Registered Kenya · PPB

MIRO 5MG TABLET (MIROGABALIN AS BESYLATE)

MIROGABALIN BESYLATE

H2026/CTD13008/27778 EACH FILM COATED TABLET CONTAINS MIROGABALIN AS BESYLATE…...5 MG GENERIC/BIOSIMILARS

What it does

Mirogabalin is a medication used to help relieve nerve pain.

Commonly used for: nerve pain (neuropathic pain)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2026/CTD13008/27778
Registration date
-
Expiry date
2031 January 18
Status
Registered
Active ingredient
MIROGABALIN BESYLATE
Dosage form
EACH FILM COATED TABLET CONTAINS MIROGABALIN AS BESYLATE…...5 MG
Strength
-
Pack size
3 X 10’SALU-ALU BLISTER PACK IN UNIT CARTON ALONG WITH LEAFLET
Therapeutic class
GENERIC/BIOSIMILARS
Manufacturer / MAH
Harleys
Applicant / LTR
NABIQASIM INDUSTRIES (PVT) LTD
Country of origin
FOREIGN
Manufacturer location
63 Westlands Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:16:34 · updated 2026-09-29 02:07:30

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Mirogabalin is a medication used to help relieve nerve pain.

What it treats

  • nerve pain (neuropathic pain)

How it works

Mirogabalin works by calming overactive nerves in the body, which helps to reduce feelings of pain.

Who it's for

This medication is for adults experiencing nerve pain, often due to conditions like diabetes or injury.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: mirogabalin

BNF-referenced

Mirogabalin is a novel drug that acts as a selective ligand for the alpha-2-delta subunit of voltage-gated calcium channels. It is primarily used for the treatment of neuropathic pain, which can arise from various conditions such as diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia. Mirogabalin offers a different mechanism of action compared to traditional analgesics, targeting pain pathways at the level of the nervous system.

Indications

  • Neuropathic pain
  • Diabetic neuropathy
  • Post-herpetic neuralgia
  • Fibromyalgia

Dosage

Children: Refer to BNF for Children for specific dosing information.

Adults: Refer to BNF for specific dosing guidelines.

Mechanism of action

Mirogabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels, inhibiting the influx of calcium ions into neurons. This action reduces the release of excitatory neurotransmitters, ultimately decreasing the transmission of pain signals. By modulating the excitability of neurons, it helps in alleviating neuropathic pain.

Pharmacodynamics

Mirogabalin exhibits analgesic properties by modulating neurotransmitter release in the central nervous system. Its selective binding to the alpha-2-delta subunit enhances its efficacy in treating neuropathic pain while potentially reducing side effects associated with non-selective agents. The onset of action may vary, but users typically report pain relief within a few weeks of starting therapy.

Pharmacokinetics

Mirogabalin is absorbed following oral administration, with peak plasma concentrations usually attained within a few hours. Its bioavailability is influenced by factors such as food intake, which may alter absorption rates. The drug undergoes minimal metabolism, primarily excreted unchanged in urine. The half-life allows for once or twice-daily dosing to maintain therapeutic levels.

Adverse effects

  • Dizziness
  • Somnolence
  • Dry mouth
  • Constipation
  • Peripheral edema

Precautions

  • Caution in patients with a history of substance abuse
  • Monitor for signs of misuse or abuse
  • Consider dose adjustments in renal impairment

Pregnancy

There is limited data on the use of mirogabalin in pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether mirogabalin is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Capsule
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: mirogabalin

PubChem CID 59509752

Molecular formula: C12H19NO2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.