A fixed-dose combination (FDC) analgesic and antispasmodic medication. Dicyclomine is an anticholinergic/antispasmodic agent that relieves smooth muscle spasms, particularly in the gastrointestinal tract. Paracetamol (Acetaminophen) is a centrally-acting analgesic and antipyretic. Tramadol is a centrally-acting synthetic opioid analgesic with weak mu-opioid receptor agonist activity and inhibition of norepinephrine and serotonin reuptake. This combination is primarily used for the management of moderate to severe pain associated with smooth muscle spasm, such as in renal colic, biliary colic, and dysmenorrhea.
Adult: One tablet every 4-6 hours as needed for pain. The maximum recommended dose is 4 tablets in 24 hours (not exceeding Tramadol 150mg, Paracetamol 2000mg, Dicyclomine 80mg). Should be used at the lowest effective dose for the shortest duration.
Note: Take with or after food to minimize gastrointestinal upset (nausea, dizziness). Swallow whole with a full glass of water. Do not crush, chew, or break the tablet. Should be used for acute, short-term pain management only.
This combination provides a multi-modal approach to pain relief. Dicyclomine acts as a competitive muscarinic acetylcholine receptor antagonist, reducing smooth muscle tone and motility in the GI and biliary tracts, thereby relieving spasm. Paracetamol's exact mechanism is not fully understood but is believed to involve inhibition of cyclooxygenase (COX) isoforms, particularly COX-2, in the central nervous system, reducing prostaglandin synthesis and elevating the pain threshold. Tramadol is a centrally-acting synthetic opioid that binds weakly to μ-opioid receptors and also inhibits the reuptake of norepinephrine and serotonin in the descending inhibitory pain pathways, providing dual analgesic action.
Pregnancy: Category C (US FDA). Tramadol: Avoid in late pregnancy due to risk of neonatal withdrawal syndrome. Paracetamol: Generally considered safe for short-term use. Dicyclomine: Data insufficient. Use only if potential benefit justifies potential fetal risk. Not recommended for routine use.
Driving: May cause dizziness, drowsiness, sedation, and blurred vision. Patients should be advised not to drive, operate machinery, or perform hazardous tasks until they know how the medication affects them.
| Other Opioids (Morphine, Codeine) | Additive CNS depression, respiratory depression, and constipation. | Major |
| Benzodiazepines (Alprazolam, Diazepam) | Profound sedation, respiratory depression, coma, death. | Major |
| Alcohol | Increased CNS depression and risk of hepatotoxicity. | Major |
| MAO Inhibitors (Phenelzine, Selegiline) | Risk of serotonin syndrome, hyperpyrexia, seizures. | Contraindicated |
| SSRIs/SNRIs (Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome. | Major |
| CNS Depressants (Antipsychotics, Antihistamines) | Additive sedation and impaired motor skills. | Moderate |
| Anticholinergics (Atropine, Trihexyphenidyl) | Enhanced anticholinergic side effects (dry mouth, urinary retention, constipation). | Moderate |
| Warfarin | Paracetamol may potentiate anticoagulant effect with long-term, high-dose use. | Moderate |
| CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine) | Reduced conversion of Tramadol to active M1 metabolite, decreasing analgesia. | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine) | Increased metabolism of Tramadol, reducing its effect. | Moderate |
Same composition (Dicyclomine (20mg) + Paracetamol (500mg) + Tramadol (37.5mg)), different brands: