Miraba 5 Tablet

✔️ Side Effects

• Drowsiness (somnolence)
• Dizziness
• Edema (swelling)
• Weight gain

✔️ Dosage & Administration

Adults:

• Initial dose: 5 mg twice daily
• Gradually increase by 5 mg at intervals of at least one week
• Usual target dose: 15 mg twice daily
• Dose may be adjusted between 10 mg and 15 mg twice daily depending on patient response and tolerability

Children & Adolescents:

• Safety and efficacy have not been established

Hepatic Impairment:

• Mild to moderate impairment: generally well tolerated with a single 15 mg dose
• Severe impairment: insufficient data available

Renal Impairment:

• Mild: Start 5 mg twice daily → increase gradually to 10 mg twice daily
• Moderate: Start 2.5 mg twice daily → increase to 7.5 mg twice daily
• Severe: Start 2.5 mg once daily → increase to 7.5 mg once daily

✔️ Drug Interactions

With medicines:

• Co-administration with cimetidine or probenecid may increase plasma levels of Mirogabalin
• Use with lorazepam may enhance central nervous system (CNS) depression
• Mirogabalin is a substrate of transporters such as OAT1, OAT3, OCT2, MATE1, MATE2-K, and UGT
• Inhibitors of these transporters may increase drug exposure

With food & alcohol:

• Food does not significantly affect absorption
• Alcohol should be avoided as it may increase sedation and impair motor coordination

✔️ Mirogabalin should not be used in:

• Patients with known hypersensitivity to the drug
• Patients with mild to moderate hepatic or renal impairment

✔️ Pregnancy & Lactation

• Use during pregnancy only if the expected benefit outweighs potential risks
• Animal studies indicate placental transfer
• The drug may pass into breast milk; breastfeeding decisions should be made after evaluating risks and benefits

✔️ Precautions & Warnings

• May cause dizziness, drowsiness, or loss of consciousness; avoid driving or operating machinery
• Increased risk of falls, especially in elderly patients
• May cause weight gain and visual disturbances (blurred or double vision)
• Dose adjustment is necessary in renal impairment
• Discontinue immediately if allergic reactions occur
• Consult a doctor before combining with other medications

✔️ Storage:

• Store below 30°C in a dry place
• Protect from light and moisture
• Keep out of reach of children