Dosing & Uses
Dosage Forms & Strengths
tablet, extended-release
- 25mg
- 50mg
Overactive Bladder
Monotherapy
- Indicated for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
- 25 mg PO qDay
- 25 mg dose is typically effective within 8 weeks
- May increase to 50 mg PO qDay based on individual efficacy and tolerability
Combination with muscarinic antagonist
- Indicated in combination with the muscarinic antagonist solifenacin succinate for treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency
- Combination regimen: 25 mg PO qDay plus solifenacin succinate 5 mg PO qDay
- May increase mirabegron to 50 mg PO qDay after 4-8 weeks based on individual efficacy and tolerability
Dosage Modifications
Renal impairment
- Mild-to-moderate (eGFR ≥30 mL/min/1.73 m2): No dosage adjustment required
- Severe (eGFR 15-29 mL/min/1.73 m2): Not to exceed 25 mg/day
- eGFR <15mL/min/1.73 m2 or on dialysis: Not recommended
Hepatic impairment
- Mild (Child-Pugh A): No dosage adjustment required
- Moderate (Child-Pugh B): Not to exceed 25 mg/day for either starting or maximum dose
- Severe (Child Pugh C): Not recommended
Dosing Considerations
Granules and tablets are 2 different products and are not substitutable on a milligram-per-milligram basis
Recommended dosage for granules in adults has not been determined
Dosage Forms & Strengths
tablet, extended-release
- 25mg
- 50mg
granules for extended-release oral suspension
- 8mg/mL after reconstitution
Neurogenic Detrusor Overactivity
Indicated for neurogenic detrusor overactivity (NDO) in children aged 3 years and older
<3 years: Safety and efficacy not established
Aged ≥3 years, weight <35 kg
-
Granules for oral suspension
- 11 kg to <22 kg: 24 mg (3 mL) PO qDay initially; may increase to maximum of 48 mg/day (6 mL)
- 22 kg to <35 kg: 32 mg (4 mL) PO qDay initially; may increase to maximum of 64 mg/day (8 mL)
Aged ≥3 years, weight ≥35 kg
- Tablets: 25 mg PO qDay initially; may increase to maximum of 50 mg/day after 4-8 weeks
- Granules for oral suspension: 48 mg (6 mL) PO qDay initially; may increase to maximum of 80 mg/day (10 mL) after 4-8 weeks
Dosage Modifications
Renal impairment <35 kg
- Granules for oral suspension
- eGFR >30 mL/min/1.73 m2: No dosage adjustment required
-
eGFR 15-29 mL/min/1.73 m2
- 11 kg to <22 kg: Not to exceed 24 mg (3 mL) for either starting or maximum dose
- 22 kg to <35 kg: Not to exceed 32 mg (4 mL) for either starting or maximum dose
- eGFR <15 mL/min/1.73 m2 or on dialysis: Not recommended
Renal impairment ≥35 kg
-
Granules for oral suspension
- eGFR ≥30 mL/min/1.73 m2: No dosage adjustment required
- eGFR 15-29 mL/min/1.73 m2: 48 mg (6 mL) for either starting or maximum dose
- eGFR <15 mL/min/1.73 m2 or on dialysis: Not recommended
-
Tablets
- eGFR ≥30 mL/min/1.73 m2: No dosage adjustment required
- eGFR 15-29 mL/min/1.73 m2: 25 mg for either starting or maximum dose
- eGFR <15 mL/min/1.73 m2 or on dialysis: Not recommended
Hepatic impairment <35 kg
- Granules for oral suspension
- Mild (Child-Pugh A): No dosage adjustment required
-
Moderate (Child-Pugh B)
- 11 kg to <22 kg: Not to exceed 24 mg (3 mL) for either starting or maximum dose
- 22 kg to <35 kg: Not to exceed 32 mg (4 mL) for either starting or maximum dose
- Severe (Child-Pugh C): Not recommended
Hepatic impairment ≥35 kg
-
Granules for oral suspension
- Mild (Child-Pugh A): No dosage adjustment required
- Moderate (Child-Pugh B): Not to exceed 48 mg (6 mL) for either starting or maximum dose
- Severe (Child Pugh C): Not recommended
-
Tablets
- Mild (Child-Pugh A): No dosage adjustment required
- Moderate (Child-Pugh B): Not to exceed 25 mg/day for either starting or maximum dose
- Severe (Child Pugh C): Not recommended
Dosing Considerations
Granules and tablets are 2 different products and are not substitutable on a milligram-per-milligram basis
Select recommended product based on the indication and child’s weight
Do not combine tablets and granules to achieve a total dose
Recommended dosage for granules in adults has not been determined
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- metoclopramide intranasal
mirabegron will increase the level or effect of metoclopramide intranasal by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Concurrent use of metoclopramide intranasal and strong CYP2D6 inhibitors is not recommended since the metoclopramide intranasal dose cannot be adjusted.
- ozanimod
ozanimod increases toxicity of mirabegron by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Because the active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis. Therefore, coadministration of ozanimod with drugs that can increase norepinephrine or serotonin is not recommended. Monitor for hypertension with concomitant use.
Monitor Closely (60)
- amitriptyline
mirabegron will increase the level or effect of amitriptyline by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- amoxapine
mirabegron will increase the level or effect of amoxapine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- aripiprazole
mirabegron will increase the level or effect of aripiprazole by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- atomoxetine
mirabegron will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- betaxolol
mirabegron will increase the level or effect of betaxolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- captopril
mirabegron will increase the level or effect of captopril by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- carvedilol
mirabegron will increase the level or effect of carvedilol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- chloroquine
mirabegron will increase the level or effect of chloroquine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- chlorpromazine
mirabegron will increase the level or effect of chlorpromazine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- cinacalcet
mirabegron will increase the level or effect of cinacalcet by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- citalopram
mirabegron will increase the level or effect of citalopram by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- clomipramine
mirabegron will increase the level or effect of clomipramine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- codeine
mirabegron will increase the level or effect of codeine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- desipramine
mirabegron will increase the level or effect of desipramine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- deutetrabenazine
mirabegron will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.
- dextroamphetamine transdermal
mirabegron will increase the level or effect of dextroamphetamine transdermal by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine transdermal and CYP2D6 inhibitor.
- digoxin
mirabegron will increase the level or effect of digoxin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- doxepin
mirabegron will increase the level or effect of doxepin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- doxepin cream
mirabegron will increase the level or effect of doxepin cream by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- doxorubicin
mirabegron will increase the level or effect of doxorubicin by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- doxorubicin liposomal
mirabegron will increase the level or effect of doxorubicin liposomal by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- duloxetine
mirabegron will increase the level or effect of duloxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- flecainide
mirabegron will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- fluoxetine
mirabegron will increase the level or effect of fluoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- fluphenazine
mirabegron will increase the level or effect of fluphenazine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- fluvoxamine
mirabegron will increase the level or effect of fluvoxamine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- haloperidol
mirabegron will increase the level or effect of haloperidol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- iloperidone
mirabegron will increase the level or effect of iloperidone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- imipramine
mirabegron will increase the level or effect of imipramine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- lofexidine
mirabegron will increase the level or effect of lofexidine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Concomitant use of lofexidine with strong CYP2D6 inhibitors may increase lofexidine plasma levels. Monitor for symptoms of orthostasis and bradycardia if coadministered with a CYP2D6 inhibitor. Consider lofexidine dose reduction.
- maprotiline
mirabegron will increase the level or effect of maprotiline by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- metaxalone
mirabegron will increase the level or effect of metaxalone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- methamphetamine
mirabegron will increase the level or effect of methamphetamine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- metoprolol
mirabegron will increase the level or effect of metoprolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- mirtazapine
mirabegron will increase the level or effect of mirtazapine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- nebivolol
mirabegron will increase the level or effect of nebivolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- nefazodone
mirabegron will increase the level or effect of nefazodone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- nortriptyline
mirabegron will increase the level or effect of nortriptyline by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- oliceridine
mirabegron will increase the level or effect of oliceridine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. If concomitant use is necessary, may require less frequent oliceridine dosing. Closely monitor for respiratory depression and sedation and titrate subsequent doses accordingly. If inhibitor is discontinued, consider increase oliceridine dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
- paroxetine
mirabegron will increase the level or effect of paroxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- perphenazine
mirabegron will increase the level or effect of perphenazine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- pindolol
mirabegron will increase the level or effect of pindolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- pitolisant
mirabegron will increase the level or effect of pitolisant by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. If coadministered with strong CYP2D6 inhibitors, initiate pitolisant at 8.9 mg/day and increase after 7 days to maximum of 17.8 mg/day. For patients currently taking pitolisant, reduce pitolisant dose by half upon initiating strong CYP2D6 inhibitors.
