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 to reduce neuronal excitability, 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, etc.). May be initiated at a lower dose (e.g., once daily) in sensitive patients and titrated based on response and tolerability.
Note: Administer orally with or without food. Swallow whole with a glass of water. Do not crush or chew. The total daily dose of pregabalin should be divided into two or three doses. Adherence to the prescribed schedule is important for consistent pain control.
Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing calcium influx and subsequent release of excitatory neurotransmitters (e.g., glutamate, substance P). This dampens neuronal hyperexcitability, the hallmark of neuropathic pain. Methylcobalamin is essential for myelin synthesis and maintenance of neuronal integrity. Pyridoxine is a cofactor in neurotransmitter synthesis (GABA, serotonin). Folic Acid, along with B12, is crucial for homocysteine metabolism; elevated homocysteine is implicated in neurovascular damage in diabetes.
Pregnancy: Pregabalin: Category C (US FDA). Risk cannot be ruled out. Use only if potential benefit justifies potential fetal risk. B vitamins (B12, B6, Folic Acid): Category A/C, generally considered safe and recommended in pregnancy (especially folic acid). However, this FDC is not recommended unless neuropathic pain is severe and uncontrolled by safer alternatives.
Driving: NOT ADVISABLE, especially during initiation and dose titration. Pregabalin can cause dizziness, somnolence, and blurred vision, impairing the ability to drive or operate machinery. Patients should not drive until they know how the medication affects them.
| CNS Depressants (e.g., Lorazepam, Oxycodone, Alcohol) | Additive CNS depression (sedation, dizziness, respiratory depression). | Major |
| Angiotensin-converting enzyme (ACE) inhibitors (e.g., Ramipril) | Increased risk of angioedema. | Major |
| Thiazolidinediones (e.g., Pioglitazone) | Potentiates risk of peripheral edema and weight gain. | Moderate |
| Levodopa | Pyridoxine (at high doses >5mg) can decrease efficacy of Levodopa. Not significant at 3mg. | Minor |
| Phenytoin, Phenobarbital | May reduce serum levels of these anticonvulsants (theoretical). | Moderate |
| Oral Contraceptives | May cause a slight decrease in Pyridoxine levels. | Minor |
Same composition (Pregabalin (75mg) + Methylcobalamin (1500mcg) + Vitamin B6 (Pyridoxine) (3mg) + Folic Acid (5mg)), different brands: