E.M., Winecker, R.E is to provide you with the most and.