Products

Presentation

Sindola^™ 2.5: Each film-coated tablet contains Mirogabalin Besylate INN equivalent to Mirogabalin 2.5 mg.

Sindola^™ 5: Each film-coated tablet contains Mirogabalin Besylate INN equivalent to Mirogabalin 5 mg.

Sindola^™ 10: Each film-coated tablet contains Mirogabalin Besylate INN equivalent to Mirogabalin 10 mg.

Description

Mirogabalin has selective and potent binding affinities for human α₂δ subunits of VGCCs, which reduce calcium (Ca²⁺) influx and neurotransmission in DRG, inhibiting neurotransmitter release in pre-synaptic neuron endings. Due to the inhibition of neurotransmitter release, the hyperexcitability of central nervous system (CNS) neurons reduces.

Indications

Mirogabalin is indicated for the treatment of-

• Neuropathic Pain
• Diabetic peripheral neuropathic pain (DPNP)
• Postherpetic neuralgia (PHN)
• Peripheral neuropathic pain (PNP)

Dosage & Administration

Adult dose: The initial dose for adults is 5 mg of Mirogabalin twice daily. Then the dose is gradually increased by 5 mg at an interval of at least a week to 15 mg twice daily. The dose may be adjusted appropriately between 10 mg and 15 mg twice daily depending on ages and symptoms.

Use in Children and Adolescents: It is not known if Mirogabalin is safe and effective in children and adolescents.

Hepatic Impairment: A single 15 mg dose of Mirogabalin does not produce significant adverse reaction, in patients with mild to moderate hepatic impairment. No data is available for severe hepatic impairment.

Renal Impairment: In mild renal dysfunction, the initial dose starts from 5 mg twice a day, slowly increased by 5 mg at an interval of 1 week to 10 mg. In moderate renal dysfunction, the initial dose starts from 2.5 mg twice a day and slowly increases by 2.5 mg at an interval of 1 week to 7.5 mg twice a day. In severe renal dysfunction, the initial dose starts from 2.5 mg once a day and slowly increased by 2.5 mg at an interval of 1 week to 7.5 mg once a day

Side Effects

The most reported adverse reactions include somnolence, dizziness, edema, and weight gain. If
any of these symptoms occur, stop taking this medicine and see your doctor immediately.

• Light headedness, a state close to sleep with impaired consciousness, loss of consciousness (dizziness, somnolence, unconsciousness)
• General malaise, loss of appetite, nausea, vomiting, jaundice (liver dysfunction)

Precautions

This medicine may cause dizziness, somnolence, or loss of consciousness. Avoid operating dangerous machinery, such as driving a car. Especially for elderly patients, careful attention should be taken. This medicine may cause weight gain. This medicine may cause blurred vision and double vision.

Use in Pregnancy & Lactation

For pregnant or potentially pregnant women, administer only if the therapeutic benefit outweighs the risks. The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding.

Drug Interaction

Co-administration of Mirogabalin with Cimetidine or Probenecid may raise the Mirogabalin plasma concentration. Importantly, if Mirogabalin is taken with Lorazepam, the depressive effects on the CNS may be potentiated. Administration of Mirogabalin with food has no clinically relevant effect on the total absorption of Mirogabalin.

Storage

Do not store above 30°C. Keep away from light and out of the reach of children.

Commercial Pack

Sindola^™ 2.5: Each box contains 3 blister strips of 10 tablets.
Sindola^™ 5: Each box contains 3 blister strips of 10 tablets.
Sindola^™ 10: Each box contains 2 blister strips of 10 tablets.