A fixed-dose combination (FDC) of an antispasmodic (Drotaverine) and a non-steroidal anti-inflammatory drug (NSAID) (Diclofenac). Drotaverine is a selective phosphodiesterase-4 (PDE-4) inhibitor that relieves smooth muscle spasm, while Diclofenac inhibits cyclooxygenase (COX) enzymes, providing analgesic and anti-inflammatory effects. This combination is widely used in India for the symptomatic management of pain associated with smooth muscle spasms, particularly in renal and biliary colic, dysmenorrhea, and gastrointestinal spasms.
Adult: One tablet (Drotaverine 80mg + Diclofenac 50mg) orally, 2 to 3 times daily. Should be taken with or after food.
Note: Swallow whole with a full glass of water. Take with food or milk to minimize gastrointestinal upset. Do not crush or chew. The tablet should not be taken on an empty stomach.
The combination works synergistically. Drotaverine causes direct smooth muscle relaxation by inhibiting phosphodiesterase-4 (PDE-4), leading to increased intracellular cyclic adenosine monophosphate (cAMP). Elevated cAMP reduces intracellular calcium, inhibiting myosin light chain kinase activity and relaxing smooth muscle. Diclofenac provides analgesia and reduces inflammation by non-selectively inhibiting cyclooxygenase-1 and 2 (COX-1 & COX-2) enzymes, thereby blocking the conversion of arachidonic acid to prostaglandins and thromboxanes, which are mediators of pain, inflammation, and fever.
Pregnancy: Category C (first and second trimester): Use only if potential benefit justifies potential risk. Avoid in third trimester (Category D) due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor.
Driving: May cause dizziness, vertigo, or drowsiness. Patients should not drive or operate machinery if affected.
| Anticoagulants (Warfarin, Acenocoumarol) | Increased risk of bleeding | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Increased risk of GI bleeding | Major |
| Other NSAIDs (Ibuprofen, Naproxen) | Increased risk of GI and renal toxicity | Major |
| ACE Inhibitors (Ramipril, Enalapril) | Reduced antihypertensive effect; risk of renal impairment | Moderate |
| Diuretics (Furosemide, Hydrochlorothiazide) | Reduced diuretic effect; risk of renal impairment | Moderate |
| Lithium | Increased lithium levels and toxicity | Major |
| Methotrexate | Increased methotrexate toxicity | Major |
| Corticosteroids (Prednisolone) | Increased risk of GI ulceration | Major |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of GI bleeding | Moderate |
| Antidiabetics (Glibenclamide) | May potentiate hypoglycemic effect | Moderate |
Same composition (Drotaverine (80mg) + Diclofenac (50mg)), different brands: