A fixed-dose combination (FDC) of an antispasmodic (Drotaverine) and a non-steroidal anti-inflammatory drug (NSAID) of the phenylacetic acid group (Aceclofenac). It is primarily indicated for the management of pain and spasm in conditions like dysmenorrhea, renal colic, and biliary colic. The combination provides synergistic action: Drotaverine relieves smooth muscle spasm, while Aceclofenac reduces inflammation and pain at the nociceptive source. This FDC is widely used in India for acute, painful spasmodic conditions.
Adult: One tablet (Drotaverine 80mg + Aceclofenac 100mg) orally, twice daily after meals. Maximum: 2 tablets in 24 hours.
Note: Should be taken with or immediately after food with a full glass of water to minimize gastrointestinal irritation. Do not crush or chew. The tablet should be swallowed whole. Should be used for the shortest duration necessary to control symptoms, typically not exceeding 7-10 days for acute conditions unless advised by a physician.
The combination works via two distinct but complementary mechanisms. Drotaverine is a selective inhibitor of phosphodiesterase-IV (PDE-IV), leading to increased intracellular cyclic adenosine monophosphate (cAMP) in smooth muscle cells. Elevated cAMP inhibits myosin light chain kinase (MLCK) activity, resulting in smooth muscle relaxation without significant anticholinergic effects. Aceclofenac is a potent NSAID that inhibits both cyclooxygenase-1 (COX-1) and COX-2 enzymes, with a higher selectivity for COX-2. This inhibition blocks the conversion of arachidonic acid to prostaglandins (PGs) and thromboxanes, mediators of pain, inflammation, and fever.
Pregnancy: Category C (first and second trimester) and Category D (third trimester). Avoid in third trimester due to risk of premature closure of ductus arteriosus, oligohydramnios, and prolonged labor. Use in first and second trimesters only if potential benefit justifies potential fetal risk.
Driving: May cause dizziness, vertigo, fatigue, or visual disturbances. Patients should be cautioned about operating machinery or driving until they are sure they are not affected.
| Anticoagulants (Warfarin, Acenocoumarol) | Increased risk of bleeding due to platelet inhibition and potential displacement from protein binding. | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Additive risk of GI bleeding. | Major |
| Other NSAIDs (Ibuprofen, Diclofenac, Naproxen) | Increased risk of GI toxicity and renal impairment with no added benefit. | Major |
| Corticosteroids (Prednisolone) | Markedly increased risk of GI ulceration and bleeding. | Major |
| ACE Inhibitors (Ramipril, Enalapril) / ARBs (Losartan) | Reduced antihypertensive effect; increased risk of renal impairment. | Moderate |
| Diuretics (Furosemide, Hydrochlorothiazide) | Reduced diuretic and antihypertensive efficacy; risk of renal failure. | Moderate |
| Lithium | Increased serum lithium levels and risk of toxicity. | Major |
| Methotrexate | Increased methotrexate levels and toxicity (especially with high dose). | Major |
| Antidiabetics (Sulfonylureas) | Enhanced hypoglycemic effect. | Moderate |
| Quinolone antibiotics (Ciprofloxacin) | Increased risk of CNS stimulation and seizures (theoretical with Drotaverine). | Moderate |
| SSRIs (Fluoxetine, Sertraline) | Increased risk of upper GI bleeding. | Moderate |
Same composition (Drotaverine (80mg) + Aceclofenac (100mg)), different brands: