ZENFENAC-P

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Aceclofenac and Paracetamol Tablets

ZENFENAC-P

Zenfenac_P

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.

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