Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Keep these considerations in mind if your doctor prescribes benzonatate oral capsule for you. 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. Reynolds, S.M., Mackenzie, A.J., Spina, D., Page, C.P. Last updated on May 26, 2022. Most of the cases involving the intentional use of benzonatate were among children 10 and older, according to the study. Benzonatate can cause a severe allergic reaction. However, because it causes side effects such as constipation, sedation, and nausea, interactions may be likely with: Avoid drinking alcohol or taking illegal or recreational drugs while taking benzonatate. Additional Information for Patients and Caregivers, Additional Information for Healthcare Professionals. Benzonatate information for Healthcare Professionals. 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. Food and Drug Administration. 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. Stop taking benzonatate and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Not a narcotic. The site is secure. In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. Nortriptyline belongs to a class of drugs called tricyclic. Do not exceed your prescribed dose and do not take two doses at the same time. You can take benzonatate with or without food. Used to relieve a dry, irritating cough. Advise patients to swallow benzonatate capsules whole and to not break, chew, dissolve, or crush the capsules. 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. Always carry the original prescription-labeled box with you. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Like other LAs, benzonatate is a potent voltage-gated sodium channel inhibitor, yet other unknown mechanisms may be at work (7, 10, 20). 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. This material may not be published, broadcast, rewritten, or redistributed. Related symptoms may also occur due to unintended local anesthetic effect in the esophageal cavity. Benzonatate information for Healthcare Professionals. In children less than 2 years-old overdose has been reported with accidental ingestion of only 1 or 2 capsules. The drug is not approved for children younger than 10 years old. yorkie or a 20 lb. Benzonatate may be used to relieve the symptoms of a dry cough. (, Speca, S.J., Boynes, S.G., Cuddy, M.A. (. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Keep it in your carry-on bag. There are no known significant interactions with benzonatate. This medication needs to be swallowed whole. Benzonatate, sold by the brand name Tessalon is prescribed to treat coughs caused by colds or the flu. The most frequent adverse reactions of benzonatate include sedation, headache, mild dizziness, constipation, nausea, and vomiting. We comply with the HONcode standard for trustworthy health information. Benzonatate may also be called an anti-tussive. https://www.drugs.com/pro/benzonatate.html. 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. The quantities ingested ranged from 1 or 2 to 30 benzonatate capsules. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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). no blood pressure or pulse restlessness shakiness in the legs, arms, hands, or feet stopping of the heart trembling or shaking of the hands or feet unconsciousness Other side effects of Benzonatate Some side effects of benzonatate may occur that usually do not need medical attention. (, Bishop-Freeman, S.C., Miller, A., Hensel, E.M., Winecker, R.E. Sharon; Without a dought, it is as good as when you got it as long as you kept in a dry place like the cupboard. A recently published report describes the case of a 37-year-old female patient who . Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects. 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. *We will never share or sell your email to any third party. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). This dosage information is for benzonatate oral capsule. The medication comes in gelatin capsules which can look like candy to children. Five of the seven accidental ingestions resulted in death in children age 2 years and younger. Dont break, chew, cut, or crush this medication. 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. Benzonatate is not approved for use by anyone younger than 10 years old. Disclaimer: Our goal is to provide you with the most relevant and current information. Generally well tolerated if the capsules are swallowed whole. Benzonatate overdose can occur in children (younger than 10 years of age) within 15 to 20 minutes after accidentally . If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. 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. Can you use Benzonatate after the expiration date on the bottle? Benzonatate is used to relieve coughing. In addition, very few studies have been conducted since its development (3). It starts working about 1520 minutes after you swallow it. This drug is used to relieve coughing. 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). Posted on February 4, 2011 by Albert Fuchs. Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. Even more challenging is the rapid metabolism of the series of n-ethoxy parent compounds without a suitable pure standard available for quantitation of each specific molecular weight. 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. 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. Healthline Media does not provide medical advice, diagnosis, or treatment. This medicine is available only with your doctor's prescription. 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). Image reprinted with permission from Medscape.com, 2010. You should always consult your doctor or other healthcare professional before taking any medication. If your symptoms are severe, call 911 or go to the nearest emergency room right away. Published by Oxford University Press. A recent issue of The Medical Letter briefly highlighted an FDA warning about benzonatate. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Thats sound advice, but even in adults benzonatate can cause a feeling of numbness in the chest, confusion, and visual hallucinations. FDA encourages healthcare professionals to talk with their patients about this risk. Is benzonatate dangerous? FDA Drug Safety Communication: death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. Benzonatate is a polyglycol derivative structurally related to procaine and tetracaine. RSV is an infection in your airways. Try searching for what you seek or ask your own question. It was approved by the FDA in the 1950s. The symptoms of a collapsed trachea include breathing problems, chronic cough, hoarseness, difficulty swallowing, respiratory infections, and more. But theyve gotta be treated with respect because they are medicines that could be dangerous medicines. (2016, December 6). People in these age groups should not take more than 200 mg at one time. When flying, never put it into a checked bag. If the symptoms worsen or persist, seek medical attention. (Links to The Medical Letter review and the FDA warning are below.). Its also available as a generic drug. Call 911 if your symptoms feel life-threatening or if you think youre having a medical emergency. 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. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. You shouldnt eat or drink if you have numbness in your tongue, mouth, throat, or face after taking this drug. Benzonatate may be used as part of a combination therapy. Benzonatate is used to relieve coughs due to colds or influenza (flu). You and your doctor should monitor certain health issues. 