COMPOSITION
Each film-coated tablet contains:
- Aceclofenac 100 mg
- Paracetamol (Acetaminophen) 325 mg
CLINICAL PHARMACOLOGY
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase
(COX), thereby reducing prostaglandin synthesis involved in pain and inflammation.
Paracetamol has analgesic and antipyretic actions, primarily acting in the CNS by inhibiting COX-3 and enhancing the pain threshold.
The combination provides synergistic effects for better pain and inflammation control with improved tolerability.
INDICATIONS AND USAGE
- Relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
- Management of musculoskeletal disorders, back pain, and dental pain.
- Short-term relief of fever and moderate pain where dual action is beneficial.
CONTRAINDICATIONS
- Hypersensitivity to aceclofenac, paracetamol, or any other NSAIDs.
- History of gastrointestinal bleeding or active peptic ulcer.
- Severe hepatic or renal impairment.
PRECAUTIONS
- Use with caution in patients with liver dysfunction, asthma, or hypertension.
- Prolonged use may cause hepatotoxicity (due to paracetamol) or GI irritation (due to aceclofenac).
- Avoid alcohol consumption to reduce risk of liver damage.
DRUG INTERACTIONS
- May enhance the effect of anticoagulants like warfarin, increasing bleeding risk.
- Concurrent use with methotrexate or other NSAIDs may elevate toxicity.
- Alcohol and enzyme-inducing drugs can increase hepatotoxic potential of paracetamol.
PREGNANCY & LACTATION
- Not recommended during the third trimester of pregnancy due to risk of ductus arteriosus closure.
- Use only if clearly needed and under medical supervision during pregnancy or breastfeeding.
- Paracetamol is considered relatively safe in pregnancy at therapeutic doses.
DOSAGE AND ADMINISTRATION
- One tablet twice daily after meals, or as prescribed by the physician.
- Swallow whole with water, do not crush or chew.
- Do not exceed the prescribed dose to avoid hepatotoxicity.
ADVERSE REACTIONS
- Common: Gastric discomfort, nausea, dizziness, rash.
- Serious: Gastrointestinal bleeding, liver enzyme elevation, hypersensitivity reactions.
- Rare: Blood dyscrasias, nephrotoxicity, or anaphylactic reactions.