Maximum Dosage of Aceclofenac
The maximum recommended dosage of aceclofenac is 200 mg daily, taken as a single dose or divided into two doses of 100 mg twice daily. 1
Dosage Forms and Administration
Aceclofenac is available in two main formulations:
- Immediate-release tablets: 100 mg twice daily (total 200 mg/day) 2
- Controlled-release (CR) formulation: 200 mg once daily 1, 3
The controlled-release formulation (Clanza CR) provides biphasic release consisting of immediate release of 85 mg followed by sustained release of 115 mg, allowing for once-daily dosing while maintaining equivalent bioavailability to the immediate-release formulation 3.
Clinical Evidence and Usage
Aceclofenac is a phenylacetic acid derivative NSAID with anti-inflammatory and analgesic properties similar to diclofenac but with potentially improved gastrointestinal tolerability 4. It is indicated for:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Abarticular inflammations
- Post-trauma or post-operative inflammations 2
In clinical trials, aceclofenac has demonstrated efficacy comparable to other NSAIDs including ketoprofen, indomethacin, diclofenac, piroxicam, tenoxicam, and naproxen across various rheumatic conditions 4, 5.
Special Considerations
Duration of Treatment
When used for chronic non-bacterial osteitis (CNO), expert consensus recommends NSAIDs at maximum tolerated and approved dosage for 2-4 weeks, followed by evaluation of treatment response 6. If response is sufficient, treatment can be continued with consideration of switching to on-demand treatment or dose tapering after 12 weeks of sustained response.
Safety Precautions
As with all NSAIDs, aceclofenac carries risks of:
- Gastrointestinal adverse effects
- Cardiovascular complications
- Renal complications
- Hepatic complications 6
Contraindications
Aceclofenac should be avoided in patients with:
- History of NSAID-associated upper GI tract bleeding
- Moderate to severe kidney disease
- Cirrhosis
- Congestive heart failure
- Aspirin/NSAID-induced asthma 6
Food Effect
Food does not significantly affect the bioavailability of controlled-release aceclofenac. The 90% confidence intervals of the geometric mean ratios for AUC24 and Cmax of aceclofenac in fed and fasted states were within the bioequivalence range, indicating that controlled-release aceclofenac can be taken without regard to meals 3.
Monitoring Recommendations
For patients on long-term aceclofenac therapy:
- Monitor renal function
- Monitor blood pressure
- Monitor for GI symptoms
- Assess pain control using validated tools to determine treatment efficacy
Conclusion
The maximum daily dose of aceclofenac is 200 mg, which can be administered as either 100 mg twice daily (immediate-release) or 200 mg once daily (controlled-release). This dosage should not be exceeded due to increased risk of adverse effects without additional therapeutic benefit.