Acedol SR

• Approved Uses:
• Relief of pain and inflammation in rheumatoid arthritis (RA).
• Osteoarthritis (OA).
• Ankylosing spondylitis.
• Musculoskeletal disorders causing acute and chronic pain (e.g., soft tissue injuries, back pain).
• Postoperative pain and dental pain management.
• Important Off-label Uses (Clinically Accepted):
• Management of inflammatory conditions such as bursitis and tendinitis.
• Pain associated with dysmenorrhea.
• Symptomatic treatment in gouty arthritis flare-ups.

রেজিস্টার্ড চিকিৎসকের পরামর্শ ছাড়া ওষুধ সেবন করবেন না।

• Adults:
• Typical dose: 100 mg orally twice daily.
• Take after meals to minimize gastrointestinal discomfort.
• Elderly:
• Use with caution; start at the lowest effective dose.
• Monitor closely for adverse effects, especially gastrointestinal and renal.
• Pediatric:
• Safety and efficacy not well established; generally not recommended under 18 years.
• Renal Impairment:
• Avoid use in severe renal impairment (creatinine clearance <30 mL/min).
• Use with caution in mild to moderate impairment; monitor renal function.
• Hepatic Impairment:
• Use cautiously; no specific dose adjustment available.
• Special Conditions:
• In patients with cardiovascular risk factors, use the lowest effective dose for the shortest duration.

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits cyclooxygenase enzymes, primarily COX-2, resulting in decreased synthesis of prostaglandins which mediate pain, inflammation, and fever. By reducing prostaglandin production at the site of inflammation, aceclofenac exerts analgesic, anti-inflammatory, and antipyretic effects, providing symptomatic relief in inflammatory and painful conditions.

• Absorption:
• Well absorbed orally with peak plasma concentrations reached within 1.25 to 3 hours post-dose.
• Bioavailability approximately 100% (rapid and almost complete absorption).
• Distribution:
• Widely distributed; approximately 99.7% bound to plasma proteins.
• Volume of distribution is about 0.12–0.17 L/kg.
• Metabolism:
• Primarily metabolized in the liver to active metabolite 4'-hydroxyaceclofenac and other inactive metabolites.
• Metabolism involves cytochrome P450 enzymes, mainly CYP2C9.
• Excretion:
• Eliminated mainly via renal route (around 75%).
• Half-life is approximately 4 hours.
• Also excreted via bile into feces.

• Pregnancy:
• Category C (FDA): Use only if potential benefit justifies the potential risk to the fetus.
• Avoid in the third trimester due to risk of premature closure of the ductus arteriosus and other fetal toxicities.
• Lactation:
• Excreted in breast milk in small amounts.
• Caution advised; breastfeeding not recommended unless benefits outweigh risks.
• Data Limitations:
• Limited human data; caution advised when prescribing during pregnancy and lactation.

• Primary Class: Nonsteroidal Anti-Inflammatory Drug (NSAID).
• Subclass: Preferential COX-2 inhibitor NSAID.

• Hypersensitivity to aceclofenac or any NSAIDs.
• History of asthma, urticaria, or allergic-type reactions after NSAIDs.
• Active or history of recurrent peptic ulcer or gastrointestinal bleeding.
• Severe renal impairment or severe hepatic impairment.
• Third trimester of pregnancy.
• Concurrent use with other NSAIDs (except low-dose aspirin).
• Established cardiovascular disease with caution; avoid in recent coronary artery bypass graft surgery.

• Risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke; caution in patients with cardiovascular risk factors.
• Gastrointestinal bleeding, ulceration, and perforation can occur, especially in elderly or those with history of GI disease; monitor for signs such as melena, hematemesis.
• Renal toxicity risk; monitor renal function in prolonged use, especially in elderly and those with pre-existing renal disease.
• Hepatic effects; monitor liver enzymes in prolonged therapy.
• May cause hypersensitivity reactions including anaphylaxis.
• Avoid use in patients with severe heart failure.
• Use the lowest effective dose for the shortest duration to reduce risks.

• Common:
• Gastrointestinal: dyspepsia, nausea, abdominal pain, diarrhea.
• Central nervous system: headache, dizziness.
• Skin reactions: rash, pruritus.
• Serious/Rare:
• GI bleeding, ulcers, perforation.
• Hepatotoxicity.
• Renal impairment or acute renal failure.
• Severe hypersensitivity reactions (anaphylaxis, Stevens-Johnson syndrome).
• Cardiovascular events (MI, stroke).
• Onset usually within days to weeks of starting therapy, dose-dependent for GI and renal effects.

• Warfarin and other anticoagulants: Increased risk of bleeding.
• ACE inhibitors/ARBs: Reduced antihypertensive effect; increased risk of renal impairment.
• Diuretics: Reduced diuretic efficacy; increased nephrotoxicity risk.
• Lithium: Increased lithium plasma levels and toxicity.
• Methotrexate: Increased risk of toxicity due to reduced renal clearance.
• Other NSAIDs and corticosteroids: Increased risk of GI adverse effects.
• Cytochrome P450: Metabolized mainly by CYP2C9; inhibitors or inducers may alter aceclofenac levels.
• Alcohol: Increased risk of GI bleeding.

• Recent clinical guidelines recommend careful cardiovascular risk assessment prior to NSAID use, including aceclofenac.
• EMA and FDA stress minimizing duration and dose, especially in high-risk groups.
• Updated contraindications in severe heart failure and recent cardiac surgery.
• Monitoring liver and renal function advised during prolonged therapy.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• Do not freeze.
• Tablets should not be crushed or split if sustained-release formulation.
• No reconstitution or refrigeration required.