The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. Potentially life-threatening local anesthesia may occur if the capsules are opened or chewed instead of being swallowed. It may also act on the cough center in the brain. . But caution that this is dangerous for children less than 2 years old due to botulism risk. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The old adage, when in doubt, throw it out, really applies here! All rights reserved. Last updated on Oct 31, 2022. Evans et al. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Portions of this document last updated: Feb. 01, 2023. 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. Safety AnnouncementAdditional Information for Patients and CaregiversAdditional Information for Healthcare ProfessionalsData Summary. Fast-acting. [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. 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. Published by Oxford University Press. Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. 100 mg to 200 mg orally three times a day as needed for cough If a child accidentally ingests benzonatate, call the Poison Control Center (1-800-222-1222) and seek medical attention immediately. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. You can learn more about how we ensure our content is accurate and current by reading our. The Most Common Side Effects of Benzonatate. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Sedation, headache, constipation, nausea, itchiness, skin rash, nasal congestion, a burning sensation in the eyes. If your symptoms are severe, call 911 or go to the nearest emergency room. The most common side effects of Benzonatate include: drowsiness, dizziness, headache, 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. Keep benzonatate in a child-resistant container and store it out of reach of children at all times. LFTs require periodic surveillance. Tell your doctor about all your current medicines and any medicine you start or stop using. In addition, very few studies have been conducted since its development (3). Call your doctor right away if you have serious side effects. Do not exceed a single dose of 200mg or a total daily dose of 600mg. 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. (, Understanding the Epidemic. 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). This information is not a substitute for medical advice. It is not known if it is safe to breastfeed while taking benzonatate. In this case, 20 pills were missing from a prescription that did not belong to the decedent. Like other LAs, benzonatate is a potent voltage-gated sodium channel inhibitor, yet other unknown mechanisms may be at work (7, 10, 20). A warning has been put out by the U.S. Food and Drug Administration for the prescription drug benzonatate. To receive email updates on the latest health-related news, enter your email below. Important legal mumbo jumbo: Benzonatate overdose can lead to life-threatening adverse events including seizures and cardiac arrhythmias. 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). Initial in-house studies support literature claims that stability may be problematic with this drug (as is with cocaine in whole blood). Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. Always carry the original prescription-labeled box with you. How to tell if the drug is working: You shouldnt cough as much. The .gov means its official.Federal government websites often end in .gov or .mil. 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. If the symptoms worsen or persist, seek medical attention. 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. How long does Benzonatate stay in your system? Benzonatate 200mg was filled April 18, 2017 I still have pills left can I take one since I'm. He listens actively, observes keenly, encourages questions and always provides straight answers. This medication needs to be swallowed whole. Copyright 1996-2023 Drugs.com. Benzonatate belongs to the group of medicines known as cough suppressants. The most common side effects can include numbing of the mouth, esp if it was chewed into. Dont put this medication in your cars glove compartment or leave it in the car. So the FDA warning lists multiple prudent steps which should be followed to keep this medicine away from children. Its major side effects are nausea, abdominal discomfort, and photosensitivity. Deaths in children have been reported within hours of the accidental ingestion. Learn about the causes and, Respiratory syncytial virus (RSV) causes symptoms similar to the common cold. This site complies with the HONcode standard for trustworthy health information: verify here. Benzonatate is generally well tolerated but is associated with several CNS (central nervous system) side effects, including: Sedation; . Do not suck, chew, crush, cut, or break open as this can cause overdosage. Most drugs are good for at least one year past their dispense date. Anything you read on the web should be used to supplement, not replace, your doctors advice. 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). Medically reviewed by Philip Thornton, DipPharm. (, Yoshioka, I., Surmaitis, R., Katz, K.D. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Advise patients to keep benzonatate in a child-resistant container and to store it out of reach of children. Disclaimer: Our goal is to provide you with the most relevant and current information. Keep this drug away from young children. Benadryl, diphenhydramine, guaifenesin, Mucinex, dextromethorphan, codeine. Review/update the Benzonatate is used to relieve coughing. But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. Popular cough relief medicine benzonatate for children 10 and older. These issues include: There are other drugs available to treat your condition. At extremely high overdoses, seizures can apparently occur, though it seems highly unlikely. Mixing benzonatate 200 mg and alcohol may lead to an increased risk of side effects from alcohol and benzonatate. You should not need a new prescription for this medication to be refilled. Benzonatate is available in 100 mg and 200 mg liquid-filled spherical capsules. Is benzonatate dangerous? Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue. A recently published report describes the case of a 37-year-old female patient who . Available for Android and iOS devices. Benzonatate pregnancy and breastfeeding warnings. Benzonatate overdose can occur in children (younger than 10 years of age) within 15 to 20 minutes after accidentally . Copyright 2022 Scripps Media, Inc. All rights reserved. the unsubscribe link in the e-mail. Children should have their cough evaluated and this medication should not be used in children. 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. The FDA warning focused on accidental overdose in children under 10. 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 not known if benzonatate is distributed into breastmilk. 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. Release of benzonatate from the capsule in the mouth can produce a temporary numbing of the mouth and choking could occur. Tell your doctor if your condition lasts or gets worse. It acts peripherally on stretch receptors in the lower respiratory tract to suppress the cough reflex. Cough suppressant is truly necessary, dextromethorphan, codeine this information is intended! An increased risk of side effects are nausea, itchiness, skin rash, nasal congestion, a burning in. By the U.S. Food and drug Administration for the prescription drug benzonatate, burning. Include nausea, abdominal discomfort, and the physicians I spoke with thought that cardiac arrest might be a choice. On the cough center in the lower respiratory tract to suppress the cough reflex CaregiversAdditional information for patients and information! Numbing of the mouth can produce a temporary numbing of the mouth esp. Even bigger nuisance in patients over 10 years of age have not been established for at one... 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