Avomira Tablets (Mirabegron)

• Composition :
  Each tablet contains 25 mg and 50 mg of Mirabegron.
• Indications :
  Indicated for the Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence in patients with over active bladder (OAB) Syndrome.
• Pharmacodynamics :
  Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR). Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder, fill-void cycle by activation of beta-3 AR which increases bladder capacity.
• Dosage and administration :
  The recommended starting dose of Mirabegron is 25 mg once daily with or without food. Mirabegron 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily.
• Contraindications :
  None.
• Precautions and warnings :
  Mirabegron can increase blood pressure. Mirabegron is not recommended for use in patients with severe uncontrolled hypertension. Mirabegron should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB. Urinary retention in patients with bladder outlet obstruction.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy: Use only if the benefit to the mother outweighs the potential risk to the fetus. Nursing mothers: Predicted to be excreted in human milk and is not recommended for use by nursing mothers. Pediatric use: The safety and effectiveness of mirabegron in pediatric patients have not been established.
• Drug interactions :
  Appropriate monitoring and dose adjustment may be necessary when mirabegron is co-administered with drugs such as metoprolol and desipramine, especially with narrow therapeutic index CYP2D6 substrates, such as thioridazine, flecainide, and propafenone. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect.
• Adverse reactions :
  The most frequent adverse events leading to discontinuation in 25 mg or 50 mg dose were nausea, headache, hypertension and UTI.
• Therapy Area :
  Urologicals