A fixed-dose combination (FDC) of Aceclofenac, a potent non-steroidal anti-inflammatory drug (NSAID) of the phenylacetic acid group, and Rabeprazole, a proton pump inhibitor (PPI) of the benzimidazole class. This combination is designed to provide effective analgesic and anti-inflammatory action for musculoskeletal conditions while mitigating the risk of NSAID-induced gastroduodenal ulcers and dyspepsia. It is a rational therapy for conditions requiring prolonged NSAID use, particularly in patients with a history of or risk factors for GI toxicity.
Adult: One tablet (Aceclofenac 200mg + Rabeprazole 20mg) orally, twice daily. Preferably taken after food to minimize GI discomfort. The lowest effective dose for the shortest duration should be used.
Note: Swallow the tablet whole with a full glass of water. Do not crush, chew, or break. Should be taken after meals. The rabeprazole component is an enteric-coated tablet; breaking it destroys the coating. Maintain adequate hydration during therapy.
Aceclofenac exerts its therapeutic effects primarily through the inhibition of the cyclooxygenase (COX) enzyme, specifically COX-2, thereby reducing the synthesis of prostaglandins (PGs) which are key mediators of pain, inflammation, and fever. It also demonstrates stimulatory effects on cartilage matrix synthesis (glycosaminoglycans). Rabeprazole is a prodrug that accumulates in the acidic environment of parietal cells, where it is activated and forms covalent disulfide bonds with cysteine residues on the H+/K+ ATPase (proton pump), irreversibly inhibiting the final step of gastric acid secretion.
Pregnancy: Pregnancy Category C (first and second trimester) and Category D (third trimester). Avoid use in the third trimester due to risk of premature closure of ductus arteriosus, oligohydramnios, and delayed labor. Use during 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 if they experience these effects.
| Anticoagulants (Warfarin) | Increased risk of bleeding due to NSAID-induced platelet inhibition and potential displacement from protein binding. | Major |
| Anti-platelets (Aspirin, Clopidogrel) | Additive risk of GI bleeding. Aceclofenac may antagonize antiplatelet effect of low-dose aspirin. | Major |
| Corticosteroids (Prednisolone) | Significantly increased risk of GI ulceration and bleeding. | Major |
| Diuretics (Furosemide, Thiazides) | Reduced diuretic and antihypertensive efficacy; increased risk of renal impairment. | Moderate |
| ACE Inhibitors / ARBs (Ramipril, Losartan) | Reduced antihypertensive effect; increased risk of renal impairment, especially in volume-depleted patients. | Moderate |
| Methotrexate | May decrease methotrexate clearance, increasing toxicity risk (myelosuppression). | Major |
| Lithium | Aceclofenac may increase lithium serum levels, risking toxicity. | Moderate |
| Cyclosporine, Tacrolimus | Increased risk of nephrotoxicity. | Moderate |
| Other NSAIDs (including topical) | Increased risk of GI and renal adverse effects without added benefit. | Major |
| Clopidogrel | Rabeprazole (a weak CYP2C19 inhibitor) may have less impact on clopidogrel's antiplatelet activity compared to omeprazole, but caution is still advised. | Moderate |
| Ketoconazole, Itraconazole | Rabeprazole increases gastric pH, which can reduce absorption of these pH-dependent azole antifungals. | Moderate |
| Digoxin | Increased gastric pH may slightly increase digoxin bioavailability. | Minor |
Same composition (Aceclofenac (200mg) + Rabeprazole (20mg)), different brands: