The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. These cookies will be stored in your browser only with your consent. This therapy is for treating seizures by spraying the medicine on the skin inside the nose (intranasal injection). These patients received the other study drug at the 10-minute evaluation. Prospective and retrospective evidence shows that intranasal midazolam terminates seizures at least as fast as rectal diazepam.1,5,8,1215 Most clinical studies have used a 5 mg/mL midazolam solution dosed at 0.2 mg/kg (divided into each nostril) administered via an intranasal mucosal atomization (IN-MADD) device or nasal dropper as suggested by Kyrkou and colleagues.16. Initial dose: 0.025 to 0.05 mg/kg IV injection, with evaluation for sedation. The authors concluded that midazolam has a good safety profile when given via the nares. Emergency medication | Epilepsy Society Maintenance dose: After thorough clinical evaluation, additional doses may be given in increments of 25% of the initial dose used to reach sedation. Data show substantially better results for the intranasal midazolam group compared with the rectal diazepam group. A total IV dose greater than 3.5 mg is usually not necessary. Important Safety Information | Prescribing Information | Patient Medication Guide | Instructions for Use. A good safety profile also supports the use of intranasal midazolam, with fewer patients experiencing respiratory depression and oxygen desaturation compared with rectal diazepam. Do not use this medicine for more than one episode every 3 days and more than 5 episodes per month. Midazolam works by reducing electrical activity in the brain which can stop seizures. Buccal Midazolam Buccal midazolam is one type of emergency medicine used to stop prolonged seizures. However, Holsti and colleagues1 did not find a statistical difference in administration time. Rectal diazepam gel in the home management of seizures in children. 0 Dilution with other liquids should be avoided. Midazolam injection is in a class of medications called . trouble breathing severe drowsiness or confusion shortness of breath severe weakness chest pain or pressure slurred speech seizures that do not stop What other important information should I know about midazolam? This may be a viable option in the future if development of a premixed lidocaine/midazolam solution is feasible, but the delay in midazolam administration that would occur from giving lidocaine first is not ideal and could lead to patient harm. Nayzilam (midazolam) is a brand-name prescription medication. benzodiazepines, pediatrics, prehospital, seizures, therapeutics. The devicedoes not contain any active medication, and it can be reset and practiced with again and again. The individual who has been prescribed buccal midazolam should also have been given a care plan completed by a member of their healthcare team. Baseline characteristics were similar between the 2 groups. Sedation duration (drug administration to full recovery) without supplemental inhalation anesthesia had a mean of 30.2 min and ranged from 14 to 52 min (n = 13). NAYZILAM may cause serious breathing problems and excessive sleepiness (sedation). Use this medicine only as directed by your doctor. IV: 1 mg slow IV every 2 minutes as needed for sedation. Studies of Intranasal Midazolam1,5,8,1215. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. Rey E, Trluyer JM, Pons G. Pharmacokinetic optimization of benzodiazepine therapy for acute seizures: focus on delivery routes. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured. Treat with one of the following: Buccal midazolam as first-line treatment in the community. The initial pediatric dose of midazolam for sedation/anxiolysis/amnesia is age, procedure, and route-dependent. Initial dose: 0.05 to 0.1 mg/kg IV injection, with evaluation for sedation. More than 6% of the diazepam group experienced a seizure within 1 hour of drug administration, but only 3% of patients in the midazolam group experienced such recurrence. Maintenance dose: 0.2 to 0.1 mg/kg via IV infusion per hour Doses should be adjusted up or down by 25% to 50% of the initial infusion rate to assure adequate sedation. PayPal sets this cookie for secure transactions. NAYZILAM may cause serious side effects, including: The most common side effects of NAYZILAM include: These are not all the possible side effects of NAYZILAM. If there is a lot of nasal drainage, clear your child's nose with a tissue. Parenteral solution: Prior to administration, this drug should be inspected for particulate matter and discoloration. Initial and quick seizure cessation is considered important in these situations, as prolonged epileptic seizure activity can lead to permanent brain injury and systemic complications. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Drug information provided by: Merative, Micromedex. PDF Intransal Midazolam; Giving your child intranasal midazolam using a We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. }?%_`_TwE%saEy5>?QR:BMIvQI`+!Ghhhn pI-TrK|/n9oo;1/}0.>D.9 i~-2-]ri? Holsti and colleagues8 retrospectively studied the effectiveness and complications of intranasal midazolam compared with rectal diazepam for treatment of seizures in the prehospital setting. A second dose may be needed if the patient's seizure cluster has not stopped 10 minutes after the first dose. They can be given by mouth in some situations outside of a hospital setting. Intramuscular versus Intravenous Therapy for Prehospital Status Benzodiazepines, including NAYZILAM, can cause physical dependence and withdrawal reactions, especially if you continue to use NAYZILAM daily. PayPal sets this cookie to enable the PayPal payment service in the website. Harbord and colleagues2 evaluated the acceptance of intranasal midazolam for acute seizure management when given by parents, caregivers, teachers, and first aiders. YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. Then follow these instructions: Remove the dust cap from the top of the midazolam vial to expose the rubber seal. Midazolam injection is also used to treat status epilepticus, a severe type of seizure where there is more than one seizure within 5 minutes. Oral syrup: Once the correct dose is measured, the oral syrup should be administered directly into the mouth. Hypersensitivity to the active component or any of the ingredients, Patients with acute narrow-angle glaucoma, Intrathecal or epidural administration (parenteral formulations containing benzyl alcohol), Use in premature infants (parenteral formulations containing benzyl alcohol). Induction of general anesthesia before administration of other anesthetic agents, Component of IV supplementation of nitrous oxide and oxygen (balanced anesthesia). What is the correct way to use Nayzilam Nasal Spray? Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Remove the vial access cannula from its packaging. FIRST DOSE: Use one 5 mg nasal spray in one nostril. Patients with generalized convulsive seizures that are frequent or separated by a period of significantly impaired consciousness (ie, status epilepticus) or who are medically unstable require immediate assessment and treatment in an acute care setting (emergency department or intensive care unit). Kids Health Information : Midazolam for seizures - The Royal Children's If the seizure cluster continues for at least 10 minutes after the first dose, a second 5 mg dose may be given if your healthcare provider has instructed you to give a second dose. Rectal diazepam if preferred, or if buccal midazolam is not available. UCB is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site or its content by UCB. This medicine is for use only in the nose. 797997) in England. Do not give anyone else's medication to your child. These treatments are meant to rapidly stop seizures, whether to prevent an emergency or during one while under the care of healthcare providers. The authors determined that intranasal midazolam was more effective than rectal diazepam for controlling seizures when administered by emergency medical personnel prior to arrival at the ED. Rectal diazepam - is given rectally (into the bottom). The need for continued sedation with maintenance dosing should be carefully considered. Occurrence of repeated seizure within 12 hours, need for ED services, and respiratory depression rates were similar. The lowest effective dose should be used, and patients should be regularly assessed for sedation. are breastfeeding or plan to breastfeed. Parenteral: Before you use NAYZILAM, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Home management of breakthrough seizures. Seizures in the pediatric population commonly occur, and when proper rescue medication is not administered quickly, the risk of neurologic compromise emerges. Sedative drugs have a calming effect on the brain and can stop a seizure. PayPal sets this cookie to process payments on the site. breathing stops (which may lead to the heart stopping). Bhattacharyya and colleagues12 extensively studied adverse drug reactions of intranasal midazolam compared with rectal diazepam. Comments: Oral: HVn@}G;kR)\-ET}@yq,R 16 k9gfg`x4ri" ( DRb`ri7E X% `~{foI0,lrgJI(`tZ Q"g0!v:sg}v{'auV=I.,+BjaRKV&~y^+//]&44hDmW\Ik{vzQ. %PDF-1.5 % By clicking "Continue," you are confirming that you are a U.S. healthcare professional. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Intranasal midazolam was found to be efficacious and reasonably safe for treatment of acute seizures in the pediatric population. Dosing The dose of this medicine will be different for different patients. Oral Rescue Medicines | Epilepsy Foundation Its important to know a few things before you or someone else administers NAYZILAM (midazolam) nasal spray, CIV, so everyone can feel more comfortable using it. DISCLOSURE The authors declare no conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria. the contents by NLM or the National Institutes of Health. Call an ambulance if the seizure has not stopped within ten minutes of it starting or within five minutes of giving buccal midazolam. Medication (vial) Syringe Atomizer (white mushroom shaped device) Plastic or metal needle Step 2: Pop the protective cap off the vial of midazolam. If you arrive at a site that is not sponsored by UCB, please note that UCB is not responsible for the content or services of that site or any further links from that site. Usually prescribed as 1 spray into one nostril. Bhattacharyya M, Kalra V, Gulati S. Intra-nasal midazolam vs rectal diazepam in acute childhood seizures. Some fast-acting medicines (such as diazepam, lorazepam, or midazolam) can be used as a rescue medicine to stop seizures. Morgan HB, Miller GS. FIRST DOSE: Use one 5 mg nasal spray in one nostril. Smaller patients and/or larger volumes may receive half of the dose in one side of the mouth, and the rest of the dose in the other side of the mouth. IV formulations should be administered slowly (e.g., over 2 minutes), and the patient's sedation level should be evaluated for at least 2 minutes before administering another dose. This video shows how to give the medication Midazolam th. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with seizures. Midazolam - CURE Epilepsy Preterm and term neonates: Parenteral solution: At 0.5% concentrations, this drug is compatible with 5% dextrose in water and 0.9% sodium chloride for up to 24 hours and with lactated Ringer's solution for up to 4 hours. Of the 27 completed questionnaires, 90% reported no difficulty in administering the medication. Nayzilam: Cost, dosage, alternatives, administration, and more Nick G. is an actual patient living with seizure clusters. In most clinical situations, duration of action is an important factor to consider when choosing one agent over another within the same medication class. Seizure cessation within 10 minutes occurred in 60% (n=13) of those receiving rectal diazepam versus 87% (n=20) of patients administered intranasal midazolam (p<0.05). NAYZILAM is a ready-to-use nasal spray that can be given by anyone, whenever seizure clusters occur. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. This paper will review available data pertaining to the efficacy, safety, cost, and pharmacokinetics of intranasal midazolam versus rectal diazepam as treatment for acute seizures for children in the prehospital, home, and emergency department settings. The main goals of rapid seizure cessation include prevention of status epilepticus, avoidance of anoxic brain injury, and maintenance of neurologic function. There are other emergency medications but these may need to be administered by a healthcare professional in hospital. Wermeling DP. However, there was no difference found in seizure types between the 2 groups. Bing sets this cookie to recognize unique web browsers visiting Microsoft sites. Foreword Rarely clinical harm or error is an isolated event. %%EOF This drug should not be administered by rapid injection in the neonatal population. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. There are several methods of measuring cost-effectiveness. Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Patients younger than 55 years: Follow your doctor's orders or the directions on the label. As a component of anesthesia for sedation of intubated and mechanically ventilated patients, During treatment of intubated and mechanically ventilated patients in critical care settings, Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE, Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose. Maintenance dose: Approximately 25% of the IM dose first used to reach optimal sedation; however, the need for continued sedation with maintenance dosing should be carefully considered. Although it may seem difficult to administer an intranasal medication during a seizure, one must realize that removing garments to administer a rectal medication is challenging and time consuming. Optimal dosing of intranasal midazolam for all patients, including those with rhinitis and other nasal abnormalities, needs to be defined, although the studies presented primarily used 0.2 mg/kg per dose. Bing Ads sets this cookie to engage with a user that has previously visited the website. Other narcotics used for premedication should be administered approximately 1 hour prior to induction. Read and follow these instructions carefully. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while using NAYZILAM without first talking to your healthcare provider. ACEP Clinical Policies Committee; Clinical Policies Subcommittee on Seizures. If the emergency medicine stops the status epilepticus, the person may not need to go to hospital. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Do not double doses. Usual dose: 0.15 mg/kg IV once may provide sufficient anesthesia. Dosing should be calculated based on the patient's ideal body weight. Although it is helpful to be aware that diazepam and midazolam have durations of action of less than 2 hours and of 3 to 4 hours, respectively, clinicians must be mindful that the duration of action of benzodiazepines does not correlate directly with plasma concentration.4 Bhattacharyya and colleagues12 observed that 6.25% of patients had seizure recurrence within 60 minutes of rectal diazepam administration, which was true of only 3.26% of patients in the intranasal midazolam group. Less than 32 weeks with tracheal intubation: Chronic hepatic dysfunction: The dose should be titrated to the desired response. As contemporary as it may seem, the topic of drug formulation design is one of high importance. Your supplies, medication, and instructions should be kept all together. In: Maria BL, editor. DO NOT GIVE MORE THAN 2 DOSESTO TREAT A SEIZURE CLUSTER. The responders commented that the intranasal midazolam was less intrusive, allowed greater privacy, and was more suitable for use in the community compared with rectal diazepam. As a library, NLM provides access to scientific literature. Fifty-seven children with a variety of seizure disorders were evaluated and treated with either intranasal midazolam or rectal diazepam by the paramedics prior to arrival at the ED. If you have any questions about your condition or NAYZILAM, please speak with your healthcare provider or pharmacist. Last updated on Mar 2, 2022. In addition, if there is less hesitation to administer the medication by other personnel, such as a schoolteacher, improvement in patient care and outcomes may be seen. Convulsive status epilepticus (seizures lasting 5 minutes or more), Repeated/cluster seizures (usually 3 or more seizures which stop on their own in 24 hours), Prolonged seizures (seizures lasting more than 2 minutes longer than a persons usual seizure). PayPal sets this cookie to enable secure transactions through PayPal. These effects were believed to be due to pain associated with nasal mucosal irritation. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow at least an additional 2 minutes to fully evaluate the sedative effect. Although well accepted, rectal diazepam gel does have a few disadvantages. INDIVIDUALIZATION OF DOSAGE: Press the plunger firmly using 1 motion to get your dose. To dissolve and therefore become suitable for intranasal use, midazolam must be buffered to a pH of 3, which is irritating to the nares.6 One method of preventing nasal irritation is to administer intranasal lidocaine 60 seconds before midazolam using a mucosal atomization device. This drug should not be used to treat more than 1 episode every 3 days, and no more than 5 episodes/month. Seizures stopped within 10 minutes of drug administration in 88.5% of the diazepam group and 96.7% in the midazolam group (p=0.06). Once trained to administer midazolam directly into the nares from the original plastic ampule, 100% of parents, 79% of teachers, and 58% of school assistants preferred its use to waiting anxiously for an ambulance to arrive. Used by Microsoft Advertising as a unique ID for visitors. You do not need to breathe in deeply. hbbd```b``"j@$"2 ,~L`z RL>'L$w 0LN20120b`0? 7XI Rey E, Delaunay L, Pons G. Pharmacokinetics of midazolam in children: comparative study of intranasal and intravenous administration. The intramuscular administration of midazolam by EMS is a practical, safe, and effective alternative to the intravenous route for treating prolonged convulsive seizures in the prehospital setting . ABSTRACT Management of emergency epileptic seizures, such as status epilepticus, can be a common issue faced either by the owner at home or a vet at hospital. Intended for residents of the United States only. IV and oral syrup formulations have been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Data sources include IBM Watson Micromedex (updated 3 July 2023), Cerner Multum (updated 10 July 2023), ASHP (updated 10 July 2023) and others. Limitations of use: This drug should be limited to healthcare providers who are capable of monitoring and treating respiratory/cardiovascular adverse events, including respiratory and cardiac resuscitation. The need for emergent intubation (11% vs. 42%), requirement for hospital admission (40% vs. 89%), and intensive care unit admission (16% vs. 59%) all statistically favor intranasal midazolam administration at a dose of 0.2 mg/kg divided into each nare using a mucosal atomization device. Initial dose: 0.3 to 0.35 mg/kg IV once, administered over 20 to 30 seconds. Although time to seizure cessation varied from study to study, intranasal midazolam proved efficacious when administered not only by ED personnel, but also by paramedics and caregivers in the prehospital and home settings. Seizures in children account for up to 25% of all pediatric emergency medical service calls in the United States and may account for up to 15% of pediatric air transports.1 Most seizures self-terminate within 5 minutes, but those lasting longer warrant medication administration for seizure cessation and status epilepticus avoidance.2 Although the time period for diagnosing status epilepticus is controversial, traditional classification is defined as either one continuous seizure lasting 30 minutes, or a series of seizures that recurs in which the patient did not regain full consciousness between seizures.3 When seizures are prolonged or seizure activity is recurrent, the patient is at risk for neurologic compromise, as well as increased morbidity and mortality.3 In addition to a drug's efficacy in terminating status epilepticus, its pharmacokinetics, route, and ease of administration are key factors to consider in drug selection. Midazolam | SpringerLink ^aC)l 6LMm f_rct>Zt$].1YL85>@KB An overview of the steps is below. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. There is a risk of abuse, misuse, and addiction with benzodiazepines, including NAYZILAM, which can lead to overdose and serious side effects including coma and death. Lower doses are necessary for older (over 60 ears) or debilitated patients, and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. 1Department of Pharmacy, Rockingham Memorial Hospital, Harrisonburg, Virginia, 2Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, Auburn, Alabama, 3Department of Pediatrics, UAB School of Medicine, Huntsville Regional Medical Campus, Huntsville, Alabama. Seizures stopped within 10 minutes of drug administration in 88.5% of the diazepam group and 96.7% in the midazolam group (p=0.06). 768 0 obj <>/Filter/FlateDecode/ID[<89682693CCEF5B4B801874752788FCF5>]/Index[750 42]/Info 749 0 R/Length 97/Prev 343057/Root 751 0 R/Size 792/Type/XRef/W[1 3 1]>>stream Some patients may achieve sufficient sedation with an IM dose of 1 mg if the intensity and duration of sedation is less critical. Midazolam | Drugs | BNF | NICE But, seizures were refractory to midazolam, suggestive of lack of efficacy to midazolam. Phone 999: If seizure does not stop within 5 minutes of last dose of midazolam being given. Doses and the duration of therapy should be limited to the minimum required. Do not get any of it into your eyes or on your skin. midazolam nasal: Uses, Side Effects, Interactions, Pictures - WebMD Medications need to be simple and convenient to use for patients and their caregivers to remain compliant with anticonvulsant rescue therapies. Intravenous lorazepam if intravenous access is already established and resuscitation facilities are available. If seizures return within 24 hours of the last administration of midazolam. You are encouraged to report negative side effects of prescription drugs to the FDA. Do not use a second dose of this medicine if the patient has difficulty with breathing or excessive sleepiness during a seizure cluster episode. Use exactly as your healthcare provider tells you to use it (in the nose, never more than two doses). In all cases, midazolam in a dose of 2.5-15 mg rapidly terminated the seizure. IV formulations: For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. PDF Midazolam administration - Department of Health PDF Home Therapy for Seizures Using Intranasal Midazolam Therapy BEST PRACTICE GUIDELINES FOR THE ADMINISTRATION OF BUCCAL (OROMUCOSAL) MIDAZOLAM FOR THE TREATMENT OF PROLONGED AND/OR CLUSTERS OF EPILEPTIC SEIZURES IN THE COMMUNITY 1. Do not use more than 2 doses to treat one seizure cluster, unless specifically instructed by your healthcare provider. How to Use and How to Give NAYZILAM (midazolam) nasal spray, CIV