Indications

Sindola is indicated for the treatment of:

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

Pharmacology

Mirogabalin, the active ingredient in Sindola, is a gamma amino acid derivative that selectively binds to the α2δ subunits of voltage-gated calcium channels. By doing so, it reduces calcium influx and neurotransmission, which in turn inhibits the release of neurotransmitters. This action decreases the hyper-excitability of central nervous system (CNS) neurons. Mirogabalin is rapidly absorbed, has a low plasma protein binding of approximately 25%, and is primarily eliminated unchanged (61-72%) through renal excretion.

Dosage & Administration

• Adults: The initial dose is 5 mg twice daily. The dose is then gradually increased by 5 mg at intervals of at least one week, up to a dose of 15 mg twice daily. The dose may be adjusted to between 10 mg and 15 mg twice daily depending on the patient's age and symptoms.
• Children and Adolescents: The safety and effectiveness of Sindola in this population have not been established.
• Hepatic Impairment: A single 15 mg dose does not cause significant adverse reactions in patients with mild to moderate hepatic impairment. There is no data for severe hepatic impairment.
• Renal Impairment: The dose must be adjusted:
  • Mild: Initial dose is 5 mg twice daily, increasing to 10 mg at weekly intervals.
  • Moderate: Initial dose is 2.5 mg twice daily, increasing to 7.5 mg twice daily at weekly intervals.
  • Severe: Initial dose is 2.5 mg once daily, increasing to 7.5 mg once daily at weekly intervals.

Interaction

• With medicine: Co-administration with Cimetidine or Probenecid may increase mirogabalin plasma concentration. Concomitant use with Lorazepam may potentiate the CNS depressant effects. Use with caution with OAT1, OAT3, OCT2, MATE1, MATE2-K, or UGT inhibitors as they may increase mirogabalin exposure.
• With food & alcohol: Food does not have a clinically relevant effect on total absorption. Alcohol should be avoided as it may potentiate the sedative effects and impairment of motor skills.

Contraindications

Sindola is contraindicated in patients with:

• Hypersensitivity to mirogabalin.
• Mild to moderate hepatic and renal impairment.

Side Effects

The most commonly reported adverse reactions are somnolence (sleepiness), dizziness, edema (swelling), and weight gain. Rare but serious side effects include liver dysfunction (general malaise, loss of appetite, nausea, vomiting, jaundice) and loss of consciousness.

Pregnancy & Lactation

This drug should be administered to pregnant or potentially pregnant women only if the therapeutic benefits outweigh the risks. Animal studies have shown placental transfer and excretion into milk. A decision to continue or discontinue breastfeeding should be made after considering the therapeutic benefits for the mother and the breastfeeding benefits for the child.

Precautions & Warnings

• Sindola may cause dizziness, sleepiness, or loss of consciousness. Patients should be advised to avoid operating hazardous machinery, such as driving a car.
• Patients should be cautious, especially the elderly, due to the risk of falls and fractures.
• The medication may cause weight gain, blurred vision, and double vision. Patients should consult a doctor if these vision symptoms appear.
• Dose adjustment is necessary for patients with renal dysfunction.
• If an allergic reaction occurs, the medicine should be stopped immediately, and a doctor should be consulted.

Therapeutic Class

Sindola is classified as an adjunct anti-epileptic drug and a primary anti-epileptic drug.

Storage Conditions

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