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SANDOZ MIRABEGRON is a brand name for Mirabegron, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Note:
Sandoz Mirabegron is only available in 50 mg tablets Dosing Considerations No dose adjustment is necessary for the elderly. The pharmacokinetics of mirabegron are not significantly influenced by age (see ACTION AND CLINICAL PHARMACOLOGY).
Sandoz Mirabegron is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C) (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
For patients with severe renal impairment or moderate hepatic impairment, see Recommended Dose and Dosage Adjustment. Sandoz Mirabegron is not recommended for use during pregnancy (see CONTRAINDICATIONS). Recommended Dose and Dosage Adjustment The recommended initial dose and usual therapeutic dose of mirabegron is 25 mg administered once daily with or without food.
Based on individual patient efficacy and tolerability, the dosage may be increased to a maximum recommended dose of 50 mg once daily with or without food. Mirabegron 25 mg is effective within 8 weeks (see CLINICAL TRIALS). The maximum recommended dose of 50 mg once daily should not be exceeded because of greater than dose-proportional increases in bioavailability (see ACTION AND CLINICAL PHARMACOLOGY, Absorption) and a possible increase in the risk of serious adverse events and adverse events (see ADVERSE REACTIONS).
73 m2) (see WARNINGS AND PRECAUTIONS, Renal and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency). • Patients with moderate hepatic impairment (Child-Pugh Class B) (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
• Patients taking drugs metabolized by CYP2D6 with a narrow therapeutic index, such as flecainide and propafenone (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism; ACTION AND CLINICAL PHARAMACOLOGY).
Sandoz Mirabegron Page 17 of 42 Note:
Sandoz Mirabegron is only available in 50 mg tablets Sandoz Mirabegron is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C) (see WARNINGS AND PRECAUTIONS, Renal and Hepatic/Biliary/Pancreatic and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency and Hepatic Insufficiency).
5% of patients treated with mirabegron 50 mg, mirabegron 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with mirabegron 100 mg included breast cancer, lung neoplasm malignant and prostate cancer.
In a clinical study in Japan, a single case was reported as Stevens-Johnson syndrome with increased serum ALT, AST and bilirubin in a patient taking mirabegron 100 mg as well as an herbal medication (Kyufu Gold) (see ADVERSE REACTIONS).
3%) taking mirabegron 50 mg, and these markers subsequently returned to baseline while both patients continued mirabegron (see ADVERSE REACTIONS).
Cardiovascular QTc Prolongation:
Mirabegron was associated with dose-dependent QTc prolongation that was more pronounced in females. At the maximal recommended therapeutic dose of 50 mg, the largest mean difference from placebo in the QTc interval was <5 ms in healthy male and female subjects at steady-state (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics, Cardiac Electrophysiology and Haemodynamics).
, hypokalemia) or patients who are taking medications known to prolong the QT interval (see DRUG-DRUG INTERACTIONS, Drugs that Cause QT/QTc Prolongation).
Blood Pressure:
Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with Sandoz Mirabegron, especially in hypertensive patients. Mirabegron was not studied in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) and, therefore is not recommended in these patients (see CONTRAINDICATIONS).
In a healthy volunteer study, mirabegron was associated with dose-dependent increases in supine systolic/diastolic blood pressure. 7 mm Hg greater than placebo. 5-1 mm Hg compared to placebo. Both systolic blood pressure and diastolic blood pressure increases were reversible upon discontinuation of treatment (see ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology and Haemodynamics, Effects on Pulse Rate and Blood Pressure in Patients with OAB).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mirabegron in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Missed Dose If a dose is missed, the next scheduled dose should be taken as usual. The patient should not take a double dose to make up for a missed dose. Administration Sandoz Mirabegron should be taken once daily with or without food, swallowed whole with water and should not be chewed, divided or crushed.
OVERDOSAGE Mirabegron 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 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 overdosage should be symptomatic and supportive. In the event of overdosage, pulse rate, blood pressure and ECG monitoring is recommended.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669). ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Mirabegron is a potent and selective beta 3-adrenoceptor (AR) agonist.
Mirabegron showed relaxation of bladder smooth muscle in rat and human isolated tissue, increased cAMP concentrations in rat bladder tissue and showed a bladder relaxant effect in rat urinary bladder function models. Mirabegron showed very low intrinsic activity for cloned human beta 1-AR and beta 2-AR in vitro.
However, oral administration of mirabegron to animals at high doses suggests a potential for cross-activation with beta 1-AR. Mirabegron 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-ARs in the bladder. Studies in animal models have shown that mirabegron increases bladder capacity.
Sandoz Mirabegron Page 18 of 42 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-AR induced increases in cAMP. Therefore, beta 3-AR 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.
Pharmacodynamics Urodynamics The effects of mirabegron on maximum flow rate and detrusor pressure at maximum flow rate were assessed in an urodynamic study consisting of 200 male patients with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
Administration of mirabegron at doses of 50 mg and a supra-therapeutic dose of 100 mg once daily for 12 weeks did not […]
Heart Rate Increase:
Mirabegron is associated with increased heart rate that correlates with increasing dose (see ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology and Haemodynamics). In a healthy volunteer study, mirabegron was associated with dose-dependent increases in heart rate.
5 bpm in males at steady-state. In patients with OAB in clinical trials receiving the maximum recommended dose of mirabegron 50 mg, a mean heart rate increase of approximately 1 bpm compared to placebo was observed that was reversible upon discontinuation of treatment.
Accordingly, caution should be used when administering Sandoz Mirabegron to patients who have a history of ischemic heart disease or tachyarrhythmias.
Endocrine and Metabolism CYP2D6:
Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates such as metoprolol and desipramine is increased when co-administered with mirabegron (≥100 mg). Therefore, caution is advised if Sandoz Mirabegron is co-administered with these drugs as appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.
The dose of mirabegron should not exceed 25 mg when co-administered with narrow therapeutic index drugs, such as flecainide and propafenone (see DRUG INTERACTIONS and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Genitourinary Urinary Retention:
Urinary retention has been reported in post-marketing experience in patients taking mirabegron, in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. Sandoz Mirabegron should be administered with caution to patients with clinically significant BOO.
Sandoz Mirabegron should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions; ACTION AND CLINICAL PHARMACOLOGY and DRUG INTERACTIONS).
Hepatic/Biliary/Pancreatic Mirabegron has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, is not recommended for use in this patient population (see DOSAGE AND ADMINISTRATION, Dosing Consideration).
In patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of mirabegron should not exceed 25 mg. No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A) (see DOSAGE AND ADMINISTRATION, Dosing Consideration and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
Immune Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron. In some cases angioedema occurred after the first dose. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses.
Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue Sandoz Mirabegron and initiate appropriate therapy and/or measures […]