A fixed-dose combination (FDC) of an antispasmodic (Dicyclomine) and a non-steroidal anti-inflammatory drug (NSAID, Diclofenac). Dicyclomine relieves smooth muscle spasm in the gastrointestinal and genitourinary tracts, while Diclofenac provides analgesic and anti-inflammatory effects. This combination is primarily used for conditions involving pain associated with smooth muscle spasm, such as renal colic, biliary colic, and dysmenorrhea. The FDC was banned by the Indian government in 2018 due to safety concerns regarding irrationality and increased risk of adverse effects, but some brands may still be available under specific circumstances or older stock.
Adult: One tablet (Dicyclomine 20mg + Diclofenac 50mg) every 6-8 hours, as needed for pain. The total daily dose of Diclofenac should not exceed 150mg (i.e., 3 tablets). Should be taken with food or milk to minimize GI upset.
Note: Take with a full glass of water, with food or immediately after meals to reduce gastrointestinal irritation. Do not crush or chew. Swallow whole. Do not lie down for at least 10 minutes after taking the tablet.
Dicyclomine is a direct smooth muscle relaxant with potent antimuscarinic (anticholinergic) activity. It blocks acetylcholine at muscarinic receptors in visceral smooth muscle, reducing tone and amplitude of contractions. Diclofenac is a prototypical NSAID that inhibits the enzyme cyclooxygenase (COX), preferentially COX-2, thereby reducing the synthesis of prostaglandins, thromboxanes, and prostacyclin from arachidonic acid. This inhibition mediates its anti-inflammatory, analgesic, and antipyretic effects.
Pregnancy: Category C (first and second trimester) and Category D (third trimester). Diclofenac may cause premature closure of ductus arteriosus, oligohydramnios, and neonatal pulmonary hypertension. Dicyclomine may cause fetal tachycardia. Use only if potential benefit justifies potential fetal risk. Avoid in third trimester.
Driving: May impair mental and/or physical abilities. Dicyclomine can cause drowsiness, dizziness, and blurred vision. Patients should not drive or operate machinery until they know how the medication affects them.
| Other NSAIDs (e.g., Aspirin, Ibuprofen, Naproxen) | Increased risk of GI ulceration and bleeding, additive nephrotoxicity. | Major |
| Anticoagulants (Warfarin, Acenocoumarol) | Diclofenac displaces warfarin from protein binding and inhibits platelet function, increasing bleeding risk. | Major |
| Oral Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration and bleeding. | Major |
| ACE Inhibitors (Ramipril, Enalapril) / ARBs (Losartan) | Diclofenac reduces their antihypertensive effect and increases risk of renal impairment. | Major |
| Diuretics (Furosemide, Hydrochlorothiazide) | Diclofenac reduces diuretic efficacy and increases nephrotoxicity risk. | Major |
| Lithium | Diclofenac decreases renal clearance of lithium, leading to toxicity. | Major |
| Methotrexate | Diclofenac may increase methotrexate levels and toxicity. | Major |
| Anticholinergics (Amitriptyline, Oxybutynin) | Additive anticholinergic side effects (dry mouth, constipation, urinary retention, confusion). | Moderate |
| CYP2C9 Inhibitors (Fluconazole, Amiodarone) | May increase Diclofenac levels and toxicity. | Moderate |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of upper GI bleeding. | Moderate |
Same composition (Dicyclomine (20mg) + Diclofenac (50mg)), different brands: