A fixed-dose combination (FDC) product designed for the comprehensive management of neuropathic pain, particularly diabetic peripheral neuropathy (DPN). It combines the analgesic and anti-hyperalgesic action of pregabalin with neurotropic B vitamins (Benfotiamine, Methylcobalamin, Pyridoxine) and Folic Acid. This combination aims to target both the symptomatic relief of neuropathic pain and the underlying metabolic/vascular dysfunction contributing to nerve damage, a common therapeutic approach in the Indian clinical setting for DPN.
Adult: One capsule/tablet twice daily (B.D.), or as directed by the physician. The dose may be initiated at once daily for tolerability, especially in elderly or renally impaired patients.
Note: Can be taken with or without food. Swallow whole with a glass of water. Do not crush or chew. Maintain a consistent dosing schedule.
This combination works via a dual mechanism: 1) Symptomatic Control: Pregabalin binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters (e.g., glutamate, substance P, noradrenaline), thereby dampening neuronal hyperexcitability and pain signaling. 2) Neurotropic & Metabolic Support: Benfotiamine (a lipid-soluble thiamine prodrug) increases transketolase activity, reducing toxic advanced glycation end-products (AGEs) and hexosamine pathway flux implicated in diabetic complications. Methylcobalamin is essential for myelin synthesis and nerve regeneration. Pyridoxine (as PLP) is a cofactor in neurotransmitter synthesis. Folic Acid works synergistically with B12 in homocysteine metabolism, potentially improving endothelial function and nerve blood flow.
Pregnancy: Pregnancy Category C (US FDA) for pregabalin. Data on B vitamins is generally favorable, but the combination is not recommended unless clearly needed. Risk vs. benefit must be assessed by the physician. Folic Acid is recommended in pregnancy for neural tube defect prevention, but at different doses.
Driving: WARN: May cause dizziness and somnolence. Patients should not drive or operate heavy machinery until they know how the medication affects them.
| CNS Depressants (e.g., Alcohol, Benzodiazepines, Opioids, Barbiturates) | Additive CNS depression (sedation, dizziness, respiratory depression) | Major |
| Angiotensin-Converting Enzyme (ACE) Inhibitors (e.g., Ramipril, Enalapril) | Increased risk and severity of angioedema | Major |
| Thiazolidinediones (e.g., Pioglitazone) | Potentiation of peripheral edema and weight gain | Moderate |
| Levodopa | Pyridoxine (in high doses >5mg) may accelerate peripheral metabolism of Levodopa, reducing its efficacy. The dose in this FDC is low risk. | Moderate |
| Phenytoin, Phenobarbital | May reduce serum levels of the vitamins, particularly folate. | Moderate |
Same composition (Benfotiamine (7.5mg) + Folic Acid (0.750mg) + Methylcobalamin (0.750mg) + Pregabalin (75mg) + Vitamin B6 (Pyridoxine) (1.5mg)), different brands: