Acenac
Generic Name
acenac (aceclofenac)
Manufacturer
Various (e.g., Square Pharmaceuticals)
Country
Global (e.g., Bangladesh, India)
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Description
Overview of the medicine
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also has antipyretic properties.
Uses & Indications
Dosage
Adults
100 mg twice daily. Maximum daily dose is 200 mg.
Elderly
No specific dose adjustment is usually required, but caution is advised due to increased risk of side effects. Lowest effective dose should be used.
Renal_impairment
No dose reduction in mild renal impairment. Not recommended in patients with severe renal impairment.
How to Take
Oral administration. Tablets should be swallowed whole with a sufficient amount of liquid, with or after food to minimize gastrointestinal discomfort.
Mechanism of Action
Aceclofenac primarily acts by inhibiting prostaglandin synthesis, mainly through the selective inhibition of cyclooxygenase-2 (COX-2) enzyme. This reduces the production of inflammatory mediators.
Pharmacokinetics
Onset
Analgesic effects typically begin within 1 hour.
Excretion
Approximately two-thirds of the administered dose is excreted in the urine, and one-third in the faeces, mainly as hydroxylated metabolites.
Half life
The plasma elimination half-life is approximately 4-4.3 hours.
Absorption
Well absorbed orally, with peak plasma concentrations occurring 1-3 hours after administration. Absolute bioavailability is approximately 98%.
Metabolism
Extensively metabolized in the liver, primarily via CYP2C9, into its main metabolite, 4'-hydroxyaceclofenac, and then to other metabolites including diclofenac.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any component of the formulation
- Patients with active peptic ulcer or gastrointestinal bleeding
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
- Severe renal impairment
- Severe hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- Patients in whom aspirin or other NSAIDs precipitate attacks of asthma, urticaria, or acute rhinitis
Drug Interactions
Lithium
Increased plasma lithium levels; monitoring of lithium levels is recommended.
Methotrexate
Increased methotrexate toxicity; caution is advised when administered concurrently.
Diuretics and ACE inhibitors
Reduced antihypertensive effect; increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding. Close monitoring of coagulation parameters is required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Management: Symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered shortly after ingestion. Monitor renal and liver function.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to potential adverse effects on the fetus and complications during labor. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Lactation: Not recommended during breastfeeding as it is not known whether aceclofenac is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any component of the formulation
- Patients with active peptic ulcer or gastrointestinal bleeding
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
- Severe renal impairment
- Severe hepatic impairment
- Severe heart failure
- Third trimester of pregnancy
- Patients in whom aspirin or other NSAIDs precipitate attacks of asthma, urticaria, or acute rhinitis
Drug Interactions
Lithium
Increased plasma lithium levels; monitoring of lithium levels is recommended.
Methotrexate
Increased methotrexate toxicity; caution is advised when administered concurrently.
Diuretics and ACE inhibitors
Reduced antihypertensive effect; increased risk of renal impairment.
Warfarin and other anticoagulants
Increased risk of bleeding. Close monitoring of coagulation parameters is required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Management: Symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered shortly after ingestion. Monitor renal and liver function.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to potential adverse effects on the fetus and complications during labor. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Lactation: Not recommended during breastfeeding as it is not known whether aceclofenac is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Widely Approved (e.g., DGDA, EMA)
Patent Status
Off-patent
Clinical Trials
Numerous clinical trials have evaluated the efficacy and safety of aceclofenac in various inflammatory and painful conditions, confirming its role as an effective NSAID.
Lab Monitoring
- Complete blood count (CBC) should be monitored periodically during long-term therapy.
- Liver function tests (LFTs) should be performed regularly, especially in patients with pre-existing hepatic impairment.
- Renal function tests (e.g., serum creatinine, BUN) should be monitored, particularly in elderly patients or those with renal impairment.
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- Monitor patients for signs and symptoms of GI bleeding and cardiovascular events, especially during long-term therapy.
- Exercise caution in patients with a history of hypertension, heart failure, liver or kidney dysfunction.
Patient Guidelines
- Always take this medicine exactly as your doctor has told you.
- Do not exceed the recommended dose.
- Take with or after food to reduce stomach upset.
- Inform your doctor if you experience any unusual symptoms or side effects.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
Driving Precautions
Aceclofenac may cause dizziness or visual disturbances. If you experience these effects, you should not drive or operate machinery.
Lifestyle Advice
- Avoid consuming alcohol while on this medication, as it may increase the risk of stomach irritation and bleeding.
- Maintain a healthy diet and stay hydrated.
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