Miraba 2.5 Tablet

Dosage & Administration of Miraba 2.5 mg/Mirogabalin Besylate Tablet 
Adults: Treatment usually begins with 5 mg twice daily. The dose may be increased gradually by 5 mg per dose at intervals of at least one week until reaching 15 mg twice daily. Maintenance doses generally range from 10–15 mg twice daily, depending on individual response and tolerability.

Children and Adolescents: Safety and effectiveness have not been established.

Hepatic Impairment: No significant dose adjustment is generally required in mild to moderate liver impairment. Data are insufficient for patients with severe hepatic impairment.

Renal Impairment: Dose adjustments are necessary:

• Mild impairment: Start with 5 mg twice daily and increase gradually to 10 mg twice daily.
• Moderate impairment: Start with 2.5 mg twice daily and increase gradually to 7.5 mg twice daily.
• Severe impairment: Start with 2.5 mg once daily and increase gradually to 7.5 mg once daily.

Drug Interactions

• Blood levels of Mirogabalin may increase when taken with medications such as cimetidine or probenecid.
• Concurrent use with lorazepam may enhance central nervous system depression, leading to increased drowsiness or sedation.
• Caution is advised when used with inhibitors of renal transporters or UGT enzymes, as these may increase Mirogabalin exposure.
• Food does not significantly affect its absorption.
• Alcohol should be avoided, as it may worsen dizziness, drowsiness, and impaired coordination.

Contraindications
Mirogabalin should not be used in:

• Patients with known hypersensitivity to Mirogabalin or any of its components.
• Patients for whom the drug is considered unsuitable due to specific hepatic or renal conditions, as determined by a healthcare professional.

Side Effects
Common side effects include:

• Drowsiness (somnolence)
• Dizziness
• Peripheral edema (swelling)
• Weight gain

Less common but serious reactions may include:

• Loss of consciousness or severe drowsiness
• Nausea, vomiting, poor appetite, or general weakness
• Signs of liver problems such as jaundice

Patients experiencing severe or unusual symptoms should seek medical attention promptly.

Pregnancy & Lactation
Mirogabalin should be used during pregnancy only when the expected benefits outweigh potential risks. Animal studies suggest placental transfer. The drug has also been found in animal milk; therefore, breastfeeding decisions should be made after careful consideration of the benefits and risks.

Precautions & Warnings

• May cause dizziness, sleepiness, blurred vision, or double vision.
• Patients should avoid driving, operating machinery, or engaging in hazardous activities until they know how the medicine affects them.
• Elderly patients may be at increased risk of falls and fractures.
• Weight gain may occur during treatment.
• Dose adjustments are required in patients with impaired kidney function.
• Discontinue the medication and seek medical advice if signs of an allergic reaction develop.

Therapeutic Class
Antiepileptic agent; also used as an adjunctive treatment for neuropathic conditions.

Storage Conditions
Store below 30°C in a dry place, protected from light and moisture. Keep out of the reach of children.