A fixed-dose combination analgesic and antispasmodic agent. Dicyclomine is an anticholinergic/antispasmodic that relieves smooth muscle spasms in the gastrointestinal tract. Dextropropoxyphene is a centrally-acting opioid analgesic (narcotic) used for mild to moderate pain. Paracetamol (acetaminophen) is a non-opioid, centrally and peripherally acting analgesic and antipyretic. This combination is primarily indicated for the relief of moderate to severe pain associated with smooth muscle spasm, such as in renal or biliary colic, dysmenorrhea, and post-operative pain. Its use is highly controversial and restricted due to the safety profile of dextropropoxyphene.
Adult: One tablet every 4-6 hours as needed for pain. The maximum recommended dose is 3 tablets in 24 hours. Should be used for the shortest duration possible, typically not exceeding 5 days.
Note: Take with or after food to minimize gastric irritation. Swallow whole with a full glass of water. Do not crush, chew, or break. Do not consume alcohol. Should be taken only when in pain, not on a fixed schedule for chronic use.
The combination provides synergistic pain relief through three distinct mechanisms: 1) Dicyclomine acts as a direct smooth muscle relaxant and a competitive muscarinic acetylcholine receptor antagonist, reducing spasms in hollow viscera. 2) Dextropropoxyphene is a weak mu-opioid receptor agonist in the central nervous system, altering the perception of and emotional response to pain. 3) Paracetamol's exact mechanism is unclear but involves inhibition of prostaglandin synthesis in the CNS, possibly via COX-2 and COX-3 inhibition, and modulation of the endogenous cannabinoid and serotonergic systems.
Pregnancy: Category C (US FDA). Not recommended, especially in third trimester. Dextropropoxyphene may cause neonatal respiratory depression and withdrawal symptoms. Dicyclomine may reduce uterine contractions. Use only if potential benefit justifies fetal risk. Avoid during labor.
Driving: Patients must NOT drive or operate heavy machinery. The combination causes significant dizziness, drowsiness, sedation, and blurred vision, impairing mental and physical abilities.
| Alcohol / CNS Depressants (Benzodiazepines, Barbiturates) | Additive CNS and respiratory depression, increased risk of fatal overdose. | Major |
| Other Opioids (Codeine, Tramadol, Morphine) | Increased risk of profound CNS depression, respiratory arrest, and death. | Major |
| MAO Inhibitors (Phenelzine, Tranylcypromine) | Can precipitate serotonin syndrome or opioid toxicity (excitation, hyperpyrexia). | Major |
| Warfarin | Paracetamol may potentiate anticoagulant effect, increasing INR and bleeding risk with prolonged high dose. | Moderate |
| CYP3A4 Inhibitors (Ketoconazole, Erythromycin, Clarithromycin, Ritonavir) | Increase dextropropoxyphene levels, risk of toxicity (CNS/respiratory depression, QT prolongation). | Major |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin) | Decrease dextropropoxyphene efficacy. | Moderate |
| Anticholinergics (Atropine, Tricyclic Antidepressants, Antipsychotics) | Additive anticholinergic side effects (dry mouth, urinary retention, ileus, hyperthermia). | Major |
| SSRIs/SNRIs (Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome. | Moderate |
| Antiarrhythmics (Amiodarone, Sotalol), Antipsychotics | Increased risk of QT prolongation and fatal arrhythmias. | Major |
| Metoclopramide, Domperidone | Antagonizes GI motility effects of dicyclomine. | Moderate |
Same composition (Dicyclomine (10mg) + Dextropropoxyphene (65mg) + Paracetamol (400mg)), different brands: