A fixed-dose combination (FDC) medication 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 address both the symptomatic pain and the underlying metabolic and degenerative components of nerve damage. Benfotiamine, a lipid-soluble prodrug of thiamine, is included for its potential to reduce advanced glycation end-products (AGEs) and improve nerve conduction velocity.
Adult: One tablet twice daily (BD), 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. Maintain a consistent dosing schedule. Do not crush or chew. Avoid abrupt discontinuation; taper gradually over at least one week to prevent withdrawal symptoms (insomnia, nausea, headache, anxiety).
The combination works via synergistic and complementary mechanisms. Pregabalin binds to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters (glutamate, noradrenaline, substance P). This results in analgesic, anxiolytic, and anticonvulsant activity. The B-vitamin complex addresses the metabolic pathology of neuropathy: Benfotiamine activates transketolase, diverting glycolytic intermediates and reducing toxic advanced glycation end-products (AGEs) and oxidative stress. Methylcobalamin is essential for myelin synthesis and nerve regeneration. Pyridoxine (as PLP) is a cofactor in neurotransmitter synthesis (GABA, serotonin) and nerve function. Folic Acid works synergistically with B12 in homocysteine metabolism, potentially reducing hyperhomocysteinemia linked to vascular endothelial damage in diabetes.
Pregnancy: Pregnancy Category C (US FDA). Pregabalin: Animal studies showed teratogenicity. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. High-dose Folic Acid (0.75mg) is safe and recommended for neural tube defect prevention, but the combination is not intended for this purpose. A safer alternative for neuropathic pain in pregnancy should be sought.
Driving: WARN: May cause dizziness, somnolence, blurred vision, and reduced alertness. Patients should not drive, operate complex machinery, or engage in hazardous activities until they know how the medication affects them, especially during dose initiation and titration.
| CNS Depressants (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 peripheral edema and angioedema. | Major |
| Thiazolidinediones (Pioglitazone, Rosiglitazone) | Increased risk of peripheral edema and weight gain. | Moderate |
| Phenytoin, Carbamazepine | May reduce the absorption and efficacy of Folic Acid. | Moderate |
| Levodopa | High-dose Pyridoxine (>5mg) can decrease its efficacy. Not a concern at 1.5mg. | Minor |
| Methotrexate, Trimethoprim, Pyrimethamine | Folate antagonists; this supplement may reduce their efficacy in conditions like rheumatoid arthritis or Pneumocystis pneumonia prophylaxis. | Moderate |
Same composition (Benfotiamine (7.5mg) + Folic Acid (0.75mg) + Methylcobalamin (750mcg) + Pregabalin (75mg) + Vitamin B6 (Pyridoxine) (1.5mg)), different brands: