A fixed-dose combination (FDC) medication primarily indicated for the management of neuropathic pain, particularly diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN), with adjunctive neurotropic B vitamins. Pregabalin is a gabapentinoid that modulates calcium channels, while Methylcobalamin, Pyridoxine, and Folic Acid support nerve health, myelin synthesis, and homocysteine metabolism, potentially offering a synergistic effect in neuropathic conditions prevalent in the Indian population.
Adult: One capsule/tablet twice daily (Total: Pregabalin 150mg/day, Methylcobalamin 3000mcg/day, Pyridoxine 40mg/day, Folic Acid 10mg/day). May be initiated at a lower dose (e.g., once daily) in elderly or renally impaired patients.
Note: Administer orally with or without food. Swallow whole with a glass of water. Do not crush or chew. Can be taken at the same time each day to improve compliance.
Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the influx of calcium and subsequent release of excitatory neurotransmitters (e.g., glutamate, substance P). This results in analgesic, anxiolytic, and anticonvulsant effects. Methylcobalamin is essential for myelin synthesis and maintenance of neuronal integrity. Pyridoxine (as Pyridoxal Phosphate) is a cofactor in neurotransmitter synthesis (GABA, serotonin) and nerve function. Folic Acid is crucial for nucleotide synthesis and, along with B12, for homocysteine metabolism; elevated homocysteine is implicated in neuropathy.
Pregnancy: Pregabalin: Category C (US FDA). Limited human data, potential risk. Use only if benefit outweighs risk. B vitamins are generally safe and recommended in pregnancy, but this high-dose combination is not intended for routine prenatal supplementation. Consult obstetrician.
Driving: May impair ability to drive or operate machinery. Patients should not drive until they know how the medication affects them, especially during dose titration.
| CNS Depressants (Alcohol, Benzodiazepines, Opioids) | Potentiated sedation, dizziness, respiratory depression | Major |
| Angiotensin-converting enzyme (ACE) inhibitors (e.g., Ramipril) | Increased risk and severity of peripheral edema | Moderate |
| Thiazolidinediones (e.g., Pioglitazone) | Increased risk of weight gain and edema | Moderate |
| Levodopa | Pyridoxine (>5mg) may decrease levodopa efficacy if not given with a decarboxylase inhibitor | Moderate |
| Phenytoin, Phenobarbital | May reduce serum levels of these antiepileptics (minor effect) | Minor |
| Oral Contraceptives | May slightly decrease Pyridoxine levels | Minor |
Same composition (Pregabalin (75mg) + Methylcobalamin (1500mcg) + Vitamin B6 (Pyridoxine) (20mg) + Folic Acid (5mg)), different brands: