In addition, very few studies have been conducted since its development (3). 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. Posted on February 4, 2011 by Albert Fuchs. Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. If you take too much: You could have dangerous levels of the drug in your body. Healthline Media does not provide medical advice, diagnosis, or treatment. RSV is a contagious virus that can be spread by inhaling respiratory droplets that contain the virus. Benzonatate information for Healthcare Professionals. You can learn more about how we ensure our content is accurate and current by reading our. The FDA warning focused on accidental overdose in children under 10. via the central nervous system) by inhibiting the transmission of the cough reflex via pathways in the brain. According to NBC, the findings were based on more than 4600 cases reported to poison control centers. Its effects last for 38 hours. . Benzonatate is a non-narcotic cough medicine. As a cough suppressant, benzonatate is unique in that it is structurally related to the local anesthetics (LAs) procaine and tetracaine (6, 7). Benzonatate is in a class of medications called antitussives (cough suppressants). It is usually taken three times a day as needed. 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). Benzonatate works by numbing the throat and lungs, making the cough reflex less active. Other drugs that have the same active ingredients (e.g. Serious side effects and their symptoms can include the following: Disclaimer: Our goal is to provide you with the most relevant and current information. This can be harmful or prevent the drug from working well. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Benzonatate is generally well tolerated but is associated with several CNS (central nervous system) side effects, including: Sedation; . This drug is used to relieve coughing. If a child accidentally ingests benzonatate, seek medical attention immediately. You should swallow this drug whole. Fast-acting. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. LAs will act on bronchial smooth muscle at non-overdose concentrations and may impact respiratory function at near overdose concentrations (19). 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. Is it okay to take propranolol past the expiration date on the bottle. Adults and children 10 and older can take 100 milligrams of benzonatate up to three times a day, according to Mayo Clinic . Benzonatate is not approved for use by anyone younger than 10 years old. It was approved by the FDA in the 1950s. https://www.drugs.com/pro/benzonatate.html. 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). Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Benzonatate is used to relieve coughs due to colds or influenza (flu). Use: Symptomatic relief of cough, Children older than 10 years: More common side effects The more common side effects of benzonatate oral capsule include: drowsiness dizziness. Anything that I write is no exception. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. 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. Children should have their cough evaluated and this medication should not be used in children. Benzonatate benzonatate capsule. 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). Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. LFTs require periodic surveillance. Revision date: May 25, 2022. The .gov means its official.Federal government websites often end in .gov or .mil. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Benzonatate can cause a severe allergic reaction. Symptoms include stuffy nose, coughing, sore throat, fever. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Tell your doctor about all your current medicines and any medicine you start or stop using. Do not give to children aged less than 10. It is chemically related to medicines used as local anesthetics and works by. Take benzonatate exactly as prescribed by your doctor. information is beneficial, we may combine your email and website usage information with CERT1_4-03. Readers had love on their minds with the most recent inquiries submitted to Dear Tabby.. 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! 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. It may also act on the cough center in the brain. Nortriptyline belongs to a class of drugs called tricyclic. An overdose of benzonatate can be fatal, especially to a child. This can help make sure you stay safe while you take this drug. It is not known if benzonatate is distributed into breastmilk. Creighton University, Center for Drug Information and Evidence-Based Practice, Nortriptyline oral capsule is a prescription medication thats used to treat depression. Is it OK to take hydroxyzine hcl syrup after expiration date, and if so is it still effective? Its effects last for 3 to 8 hours. FDA Drug Safety Communication: target=_blank>Benzonatate Warning. 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. Taking it again could be fatal (cause death). FDA encourages healthcare professionals to talk with their patients about this risk. ill take my chances. Eat 2 to 5 mL of honey 2 times each day. Among six overdose cases (median age 10 years, range 1 to 39 years) which included a specific timeframe of events following the overdose, all cases developed symptoms within one hour of ingestion. 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. This makes you cough less after taking the drug. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. They should not take 2 doses of benzonatate at one time. We comply with the HONcode standard for trustworthy health information. Not a narcotic. Perhaps the reason for sparse literature data for benzonatate over-ingestion (29) is the inability to detect benzonatate and recognize the metabolites. 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Do not suck, chew, crush, cut, or break open as this can cause overdosage. RSV is an infection in your airways. Your dosage, drug form, and how often you take the drug will depend on: Take 100200 mg three times per day as needed for your cough. Keep it in your carry-on bag. 