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Aceclofenac

 

1. Generic Name & Brand Names

  • Generic Name: Aceclofenac

  • Common Brand Names (Varies Globally):

    • Aceproxy® (India, MENA)

    • Airtal® (Europe, LATAM)

    • Zerodol®/Zerodol-SP® (India - with muscle relaxants)

    • Preservex® (UK)

    • Generic brands (e.g., "Aceclofenac," "Aceclo")

2. Dosage Forms

  • Oral:

    • Tablets (100 mg)

    • Dispersible tablets

    • Sustained-release tablets (200 mg)

  • Topical:

    • Gel (1.5%, 2%)

    • Cream (rare)

  • No injectable/suppository forms

3. Drug Class

  • NSAID (Non-Steroidal Anti-Inflammatory Drug)

  • Subclass: Phenylacetic acid derivative (diclofenac analogue)

  • Analgesic, Anti-inflammatory

4. Uses

  • Inflammatory Conditions:

    • Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis

  • Acute Pain:

    • Dental pain, Post-traumatic/swelling, Tendonitis

  • Off-label: Gout, Dysmenorrhea

5. Side Effects

  • Common (≥1%):

    Dyspepsia, nausea, diarrhea, abdominal pain
    Dizziness, headache

  • Serious (Require Immediate Discontinuation):

    • GI Bleeding: Melena (black stools), hematemesis

    • Cardiovascular Events: Chest pain, stroke symptoms

    • Renal Toxicity: Oliguria, ankle edema

    • Severe Skin Reactions: SJS/TEN, DRESS syndrome

    • Hepatitis: Jaundice, elevated LFTs

6. Warnings Before Taking

  • Black Box Warning (Region-Specific):

    ↑ Risk of CV thrombotic events (MI/stroke) and GI bleeding/perforation

  • Absolute Contraindications:

    • NSAID/aspirin allergy

    • Active peptic ulcer/GI bleeding

    • CABG surgery perioperative pain

    • 3rd trimester pregnancy

    • Severe heart/kidney/liver failure

  • Use with Extreme Caution If:

    Hypertension, IBD, elderly >65 years, on anticoagulants (e.g., warfarin)

  • Drug Interactions:

    • Avoid with: ACE inhibitors (e.g., lisinopril), diuretics (furosemide), lithium

7. How to Take It

  • Standard Dose: 100 mg twice daily (max 200 mg/day)

  • With Food: Always take after meals

  • Sustained-Release: Swallow whole (do not crush) - 200 mg once daily

  • Topical Gel: Apply 3-4x daily (max 4 weeks)

  • Duration: Shortest effective period (avoid >2 weeks without medical review)

8. Uses in Adults

  • Chronic inflammatory arthritis (lowest effective dose)

  • Acute pain flares (≤7 days)

  • Not for fever or mild headaches

9. Missed Dose

  • Take ASAP if within 3 hours

  • Skip if >3 hours; resume next scheduled dose

  • Never double dose

10. Overdose

  • Symptoms:

    Vomiting, GI bleeding, seizures, renal failure

  • Management:

    • Emergency medical help immediately

    • Gastric lavage + activated charcoal (within 1 hr)

    • Supportive care (no specific antidote)

11. Avoid While Taking

  • Other NSAIDs: Diclofenac, ibuprofen

  • Alcohol: ↑ GI ulcer risk

  • Corticosteroids: (e.g., prednisone) - ↑ bleeding

  • SSRIs/SNRIs: (e.g., fluoxetine) - ↑ bleeding risk

12. Storage

  • Temperature: Below 30°C (86°F)

  • Moisture: Keep in original blister pack

  • Topical Gel: Avoid freezing/sunlight

  • Keep away from children (100 mg = 10 adult doses for child)

Critical Safety Notes:

⚠️ GI Risk Mitigation:

  • Always combine with PPI (e.g., omeprazole) in high-risk patients

  • Monitor Hb regularly for occult bleeding
    ⚠️ Cardiovascular Hazard:

Avoid in established CVD/uncontrolled HTN
⚠️ Renal Check:
Assess serum creatinine before long-term use
⚠️ Topical ≠ Safe:
Systemic absorption occurs - never combine with oral NSAIDs

Requires Prescription: Not available OTC in most countries. Regular LFT/kidney monitoring recommended for chronic use.

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