Aceclofenac

Mild to moderate: As conventional tab or cap: Use the lowest effective dose for the shortest possible duration. Severe: Contraindicated.

Mild to moderate: As conventional tab or cap: Initially, 100 mg daily. Severe: Contraindicated.

Aceclofenac Should be taken with food.

Hypersensitivity to aceclofenac; history of hypersensitivity reactions (e.g. asthma, rhinitis, urticaria, angioedema) to aspirin, ibuprofen or other NSAIDs. History of stroke or MI; uncontrolled hypertension, CHF (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease, cerebrovascular disease; active gastrointestinal bleeding or perforation, history of gastrointestinal bleeding or perforation related to previous NSAID therapy, active or history of recurrent peptic ulcer/haemorrhage; active bleeding or bleeding disorders. Use in the setting of CABG surgery. Severe renal and hepatic impairment. Pregnancy (3rd trimester).

Patient with history of bronchial asthma, history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease); fluid retention, risk factors for CV events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), CHF (NYHA class I), history of cerebrovascular bleeding; SLE, mixed connective tissue disorders; hepatic porphyria. Avoid use in patients with varicella infection. Patients undergoing surgery. Mild to moderate renal and hepatic impairment. Elderly. Pregnancy (1st-2nd trimester) and lactation. Concomitant use with corticosteroids, SSRIs, antiplatelets, anticoagulants, and diuretics.

Significant: CV thrombotic events, including MI and stroke; haematologic effects (e.g. decreased platelet adhesion and aggregation, prolonged bleeding time); CNS effects (e.g. drowsiness, dizziness); hyperkalaemia, increased transaminases, fluid retention and oedema, new-onset or exacerbation of pre-existing hypertension, renal effects (e.g. deteriorated renal function, precipitate renal failure); hypersensitivity reactions, photosensitivity. Rarely, severe blood dyscrasias (e.g. aplastic anaemia, thrombocytopenia, agranulocytosis), hepatitis, blurred vision; increased risk of aseptic meningitis (particularly in patients with SLE and mixed connective tissue disorders).
Gastrointestinal disorders: Nausea, diarrhoea, dyspepsia, abdominal pain, vomiting, constipation, flatulence, gastritis, mouth ulceration.
Investigations: Increased blood BUN and creatinine.
Skin and subcutaneous tissue disorders: Rash, pruritus, dermatitis, urticaria.
Potentially Fatal: Gastrointestinal ulceration, bleeding and perforation; severe bronchospasm (particularly in patients with asthma). Rarely, serious skin reactions (e.g. Stevens-Johnsons syndrome, toxic epidermal necrolysis, exfoliative dermatitis).

This drug may cause drowsiness, dizziness or blurred vision, if affected, do not drive or operate machinery.

Monitor LFTs periodically, renal function tests (urine output, serum BUN, creatinine), blood pressure, CBC, serum potassium, and occult blood loss. Perform ophthalmic exam as necessary (long-term use).

Symptoms: Headache, vomiting, nausea, epigastric pain, gastrointestinal irritation and bleeding, diarrhoea, disorientation, excitation, dizziness, drowsiness, tinnitus, hypotension, fainting, convulsions, respiratory depression, coma, and renal failure or liver damage for significant doses.

Management: Symptomatic and supportive treatment. Give activated charcoal or perform gastric lavage within 1 hour of ingestion. Administer IV diazepam for frequent or prolonged convulsions. Closely monitor renal and hepatic function.

Increased risk of gastrointestinal ulceration and bleeding with anticoagulants (e.g. warfarin), corticosteroids, and SSRIs. Increased risk of nephrotoxicity with diuretics, ciclosporin, and tacrolimus. May inhibit the renal clearance resulting in increased plasma levels of cardiac glycosides (e.g. digoxin) and lithium. May enhance the risk of renal insufficiency with ACE inhibitors or angiotensin II receptor antagonists. May increase the plasma levels and toxicity of methotrexate. May decrease the effects of mifepristone. May enhance the risk of convulsions with quinolones.
Potentially Fatal: Increased risk of gastrointestinal ulceration and bleeding with other NSAIDs, COX-2 selective inhibitors, and antiplatelets (e.g. aspirin).

Increased risk of gastrointestinal bleeding with alcohol.

May result in a false-positive aldosterone/renin ratio (ARR).

Description:
Mechanism of Action: Aceclofenac, a phenylacetic acid derivative, a potent inhibitor of cyclooxygenase (COX) enzyme which is involved in the production of prostaglandins, thereby causing marked anti-inflammatory and analgesic effects.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract (conventional tab). Time to peak plasma concentration: 1-3 hours (conventional tab).
Distribution: Penetrates the synovial fluid. Volume of distribution: Approx 25 L (conventional tab). Plasma protein binding: >99% (conventional tab).
Metabolism: Metabolised into 4'-hydroxyaceclofenac.
Excretion: Via urine (approx ²/₃ mainly as hydroxymetabolites). Elimination half-life: Approx 4 hours (conventional tab).

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 71771, Aceclofenac. https://pubchem.ncbi.nlm.nih.gov/compound/Aceclofenac. Accessed Mar. 27, 2026.

Store below 30°C.

Thuốc kháng viêm không steroid

M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

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