Avenac® (Aceclofenac) - Professional Product Monograph

NSAID for inflammatory pain management

Indications

• Inflammatory Pain Relief:

  • Osteoarthritis • Rheumatoid arthritis • Ankylosing spondylitis

  • Acute trauma • Lumbago • Dental pain
    (Use under registered physician's guidance)

Pharmacology

Mechanism of Action

• Potent COX-1/COX-2 inhibitor → suppresses prostaglandin synthesis

• Key Effects:

  • Anti-inflammatory • Analgesic • Antipyretic

Pharmacokinetics

• Absorption: Rapid and complete (oral bioavailability >99%)

• Tₘₐₓ: 1.3-3 hours

• Half-life: 4-4.3 hours

• Metabolism: Hepatic (CYP2C9) → active metabolite *4'-hydroxyaceclofenac*

• Excretion: Renal (70-80%)

Dosage & Administration

• Take with food to reduce GI irritation

• Use lowest effective dose for shortest duration
  (Follow registered physician's advice)

Drug Interactions

Contraindications

• Hypersensitivity to NSAIDs/aspirin

• History of NSAID-induced asthma/bronchospasm

• Active GI bleeding/peptic ulcer

• Third trimester pregnancy

• Severe heart failure (NYHA Class IV)

Side Effects

Common (≥5%):

• Dyspepsia • Nausea • Abdominal pain • Diarrhea

• Dizziness • Headache

Serious (Require Discontinuation):

• GI ulceration/hemorrhage (melena, hematemesis)

• Hepatotoxicity (↑ ALT/AST >3× ULN)

• Renal impairment (↑ creatinine, oliguria)

• Cardiovascular thrombosis (MI/stroke)

Pregnancy & Lactation

• Pregnancy (Category C):

  • Avoid in first/second trimester unless essential

  • Contraindicated in third trimester (premature ductus arteriosus closure)

• Lactation:

  • Excreted in milk; avoid nursing

Precautions & Warnings

1. GI Risk:

   • Screen for H. pylori; add PPI in high-risk patients (age >65, steroid co-therapy)

2. Cardiovascular:

   • Avoid in established CAD/stroke; monitor BP

3. Hepatic/Renal:

   • Baseline and periodic LFTs/renal function

   • Avoid if CrCl <30 mL/min or Child-Pugh C

4. Hypersensitivity:

   • Cross-reactivity with sulfonamides/salicylates

Use in Special Populations

Therapeutic Class

Non-Steroidal Anti-Inflammatory Drug (NSAID)

Storage

• Below 30°C • Protect from light/moisture

• Keep out of children's reach