Aceclofenac - instructions, indications, composition, side effects

Active Ingredient: Aceclofenac

Excipients: May include lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and other inactive ingredients depending on the formulation.

Tablets: Available in various strengths, including 100 mg and 200 mg tablets.

Solution for Injections: Available in 50 mg/ml concentration in ampules of 1 ml or 2 ml.

Aceclofenac belongs to the pharmacological group of nonsteroidal anti-inflammatory drugs (NSAIDs), specifically a derivative of diclofenac (ATC code: M01A B16).

Pharmacodynamics: Aceclofenac exerts anti-inflammatory, analgesic, and antipyretic effects by inhibiting the enzyme cyclooxygenase (COX), thereby reducing the synthesis of prostaglandins involved in pain and inflammation.

Pharmacokinetics: Following oral administration, aceclofenac is rapidly and well-absorbed from the gastrointestinal tract. It undergoes extensive metabolism in the liver and is primarily eliminated through urinary and biliary excretion.

Aceclofenac is indicated for the treatment of:

• Pain and inflammation associated with osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute musculoskeletal disorders
• Postoperative pain

Aceclofenac is contraindicated in individuals with a history of hypersensitivity to aceclofenac, other NSAIDs, or any component of the formulation. It should not be used in patients with active peptic ulcer disease, severe heart failure, or renal impairment.

Aceclofenac may interact with other medications, including anticoagulants, antiplatelet drugs, diuretics, ACE inhibitors, and lithium, potentially increasing the risk of bleeding or adverse effects. Caution is advised when co-administering aceclofenac with other drugs.

Aceclofenac tablets should be taken orally with or after food to reduce the risk of gastrointestinal irritation. The dosage and duration of therapy should be individualized based on the patient’s condition, response to treatment, and risk factors for adverse effects.

Aceclofenac is contraindicated during pregnancy, especially in the third trimester, due to the potential risk of fetal harm. It should be avoided in breastfeeding women, as it may be excreted in breast milk and could harm the nursing infant.

Aceclofenac may cause dizziness, drowsiness, or visual disturbances in some patients. Therefore, caution is advised when driving or operating machinery, especially during the initiation of therapy or following dosage adjustments.

The recommended dosage of aceclofenac varies depending on the indication, severity of pain, and patient factors. Healthcare providers will determine the appropriate dose and treatment duration based on clinical judgment and guidelines.

In the event of an overdose, supportive measures should be initiated as needed. Aceclofenac overdoses may lead to symptoms such as gastrointestinal irritation, nausea, vomiting, and renal impairment. Immediate medical attention is required in cases of overdose.

Common side effects of aceclofenac may include gastrointestinal disturbances (e.g., dyspepsia, abdominal pain), headache, dizziness, and rash. Serious adverse effects such as gastrointestinal bleeding, cardiovascular events, and renal impairment are rare but may occur, especially with prolonged use or at high doses.

Aceclofenac tablets and solution for injections should be stored at room temperature (15-30°C) in a dry place, protected from light and moisture. Keep out of reach of children. Check the expiration date on the packaging and discard any expired or unused medication.

These extended instructions provide comprehensive information on the composition, pharmacological properties, indications, contraindications, interactions, administration, side effects, storage, and usage of Aceclofenac, aiding healthcare professionals and patients in safe and effective pain management. Always consult a healthcare provider for personalized medical advice.