Mirogabalin has been used in trials studying the treatment of Post-herpetic Neuralgia, Pain Associated With Fibromyalgia, and Diabetic peripheral neuropathic pain
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Sindola 10 is an antiepileptic medication. When given for epilepsy, it is believed to work by reducing the abnormal electrical activity in the brain, thus preventing seizures. It is also used to treat nerve pain, which blocks pain by interfering with pain signals traveling through the damaged nerves and brain. For the treatment of anxiety, it is believed to work by stopping the release of certain chemical messengers (neurotransmitters) that make you feel anxious.
Sleepiness, Weight gain, Dryness in mouth, Blurred vision, Dizziness, Peripheral edema
Mirogabalin belongs to the class of gamma amino acids and its derivatives. It selectively binds α2δ subunits of voltage-gated calcium channels (VGCCs). It reduces calcium (Ca2+) influx and neurotransmission, which inhibits neurotransmitter release in presynaptic neuron endings. Due to the inhibition of neurotransmitter release, the hyper-excitability of central nervous system (CNS) neurons decreases.
Mirogabalin is rapidly absorbed after oral administration; the median time to maximum plasma concentration is 0.5-1.5h. Mirogabalin has a low plasma protein binding of approximately 25%. Mirogabalin has a mean apparent volume of distribution of 64-88L after single or multiple doses. The drug is cleared mainly unchanged (61-72%) via renal excretion by filtration and active secretion, however, a slight fraction (13-20%) is metabolized by hepatic uridine 5'-diphosphate-glucuronosyltransferase isoforms. The mean elimination half-life of mirogabalin was observed at 2-4.9h. 99% of mirogabalin is excreted through the kidneys, and only 1% of the dose is excreted through feces.
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 reactions, in patients with mild to moderate hepatic impairment. No data available for severe hepatic impairment.
Renal Impairment: In mild renal dysfunction, the initial dose starts from 5 mg twice a day, slowly increasing, the initial dose starts from 2.5 mg twice a day, In renal dysfunction, the initial dose starts from 2.5 mg once a day, slowly increases by 2.5 mg at an interval of 1 week to 7.5 mg once a day.
With Medicine: Co-administration of Sindola with Cimetidine or Probenecid may raise the Sindola plasma concentration. Importantly, if Sindola is taken with Lorazepam, the depressive effects on the CNS may be potentiated. Sindola is OAT1, OAT3, OCT2, MATE1, MATE2-K and UGT substrate. Sindola does not inhibit or induce major human CYP molecular species and does not inhibit activities of drug transporters (including OAT1, OAT3, organic cation transporter OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2-K, P-gp, and BCRP). Co-administrated with OAT1, OAT3, OCT2, MATE1, MATE2-K or UGT inhibitors may increase mirogabalin exposure, so use caution.
With food & others: Administration of Sindola with food has no clinically relevant effect on the total absorption of Sindola. Avoid consuming alcohol while taking Sindola, as Sindola may potentiate the impairment of motor skills and sedating effects of alcohol.
For pregnant or potentially pregnant women, administer only if the therapeutic benefit outweighs the risks. The presence of placental passage has been reported in animal studies. Consider the therapeutic and breastfeeding benefits then consider continuing or discontinuing breastfeeding. It has been reported in animal studies that it is transferred into milk.
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.
If an allergic reaction occurs, stop taking the medicine and consult with a doctor. Dose adjustment is needed in patients with renal dysfunction. If taking any other medication, please consult with a doctor before administering Sindola. As this medicine may cause dizziness or somnolence, the patient should avoid operating in potentially hazardous activities such as driving a car. Elderly patients should be aware of falls and fractures. The patient should consult with the doctor if signs of blurred vision or double vision appear while taking this medication.
Store at below 30°C and dry place, away from light and moisture. Keep out of the reach of children.
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