A fixed-dose combination (FDC) of an antispasmodic (Drotaverine) and an analgesic-antipyretic (Paracetamol). Drotaverine is a selective phosphodiesterase-4 (PDE-4) inhibitor that relieves smooth muscle spasm, while Paracetamol acts centrally to alleviate pain and fever. This combination is widely used in India for the symptomatic management of pain associated with smooth muscle spasms, particularly in abdominal and genitourinary conditions.
Adult: One tablet (Drotaverine 80mg + Paracetamol 500mg) orally every 6-8 hours as needed for pain. Maximum: 3 tablets in 24 hours.
Note: Take with or after food to minimize gastric upset. Swallow whole with a glass of water. Do not crush or chew. Can be taken as needed for acute episodes of pain, but not for prolonged use without diagnosis.
Drotaverine exerts its antispasmodic effect by selective inhibition of phosphodiesterase-4 (PDE-4), leading to increased intracellular cyclic adenosine monophosphate (cAMP) in smooth muscle cells. Elevated cAMP inhibits myosin light chain kinase (MLCK), resulting in smooth muscle relaxation without affecting autonomic receptors. Paracetamol's exact mechanism is not fully elucidated but is believed to involve central inhibition of cyclooxygenase (COX), particularly the COX-2 variant, and modulation of the endocannabinoid and serotonergic pathways, leading to analgesic and antipyretic effects with minimal peripheral anti-inflammatory activity.
Pregnancy: Category B (Drotaverine) / Category A (Paracetamol - in 1st & 2nd trimester) / Category C (Paracetamol - in 3rd trimester, if used long-term/high dose). Use only if clearly needed and under medical supervision. Avoid in first trimester unless benefit outweighs risk. Paracetamol is generally considered the analgesic of choice in pregnancy, but the Drotaverine component requires caution.
Driving: May cause dizziness, lightheadedness, or blurred vision. Patients should not drive or operate machinery until they know how the medicine affects them.
| Warfarin and other Coumarin Anticoagulants | Paracetamol may potentiate anticoagulant effect, increasing INR and bleeding risk, especially with high doses (>2g/day) or chronic use. | Moderate |
| Enzyme Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine, Phenobarbital, St. John's Wort) | Increased metabolism of Paracetamol to toxic metabolite (NAPQI), raising risk of hepatotoxicity even at therapeutic doses. | Major |
| Isoniazid | Increases risk of Paracetamol-induced hepatotoxicity. | Moderate |
| Probenecid | Decreases Paracetamol clearance, potentially increasing its levels and toxicity. | Moderate |
| Metoclopramide, Domperidone | May increase absorption rate of Paracetamol. | Minor |
| Cholestyramine | Reduces absorption of Paracetamol if taken within 1 hour. | Moderate |
| Alcohol (Chronic/Heavy Use) | Induces CYP2E1, increasing Paracetamol toxicity risk. Acute intoxication may also impair judgment leading to overdose. | Major |
| Other products containing Paracetamol (e.g., cold & flu remedies) | Risk of unintentional Paracetamol overdose exceeding 4g/day. | Major |
| Antihypertensives, Nitrates | Drotaverine may cause additive vasodilation and hypotension. | Moderate |
Same composition (Drotaverine (80mg) + Paracetamol (500mg)), different brands: