Clofenac
Generic Name
Diclofenac Sodium 125 mg Suppository
Manufacturer
Various Manufacturers
Country
Globally manufactured
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| clofenac 125 mg suppository | ৳ 12.00 | N/A |
Description
Overview of the medicine
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain, swelling, and inflammation. The 125 mg suppository is administered rectally for systemic effects, often used when oral administration is not feasible or for local conditions, though primarily for systemic pain management.
Uses & Indications
Dosage
Adults
Typically, 125 mg once daily, usually at bedtime. Maximum daily dose generally should not exceed 150 mg for any formulation.
Elderly
Lower doses and careful monitoring are recommended due to increased risk of adverse effects. Typically, 75 mg to 100 mg daily, divided if necessary, or 125 mg once daily based on clinical need and tolerability.
Renal_impairment
Use with caution in mild to moderate renal impairment; avoid in severe renal impairment. Lower initial doses and close monitoring are necessary.
How to Take
For rectal administration only. The suppository should be inserted high into the rectum, preferably after defecation. The patient should lie on their side for a few minutes after insertion to prevent expulsion.
Mechanism of Action
Diclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for the synthesis of prostaglandins. Prostaglandins mediate inflammation, pain, and fever. By inhibiting their synthesis, diclofenac reduces these symptoms.
Pharmacokinetics
Onset
Within 30 minutes to 1 hour for analgesic effects.
Excretion
Approximately 60% of the dose is excreted in the urine as metabolites, and about 35% via bile in the faeces.
Half life
Plasma elimination half-life is approximately 1-2 hours for the parent compound, but the duration of effect is longer due to tissue distribution.
Absorption
Well absorbed rectally, though with somewhat slower and more variable absorption compared to oral forms. Peak plasma concentrations are typically reached within 1-2 hours.
Metabolism
Extensive hepatic metabolism, primarily by CYP2C9, leading to inactive hydroxylated metabolites. Undergoes first-pass metabolism.
Side Effects
Contraindications
- Hypersensitivity to diclofenac or other NSAIDs
- Active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Increased plasma lithium levels, leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, leading to toxicity.
Diuretics and ACE Inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Storage
Store below 30°C (86°F) in a dry place, protected from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and coma. Management is symptomatic and supportive, including gastric decontamination if oral ingestion, but for suppositories, close monitoring and supportive care are key. There is no specific antidote.
Pregnancy & Lactation
Category C in first two trimesters, D in third trimester. Avoid during pregnancy, especially in the third trimester due to potential adverse effects on fetal cardiovascular system (premature closure of ductus arteriosus). Diclofenac is excreted in breast milk; therefore, use is generally not recommended during lactation or should be used with caution.
Side Effects
Contraindications
- Hypersensitivity to diclofenac or other NSAIDs
- Active gastrointestinal ulceration, bleeding, or perforation
- Severe heart failure
- Severe renal or hepatic impairment
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
Drug Interactions
SSRIs
Increased risk of gastrointestinal bleeding.
Lithium
Increased plasma lithium levels, leading to toxicity.
Methotrexate
Increased plasma methotrexate levels, leading to toxicity.
Diuretics and ACE Inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Storage
Store below 30°C (86°F) in a dry place, protected from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, and coma. Management is symptomatic and supportive, including gastric decontamination if oral ingestion, but for suppositories, close monitoring and supportive care are key. There is no specific antidote.
Pregnancy & Lactation
Category C in first two trimesters, D in third trimester. Avoid during pregnancy, especially in the third trimester due to potential adverse effects on fetal cardiovascular system (premature closure of ductus arteriosus). Diclofenac is excreted in breast milk; therefore, use is generally not recommended during lactation or should be used with caution.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date when stored correctly.
Availability
Available in pharmacies worldwide
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Diclofenac has been extensively studied in numerous clinical trials for its efficacy and safety across various pain and inflammatory conditions. Ongoing research may explore new formulations or specific indications.
Lab Monitoring
- Complete Blood Count (CBC) periodically, especially with long-term use
- Liver Function Tests (LFTs) periodically
- Renal Function Tests (RFTs) periodically
- Blood pressure monitoring
Doctor Notes
- Evaluate cardiovascular risk factors before prescribing, especially for long-term use.
- Assess gastrointestinal risk, consider PPI co-administration for high-risk patients.
- Monitor renal function, blood pressure, and liver enzymes during prolonged therapy.
- Avoid concomitant use with other NSAIDs.
- Not recommended for children unless specifically indicated by a physician.
Patient Guidelines
- Use the lowest effective dose for the shortest possible duration to minimize risks.
- Report any signs of gastrointestinal bleeding (black, tarry stools) or cardiovascular events (chest pain, shortness of breath) immediately.
- Avoid concurrent use of other NSAIDs.
- Inform your doctor if you have a history of heart disease, high blood pressure, kidney or liver problems.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Diclofenac may cause dizziness, drowsiness, or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Limit alcohol intake, as it may increase the risk of stomach bleeding.
- Maintain a healthy diet and stay hydrated.
- Regular exercise may help manage chronic pain conditions.
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