concentration and AUC increased by 170% and 80%, respectively, in fasted stated compared to the fed state Distribution Adults (tablets) Protein bound: 71% Vd, steady state: 1670 L Pediatrics (tablets or oral suspension) Vd: 4895-13,726 L Metabolism Via multiple pathways including dealkylation, (direct) glucuronidation, amide hydrolysis, and minimal oxidative metabolism in vivo by CYP2D6 and CYP3A4 Possible involvement of butylcholinesterase, uridine diphospho-glucuronosyltransferases (UGT) and alcohol dehydrogenase Moderate CYP2D6 inhibitor Elimination Adults (tablets) Half-life: 50 hr Total body clearance: 57 L/hr (following IV administration) Excretion: Urine (55%); feces (34%) Excretion, unchanged: Urine (~25%); feces (0%) Pediatrics (tablets or oral suspension) Half-life: ~26-31 hr Oral Suspension Preparation Prepare oral suspension at time of dispensing Keep bottle in pouch until time of reconstitution Reconstitution Discard pouch and desiccant before reconstitution; do not dispense Tap closed bottle several times to loosen granules Add 100 mL of water to bottle, and immediately shake vigorously for 1 minute, then let it stand for 10-30 minutes; shake vigorously again for 1 minute If granules have not dispersed, shake vigorously for another 1 minute Record 28-day expiration date on container and carton based on reconstitution date Dispense with an appropriate dosing measuring device Reconstituted suspension contains 8 mg/mL Oral Administration Tablets Adults: May take with or without food Children: Take with food to reduce potential exposure-related risks (eg, increased heart rate) Swallow tablet whole with water, do not chew, divide, or crush Oral suspension For pediatric use only; dosage for adults not determined Take with food to reduce potential exposure-related risks (eg, increased heart rate) Missed dose <12 hours since missed dose: Take as soon as remembered >12 hours since missed dose: Skip dose and take next dose at usual time Storage Extended-release tablets or oral granules: Store at 25°C (77°F) with excursions permitted from 15-30°C (59-86°F) Reconstituted oral granules for suspension Store at 20-25ºC (68-77ºF) for up to 28 days Discard unused portion after 28 days BRAND FORM. UNIT PRICE PILL IMAGE Myrbetriq oral- 25 mg tabletMyrbetriq oral- 50 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationmirabegron oral MIRABEGRON EXTENDED-RELEASE SUSPENSION - ORAL (MIR-a-BEG-ron) COMMON BRAND NAME(S): Myrbetriq USES: This medication is used to treat a certain bladder problem (neurogenic detrusor overactivity-NDO). NDO is a bladder control condition caused by brain, spinal cord, or nerve problems. Symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence). Mirabegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of NDO. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking mirabegron and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually once daily. You will receive this medication from the pharmacy as a suspension that has been prepared by your pharmacist. Shake the bottle well for 1 minute before use. Then let it stand until the foam on top of the suspension is gone (about 1 to 2 minutes). If the granules have not mixed well, shake the bottle well again for 1 minute and let it stand until the foam is gone. Carefully measure the dose using a special measuring device/spoon. Disregard any bubbles when measuring. Do not use a household spoon because you may not get the correct dose. Take within 1 hour after you have measured out the dose. Wash the special measuring device/spoon after each use and let it air dry.If the suspension will not be used for 2 or more days, shake the bottle well for 1 minute each day.The dosage is based on your medical condition, weight, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition does not get better or if it gets worse. SIDE EFFECTS: Constipation, pain/swelling of the nose or throat, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: burning/painful urination.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking mirabegron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (such as blockage), high blood pressure, kidney problems, liver problems.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include flecainide, propafenone, thioridazine, among others. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure) may be done while you are taking this medication. Keep all medical and lab appointments. MISSED DOSE: If you miss a dose and it is within 12 hours of the time you usually take the dose, take it as soon as you remember. If it is more than 12 hours from the usual time of your dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Throw away any unused medication after 28 days (4 weeks after the pharmacist prepares the suspension).Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised August 2021. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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