A fixed-dose combination (FDC) of a peripherally-acting dopamine D2 receptor antagonist (Domperidone) and a centrally-acting analgesic-antipyretic (Paracetamol). Domperidone acts as an antiemetic and prokinetic agent, while Paracetamol provides analgesic and antipyretic effects. This combination is primarily used for the symptomatic relief of pain and associated nausea/vomiting, commonly in conditions like migraine, tension headache, and musculoskeletal pain. The FDC is widely used in India, though its regulatory status has been reviewed due to safety concerns regarding high-dose domperidone.
Adult: One tablet (Domperidone 20mg + Paracetamol 500mg) every 6-8 hours as needed. Maximum: 3 tablets in 24 hours. Duration should not exceed 3 days for self-medication of pain/fever; for nausea/vomiting associated with migraine, use as directed by a physician.
Note: Take orally with a glass of water, preferably 15-30 minutes before meals for optimal prokinetic effect of domperidone. Can be taken after food if gastric irritation occurs. Do not crush or chew unless advised. Do not co-administer with antacids or antisecretory drugs (H2 blockers, PPIs) as they may reduce domperidone absorption.
Domperidone acts as a selective antagonist of dopamine D2 and D3 receptors in the chemoreceptor trigger zone (CTZ) located in the area postrema (outside the blood-brain barrier), blocking the emetic signal. It also blocks dopamine receptors in the upper gastrointestinal tract, increasing esophageal sphincter tone, enhancing gastric peristalsis, and promoting gastric emptying (prokinetic effect). Paracetamol's exact mechanism is not fully elucidated but is believed to act centrally by inhibiting cyclooxygenase (COX), particularly the COX-2 variant, and modulating the endogenous cannabinoid and serotonergic pathways, leading to analgesic and antipyretic effects with minimal peripheral anti-inflammatory activity.
Pregnancy: Category C (US FDA). Domperidone: Animal studies show potential risk; human data insufficient. Paracetamol: Generally considered safe for short-term use. Use only if the potential benefit justifies the potential risk to the fetus, and under strict medical supervision.
Driving: May cause dizziness, drowsiness, or blurred vision. Patients should not drive or operate machinery until they know how the medication affects them.
| Ketoconazole, Fluconazole, Itraconazole | Potent CYP3A4 inhibition, drastically increases Domperidone plasma levels and risk of QTc prolongation. | Contraindicated |
| Clarithromycin, Erythromycin | CYP3A4 inhibition, increases Domperidone levels and cardiac risk. | Contraindicated |
| Ritonavir, Saquinavir (Protease Inhibitors) | Strong CYP3A4 inhibition, increases Domperidone levels. | Contraindicated |
| Anticholinergics (e.g., Dicyclomine, Atropine) | Antagonizes the prokinetic effect of Domperidone. | Major |
| Warfarin | Paracetamol may potentiate anticoagulant effect with chronic, high-dose use (>2g/day for several days). | Moderate |
| Alcohol (Chronic use) | Induces CYP2E1, increasing risk of Paracetamol hepatotoxicity even at therapeutic doses. | Major |
| Other QTc-prolonging drugs (e.g., Amiodarone, Sotalol, Fluoroquinolones) | Additive risk of ventricular arrhythmias. | Major |
Same composition (Domperidone (20mg) + Paracetamol (500mg)), different brands: