Celofen

Aceclofenac is indicated for the relief of pain and inflammation in the following conditions:

• Osteoarthritis
  For the symptomatic treatment of pain and inflammation associated with osteoarthritis.
• Rheumatoid Arthritis
  For the symptomatic treatment of pain, swelling, and stiffness in patients with rheumatoid arthritis.
• Ankylosing Spondylitis
  For the relief of pain and inflammation in patients with ankylosing spondylitis.
• Acute Musculoskeletal Disorders and Other Painful Conditions
  May also be used for the management of acute musculoskeletal pain, dental pain, postoperative pain, and other inflammatory conditions, as advised by a healthcare professional.

  Adults:
The recommended dose is 100 mg orally twice daily — once in the morning and once in the evening.

  Administration Instructions:

• Take with or after food to minimize gastrointestinal discomfort.
• Swallow the tablet whole with water; do not crush or chew.

  Elderly Patients:

• Use with caution, as they may be more susceptible to adverse effects.
• Consider using the lowest effective dose for the shortest duration.

  Children:

• Not recommended for pediatric use due to insufficient data on safety and efficacy.

  Renal or Hepatic Impairment:

• Use with caution and adjust the dose if necessary based on clinical condition and monitoring.

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works primarily by inhibiting the cyclooxygenase (COX) enzymes, specifically COX-2 more than COX-1. These enzymes are responsible for the synthesis of prostaglandins, which are chemical mediators involved in inflammation, pain, swelling, and fever. By reducing prostaglandin production, Aceclofenac exerts anti-inflammatory, analgesic, and antipyretic effects, making it effective in the treatment of conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

• Absorption:
  Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are typically reached within 1.25 to 3 hours.
• Distribution:
  It is highly protein-bound (≥99%) and distributes well into inflamed tissues, particularly synovial fluid.
• Metabolism:
  Aceclofenac is extensively metabolized in the liver, primarily to diclofenac, which also has anti-inflammatory properties. The metabolism is mainly via the cytochrome P450 system (CYP2C9).
• Elimination:
  Elimination is primarily through the renal route, with about 70% excreted in the urine, mostly as metabolites. The elimination half-life is approximately 4 to 4.3 hours.

• Anticoagulants (e.g., warfarin):
  Concurrent use may increase the risk of bleeding. Monitor INR and signs of bleeding closely.
• Aspirin and Other NSAIDs:
  Combined use may increase the risk of gastrointestinal ulcers and bleeding. Avoid using together unless clearly indicated.
• Antihypertensives (e.g., ACE inhibitors, ARBs, beta-blockers, diuretics):
  NSAIDs may reduce the antihypertensive effects and increase the risk of nephrotoxicity, especially in volume-depleted patients.
• Methotrexate:
  May increase methotrexate toxicity due to reduced renal clearance. Use with caution and monitor renal function.
• Lithium:
  Aceclofenac may increase lithium plasma levels, leading to toxicity. Monitor lithium levels closely if co-administered.
• Corticosteroids:
  Concurrent use may further increase the risk of gastrointestinal side effects, including ulcers and bleeding.
• Diuretics:
  May reduce diuretic effectiveness and increase the risk of kidney impairment, particularly when combined with ACE inhibitors or ARBs.
• Cyclosporine and Tacrolimus:
  Increased risk of nephrotoxicity when used together with NSAIDs.

• Hypersensitivity to aceclofenac, diclofenac, or any other NSAIDs.
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• Active or history of peptic ulcer disease or gastrointestinal bleeding.
• Severe hepatic, renal, or cardiac impairment.
• Pregnancy (especially third trimester), due to risk of fetal harm and premature closure of the ductus arteriosus.
• Cerebrovascular bleeding or other active bleeding disorders.
• Use in children is not recommended due to insufficient data on safety and efficacy.

Common side effects:

• Gastrointestinal issues such as dyspepsia, abdominal pain, nausea, diarrhea, flatulence, and occasionally gastritis.
• Headache, dizziness, and skin rash may also occur.

Less common but serious side effects:

• Gastrointestinal bleeding, peptic ulceration, or perforation, especially with prolonged use.
• Hepatic dysfunction, including elevated liver enzymes and, rarely, hepatitis.
• Renal impairment, especially in patients with existing kidney disease or on concurrent nephrotoxic drugs.
• Hypersensitivity reactions, such as angioedema, bronchospasm, or anaphylactoid reactions.
• Cardiovascular risks, such as hypertension, edema, and increased risk of thrombotic events with long-term use.

• Pregnancy:
  Aceclofenac is contraindicated during the third trimester of pregnancy due to the risk of premature closure of the ductus arteriosus, delayed labor, and potential fetal renal impairment. Its use during the first and second trimesters is generally not recommended, unless absolutely necessary, and only under medical supervision.
• Lactation:
  There is limited information on the excretion of aceclofenac in human breast milk. As a precaution, its use during breastfeeding should be avoided or used with caution, especially with prolonged treatment. If used, monitor the infant for any signs of adverse effects such as gastrointestinal disturbances.

NSAID (Aryl Acetic Acid Derivative)

Store below 25°C in a cool, dry place, away from direct sunlight and moisture.
Keep out of reach of children.