Usage
Aceclofenac + Beta-Cyclodextrin is primarily prescribed for managing pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and other musculoskeletal disorders. It is also effective in managing fever.
- Pharmacological Classification: Non-steroidal anti-inflammatory drug (NSAID)
- Mechanism of Action: Aceclofenac inhibits cyclooxygenase (COX) enzymes, primarily COX-2, reducing the production of prostaglandins, mediators of pain and inflammation. Beta-cyclodextrin enhances aceclofenac’s solubility and bioavailability, leading to faster and increased absorption.
Alternate Names
- Aceclofenac-Beta-Cyclodextrin Complex
Brand Names:
Acent, Bextrin
How It Works
Pharmacodynamics: Aceclofenac exerts its analgesic and anti-inflammatory effects by inhibiting COX enzymes. This inhibition reduces prostaglandin synthesis, which are key mediators of pain, inflammation, and fever. Beta-cyclodextrin itself doesn’t have a direct pharmacological effect but improves aceclofenac’s delivery.
Pharmacokinetics:
- Absorption: Beta-cyclodextrin enhances aceclofenac absorption, leading to higher plasma concentrations compared to aceclofenac alone. Administration with food can slow the rate but not the extent of absorption.
- Metabolism: Aceclofenac is primarily metabolized in the liver through conjugation and oxidation.
- Elimination: Excreted primarily through the kidneys as metabolites.
Dosage
Standard Dosage
Adults:
100 mg of aceclofenac with 100mg of beta-cyclodextrin taken orally twice daily after meals. The maximum recommended daily dose is 200 mg of aceclofenac.
Children:
Dosage for children is not specifically established and depends on weight and age. The drug’s use in children should be done with caution and under strict medical supervision as pediatric safety data is limited.
Special Cases:
- Elderly Patients: Start with a lower dose (e.g., 100 mg once daily) and titrate up as needed based on tolerability and therapeutic response. Closely monitor renal and hepatic function.
- Patients with Renal Impairment: Dose reduction may be necessary depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Start with a lower dose (e.g., 100 mg once daily) and titrate up as needed, closely monitoring liver function.
- Patients with Comorbid Conditions: Exercise caution in patients with cardiovascular disease, diabetes, hypertension, and gastrointestinal disorders. Adjustments may be necessary.
Clinical Use Cases
Aceclofenac + Beta-Cyclodextrin’s usage in specific clinical scenarios like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations is not standard practice and lacks established dosing guidelines. Pain management in these situations usually involves other analgesics or anesthetics better suited for the circumstances.
Dosage Adjustments
Dosage modifications are necessary for patients with hepatic or renal impairment based on organ function. Considerations for metabolic disorders or genetic polymorphisms impacting drug metabolism may also necessitate adjustments.
Side Effects
Common Side Effects:
- Nausea
- Dyspepsia
- Headache
- Dizziness
- Diarrhea
- Abdominal Pain
- Heartburn
Rare but Serious Side Effects:
- Gastrointestinal bleeding
- Severe skin reactions (e.g., Stevens-Johnson syndrome)
- Blood disorders
- Anaphylaxis
Long-Term Effects:
- Increased risk of gastrointestinal issues with prolonged NSAID use
- Potential for renal or hepatic dysfunction with chronic use
Adverse Drug Reactions (ADR):
- Anaphylaxis
- Steven-Johnson Syndrome
- Toxic epidermal necrolysis
Contraindications
- Hypersensitivity to aceclofenac, beta-cyclodextrin, or any component of the medication
- Active gastrointestinal bleeding or ulceration
- Severe liver or kidney impairment
- History of asthma, urticaria, or allergic reaction triggered by NSAIDs or aspirin
- Third trimester of pregnancy
- Active bleeding disorders
- Coronary artery bypass graft surgery
Drug Interactions
- Other NSAIDs: Increased risk of gastrointestinal adverse effects.
- Anticoagulants (e.g., warfarin): Increased risk of bleeding.
- Antiplatelet agents (e.g., clopidogrel): Increased risk of bleeding.
- Corticosteroids: Increased risk of GI ulcers.
- Diuretics: Reduced diuretic effect and increased risk of renal impairment.
- ACE inhibitors: Reduced antihypertensive effect and increased risk of renal impairment.
- Lithium: Increased lithium levels.
- Methotrexate: Increased methotrexate toxicity.
- Cyclosporine: Increased risk of nephrotoxicity.
- Alcohol: Increased risk of gastrointestinal bleeding.
Pregnancy and Breastfeeding
- Pregnancy: Contraindicated during the third trimester. Use during the first and second trimesters should be avoided unless clearly necessary, and the lowest effective dose should be used for the shortest duration.
- Breastfeeding: Should be avoided as it may pass into breast milk.
Drug Profile Summary
- Mechanism of Action: COX inhibitor, primarily COX-2. Reduces prostaglandin synthesis.
- Side Effects: Nausea, dyspepsia, headache, dizziness, gastrointestinal bleeding (rare), skin reactions (rare), blood disorders (rare).
- Contraindications: Hypersensitivity, GI bleeding/ulcer history, severe hepatic/renal impairment, third-trimester pregnancy, active bleeding disorders.
- Drug Interactions: Other NSAIDs, anticoagulants, diuretics, lithium, methotrexate, alcohol.
- Pregnancy & Breastfeeding: Contraindicated in the third trimester and should be avoided during breastfeeding. Use with caution in the first and second trimesters.
- Dosage: Adults: 100 mg twice daily after meals. Adjustments needed for special populations.
- Monitoring Parameters: Renal function, liver function, signs of gastrointestinal bleeding.
Popular Combinations
Aceclofenac is sometimes combined with paracetamol for enhanced analgesic effects. However, using other NSAIDs concurrently is generally not recommended.
Precautions
- Pre-existing medical conditions: Patients with heart, liver, or kidney problems require close monitoring.
- Pregnant Women: Avoid use unless absolutely necessary and only under close medical supervision.
- Breastfeeding Mothers: Risk of neonatal exposure, avoid if possible.
- Children and Elderly: Close monitoring is recommended.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Beta-Cyclodextrin?
A: The typical adult dose is 100 mg twice daily after meals. Dosage adjustments are necessary for children, the elderly, and patients with hepatic or renal impairment.
Q2: What are the common side effects?
A: Common side effects include nausea, dyspepsia, headache, and dizziness.
Q3: Is Aceclofenac + Beta-Cyclodextrin safe during pregnancy?
A: It is contraindicated during the third trimester. Use in the first and second trimesters should be avoided unless clearly necessary and under close medical supervision.
Q4: Can I take this medication with alcohol?
A: Alcohol should be avoided as it can increase the risk of gastrointestinal bleeding.
Q5: How does Beta-cyclodextrin affect Aceclofenac?
A: Beta-cyclodextrin enhances the solubility and bioavailability of Aceclofenac, leading to improved absorption.
Q6: What conditions is this medication used to treat?
A: Primarily osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and other musculoskeletal disorders; also effective in managing fever.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is close to the time for your next dose. Do not double the dose to catch up.
Q8: Are there any serious side effects I should be aware of?
A: While rare, serious side effects can include gastrointestinal bleeding, severe skin reactions, and blood disorders. Seek immediate medical attention if these occur.
Q9: Can this medicine interact with other drugs I’m taking?
A: Yes, Aceclofenac + Beta-Cyclodextrin can interact with numerous medications, including other NSAIDs, anticoagulants, diuretics, and certain heart medications. Be sure to inform your doctor about all other medications you are using.
