Product Description

Indications: Sindola tablet is indicated for the management of neuropathic pain including diabetic peripheral neuropathic pain (DPNP), postherpetic neuralgia (PHN), and peripheral neuropathic pain (PNP).

Pharmacology: Mirogabalin belongs to the gamma amino acid derivative class and selectively binds to the α2δ subunits of voltage-gated calcium channels (VGCCs). It decreases calcium influx and suppresses neurotransmitter release from presynaptic neurons, thereby reducing central nervous system hyperexcitability and relieving neuropathic pain. Mirogabalin is rapidly absorbed after oral administration with peak plasma concentration occurring within 0.5 to 1.5 hours. It has low plasma protein binding and is primarily excreted unchanged through the kidneys, while a small portion undergoes hepatic metabolism.

Dosage & Administration: The recommended starting dose for adults is 5 mg twice daily. The dose may be gradually increased by 5 mg at intervals of at least one week up to 15 mg twice daily depending on patient response and tolerability. In mild renal impairment, treatment should begin with 5 mg twice daily and may be increased to 10 mg twice daily. In moderate renal impairment, the starting dose is 2.5 mg twice daily and may be increased to 7.5 mg twice daily. In severe renal impairment, treatment should start with 2.5 mg once daily and may be increased to 7.5 mg once daily. Dose adjustment may be necessary based on age, symptoms, and renal function.

Interaction: Co-administration with cimetidine or probenecid may increase plasma levels of mirogabalin. Concurrent use with lorazepam may enhance CNS depressive effects. Caution is advised when used with OAT1, OAT3, OCT2, MATE1, MATE2-K, or UGT inhibitors as they may increase mirogabalin exposure. Food does not significantly affect absorption. Alcohol should be avoided because it may increase sedation and impair motor skills.

Contraindications: Sindola is contraindicated in patients with hypersensitivity to mirogabalin and in patients with certain hepatic or renal impairments as advised by a physician.

Side Effects: Common adverse effects include somnolence, dizziness, edema, and weight gain. Rare but serious reactions may include loss of consciousness, severe dizziness, nausea, vomiting, jaundice, blurred vision, or double vision. Patients experiencing these symptoms should discontinue the medication and seek medical attention immediately.

Pregnancy & Lactation: Sindola should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus. Animal studies have shown placental transfer and excretion into milk. Caution is advised during breastfeeding.

Precautions & Warnings: This medicine may cause dizziness, drowsiness, blurred vision, or loss of consciousness. Patients should avoid driving or operating heavy machinery while taking Sindola. Elderly patients should be monitored carefully due to increased risk of falls and fractures. Dose adjustment is recommended in renal impairment. Patients should consult a physician before taking other medications concurrently.

Therapeutic Class: Adjunct anti-epileptic drugs, Primary anti-epileptic drugs.

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