- procainamide
mirabegron will increase the level or effect of procainamide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- promethazine
mirabegron will increase the level or effect of promethazine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- propafenone
mirabegron will increase the level or effect of propafenone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- propranolol
mirabegron will increase the level or effect of propranolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- protriptyline
mirabegron will increase the level or effect of protriptyline by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- risperidone
mirabegron will increase the level or effect of risperidone by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- ritonavir
mirabegron will increase the level or effect of ritonavir by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- sertraline
mirabegron will increase the level or effect of sertraline by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- solifenacin
mirabegron increases toxicity of solifenacin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor patients for signs/symptoms of urinary retention.
- tamoxifen
mirabegron will decrease the level or effect of tamoxifen by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- thioridazine
mirabegron will increase the level or effect of thioridazine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- timolol
mirabegron will increase the level or effect of timolol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- timolol ophthalmic
mirabegron will increase the level or effect of timolol ophthalmic by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- tolterodine
mirabegron will increase the level or effect of tolterodine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- tramadol
mirabegron will increase the level or effect of tramadol by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- trimipramine
mirabegron will increase the level or effect of trimipramine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- venlafaxine
mirabegron will increase the level or effect of venlafaxine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
Minor (1)
- benazepril
mirabegron decreases effects of benazepril by pharmacodynamic antagonism. Minor/Significance Unknown. Monitor blood pressure.
Adverse Effects
>10%
Adults
- Elevated BP occurring predominantly in patients with preexisting hypertension (7.5-11.5%)
Children aged 3-17 years
- Urinary tract infection (24.4%)
1-10%
Adults
-
Monotherapy
- Dry mouth (3-9%)
- Urinary tract infection (UTI) (2.9-4.2%)
- Nasopharyngitis (3.5-3.9%)
- Headache (2.1-3.2%)
- Back pain (2.8%)
- Sinusitis (2.7%)
- Arthralgia (1.3-2.1%)
- Cystitis (2.1%)
- Dizziness (2%)
- Constipation (1.6%)
- Tachycardia (1.2-1.6%)
- Diarrhea (1.2-1.5%)
- Fatigue (1.2-1.4%)
- Reports of neoplasms (0-1%)
-
Combination with solifenacin
- Dry mouth (7.2-9.3%)
- UTI (4-8.4%)
- Constipation (3.9-4.2%)
- Tachycardia (0.9-2.2%)
- Dyspepsia (1.1-1.3%)
- Dizziness (0.4-1.3%)
- Blurred vision (0.7-1.1%)
- Arthralgia (0.5-1.1%)
Children aged 3-17 years
- Nasopharyngitis (5.8%)
- Constipation (4.7%)
- Headache (3.5%)
- Nausea (2.3%)
- Gastroenteritis (2.3%)
- Rhinitis (2.3%)
- Cough (2.3%)
<1%
Cardiac disorders (eg, palpitations, elevated BP)
Eye Disorders (eg, glaucoma, blurry vision)
GI disorders (eg, dyspepsia, gastritis, abdominal distension)
Rhinitis
Elevations in GGT, AST, ALT, LDH
Renal and urinary disorders (eg, nephrolithiasis, bladder pain)
Reproductive system disorders (eg, vulvovaginal pruritis, vaginal infection)
Skin and subcutaneous tissue disorders (eg, urticaria, leukocytoclastic vasculitis, rash, pruritus, purpura, lip edema)
Stevens-Johnson syndrome associated with increased serum ALT, AST and bilirubin
Postmarketing Reports
Cardiac disorders: Atrial fibrillation
Gastrointestinal disorders: Nausea, constipation, diarrhea
Nervous system disorders: Dizziness, headache
Skin and subcutaneous tissue disorders: Angioedema of the face, lips, tongue, and larynx, with or without respiratory symptoms; pruritus
Renal and urinary disorders: Urinary retention
Warnings
Contraindications
Hypersensitivity
Cautions
Angioedema of the face, lips, tongue, and/or larynx reported; may occur after the first dose or following multiple doses; promptly discontinue and initiate appropriate therapy to ensure a patent airway
Increased blood pressure
- May increase blood pressure (BP); monitor BP periodically, especially in hypertensive patients
- Not recommended for use in severe uncontrolled hypertensive patients (ie, systolic BP ≥180 mm Hg and/or diastolic BP ≥110 mm Hg for adults; systolic and/or diastolic BP >99th percentile plus 5 mm Hg for age, sex, and stature for children)
- BP increases may be larger in children aged 3 to <12 years compared with adolescents
Drug interactions overview
Moderate CYP2D6 inhibitor
-
Sensitive CYP2D6 substrates
- Appropriate monitoring is recommended and dose adjustment may be necessary for narrow therapeutic index CYP2D6 substrates
-
Digoxin
- Modify dose
- Coadministration of digoxin 0.25 mg with a combination of solifenacin 5 mg and mirabegron 50 mg increased digoxin AUC and peak plasma concentration by ~10% and 14%, respectively
- Consider initiating lowest dose for digoxin; monitor serum digoxin concentrations and titrate digoxin dose to obtain desired clinical effect
-
Concomitant antimuscarinic drugs
- Use with caution
- Urinary retention may occur with bladder outlet obstruction or with concomitant antimuscarinic therapy
Pregnancy & Lactation
Pregnancy
There are no studies with the use in pregnant women to inform drug-associated risk for birth defects or miscarriage
Animal data
- Administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in rabbits) at 14-fold the MRHD
- At maternally toxic exposures in rats (96-fold), decreased fetal weight and increased fetal mortality were observed and, in rabbits (36-fold), cardiac findings (fetal cardiomegaly and fetal dilated aortae) were observed
Lactation
There is no information on the presence of mirabegron in human milk, the effects on the breastfed child, or the effects on milk production
Mirabegron-related material was present in rat milk and in the stomach of nursing pups following administrations of a single 10 mg/kg oral dose of 14C-labeled mirabegron to lactating rats
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Beta-3 adrenergic receptor agonist which causes relaxation of the detrusor smooth muscle of the urinary bladder and increases bladder capacity
Absorption
Adults (tablets)
- Bioavailability: 29% (25-mg), 35% (50-mg)
- Peak Plasma Time: 3.5 hr
- Peak Plasma Concentration: ~3-fold increase from 50 mg dose to 100 mg dose
- AUC: ~2.5-fold increase from 50 mg dose to 100 mg dose
- Steady state: 7 days
- Effect of food: No clinically significant differences in adults
Pediatrics (tablets or oral suspension)
- Peak plasma time: 4-5 hr (single dose); 3-4 hr (steady-state)
-
Effect of food
- Tablets: AUC increased by 120% in fasted stated compared to the fed state
- Oral suspension: Peak plasma 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
Administration
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Myrbetriq oral - | 50 mg tablet |  | |
| Myrbetriq oral - | 25 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
mirabegron oral
MIRABEGRON EXTENDED-RELEASE - ORAL
(MIR-a-BEG-ron)
COMMON BRAND NAME(S): Myrbetriq
USES: This medication is used to treat certain bladder problems (overactive bladder, neurogenic detrusor overactivity). Overactive bladder is a problem with how your bladder stores urine. Neurogenic detrusor overactivity is a bladder control condition caused by brain, spinal cord, or nerve problems. Symptoms of these conditions may include frequent urination, strong sudden urges to urinate that are hard to control, 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 overactive bladder and neurogenic detrusor overactivity.
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 as directed by your doctor, usually once daily. Adults may take this medication with or without food. Children should take this medication with food. Swallow this medication whole. Do not crush, chew, or divide the medication. Doing so can release all of the drug at once, increasing the risk of side effects.The dosage is based on your medical condition and response to treatment. Children's dose is also based on weight.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: Nausea, dizziness, fast heartbeat, runny/stuffy nose, 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.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).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.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) 2022 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.
Formulary
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