A fixed-dose combination (FDC) product containing 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 used in India, though its use is subject to regulatory scrutiny regarding rationality.
Adult: One tablet (Dicyclomine 20mg + Paracetamol 325mg) every 6-8 hours as needed for pain/spasm. Maximum: 3 tablets in 24 hours. Should be taken before meals for IBS-related pain.
Note: Take with a full glass of water. Can be taken with or without food, but taking it before meals may be more effective for IBS-related pain. Do not crush or chew unless advised. Do not consume alcohol during treatment. Do not use for more than 5 days for pain or 3 days for fever without medical advice.
Dicyclomine exerts a direct relaxant effect on smooth muscle (papaverine-like action) and a competitive antagonism at muscarinic (M1/M3) receptors in the gastrointestinal and genitourinary tracts, reducing spasms and motility. 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 modulation of the endogenous cannabinoid and serotonergic systems, providing analgesic and antipyretic effects with minimal peripheral anti-inflammatory activity.
Pregnancy: Category B (US FDA). Dicyclomine: No well-controlled studies; use only if clearly needed. Paracetamol: Considered the analgesic/antipyretic of choice during pregnancy for short-term use. However, the combination should be avoided, especially in the third trimester, due to risk of anticholinergic effects in the neonate (e.g., intestinal stasis, meconium ileus). Use only if potential benefit justifies potential risk.
Driving: May impair ability to drive or operate machinery. Dicyclomine can cause dizziness, drowsiness, and blurred vision. Patients should not engage in these activities until they know how the medication affects them.
| Other Anticholinergics (e.g., atropine, hyoscine, tricyclic antidepressants, antihistamines) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision, tachycardia, confusion). | Major |
| Alcohol (chronic use) or CYP2E1 Inducers (e.g., Rifampicin, Isoniazid, Carbamazepine, Phenytoin, Barbiturates) | Increased metabolism of paracetamol to toxic metabolite (NAPQI), raising risk of hepatotoxicity even at therapeutic doses. | Major |
| Warfarin and other Coumarin Anticoagulants | Paracetamol may potentiate anticoagulant effect, increasing INR and risk of bleeding, especially with doses >2g/day for several days. | Moderate |
| Metoclopramide, Domperidone | Dicyclomine may antagonize the prokinetic effect of these drugs on GI motility. | Moderate |
| Levodopa | Dicyclomine may reduce gastric emptying and absorption of levodopa. | Moderate |
| Ketoconazole, Itraconazole | May increase dicyclomine levels by inhibiting its metabolism. | Moderate |
| Probenecid | May decrease the conjugation of paracetamol, leading to increased levels. | Minor |
| Cholinergic Agonists (e.g., bethanechol) | Dicyclomine antagonizes their effects. | Major |
| Monoamine Oxidase Inhibitors (MAOIs) | May intensify anticholinergic effects. | Moderate |
Same composition (Dicyclomine (20mg) + Paracetamol (325mg)), different brands: