سعر سوفيناسين بلس 2024

Sofenacin plus film-coated tablets combining solifenacin succinate 5 mg and mirabegron 50 mg (pack of 30) by Marcyrl, for overactive bladder.

• Overactive bladder in adults with urge urinary incontinence, urgency and urinary frequency: mirabegron alone or in combination with solifenacin succinate (US label for the separate products).Population: AdultsDailyMed (U.S. National Library of Medicine)

• Expected antimuscarinic effects: dry mouth, constipation, blurred vision, urinary retention and dry eyes; dry mouth and constipation more frequent with 10 mg than 5 mg.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Mirabegron with solifenacin succinate in adult OAB (>2% and more than placebo and comparator): dry mouth, urinary tract infection, constipation and tachycardia.General active-ingredient information · DailyMed (U.S. National Library of Medicine)

• Urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and hypersensitivity to solifenacin or tablet excipients (anaphylaxis and angioedema reported).General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Mirabegron: hypersensitivity to mirabegron or any inactive ingredient.General active-ingredient information · DailyMed (U.S. National Library of Medicine)

• Angioedema and anaphylactic reactions: discontinue promptly and treat.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Not recommended in clinically significant bladder outlet obstruction (risk of urinary retention) or decreased GI motility.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Somnolence may occur; avoid driving or operating machinery until the effect is known. Use with caution in controlled narrow-angle glaucoma. Not recommended in patients at high risk of QT prolongation.General active-ingredient information · DailyMed (U.S. National Library of Medicine)

• Strong CYP3A4 inhibitors (e.g. ketoconazole)Increase solifenacin exposure; do not exceed 5 mg daily.DailyMed (U.S. National Library of Medicine)
• CYP2D6 substrates with a narrow therapeutic index (e.g. thioridazine, flecainide, propafenone; also metoprolol, desipramine)Mirabegron is a moderate CYP2D6 inhibitor and increases their exposure; monitor and adjust dose.DailyMed (U.S. National Library of Medicine)
• DigoxinMirabegron increases digoxin concentrations; start with the lowest digoxin dose and monitor levels.DailyMed (U.S. National Library of Medicine)

• No studies in pregnant women; no adverse developmental outcomes in mice at 1.2x MRHD exposure, but maternal and developmental toxicity at 3.6x MRHD or more.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• Mirabegron: no studies in pregnant women; animal studies showed reversible skeletal variations and decreased fetal weight at exposures 14-22 times the maximum recommended human dose.General active-ingredient information · DailyMed (U.S. National Library of Medicine)
• No data on presence in human milk; solifenacin is present in mouse milk. Weigh breastfeeding benefits against the mother's need and potential infant effects.General active-ingredient information · DailyMed (U.S. National Library of Medicine)

• Solifenacin succinate: Competitive muscarinic receptor antagonist; reduces detrusor (bladder smooth muscle) contraction.
• Mirabegron: Beta-3 adrenergic receptor agonist that relaxes the detrusor smooth muscle during bladder filling, increasing bladder capacity.