Migron ER Tablet (Extended Release) 25 mg
Migron ER Tablet (Extended Release) 25 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Migron ER Tablet (Extended Release) 25 mg is a potent and selective beta 3-adrenoceptor agonist. Migron ER Tablet (Extended Release) 25 mg showed relaxation of bladder smooth muscle in rat and human isolated tissue, increased cyclic adenosine monophosphate (cAMP) concentrations in rat bladder tissue and showed a bladder relaxant effect in rat urinary bladder function models. Migron ER Tablet (Extended Release) 25 mg increased mean voided volume per micturition, and decreased the frequency of non-voiding contractions, without affecting voiding pressure or residual urine in rat models of bladder overactivity. In a monkey model, mirabegron showed decreased voiding frequency. These results indicate that mirabegron enhances urine storage function by stimulating beta 3-adrenoceptors in the bladder.
During the urine storage phase, when urine accumulates in the bladder, sympathetic nerve stimulation predominates. Noradrenaline is released from nerve terminals, leading predominantly to beta adrenoceptor activation in the bladder musculature and hence bladder smooth muscle relaxation. During the urine voiding phase, the bladder is predominantly under parasympathetic nervous system control. Acetylcholine, released from pelvic nerve terminals, stimulates cholinergic M2 and M3 receptors, inducing bladder contraction. The activation of the M2 pathway also inhibits beta 3-adrenoceptor induced increases in cAMP. Therefore beta 3-adrenoceptor stimulation should not interfere with the voiding process. This was confirmed in rats with partial urethral obstruction, where mirabegron decreased the frequency of non-voiding contractions without affecting the voided volume per micturition, voiding pressure or residual urine volume.
Migron ER Tablet (Extended Release) 25 mg exerts its pharmacologic effects by forcing bladder smooth muscle to relax, thereby expanding its capacity and relieving urgency. Migron ER Tablet (Extended Release) 25 mg does not appear to adversely affect the mean maximum flow rate or mean detrusor pressure at maximum flow rate in patients with lower urinary tract symptoms and bladder outlet obstruction (BOO), but should be used with in patients with BOO due to reports of significant urinary retention. Furthermore, mirabegron increases both blood pressure and heart rate in a dose-dependent manner and should therefore be used with caution in patients with severely uncontrolled hypertension or others for whom these increases may prove dangerous.
Trade Name | Migron ER Tablet (Extended Release) 25 mg |
Availability | Prescription only |
Generic | Mirabegron |
Mirabegron Other Names | Mirabegron |
Related Drugs | oxybutynin, Myrbetriq, solifenacin, tolterodine, Ditropan, Detrol, Botox, VESIcare, Ditropan XL, onabotulinumtoxinA |
Weight | 25 mg |
Type | Tablet (Extended Release) |
Formula | C21H24N4O2S |
Weight | Average: 396.506 Monoisotopic: 396.161996722 |
Protein binding | Mirabegron is approximately 71% protein-bound in plasma, primarily to albumin and alpha-1-acid glycoprotein. |
Groups | Approved |
Therapeutic Class | BPH/ Urinary retention/ Urinary incontinence |
Manufacturer | Ibn Sina Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
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Uses
Migron ER Tablet (Extended Release) 25 mg is a beta-3 adrenergic agonist used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Migron ER Tablet (Extended Release) 25 mg, in combination with the muscarinic antagonist solifenacin succinate, is used for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency
Migron ER Tablet (Extended Release) 25 mg is also used to associated treatment for these conditions: Neurogenic Detrusor Overactivity, Urinary Bladder, Overactive
How Migron ER Tablet (Extended Release) 25 mg works
Migron ER Tablet (Extended Release) 25 mg is a potent and selective agonist of beta-3 adrenergic receptors. The activation of beta-3 receptors relaxes detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle, which increases the bladder's storage capacity thereby alleviating feelings of urgency and frequency.
Dosage
Migron ER Tablet (Extended Release) 25 mg dosage
Recommended starting dose: 25 mg once daily, alone or in combination with solifenacin succinate 5 mg, once daily. Based on individual efficacy and tolerability, may increase dose to 50 mg once daily, alone or in combination with solifenacin succinate 5 mg, once daily. Swallow whole with water, with or without food, do not chew, divide or crush
Patients with Severe Renal Impairment or Patients with Moderate HepaticImpairment: Maximum dose is 25 mg Migron ER Tablet (Extended Release) 25 mg once daily
Patients with End Stage Renal Disease (ESRD) or Patients with SevereHepatic Impairment: Not recommended
Side Effects
The most common adverse reactions reported for patients treated with Migron ER Tablet (Extended Release) 25 mg 50 mg during the three 12-week phase 3 double-blind, placebo-controlled studies are tachycardia and urinary tract infections. The frequency of tachycardia was 1.2% in patients receiving Migron ER Tablet (Extended Release) 25 mg 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Migron ER Tablet (Extended Release) 25 mg 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Migron ER Tablet (Extended Release) 25 mg 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Migron ER Tablet (Extended Release) 25 mg 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
Toxicity
At doses of up to 400mg in healthy volunteers (~8x the recommended maximum), reported symptoms of overdose included palpitations and increased heart rate. Symptoms of chronic overdosage are similar in presentation and may also include a rise in systolic blood pressure. In cases of overdosage, employ standard symptomatic and supportive measures in addition to ECG monitoring.
Interaction
The effect of co-administered medicinal products on the pharmacokinetics of mirabegron and the effect of mirabegron on the pharmacokinetics of other medicinal products was studied in single- and multiple-dose studies. Most drug-drug interactions were studied using a dose of mirabegron 100 mg given as oral controlled absorption system (OCAS) tablets. Interaction studies of mirabegron with metoprolol and with metformin used mirabegron immediate-release (IR) 160 mg.
Clinically relevant drug interactions between mirabegron and medicinal products that inhibit, induce or are a substrate for one of the CYP isozymes or transporters are not expected, except for the inhibitory effect of mirabegron on the metabolism of CYP2D6 substrates.
Food Interaction
- Take with food. While adults may take mirabegron with or without food, prescribing information recommends that children always co-administer mirabegron with food.
[Minor] Food reduces the oral absorption and bioavailability of mirabegron.
According to the product labeling, administration of a 50 mg tablet with a high-fat meal decreased mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) by 45% and 17%, respectively, whereas administration with a low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively.
In phase 3 clinical studies demonstrating both safety and efficacy, mirabegron was administered without regards to food content and intake.
Therefore, mirabegron can be taken with or without food at the recommended dosage.
Migron ER Tablet (Extended Release) 25 mg Hypertension interaction
[Moderate] Migron ER Tablet (Extended Release) 25 mg can increase blood pressure.
In clinical studies, the use of mirabegron was associated with dose-related increases in supine blood pressure.
At the maximum recommended dose of 50 mg, the mean maximum increase in systolic Worsening of preexisting hypertension was reported infrequently in patients receiving mirabegron. Therapy with mirabegron should be administered cautiously in patients with hypertension. Periodic blood pressure determinations are recommended. Migron ER Tablet (Extended Release) 25 mg is not recommended for use in patients with severe, uncontrolled hypertension, defined as systolic blood pressure >=180 mm Hg and
Migron ER Tablet (Extended Release) 25 mg Drug Interaction
Moderate: diphenhydramine, tamsulosin, metoprolol, metoprolol, solifenacinUnknown: aspirin, aspirin, rosuvastatin, apixaban, fluticasone nasal, pregabalin, polyethylene glycol 3350, acetaminophen / hydrocodone, acetaminophen, bifidobacterium infantis / lactobacillus acidophilus, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol
Migron ER Tablet (Extended Release) 25 mg Disease Interaction
Moderate: urinary retention, hypertension, liver disease, renal dysfunction
Volume of Distribution
Following intravenous administration, mirabegron has an apparent steady-state volume of distribution (Vd) of 1670 L indicating extensive distribution.
Elimination Route
The absolute bioavailability of orally administered mirabegron ranges from 29% at a dose of 25 mg to 35% at a dose of 50 mg. The Tmax for the extended-release tablet and suspension formulations are approximately 3.5 hours, while the Tmax for the granule formulation is 4-5 hours. Both Cmax and AUC increase more than dose proportionally - an increase in dose from 50mg to 100mg results in a 2.9- and 2.6-fold increase in Cmax and AUC, respectively, whereas an increase from 50mg to 200mg results in a 8.4- and 6.5-fold increase in Cmax and AUC, respectively.
Steady-state concentrations of mirabegron are achieved after approximately 7 days of once-daily administration.
Half Life
The mean terminal elimination half-life of mirabegron in adults being treated for overactive bladder is approximately 50 hours. In pediatric patients receiving the granule formulation for the treatment of neurogenic detrusor overactivity, the mean terminal elimination half-life is approximately 26-31 hours.
Clearance
Total plasma clearance following intravenous administration is approximately 57 L/h, with renal clearance accounting for roughly 25% at approximately 13 L/h.
Elimination Route
Of a 160mg radiolabeled dose administered to healthy volunteers, approximately 55% of the radioactivity was recovered in the urine and 34% in the feces. Approximately 25% of unchanged mirabegron was recovered in the urine while 0% was recovered in the feces.
Renal elimination is achieved primarily via active tubular secretion with some contribution by glomerular filtration.
Pregnancy & Breastfeeding use
Use in Pregnancy: There are limited amount of data from the use of Migron ER Tablet (Extended Release) 25 mg in pregnant women. Studies in animals have shown reproductive toxicity. Migron ER Tablet (Extended Release) 25 mg is not recommended during pregnancy and in women of childbearing potential not using contraception.
Use in Lactation: Migron ER Tablet (Extended Release) 25 mg is excreted in the milk of rodents and therefore, is predicted to be present in human milk. No studies have been conducted to assess the impact of mirabegron on milk production in humans, its presence in human breast milk, or its effects on the breast-fed child. Migron ER Tablet (Extended Release) 25 mg should not be administered during breast-feeding
Contraindication
Migron ER Tablet (Extended Release) 25 mg is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
Special Warning
Renal and Hepatic Impairment: Migron ER Tablet (Extended Release) 25 mg has not been studied in patients with end stage renal disease
Gender: No dose adjustment is necessary according to gender.
Children: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.
Acute Overdose
Migron ER Tablet (Extended Release) 25 mg has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 beats per minute (bpm) (3 of 6 subjects). Multiple doses of mirabegron up to 300 mg daily for 10 days showed increases in pulse rate and systolic blood pressure when administered to healthy volunteers. Treatment for overdose should be symptomatic and supportive. In the event of an overdosage, pulse rate, blood pressure and ECG monitoring is recommended.
Storage Condition
Store in a cool and dry place, protected from light.
Innovators Monograph
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