A fixed-dose combination analgesic containing a centrally acting opioid agonist (Tramadol) and a peripherally acting analgesic/antipyretic (Paracetamol). This combination provides synergistic pain relief by targeting multiple pain pathways, allowing for lower doses of each component and potentially reducing side effects. It is widely used for moderate to moderately severe acute pain in the Indian context.
Adult: 1-2 tablets every 4-6 hours as needed for pain. Maximum: 8 tablets (Paracetamol 1300mg + Tramadol 150mg) in 24 hours.
Note: Take with or without food. Swallow whole with a glass of water. Do not crush, chew, or break. Use the lowest effective dose for the shortest duration.
The combination works synergistically. Tramadol is a centrally acting μ-opioid receptor agonist and inhibits the reuptake of serotonin and norepinephrine, modulating pain perception in the spinal cord and brain. Paracetamol acts peripherally by inhibiting cyclooxygenase (COX) enzymes, particularly COX-2 in the brain, reducing prostaglandin synthesis involved in pain and fever. Its central serotonergic and cannabinoid system effects may also contribute.
Pregnancy: Category C (US FDA). Avoid, especially in third trimester due to risk of neonatal opioid withdrawal syndrome (NOWS). Use only if potential benefit justifies potential fetal risk.
Driving: May impair mental and/or physical abilities required for driving or operating machinery. Dizziness and drowsiness are common. Advise patients not to drive until effect is known.
| Other Opioids (Morphine, Codeine) | Additive CNS/respiratory depression, constipation. | Major |
| Benzodiazepines (Alprazolam, Diazepam) | Profound sedation, respiratory depression, coma, death. | Major |
| Alcohol | Increased CNS depression and hepatotoxicity risk. | Major |
| SSRIs/SNRIs (Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome and seizures. | Major |
| CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine) | Reduced conversion of Tramadol to active M1, decreasing analgesia. | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin) | Reduced Tramadol efficacy. | Moderate |
| Warfarin | Paracetamol may potentiate anticoagulant effect (high dose/prolonged use). | Moderate |
| Anticholinergics (Atropine, Oxybutynin) | Increased risk of urinary retention and constipation. | Moderate |
Same composition (Paracetamol/Acetaminophen (162.5mg) + Tramadol (18.75mg)), different brands: