Edolac
Generic Name
edolac-300-mg-capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
edolac 300 mg capsule | ৳ 8.03 | ৳ 80.30 |
Description
Overview of the medicine
Edolac 300 mg Capsule contains Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. This specific 300 mg formulation is intended for once-daily dosing.
Uses & Indications
Dosage
Adults
One 300 mg capsule once daily, preferably after food, or as directed by a physician. This higher strength formulation is typically for extended-release or specific indications.
Elderly
Lower doses or careful monitoring may be required. Consultation with a physician is essential due to increased risk of adverse effects.
Renal_impairment
Use with caution and at reduced doses (e.g., 100 mg/day) in mild to moderate renal impairment. Not recommended for severe renal impairment. Physician consultation is crucial.
How to Take
Swallow the capsule whole with water, preferably after a meal to minimize gastrointestinal side effects. Do not chew or crush the capsule.
Mechanism of Action
Aceclofenac exerts its anti-inflammatory, analgesic, and antipyretic effects primarily through the inhibition of prostaglandin synthesis. It achieves this by inhibiting the cyclo-oxygenase (COX) enzyme, which is involved in the conversion of arachidonic acid to prostaglandins.
Pharmacokinetics
Onset
Typically within 30-60 minutes for analgesic effects.
Excretion
Approximately two-thirds of the dose is excreted in the urine, mainly as hydroxylated metabolites, and about one-third in the feces.
Half life
Approximately 4-4.3 hours.
Absorption
Rapidly absorbed after oral administration. Oral bioavailability is approximately 100%. Peak plasma concentrations are reached within 1.25 to 3 hours.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 2C9 (CYP2C9), to its main metabolite, 4'-hydroxyaceclofenac.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or other NSAIDs (e.g., aspirin, ibuprofen)
- 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
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Increased plasma lithium levels, potentially leading to lithium toxicity, due to reduced renal excretion of lithium.
Methotrexate
Increased plasma methotrexate levels and toxicity due to reduced renal tubular secretion of methotrexate.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Diuretics and ACE inhibitors
Reduced efficacy of antihypertensive agents; increased risk of renal impairment, especially in dehydrated patients or elderly.
Warfarin and other anticoagulants
Increased risk of bleeding due to impaired platelet function and gastrointestinal irritation. Co-administration requires careful monitoring of INR.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose with Aceclofenac may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, and rarely, diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and convulsions. In case of suspected overdose, seek immediate medical attention. Management is primarily supportive and symptomatic. Gastric lavage and activated charcoal may be considered within an hour of ingestion.
Pregnancy & Lactation
Avoid use in the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus and potential inhibition of uterine contractions. Use with caution in other trimesters only if the potential benefit outweighs the risk and under strict medical supervision. Aceclofenac is excreted in breast milk in small amounts; use with caution during lactation, and a physician's advice is recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Available in pharmacies, hospitals
Approval Status
Approved by regulatory authorities in various countries (e.g., DGDA in Bangladesh)
Patent Status
Generic available, original patent expired
Clinical Trials
Extensive clinical trials have established the efficacy and safety of Aceclofenac for various inflammatory conditions. Specific trials related to a 300 mg capsule formulation would be documented by the manufacturing company and accessible through regulatory bodies.
Lab Monitoring
- Complete Blood Count (CBC) - for long-term use or if anemia/bleeding is suspected.
- Liver function tests (LFTs) - periodically, especially with long-term therapy.
- Renal function tests (e.g., serum creatinine, Blood Urea Nitrogen - BUN) - periodically, especially in elderly or patients with renal impairment risk factors.
Doctor Notes
- Prioritize lowest effective dose for shortest duration consistent with individual patient treatment goals.
- Monitor renal and hepatic function, and blood pressure periodically during long-term therapy, especially in elderly or at-risk patients.
- Advise patients on signs and symptoms of gastrointestinal bleeding or cardiovascular events and instruct them to seek immediate medical attention if these occur.
- Caution in patients with a history of cardiovascular disease, hypertension, fluid retention, or existing gastrointestinal disorders. Co-administer with a proton pump inhibitor if GI risk is high.
- Review concomitant medications for potential drug interactions.
Patient Guidelines
- Take the capsule exactly as prescribed by your doctor and do not exceed the recommended dose.
- Take with food or milk to reduce stomach upset.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, coffee-ground vomit) to your doctor immediately.
- Avoid alcohol and other NSAIDs concurrently without consulting your doctor.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Do not use this medicine if you are pregnant (especially in the third trimester) or breastfeeding without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Edolac 300 mg Capsule may cause dizziness, drowsiness, or visual disturbances in some patients. Patients experiencing these effects should avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, as advised by your doctor, which can help manage chronic pain conditions.
- Avoid smoking and limit alcohol consumption, as these can increase the risk of gastrointestinal side effects associated with NSAIDs.
- Discuss appropriate pain management strategies with your healthcare provider.
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