A fixed-dose combination (FDC) of Tolperisone, a centrally acting muscle relaxant, and Diclofenac, a non-steroidal anti-inflammatory drug (NSAID). This combination provides a synergistic effect for the management of acute painful musculoskeletal conditions by addressing both muscle spasm and inflammation/pain. It is widely used in India for conditions like low back pain, cervical spondylosis, and post-operative orthopedic pain.
Adult: One tablet (Tolperisone 150mg + Diclofenac 50mg) two to three times daily, preferably after food. Maximum: 3 tablets/day.
Note: Swallow whole with a full glass of water. Take with food or milk to minimize gastrointestinal upset. Do not crush or chew. Should be used for the shortest duration necessary to control symptoms, typically not exceeding 7-10 days without physician reassessment.
The combination exerts a dual mechanism: Tolperisone reduces muscle tone by centrally depressing polysynaptic reflexes at the spinal cord level, possibly by blocking voltage-gated sodium and calcium channels. Diclofenac provides peripheral analgesia and anti-inflammatory effects by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis.
Pregnancy: Category C (first and second trimester): Use only if potential benefit justifies risk. Avoid in third trimester (Category D) due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor.
Driving: May impair mental and/or physical abilities. Dizziness, drowsiness, and blurred vision are common. Patients should not drive or operate machinery until their response is known.
| Anticoagulants (Warfarin, Acenocoumarol) | Increased risk of bleeding due to antiplatelet effect of Diclofenac and protein binding displacement | Major |
| Other NSAIDs (including Aspirin) | Increased risk of GI toxicity and reduced antiplatelet effect of aspirin | Major |
| ACE Inhibitors (Ramipril, Enalapril) / ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment | Moderate |
| Diuretics (Furosemide, Hydrochlorothiazide) | Reduced diuretic efficacy; increased nephrotoxicity risk | Moderate |
| Lithium | Increased serum lithium levels and toxicity risk | Major |
| Methotrexate | Increased methotrexate toxicity (especially with high dose) | Major |
| Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration | Major |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of upper GI bleeding | Moderate |
| CYP2C9 Inhibitors (Fluconazole, Amiodarone) | Increased Diclofenac levels and toxicity | Moderate |
| CYP2D6 Inhibitors (Paroxetine, Quinidine) | Increased Tolperisone levels and CNS side effects | Moderate |
Same composition (Tolperisone (150mg) + Diclofenac (50mg)), different brands: