Utromeg 25 | 1 Strip

✔️ Dosage and Administration

• Adults and Elderly: The usual starting dose is 25 mg once daily, with or without meals. Based on how the patient responds and tolerates the medication, the dose can be increased to 50 mg once daily.
• Renal/Hepatic Impairment:
• For those with severe kidney dysfunction (ClCr or eGFR between 15–29 mL/min/1.73 m²) or moderate liver impairment (Child-Pugh B), the dose should not exceed 25 mg once daily.
• The use of Mirabegron is not advised in patients with end-stage renal disease or severe hepatic impairment (Child-Pugh C).
• Gender: No dosage modification is necessary based on gender.
• Children: Safety and efficacy have not been confirmed in patients under 18 years of age.
   

Take the tablet whole with water, without crushing or chewing.
Consult a registered physician before use.

✔️ Side Effects

Common adverse effects include:

• Tachycardia (1.2%) – Rarely leads to discontinuation
• Urinary Tract Infections (2.9%) – Generally well-tolerated
• Serious reactions: Atrial fibrillation (0.2%)

Other side effects may include constipation, headache, and nasopharyngitis.

✔️ Drug Interactions

• With CYP3A/P-gp inhibitors: Co-administration with strong inhibitors like ketoconazole or ritonavir may elevate Mirabegron levels. In patients with renal or hepatic impairment also taking these inhibitors, limit the dose to 25 mg/day.
• With enzyme inducers: Agents such as rifampicin may reduce drug levels; no dose change is needed.
• Impact on CYP2D6 substrates: Mirabegron can moderately inhibit CYP2D6, increasing blood levels of drugs like metoprolol and desipramine. Use caution when combined with medications having a narrow therapeutic index.
• P-gp interaction: As a weak P-gp inhibitor, Mirabegron can raise digoxin levels. Start with the lowest possible dose of digoxin and monitor levels closely.
• Other combinations: No significant interactions were observed with solifenacin, tamsulosin, warfarin, metformin, or oral contraceptives.

✔️ Contraindications

Do not use in patients with known hypersensitivity to Mirabegron or its ingredients. Also contraindicated in individuals with severe, uncontrolled high blood pressure (systolic ≥180 mm Hg or diastolic ≥110 mm Hg).

✔️ Use in Pregnancy & Lactation

• Limited human data are available; animal studies indicate potential reproductive risks.
• Not recommended for use during pregnancy or in women trying to conceive.
• As Mirabegron is excreted in the milk of rodents, it is likely to be present in human breast milk. Therefore, breastfeeding is not advised during treatment.

✔️ Precautions and Warnings

• Renal Impairment: Avoid in patients with end-stage renal disease or those on dialysis. Reduce the dose to 25 mg in severe renal impairment, not taking strong CYP3A inhibitors.
• Hepatic Impairment: Not recommended in patients with severe liver dysfunction or those with moderate impairment receiving strong CYP3A inhibitors.
• Blood Pressure Monitoring: May elevate blood pressure; monitor especially in hypertensive patients.
• QT Prolongation: Use with caution in patients with known prolonged QT intervals.
• Bladder Outlet Obstruction or Concurrent Antimuscarinics: Caution is advised as these may increase the risk of urinary retention.

✔️ Storage:

Store in a dry, cool place away from light. Keep out of reach of children