Clofenac
Generic Name
Diclofenac Sodium 50 mg Suppository
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
clofenac 50 mg suppository | ৳ 20.00 | N/A |
Description
Overview of the medicine
Clofenac 50 mg Suppository contains diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID), used for pain and inflammation relief, particularly in conditions like arthritis, muscle pain, and fever. The suppository form is useful when oral administration is not possible or desired.
Uses & Indications
Dosage
Adults
Typically, 50 mg one to two times daily. Max 150 mg/day.
Elderly
Lower doses may be required, generally starting with 50 mg once daily, adjusted based on response and tolerability.
Renal_impairment
Use with caution; dose reduction may be necessary. Avoid in severe renal impairment (CrCl <30 mL/min).
How to Take
For rectal administration only. Insert the suppository high into the rectum, pointed end first, after ensuring the bowel is empty. Do not take by mouth.
Mechanism of Action
Diclofenac works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins are mediators of pain, inflammation, and fever. By reducing prostaglandin production, diclofenac alleviates these symptoms.
Pharmacokinetics
Onset
Pain relief typically begins within 30-60 minutes.
Excretion
Approximately 60% renally excreted as metabolites, 35% via bile/feces.
Half life
Approximately 1-2 hours (terminal half-life of parent compound).
Absorption
Rapid and complete absorption from the rectum, but subject to first-pass metabolism. Bioavailability is about 50-60%.
Metabolism
Extensive hepatic metabolism via hydroxylation and glucuronidation. Mainly by CYP2C9 and CYP2C19 enzymes.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac or other NSAIDs (e.g., aspirin-induced asthma)
- Active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Proctitis or history of rectal bleeding (for suppositories)
Drug Interactions
Lithium
Increased plasma lithium levels.
Diuretics
Reduced diuretic and antihypertensive effects; increased risk of nephrotoxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulcers and bleeding.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and coma. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if recent oral ingestion, but less relevant for suppositories. Monitor renal function, liver enzymes, and electrolyte levels.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Use only if clearly needed in first and second trimesters, and at the lowest effective dose for the shortest possible duration. Lactation: Diclofenac is excreted in breast milk in small amounts; generally considered compatible with breastfeeding with caution, but monitor infant for adverse effects.
Side Effects
Contraindications
- Known hypersensitivity to diclofenac or other NSAIDs (e.g., aspirin-induced asthma)
- Active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- Proctitis or history of rectal bleeding (for suppositories)
Drug Interactions
Lithium
Increased plasma lithium levels.
Diuretics
Reduced diuretic and antihypertensive effects; increased risk of nephrotoxicity.
Methotrexate
Increased methotrexate toxicity.
Corticosteroids
Increased risk of gastrointestinal ulcers and bleeding.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
SSRIs (Selective Serotonin Reuptake Inhibitors)
Increased risk of gastrointestinal bleeding.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms include lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and coma. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered if recent oral ingestion, but less relevant for suppositories. Monitor renal function, liver enzymes, and electrolyte levels.
Pregnancy & Lactation
Pregnancy: Avoid in the third trimester due to risk of premature closure of the fetal ductus arteriosus. Use only if clearly needed in first and second trimesters, and at the lowest effective dose for the shortest possible duration. Lactation: Diclofenac is excreted in breast milk in small amounts; generally considered compatible with breastfeeding with caution, but monitor infant for adverse effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of diclofenac for various pain and inflammatory conditions. Ongoing research explores long-term cardiovascular and gastrointestinal safety profiles.
Lab Monitoring
- Complete Blood Count (CBC)
- Liver function tests (LFTs)
- Renal function tests (e.g., Creatinine, eGFR)
- Electrolytes
- Stool for occult blood (for long-term use)
Doctor Notes
- Counsel patients on GI and CV risks, especially with prolonged use.
- Consider a proton pump inhibitor for patients at high GI risk.
- Monitor renal function, LFTs, and blood pressure periodically for chronic users.
- Avoid in patients with recent myocardial infarction or heart failure.
Patient Guidelines
- Use the lowest effective dose for the shortest possible duration.
- Do not take by mouth.
- Wash hands before and after use.
- Report any signs of gastrointestinal bleeding (e.g., black, tarry stools) or severe allergic reactions immediately.
- Avoid concomitant use with other NSAIDs (including aspirin).
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not double the dose to catch up.
Driving Precautions
May cause dizziness, drowsiness, or visual disturbances. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking this medication.
- Maintain adequate hydration.
- For chronic conditions, regular exercise and a balanced diet can support overall well-being.
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