A fixed-dose combination (FDC) of an antispasmodic (dicyclomine) and an analgesic-antipyretic (paracetamol). Dicyclomine is an anticholinergic agent that relieves smooth muscle spasm in the gastrointestinal tract, while paracetamol provides central analgesic and antipyretic effects. This combination is primarily used for the symptomatic relief of pain and spasm associated with various gastrointestinal and genitourinary conditions. The FDC is widely prescribed in India, though its use is subject to regulatory scrutiny regarding rationality.
Adult: One tablet (Dicyclomine 20mg + Paracetamol 500mg) every 6-8 hours as needed for pain and spasm. Maximum: 3 tablets in 24 hours. Should be taken before meals.
Note: Take orally with a full glass of water. Can be taken before meals to prevent abdominal spasm associated with eating. Do not crush or chew. Do not take for more than 5-7 days for pain without consulting a doctor. Do not co-administer with other paracetamol-containing products.
Dicyclomine exerts a direct relaxant effect on smooth muscle (papaverine-like) and a competitive antagonistic effect on muscarinic acetylcholine receptors, reducing spasms and motility in the GI and GU tracts. Paracetamol's exact mechanism is not fully elucidated but is believed to involve inhibition of prostaglandin synthesis centrally (COX-2 and COX-3 inhibition) and activation of descending serotonergic pathways, providing analgesia and antipyresis with minimal peripheral anti-inflammatory activity.
Pregnancy: Category B (US FDA). Dicyclomine: No well-controlled studies; use only if potential benefit justifies potential risk. Paracetamol: Considered safe for short-term use at recommended doses. Avoid in third trimester for prolonged use due to theoretical risk of premature ductus arteriosus closure. Use only under strict medical supervision.
Driving: May impair mental and/or physical abilities. Dicyclomine can cause dizziness, drowsiness, and blurred vision. Do not drive or operate machinery until effect is known.
| Other Anticholinergics (e.g., atropine, hyoscine, tricyclic antidepressants, antihistamines) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision, tachycardia). | Major |
| Opioid Analgesics (e.g., codeine, tramadol) | Additive constipation and CNS depression (drowsiness). | Moderate |
| Alcohol | Increased risk of hepatotoxicity with paracetamol; enhanced CNS depression with dicyclomine. | Major |
| Warfarin and other Coumarin Anticoagulants | Paracetamol may potentiate anticoagulant effect, increasing INR and risk of bleeding, especially with high doses (>2g/day) or chronic use. | Moderate |
| Enzyme Inducers (e.g., rifampicin, phenytoin, carbamazepine, barbiturates) | Increased metabolism of paracetamol to its toxic metabolite (NAPQI), raising risk of hepatotoxicity even at therapeutic doses. | Major |
| Metoclopramide, Domperidone | Pharmacodynamic antagonism; dicyclomine reduces GI motility, counteracting the prokinetic effect. | Moderate |
| Monoamine Oxidase Inhibitors (MAOIs) | May intensify anticholinergic effects. | Moderate |
| Probenecid | Decreases paracetamol conjugation, may slightly increase its plasma levels. | Minor |
Same composition (Dicyclomine (20mg) + Paracetamol (500mg)), different brands: