Aclo
Generic Name
Aceclofenac
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| aclo 100 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It helps in reducing swelling and improving mobility.
Uses & Indications
Dosage
Adults
The recommended dose is 100 mg twice daily, one tablet in the morning and one in the evening.
Elderly
Generally, no dose adjustment is required, but caution should be exercised. Start with the lowest effective dose.
Renal_impairment
No evidence that the dosage needs to be modified in patients with mild renal impairment. Caution is recommended. For severe renal impairment, use is contraindicated.
How to Take
Take the tablet whole with a glass of water, with or immediately after food to minimize gastrointestinal discomfort.
Mechanism of Action
Aceclofenac primarily acts by inhibiting prostaglandin synthesis, mainly through selective inhibition of cyclo-oxygenase-2 (COX-2) enzyme. This reduces the production of inflammatory mediators, thereby providing analgesic, anti-inflammatory, and antipyretic effects.
Pharmacokinetics
Onset
Analgesic effect usually starts within 30-60 minutes.
Excretion
Approximately two-thirds of the administered dose is excreted in the urine, mainly as hydroxylated metabolites, and about one-third via the faeces.
Half life
Approximately 4 hours (range 4 to 4.3 hours).
Absorption
Rapidly and completely absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached within 1.25 to 3 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, into its main metabolite 4'-hydroxyaceclofenac and other metabolites. Diclofenac is also a minor metabolite.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any excipients
- Patients with active gastrointestinal bleeding or peptic ulceration
- History of asthma, urticaria or acute rhinitis precipitated by aspirin or other NSAIDs
- Severe heart failure, severe hepatic or renal impairment
- Third trimester of pregnancy
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Digoxin
May increase plasma levels of digoxin.
Lithium
May increase plasma levels of lithium.
Methotrexate
May increase plasma levels and toxicity of methotrexate, especially at high doses.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Quinolone Antibiotics
Convulsions may occur.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Anticoagulants (Warfarin)
Increased risk of bleeding. Close monitoring of INR is required.
Diuretics and Antihypertensives (ACE inhibitors, ARBs)
May reduce the natriuretic and antihypertensive effects of these drugs. Concomitant use with ACE inhibitors or angiotensin II receptor antagonists may increase the risk of renal impairment.
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 include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and convulsions. Management is symptomatic and supportive. Gastric emptying (e.g., gastric lavage, activated charcoal) may be considered within 1 hour of ingestion.
Pregnancy & Lactation
Not recommended during the third trimester of pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Avoid during breastfeeding as it may pass into breast milk.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any excipients
- Patients with active gastrointestinal bleeding or peptic ulceration
- History of asthma, urticaria or acute rhinitis precipitated by aspirin or other NSAIDs
- Severe heart failure, severe hepatic or renal impairment
- Third trimester of pregnancy
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Digoxin
May increase plasma levels of digoxin.
Lithium
May increase plasma levels of lithium.
Methotrexate
May increase plasma levels and toxicity of methotrexate, especially at high doses.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Quinolone Antibiotics
Convulsions may occur.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Anticoagulants (Warfarin)
Increased risk of bleeding. Close monitoring of INR is required.
Diuretics and Antihypertensives (ACE inhibitors, ARBs)
May reduce the natriuretic and antihypertensive effects of these drugs. Concomitant use with ACE inhibitors or angiotensin II receptor antagonists may increase the risk of renal impairment.
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 include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and convulsions. Management is symptomatic and supportive. Gastric emptying (e.g., gastric lavage, activated charcoal) may be considered within 1 hour of ingestion.
Pregnancy & Lactation
Not recommended during the third trimester of pregnancy due to potential for premature closure of the fetal ductus arteriosus. Use with caution in the first and second trimesters only if the potential benefit outweighs the risk. Avoid during breastfeeding as it may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Available in all retail pharmacies and hospitals
Approval Status
Approved by DGDA and international regulatory bodies
Patent Status
Off-patent
Clinical Trials
Aceclofenac has undergone extensive clinical trials demonstrating its efficacy and safety in various inflammatory and painful conditions, comparing favorably with other NSAIDs.
Lab Monitoring
- Liver function tests (ALT, AST)
- Renal function tests (Creatinine, BUN)
- Complete blood count (CBC) for signs of anemia
- Stool occult blood test for long-term use
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration necessary.
- Monitor renal, hepatic, and cardiovascular function, especially in elderly or high-risk patients.
- Advise patients on signs and symptoms of GI bleeding and cardiovascular events.
- Consider gastroprotective agents for patients at high risk of GI complications.
Patient Guidelines
- Take with food to minimize stomach upset.
- Do not exceed the recommended dose.
- Inform your doctor about all other medications you are taking.
- Report any signs of stomach pain, black stools, or unusual bleeding immediately.
- Avoid alcohol consumption while on this medication.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.
Driving Precautions
Aceclofenac may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Engage in moderate exercise as advised by your doctor to improve joint health.
- Avoid smoking, as it can worsen inflammatory conditions and increase GI risks.
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Global Brand Names
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