Prescribing Details
Description
Nervion® is a preparation of Mirogabalin Besylate which is a gamma-aminobutyric acid (GABA)
derivative. It is a potent and specific ligand of the α2 subunit of voltage-dependent Ca2+ channels
that inhibits calcium ions influx and suppresses the release of neurotransmitters in the nervous
system to reduce pain.
Uses
No Data
Indications
Nervion® is indicated for the treatment of peripheral neuropathic pain (PNP): diabetic peripheral
neuropathic pain (DPNP) and postherpetic neuralgia (PHN).
Dosage and administration
Route of administration: Nervion® should be taken in oral route with or without food.
In general, for adults, the initial dose of Nervion® is 5 mg twice daily, and then the dose is
gradually increased by 5 mg at an interval of at least a week to 15 mg twice daily. A dose may
be adjusted appropriately between 10 mg and 15 mg depending on ages and symptoms, given
twice daily.
Renal impairment: No dose adjustment is recommended for mild renal impairment. For moderate renal impairment,
reduce the dose by 50%. In cases of severe renal impairment and ESRD (End-Stage Renal
Disease), reduce the dose by 75%.
| Degree of renal dysfunction (CLcr : mL/min) | ||||
| Mild (90 > CLcr ≥ 60) | Moderate (60 > CLcr ≥ 30) | Severe (including hemodialysis patients) (30 > CLcr) | ||
| Daily Dose | 10-30 mg | 5-15 mg | 2.5 - 7.5 mg | |
| Initial Dose | 5 mg twice daily | 2.5 mg twice daily | 2.5 mg once daily | |
| Effective Dose | Minimum Dose | 10 mg twice da | 5 mg twice daily | 5 mg once daily |
| Recommended Dose | 15 mg twice daily | 7.5 mg twice daily | 7.5 mg once daily | |
Hepatic impairment:
No dose adjustment is recommended for mild and moderate hepatic impairment. No
pharmacokinetic data of mirogabalin are available for severe hepatic impairment.
Use in pregnancy & lactation
Pregnancy: There are no adequate or well-controlled data on use of this combination in pregnant women. It can be
used during pregnancy only if therapeutic benefit outweighs the risk to mother and fetus.
Lactation: Levodopa has been detected in human milk. Caution should be exercised when administered to a
lactating mother.
Use in children and adolescent
Safety and effectiveness in pediatric patients have not been established. Use of this combination in patients below
the age of 18 is not recommended.
Geriatric use
Precautions
Warning and precaution
Mirogabalin may impair the ability to drive or operate machinery. Elderly people should be
aware of falling and fracture.
Side effects
No Data
Contraindications
It is contraindicated in patients with history of known hypersensitivity to mirogabalin or any other
components of this product.
Drug interactions
Drug interaction with medication: Co-administration with OAT1, OAT3, OCT2, MATE1,
MATE2-K, or UGT inhibitors may increase mirogabalin exposure, so it should be used with
caution.
Drug interaction with food and others: Not applicable.
Overdose
In the event of overdose, patient may experience CNS depression. In case of overdose, it is
recommended to seek medical attention immediately.
Preparation
No Data
Pharmaceutical precautions
No Data
Presentation
Composition
Nervion® 2.5 tablet: Each coated tablet contains Mirogabalin 2.5 mg as Mirogabalin Besylate INN.
Nervion® 5 tablet: Each coated tablet contains Mirogabalin 5 mg as Mirogabalin Besylate INN.
Nervion® 10 tablet: Each coated tablet contains Mirogabalin 10 mg as Mirogabalin Besylate INN.
Nervion® 15 tablet: Each coated tablet contains Mirogabalin 15 mg as Mirogabalin Besylate INN.
Package quantities
Storage
Store below 25°C in a dry place, protected from light. Keep away from the reach of children.
Packing
Nervion® 2.5 Tablet: Carton of 30 tablets in blister pack.
Nervion® 5 Tablet: Carton of 30 tablets in blister pack.
Nervion® 10 Tablet: Carton of 30 tablets in blister pack.
Nervion® 15 Tablet: Carton of 20 tablets in blister pack.
