Aceclofenac | Prescribing Information

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) analog of diclofenac. It is used for the relief of pain and inflammation in rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

It was patented in 1983 and approved for medical use in 1992.

Indications:

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma, and lumbago.

Pharmacology:

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed as an unchanged drug.

Dosage & Administration:

Extended-release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.

Film-coated tablet: The recommended dose in adults is 100 mg, twice daily.

Interaction:

No significant drug interactions have been observed but close monitoring of patients is required when it is used with:

  • Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
  • Diuretics: may interact with the activity of diuretics.
  • Anticoagulants: may enhance the activity of anticoagulants.
  • Methotrexate: may increase the plasma level of methotrexate.

Contraindications:

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

Side Effects:

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed as an unchanged drug.

Pregnancy & Lactation:

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Precautions & Warnings:

Caution should be exercised to patients with active or suspected peptic ulcer or gastrointestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

Use in Special Populations:

There are no clinical data on the use of Aceclofenac in children.

Storage Conditions:

  • Store in a cool & dry place below 30°C.
  • Protect from light & moisture.
  • Keep out of reach of children.

References:

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