Hi-Fenac-TR
Generic Name
Diclofenac Sodium Extended-Release 100 mg Capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
hi fenac tr 100 mg capsule | ৳ 3.00 | N/A |
Description
Overview of the medicine
Hi-Fenac-TR 100 mg Capsule contains Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID) used for the long-term treatment of chronic pain and inflammation, such as in rheumatoid arthritis and osteoarthritis.
Uses & Indications
Dosage
Adults
100 mg once daily, preferably with food. Max 100 mg/day.
Elderly
Use with caution; lower doses may be considered. Monitor renal function and for GI adverse effects.
Renal_impairment
Use with caution; dose reduction may be necessary. Avoid in severe renal impairment.
How to Take
Take the capsule whole with a glass of water, preferably during or after a meal. Do not chew, crush, or break the capsule, as it is an extended-release formulation.
Mechanism of Action
Diclofenac inhibits prostaglandin synthesis by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing inflammation, pain, and fever.
Pharmacokinetics
Onset
Pain relief usually within 1 hour, full anti-inflammatory effects may take several days.
Excretion
Excreted in urine (approx. 60%) and bile (approx. 35%) as conjugates of metabolites.
Half life
Approximately 1-2 hours for the parent compound; active metabolites have longer half-lives.
Absorption
Well absorbed from the GI tract; peak plasma concentrations reached in 2-3 hours for conventional forms, extended for TR formulations over several hours.
Metabolism
Extensively metabolized in the liver, primarily by hydroxylation and subsequent glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to diclofenac or other NSAIDs
- Active gastrointestinal bleeding or ulcer
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic reactions after aspirin or other NSAIDs
Drug Interactions
Lithium
Increased plasma lithium levels, leading to potential toxicity.
Warfarin
Increased risk of bleeding due to enhanced anticoagulant effect.
Diuretics
Reduced diuretic and antihypertensive effects; increased risk of renal impairment.
Methotrexate
Increased methotrexate toxicity due to reduced renal clearance.
Corticosteroids
Increased risk of gastrointestinal ulceration and bleeding.
ACE inhibitors/ARBs
Increased risk of renal impairment, especially in dehydrated or elderly patients.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding, hypotension, respiratory depression, and coma. Management involves symptomatic and supportive care, gastric lavage, and activated charcoal if ingestion is recent.
Pregnancy & Lactation
Avoid in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and renal dysfunction. Not recommended during breastfeeding as diclofenac passes into breast milk and may cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date, depending on the specific formulation and manufacturer's guidelines.
Availability
Pharmacies and Hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA in Bangladesh)
Patent Status
Expired for generic formulation
WHO Essential Medicine
YesClinical Trials
Diclofenac, including its extended-release formulations, has undergone extensive clinical trials supporting its efficacy and safety for its approved indications, particularly in the management of chronic inflammatory and painful conditions.
Lab Monitoring
- Complete blood count (CBC) for signs of bleeding or anemia
- Liver function tests (LFTs) periodically
- Renal function tests (Creatinine, BUN) periodically
- Blood pressure monitoring regularly, especially in hypertensive patients
Doctor Notes
- Advise patients to take the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- Monitor patients for signs of GI bleeding or cardiovascular adverse events, especially during long-term therapy.
- Assess renal function regularly in patients on long-term therapy or with risk factors for renal impairment.
- Counsel patients on the importance of taking the capsule whole without crushing or chewing.
Patient Guidelines
- Take exactly as prescribed by your doctor and do not modify the dose without consultation.
- Do not exceed the recommended dose to avoid serious side effects.
- Report any unusual bleeding, bruising, black/tarry stools, or severe stomach pain immediately.
- Avoid concomitant use of other NSAIDs or aspirin unless advised by a doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it's almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Hi-Fenac-TR may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, do not drive or operate machinery.
Lifestyle Advice
- Avoid alcohol consumption, as it may increase the risk of gastrointestinal bleeding.
- Maintain a healthy diet and stay well-hydrated.
- Consult your doctor before taking any over-the-counter pain relievers or cold medicines.
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Global Brand Names
International brand names for this medicine
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