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Miraflo Tablet (Extended Release) contains Mirabegron
Miraflo Tablet (Extended Release) side effects
The most common adverse reactions reported for patients treated with Mirabegron 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 Mirabegron 50 mg. Tachycardia led to discontinuation in 0.1% patients receiving Mirabegron 50 mg. The frequency of urinary tract infections was 2.9% in patients receiving Mirabegron 50 mg. Urinary tract infections led to discontinuation in none of the patients receiving Mirabegron 50 mg. Serious adverse reactions included atrial fibrillation (0.2%).
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.
Use in Pregnancy: There are limited amount of data from the use of Mirabegron in pregnant women. Studies in animals have shown reproductive toxicity. Mirabegron is not recommended during pregnancy and in women of childbearing potential not using contraception.
Use in Lactation: Mirabegron 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. Mirabegron should not be administered during breast-feeding
Mirabegron 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.
Renal and Hepatic Impairment: Mirabegron 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.
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