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. 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). (, Bhole, M.V., Manson, A.L., Seneviratne, S.L., Misbah, S.A. (, Cohen, V., Jellinek, S.P., Stansfield, L., Truong, H., Baseluos, C., Marshall, J.P. (, Cohan, J.A., Manning, T.J., Lukash, L., Long, C., Ziminski, K.R., Conradi, S.E. This content does not have an English version. Benzonatate is sold under the brand-name Tessalon and is also sold in generic preparations. All posts 2006 2023 Albert Fuchs MD. How should this medicine be used? Does Benzonatate make you loopy like a narcotic cough medication or just sleepy like Benadryl? Use a humidifier or vaporizer. A study done by the FDA found from 2010 to 2018, reports of pediatric poisonings involving the drug increased each year. 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. Skip the missed dose and use your next dose at the regular time. 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. Some of these side effects may result from chewing or sucking on a capsule. Copyright 1996-2023 Drugs.com. STORAGE: Store at room temperature away from light and moisture. (, Dicpinigaitis, P.V., Gayle, Y.E., Solomon, G., Gibert, R.D. It appeared as a late-eluting compound after trazodone in the base screen and was quantitated by a reference laboratory using traditional HPLC methodology. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Take the medication out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. Image reprinted with permission from Medscape.com, 2010. Sucking or chewing the capsule may cause serious side effects. It comes with risks if you dont take it as prescribed. date on bottle? 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. Two pediatric patients (ages 12 months and 4 years) were hospitalized due to accidental benzonatate ingestion and survived the event. Purchased benzonatate 2/27/16. Its also available as a generic drug. All accidental ingestions reported to FDA to date occurred in children less than 10 years of age (see Data Summarybelow). Benzonatate should not be given to kids under 10 years of age," said Eric Baggerman, Pediatrician at Amistad Community health center. Copyright 1996-2023 Cerner Multum, Inc. (, Bishop-Freeman, S.C., Miller, A., Hensel, E.M., Winecker, R.E. Therefore,prescribing benzonatate to that age group is not recommended. Benzonatate comes in the form of a capsule and a perle (smaller capsule) you take by mouth. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. Release of benzonatate from the capsule in the mouth can produce a temporary numbing of the mouth and choking could occur. It was approved by the FDA in the 1950s. A narrow safety margin for benzonatate has been demonstrated by overdose case studies (13, 20, 22, 24). Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. (, Speca, S.J., Boynes, S.G., Cuddy, M.A. It is based on benzonatate (the active ingredients of Benzonatate) and Benzonatate (the brand name). Mayo Clinic does not endorse companies or products. It is taken three times a day with food. Benzonatate starts to work within 15 to 20 minutes after swallowing the capsules whole. This medication can be dangerous or deadly for children younger than that. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. 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. privacy practices. : 1056005. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. 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. You should not need a new prescription for this medication to be refilled. Do not exceed a single dose of 200mg or a total daily dose of 600mg. 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. 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. Tell your doctor if you are pregnant or intend to become pregnant while taking benzonatate, as it may not be suitable for you. It is not known if it is safe to breastfeed while taking benzonatate. Avoid eating or drinking anything while you feel numbness or tingling in your mouth or throat. Benzonatate pregnancy and breastfeeding warnings. You and your doctor should monitor certain health issues. pug? 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. (2017, March 22), Tessalon 100 mg perles, 200 mg capsules (benzonatate, USP). Keep this drug away from young children. Available for Android and iOS devices. Learn why this happens, how to recognize the symptoms, and how to help prevent it. To help prevent interactions, your doctor should manage all of your medications carefully. We avoid using tertiary references. The effects of an overdose can develop rapidly (within 15-20 minutes in children) and may lead to death. Thats sound advice, but even in adults benzonatate can cause a feeling of numbness in the chest, confusion, and visual hallucinations. Disclaimer: Our goal is to provide you with the most relevant and current information. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Most drugs are good for at least one year past their dispense date. Available for Android and iOS devices. Always ask a doctor before giving a cough medicine to a child. The FDA product labeling reports that benzonatate has a molecular weight of 603.7 g/mol with a side chain of nine ethoxy units. 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). Give Light and the People Will Find Their Own Way. This medication needs to be swallowed whole. If your symptoms are severe, call 911 or go to the nearest emergency room. Always speak with your doctor or pharmacist about dosages that are right for you. Its usually not serious, but symptoms can be. Call your doctor right away if you have serious side effects. 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). (Links to The Medical Letter review and the FDA warning are below.). 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. Most of the cases involving the intentional use of benzonatate were among children 10 and older, according to the study. This drug starts working about 15 to 20 minutes after you swallow it. Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue.