سعر اتوبيجرون اكس ار 50 مجم 30 قرص مغلف 2025

Mirabegron 50 mg extended-release film-coated tablets (beta-3 adrenergic agonist for overactive bladder) made by ATCO Pharma, Quesna Industrial Zone, Menoufia, Egypt; carton of 3 strips x 10 tablets.

• Overactive bladder with urge urinary incontinence, urgency and urinary frequency (monotherapy)Population: AdultsATCO Pharma
• Overactive bladder, in combination with solifenacin succinatePopulation: AdultsATCO Pharma
• Neurogenic detrusor overactivity (NDO)Population: Children aged 3 years and older weighing 35 kg or moreATCO Pharma

• Adult OAB trials (12 weeks): most common adverse reactions (over 2% and above placebo) were hypertension, nasopharyngitis, urinary tract infection and headache; others at 1% or more included constipation, upper respiratory tract infection, arthralgia, diarrhoea, tachycardia, abdominal pain and fatigue.Egyptian label · ATCO Pharma

• Known hypersensitivity to mirabegron or any inactive ingredient of the tablet.Egyptian label · ATCO Pharma

• Can increase blood pressure: periodic blood pressure checks are recommended, especially in hypertensive patients; not recommended in severe uncontrolled hypertension (180/110 mm Hg or higher in adults; above the 99th percentile plus 5 mm Hg in children). Increases may be larger in children 3 to under 12 years.Egyptian label · ATCO Pharma
• Urinary retention has been reported in patients with bladder outlet obstruction and in those taking antimuscarinics for OAB (including solifenacin): use with caution and monitor.Egyptian label · ATCO Pharma
• Angioedema of the face, lips, tongue or larynx (possibly life-threatening) may occur after the first or later doses: stop promptly and secure the airway if the tongue, hypopharynx or larynx is involved.Egyptian label · ATCO Pharma

• CYP2D6 substrates (e.g. metoprolol, desipramine)Mirabegron increases exposure (e.g. metoprolol AUC +229%, desipramine AUC +241%); monitor and adjust the dose, especially for narrow therapeutic index drugs.ATCO Pharma
• DigoxinMirabegron 100 mg increased digoxin Cmax by 29% and AUC by 27%; start with the lowest digoxin dose and monitor serum digoxin concentrations to titrate.ATCO Pharma
• WarfarinSingle-dose study showed small increases in warfarin exposure without INR change; the effect with multiple warfarin doses on INR and prothrombin time has not been fully investigated.ATCO Pharma

• No studies of mirabegron in pregnant women to inform the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; adverse developmental findings occurred in animals given mirabegron during organogenesis at high exposures.Egyptian label · ATCO Pharma
• No data on mirabegron in human milk, effects on the breastfed child or milk production; mirabegron is present in rat milk. Weigh breastfeeding benefits against the mother's clinical need and potential adverse effects on the child.Egyptian label · ATCO Pharma

• Mirabegron: Agonist of the human beta-3 adrenergic receptor; relaxes the detrusor smooth muscle during the storage phase of the bladder fill-void cycle, increasing bladder capacity (Egyptian Atobegron leaflet).

Store at a temperature not exceeding 30 C in a dry place. Cartons of 1, 2 or 3 Al/Al strips of 10 tablets.