Tenac-TR
Generic Name
Aceclofenac 100 mg Sustained Release Capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tenac tr 100 mg capsule | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation in various conditions. The sustained-release (TR) formulation provides prolonged therapeutic effect, allowing for less frequent dosing.
Uses & Indications
Dosage
Adults
100 mg once daily. The capsule should be swallowed whole with fluid, preferably with food.
Elderly
Generally no dose adjustment needed, but use with caution due to increased risk of side effects. Consider lowest effective dose.
Renal_impairment
Use with caution in mild to moderate renal impairment. For severe renal impairment, it is generally contraindicated or requires significant dose reduction (e.g., 100 mg every other day).
How to Take
Take orally with food or immediately after a meal to minimize gastrointestinal discomfort. Swallow the capsule whole with water; do not crush, chew, or break it.
Mechanism of Action
Aceclofenac primarily acts by inhibiting prostaglandin synthesis through the inhibition of cyclooxygenase (COX) enzymes, particularly COX-2. This reduces inflammation, pain, and fever.
Pharmacokinetics
Onset
Pain relief typically begins within 1-2 hours; sustained release provides prolonged action over 24 hours.
Excretion
Approximately two-thirds of the dose is excreted in the urine and one-third in the feces, mainly as hydroxylated metabolites.
Half life
Approximately 4-4.3 hours.
Absorption
Well absorbed orally. Bioavailability approaches 100%. Peak plasma concentrations are achieved in 1-3 hours (for immediate release, sustained release will be longer and flatter).
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, to 4'-hydroxyaceclofenac and other metabolites.
Side Effects
Contraindications
- Hypersensitivity to Aceclofenac or any component of the formulation
- Active gastrointestinal bleeding, ulceration, or perforation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
Drug Interactions
Lithium
Increased plasma levels of lithium, leading to toxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Other NSAIDs and corticosteroids
Increased risk of gastrointestinal adverse effects.
Warfarin and other anticoagulants
Increased risk of bleeding.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of gastrointestinal bleeding.
ACE inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased 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 may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and convulsions. Management includes immediate gastric lavage, activated charcoal administration, and symptomatic and supportive treatment. Forced diuresis may be considered.
Pregnancy & Lactation
Avoid during the third trimester of pregnancy due to potential fetal harm and prolonged labor. Use with caution during the first and second trimesters only if the potential benefit outweighs the risk. Aceclofenac is excreted in breast milk; therefore, use with caution during lactation, or consider an alternative.
Side Effects
Contraindications
- Hypersensitivity to Aceclofenac or any component of the formulation
- Active gastrointestinal bleeding, ulceration, or perforation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
Drug Interactions
Lithium
Increased plasma levels of lithium, leading to toxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Other NSAIDs and corticosteroids
Increased risk of gastrointestinal adverse effects.
Warfarin and other anticoagulants
Increased risk of bleeding.
Selective Serotonin Reuptake Inhibitors (SSRIs)
Increased risk of gastrointestinal bleeding.
ACE inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased 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 may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and convulsions. Management includes immediate gastric lavage, activated charcoal administration, and symptomatic and supportive treatment. Forced diuresis may be considered.
Pregnancy & Lactation
Avoid during the third trimester of pregnancy due to potential fetal harm and prolonged labor. Use with caution during the first and second trimesters only if the potential benefit outweighs the risk. Aceclofenac is excreted in breast milk; therefore, use with caution during lactation, or consider an alternative.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Pharmacies nationwide
Approval Status
Approved by national regulatory authorities
Patent Status
Generic (Patent Expired)
Clinical Trials
Aceclofenac has undergone extensive clinical trials demonstrating its efficacy and safety in various pain and inflammatory conditions. Specific studies support the sustained-release formulation for once-daily dosing.
Lab Monitoring
- Renal function (serum creatinine, BUN) periodically, especially in long-term therapy or in patients with pre-existing renal impairment.
- Liver function tests (ALT, AST) periodically, particularly in long-term therapy.
- Complete blood count (CBC) in patients receiving long-term treatment.
Doctor Notes
- Monitor patients for signs of gastrointestinal bleeding, especially in elderly patients or those with a history of GI issues.
- Assess cardiovascular risk factors before and during treatment.
- Consider co-administration of a proton pump inhibitor (PPI) for patients at high risk of GI complications.
- Regularly assess renal function, particularly in patients with pre-existing renal impairment or those on diuretics.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Swallow the capsule whole; do not crush, chew, or break it.
- Take with food or after a meal to reduce stomach upset.
- Report any signs of stomach bleeding (e.g., black, tarry stools) or allergic reactions immediately.
- Do not exceed the recommended dose as it may increase the risk of side effects.
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 take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or visual disturbances in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while taking this medicine as it can increase the risk of gastrointestinal bleeding.
- Maintain adequate hydration, especially if you have renal impairment.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
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