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")

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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

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3. Drug Class

• NSAID (Non-Steroidal Anti-Inflammatory Drug)

• Subclass: Phenylacetic acid derivative (diclofenac analogue)

• Analgesic, Anti-inflammatory

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4. Uses

• Inflammatory Conditions:

  • Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis

• Acute Pain:

  • Dental pain, Post-traumatic/swelling, Tendonitis

• Off-label: Gout, Dysmenorrhea

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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

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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

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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)

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8. Uses in Adults

• Chronic inflammatory arthritis (lowest effective dose)

• Acute pain flares (≤7 days)

• Not for fever or mild headaches

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9. Missed Dose

• Take ASAP if within 3 hours

• Skip if >3 hours; resume next scheduled dose

• Never double dose

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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)

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11. Avoid While Taking

• Other NSAIDs: Diclofenac, ibuprofen

• Alcohol: ↑ GI ulcer risk

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

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

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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)

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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.