S-Fenac TR
Generic Name
Aceclofenac Sustained Release
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| s fenac tr 50 mg capsule | ৳ 1.20 | N/A |
Description
Overview of the medicine
S-Fenac TR 50 mg Capsule contains Aceclofenac in a sustained-release formulation. It is a Non-Steroidal Anti-inflammatory Drug (NSAID) used to relieve pain and inflammation associated with various musculoskeletal conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The sustained-release form allows for prolonged action.
Uses & Indications
Dosage
Adults
Typically, the recommended dose of aceclofenac is 100 mg twice daily. For S-Fenac TR 50 mg capsules, dosage may vary based on physician's assessment; usually 1-2 capsules daily as prescribed.
Elderly
No specific dose adjustment is usually required, but caution is advised. The lowest effective dose should be used.
Renal_impairment
Use with caution. Dosage reduction may be necessary for mild to moderate renal impairment. Contraindicated in severe renal impairment.
How to Take
Take orally, preferably with or after food, to minimize gastrointestinal upset. Swallow the capsule whole with water; do not chew or crush.
Mechanism of Action
Aceclofenac works by inhibiting the enzyme cyclooxygenase (COX), which is involved in the synthesis of prostaglandins. Prostaglandins are mediators of inflammation, pain, and fever. By inhibiting COX-1 and COX-2, aceclofenac reduces the production of prostaglandins, thereby reducing pain and inflammation.
Pharmacokinetics
Onset
Analgesic effect usually starts within 1-2 hours for immediate release, prolonged for TR formulation.
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 hours.
Absorption
Well absorbed from the gastrointestinal tract. Peak plasma concentrations are achieved slower with sustained-release formulations compared to immediate-release forms.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, to 4'-hydroxyaceclofenac and other metabolites.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any NSAID (e.g., aspirin-induced asthma, urticaria)
- Active gastrointestinal bleeding or peptic ulceration
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Cyclosporine and Tacrolimus
Increased nephrotoxicity.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
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, diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and syncope. Acute renal failure and liver damage are possible. Management is supportive and symptomatic, including gastric lavage or activated charcoal if ingestion was recent. Monitor vital signs and provide symptomatic treatment.
Pregnancy & Lactation
Avoid during the third trimester of pregnancy due to potential effects on fetal cardiovascular system. Use with caution during the first and second trimesters and during lactation only if the potential benefit outweighs the potential risk to the fetus/infant and under strict medical supervision.
Side Effects
Contraindications
- Hypersensitivity to aceclofenac or any NSAID (e.g., aspirin-induced asthma, urticaria)
- Active gastrointestinal bleeding or peptic ulceration
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- History of gastrointestinal bleeding or perforation related to previous NSAID therapy
Drug Interactions
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Cyclosporine and Tacrolimus
Increased nephrotoxicity.
Diuretics and ACE inhibitors
Reduced antihypertensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
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, diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, and syncope. Acute renal failure and liver damage are possible. Management is supportive and symptomatic, including gastric lavage or activated charcoal if ingestion was recent. Monitor vital signs and provide symptomatic treatment.
Pregnancy & Lactation
Avoid during the third trimester of pregnancy due to potential effects on fetal cardiovascular system. Use with caution during the first and second trimesters and during lactation only if the potential benefit outweighs the potential risk to the fetus/infant and under strict medical supervision.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Aceclofenac has been extensively studied in various clinical trials demonstrating its efficacy and safety in managing pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Sustained-release formulations are designed to improve patient compliance and provide prolonged therapeutic effect.
Lab Monitoring
- Renal function (creatinine, BUN) should be monitored, especially in elderly or renally impaired patients, or during long-term therapy.
- Hepatic function (AST, ALT) should be checked periodically during long-term use.
- Complete blood count (CBC) should be monitored for signs of anemia or other hematological abnormalities, particularly with prolonged use.
Doctor Notes
- Assess patient's cardiovascular and gastrointestinal risk factors before initiating therapy with aceclofenac.
- Use the lowest effective dose for the shortest possible duration to minimize adverse effects.
- Monitor renal and hepatic function, especially in elderly patients or those with pre-existing conditions.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Always take with food or after a meal to reduce stomach irritation.
- Do not exceed the recommended dose.
- Report any unusual symptoms, especially stomach pain, black stools, or yellowing of the skin/eyes, to your doctor immediately.
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 double the dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or visual disturbances in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while taking this medication as it may increase the risk of stomach problems.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, to prevent potential drug interactions.
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