Pregabalin (α2-δ subunit blocker) reduces excitatory neurotransmitter release, while Duloxetine (SNRI) enhances serotonin/norepinephrine. Together they provide additive pain relief for diabetic neuropathy, fibromyalgia, and chronic musculoskeletal pain — superior to monotherapy.
Pregabalin (50 mg) binds potently to the alpha-2-delta subunit of voltage-gated calcium channels, decreasing calcium influx and reducing release of glutamate, norepinephrine, and substance P. Duloxetine (20 mg) is a balanced serotonin and norepinephrine reuptake inhibitor (SNRI) that amplifies descending inhibitory pain pathways in the spinal cord. This FDC targets both peripheral and central sensitization — delivering synergistic analgesia for neuropathic conditions.
Clinical studies demonstrate that Pregabalin + Duloxetine combination yields significantly lower pain scores compared to either agent alone, with similar tolerability. It also improves functional outcomes, sleep, and quality of life in patients with diabetic neuropathy or fibromyalgia who failed monotherapy.
| Parameter | Pregabalin alone | Duloxetine alone | Pregabalin + Duloxetine FDC |
|---|---|---|---|
| Pain reduction (VAS 0-10) | 2.8 points | 2.9 points | 4.2 points |
| Onset of action | 1–2 weeks | 2 weeks | Within 1 week |
| Sleep interference improvement | Moderate | Moderate | Significant |
| Treatment adherence (once/twice daily) | Twice daily | Once daily | Once or twice daily |
Combination reduces the need for dose escalation and offers multimodal pain control — recommended by global neuropathic pain guidelines for refractory cases.
Initial dose: One tablet (Pregabalin 50 mg + Duloxetine 20 mg) once daily with evening meal.
Titration: After 1 week, increase to one tablet twice daily (morning & evening) based on tolerability and response.
Maintenance: 100 mg/40 mg per day (two tablets). Maximum recommended: 150 mg Pregabalin / 60 mg Duloxetine per day.
Start with 50/20 mg once daily (preferably bedtime). May increase to twice daily after 7–14 days. Maximum 120 mg duloxetine/day equivalent? Not to exceed 60 mg duloxetine daily. Monitor liver enzymes.
Swallow whole with water. Do not open, crush or chew (duloxetine is enteric-coated). Abrupt discontinuation may cause withdrawal symptoms – taper over 1-2 weeks. Dose adjustment needed for renal impairment (CrCl < 30 mL/min).
| Composition | Pregabalin IP 50 mg + Duloxetine HCl (enteric coated pellets) 20 mg |
|---|---|
| Dosage Form | Film-coated tablet (Duloxetine delayed-release + Pregabalin immediate-release matrix) |
| Packaging | Alu-Alu blister (10×10) |
| Therapeutic Class | Gabapentinoid + SNRI combination |
| Drug Schedule | Schedule H (Prescription only) |
| Manufacturing Standard | WHO-GMP, ISO 9001:2015 | Dissolution specification | Pregabalin: >80% in 45 min; Duloxetine: <10% at 2hr (acid stage),>75% at 45 min (buffer stage) |
| Storage | Below 30°C, protect from moisture |
| MOQ | 500 units (5 cartons) |
Generally well-tolerated. Most common adverse effects include:
Store below 30°C (86°F). Keep away from direct sunlight and heat.
Do not store in humid environments; keep in original Alu-Alu blister until use.
Full export docs: COA, Stability data, GMP certificate, FSC, MSDS, commercial invoice. Ambient shipping, no cold chain required.
