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 compared to higher monotherapy doses. 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. The maximum daily dose should not exceed 8 tablets (equivalent to Tramadol 300mg + Paracetamol 2600mg). Initiate with the lowest effective dose.
Note: Administer orally with or without food. Swallow whole with a glass of water. Can be taken with food if gastrointestinal upset occurs. Do not crush, chew, or break the tablet. Use for the shortest duration necessary to control pain.
The combination works synergistically. Tramadol provides central analgesia by weak μ-opioid receptor agonism and inhibition of norepinephrine and serotonin reuptake in the descending inhibitory pain pathways. Paracetamol's exact mechanism is not fully elucidated but is believed to act centrally by inhibiting prostaglandin synthesis (COX inhibition, particularly COX-2 in the brain) and modulating the endogenous cannabinoid and serotonergic systems, providing peripheral antipyretic and analgesic effects.
Pregnancy: Category C (US FDA). Tramadol: Use during pregnancy only if potential benefit justifies potential risk to the fetus. Prolonged use during pregnancy can cause Neonatal Opioid Withdrawal Syndrome (NOWS). Paracetamol: Generally considered safe for short-term use. Avoid during third trimester for chronic use due to potential fetal toxicity. Consult physician.
Driving: May impair mental and/or physical abilities required for driving or operating machinery. Dizziness and somnolence are common. Patients should be cautioned not to drive until they know how the medication affects them.
| CNS Depressants (Alcohol, Benzodiazepines, Barbiturates, Sedatives) | Additive CNS and respiratory depression, increased risk of sedation and fatal overdose. | Major |
| Serotonergic Drugs (SSRIs, SNRIs, TCAs, Triptans, MAOIs) | Increased risk of Serotonin Syndrome. | Major |
| CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine, Bupropion) | Reduced conversion of Tramadol to active M1 metabolite, potentially decreasing analgesia. | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin) | Increased metabolism of Tramadol, reducing its efficacy. | Moderate |
| CYP3A4 Inhibitors (Ketoconazole, Erythromycin, Clarithromycin) | Increased Tramadol plasma levels, raising risk of side effects and seizures. | Moderate |
| Warfarin | Paracetamol may potentiate anticoagulant effect (especially with high doses >2g/day for several days), increasing INR. | Moderate |
| Other Opioids | Additive opioid effects, increasing risk of respiratory depression. | Major |
| Anticholinergics | Increased risk of urinary retention and severe constipation. | Moderate |
Same composition (Paracetamol/Acetaminophen (325mg) + Tramadol (37.5mg)), different brands: