Miralin 5 Tablet: Each Film coated Tablet contains Mirogabalin 5mg as Mirogabalin Besilate INN.

INN

Antineuropathics

Mirogabalin is indicated for Peripheral Neuropathic Pain (PNP) including Diabetic Peripheral Neuropathic Pain (DPNP) & Postherpetic Neuralgia (PHN).

Mirogabalin is contraindicated in patients with known hypersensitivity to any of its components.

Normally, the initial dose for adults is 5 mg of mirogabalin given orally twice daily, and then the dose is gradually increased by 5 mg at an interval of at least a week to 15 mg, given twice daily. A dose may be adjusted appropriately between 10 mg and 15 mg depending on ages and symptoms, given twice daily.

The most often side effect observed in mirogabalin such as dizziness, increased weight, peripheral oedema, and somnolence.

Mirogabalin should be carefully titrated in patients with moderate-to-severe renal impairment and those with end-stage renal disease.

Mirogabalin does not induce or inhibit cytochrome P450 isoenzymes. Co-administration of mirogabalin with cimetidine or probenecid may raise the mirogabalin plasma concentration, although this increase in exposure may not be clinically relevant.

Mirogabalin co-administered with zolpidem increased the incidence of somnolence, with tramadol and ethanol headache and nausea, but with lorazepam and ethanol-dizziness and somnolence.

Safety and effectiveness of Mirogabalin in pediatric patients have not been established.

Pregnancy: For pregnant women and women who may be pregnant, mirogabalin should be administered only if the expected therapeutic benefits outweigh the possible risks associated with treatment.

Lactation: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding.

Miralin 5 Tablet: Each box contains 2 x 10’s tablet in blister pack.

Store below 30 ºC Keep out of the reach of children. Store away from direct sunlight, heat and moisture.