Medicine Information

Edifenac-TR

Name: Edifenac-TR
Brand: Edifenac-TR
Rating: 4.5 (117 reviews)

Capsule100 mgNon-Steroidal Anti-inflammatory Drugs (NSAIDs)ATC: M01AB05

Generic Name

Diclofenac Sodium (Extended Release)

Manufacturer

ACI Limited

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
edifenac tr 100 mg capsule	৳ 3.00	N/A

Description

Overview of the medicine

Edifenac-TR 100 mg Capsule contains Diclofenac Sodium, an NSAID used for the relief of pain and inflammation. The 'TR' indicates a time-release or extended-release formulation, providing prolonged action for conditions like arthritis.

Uses & Indications

Rheumatoid arthritis

Osteoarthritis

Ankylosing spondylitis

Acute musculoskeletal disorders (e.g., sprains, strains, low back pain)

Post-operative pain

Dysmenorrhea

Dosage

Adults

Typically 100 mg once daily, preferably with or after food. In some cases, dosage may be adjusted by a physician.

Elderly

Use with caution; lower initial doses may be considered due to increased risk of adverse effects, especially renal and gastrointestinal.

Renal_impairment

Use with caution in mild to moderate impairment; contraindicated in severe renal impairment. Dosage adjustment may be required.

How to Take

Take the capsule whole with a glass of water, preferably with or immediately after food to reduce gastrointestinal upset. Do not chew, crush, or break the capsule.

Mechanism of Action

Inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins, which are key mediators of inflammation, pain, and fever.

Pharmacokinetics

Onset

Analgesic effects may begin within 30 minutes to 1 hour, but full anti-inflammatory effects and sustained action from TR formulation take longer to develop.

Excretion

Approximately 60% of the drug is eliminated in the urine as metabolites, and about 30% in the bile and feces.

Half life

The terminal plasma elimination half-life is approximately 1-2 hours for the parent compound, but the duration of therapeutic action is extended due to the TR formulation.

Absorption

Well absorbed from the gastrointestinal tract. Peak plasma concentrations are reached later with extended-release formulations (e.g., 2-8 hours), ensuring sustained drug levels.

Metabolism

Extensively metabolized in the liver, primarily by hydroxylation and methoxylation, followed by glucuronidation and sulfation. CYP2C9 is a major enzyme involved.

Side Effects

Contraindications

Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (e.g., aspirin-induced asthma, urticaria, or allergic-type reactions)
Active gastrointestinal bleeding, peptic ulceration, or a history of recurrent peptic ulcer
Severe heart failure (NYHA Class III-IV)
Severe renal or hepatic impairment
Third trimester of pregnancy (due to risk of premature closure of ductus arteriosus)
Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Drug Interactions

Corticosteroids

Increased risk of gastrointestinal adverse effects, including ulceration and bleeding.

Lithium / Methotrexate

Diclofenac may increase plasma concentrations of Lithium and Methotrexate, leading to toxicity. Monitor levels closely.

Anticoagulants (e.g., Warfarin)

Increased risk of bleeding. Close monitoring of INR is recommended.

Diuretics (e.g., Furosemide, Thiazides)

May reduce the natriuretic effect of diuretics and increase the risk of renal impairment.

SSRIs (Selective Serotonin Reuptake Inhibitors)

Increased risk of gastrointestinal bleeding.

ACE Inhibitors / Angiotensin Receptor Blockers (ARBs)

May reduce the antihypertensive effect and increase the risk of renal impairment, especially in elderly or volume-depleted patients.

Storage

Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.

Overdose

Symptoms of overdose may include lethargy, drowsiness, nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory depression, and coma may occur. Management is symptomatic and supportive; there is no specific antidote.

Pregnancy & Lactation

Pregnancy: Category C in first and second trimesters, with a warning to avoid in late pregnancy due to potential fetal harm. Contraindicated in the third trimester (Category D). Lactation: Diclofenac passes into breast milk in small amounts; generally not recommended during breastfeeding.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 x 10 capsules (blister pack)3 x 10 capsules (blister pack)

Shelf Life

36 months from manufacturing date.

Availability

Available in pharmacies and hospitals

Approval Status

Approved

Patent Status

Off-patent

WHO Essential Medicine

Yes

Clinical Trials

Numerous clinical trials have established the efficacy and safety profile of diclofenac for various pain and inflammatory conditions. Extended-release formulations have been studied for their ability to provide sustained pain relief with once-daily dosing.

Lab Monitoring

Complete Blood Count (CBC) to monitor for anemia or other hematologic effects.
Liver Function Tests (LFTs) to check for hepatic toxicity, especially with long-term use.
Kidney Function Tests (Serum Creatinine, BUN) to assess renal function, particularly in elderly or high-risk patients.
Blood Pressure monitoring, as NSAIDs can cause or worsen hypertension.

Doctor Notes

Prior to prescribing, assess patient's cardiovascular risk factors and gastrointestinal history.
Use the lowest effective dose for the shortest possible duration to minimize adverse effects.
Regularly monitor renal function, liver enzymes, and blood pressure, especially in elderly patients or those on long-term therapy.
Educate patients on symptoms of GI bleeding and cardiovascular events, and advise them to seek immediate medical attention if these occur.

Patient Guidelines

Take exactly as prescribed by your doctor; do not exceed the recommended dose.
Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, coffee-ground vomit) or cardiovascular symptoms (e.g., chest pain, shortness of breath) immediately.
Avoid concurrent use with other NSAIDs or aspirin unless specifically advised by your doctor.
Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.

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 resume your regular dosing schedule. Do not double the dose to catch up.

Driving Precautions

This medicine may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving or operating heavy machinery.

Lifestyle Advice

Limit alcohol intake, as it can increase the risk of gastrointestinal side effects.
Maintain a balanced diet and stay adequately hydrated.
Regular exercise, if appropriate for your condition, can help manage pain and improve overall well-being.

Alternative Medicines in Bangladesh

Similar medicines available in the market

Diclofenac-TR 100 mg Capsule (Square Pharmaceuticals Ltd.)Diclopain-TR 100 mg Capsule (Incepta Pharmaceuticals Ltd.)Biofenac-TR 100 mg Capsule (Beximco Pharmaceuticals Ltd.)Olfen-TR 100 mg Capsule (Novartis Bangladesh Ltd.)

Global Brand Names

International brand names for this medicine

Reputable Pharma Ltd.

TabletVaries (e.g., Vitamin A 5000 IU, Vitamin C 60 mg, Zinc 15 mg)

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