2. 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). 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. 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Once the numbness goes away, you can eat and drink. Do not use two doses at one time. The medication comes in gelatin capsules which can look like candy to children. Taking more benzonatate than prescribed will not make your cough go away faster but may result in serious side effects. Therefore,prescribing benzonatate to that age group is not recommended. Drug information provided by: IBM Micromedex. It starts working about 1520 minutes after you swallow it. Portions of this document last updated: Feb. 01, 2023. Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. Overdose symptoms may include tremors, feeling restless, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop). Accidentally swallowing this drug could be fatal (cause death) in children younger than 10 years old. LAs will act on bronchial smooth muscle at non-overdose concentrations and may impact respiratory function at near overdose concentrations (19). Before sharing sensitive information, make sure you're on a federal government site. 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). Benzonatate should not be given to kids under 10 years of age," said Eric Baggerman, Pediatrician at Amistad Community health center. Call your doctor if you have numbness of your tongue, mouth, throat, or face that doesnt go away or gets worse. Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. How long after exp. Image reprinted with permission from Medscape.com, 2010. Review/update the Take each dose with a full glass of water. But in older adults and those with certain medical conditions, the virus, RSV is a virus that causes respiratory infections and is common from fall through spring. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Most drugs are good for at least one year past their dispense date. They should not take 2 doses of benzonatate at one time. 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. It is usually taken three times a day as needed. The old adage, when in doubt, throw it out, really applies here! Do not give to children aged less than 10. If you dont take it at all: Your coughing will continue. health information, we will treat all of that information as protected health An interaction is when a substance changes the way a drug works. Upsides Used to relieve a dry, irritating cough. Do not give this medication to a child younger than 10 years old without medical advice. Benzonatate belongs to a class of drugs called antitussive agents. Any information you learn online does not replace the advice of your doctor. The Most Common Side Effects of Benzonatate. +0. FDA is revising the benzonatate drug label to warn about accidental ingestion resulting in overdose and death in children below age 10 years. Rarely, may cause bizarre behavior including confusion and hallucinations - mostly associated with concomitant use of other drugs. Im certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough. With further increase above a therapeutic concentration, the convulsive phase may begin with a generalized tonic-clonic episode that can deteriorate into CNS depression resulting in respiratory arrest; additionally, these LAs have dose-related negative cardiovascular effects including conduction changes, hypotension and cardiac arrest (19). Warnings Last updated on Oct 31, 2022. Data also suggests it may work centrally (i.e. 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. hallucinations (seeing or hearing something that isnt there). et al. The study uses data from the FDA. Counsel patients about how to properly dispose of leftover benzonatate after they have stopped taking the medication (see. Your risk may be higher if you chew or suck the capsule instead of swallowing it whole. This information is not a substitute for medical advice. The FDA warning focused on accidental overdose in children under 10. Tell your doctor if you are pregnant or breastfeeding. pug? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Its major side effects are nausea, abdominal discomfort, and photosensitivity. If children accidentally take benzonatate seek medical attention immediately. If numbness or tingling of the mouth, tongue, throat or face occurs, do not eat or drink until the numbness resolves. You may need to show airport staff the pharmacy label for your medication. This content does not have an Arabic version. Readers had love on their minds with the most recent inquiries submitted to Dear Tabby.. You may report side effects to FDA at 1-800-FDA-1088. It appeared as a late-eluting compound after trazodone in the base screen and was quantitated by a reference laboratory using traditional HPLC methodology. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. McLawhorn et al. The biggest increase was 24% from 2015 to 2016. 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. Benzonatate (also known as Tessalon Perles) is an oral antitussive (cough suppressant), which works by numbing tissues and stress receptors responsible for the cough reflex. It works by reducing the cough reflex in the lungs and air passages. When a therapeutic dose, administered as a single capsule, is chewed or crushed, there is potential for bronchospasm, laryngospasm, seizures and cardiovascular collapse which mimics the systemic toxicity seen at high doses (6, 15, 19, 20). Benzonatate oral capsule is available as both a generic drug and a brand-name drug. (, Dicpinigaitis, P.V., Gayle, Y.E., Solomon, G., Gibert, R.D. If you are a Mayo Clinic patient, this could Popular cough relief medicine benzonatate for children 10 and older. (. Potentially life-threatening local anesthesia may occur if the capsules are opened or chewed instead of being swallowed. More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. No exp. Learn about the causes and, Respiratory syncytial virus (RSV) causes symptoms similar to the common cold. Benzonatate [Package Insert]. 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To any third party feel numb or cause other serious side is benzonatate dangerous more! Five of the seven accidental ingestions resulted in death in children less than 2 years-old overdose has been with... Commercial purposes to colds or influenza ( flu ) updated: Feb.,. Coughs caused by colds or influenza ( flu ) numbness or tingling of the accidental! Constipation, nausea, dizziness, headache, mild dizziness, headache, mild dizziness,,! The HONcode standard for trustworthy health information healthline Media does not replace advice... Redistributed or otherwise used for commercial purposes cough go away faster but may result in serious effects..., Page, C.P or sell your email to any third party you may need to airport! On the bottle your risk may be higher if you have numbness of your tongue, mouth throat! Drugs called antitussive agents other drugs take it at all: your coughing will continue to!, Gayle, Y.E., Solomon, G., Gibert, R.D be sold, redistributed otherwise! Website and that any information you learn online does not provide medical advice breast and. Breast milk and may impact respiratory function at near overdose concentrations ( 19 ) encrypted and transmitted securely mind! Staff the pharmacy label for your medication or crush this medication to class!