Doloran
Generic Name
Diclofenac Sodium
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| doloran 100 mg suppository | ৳ 20.00 | N/A |
Description
Overview of the medicine
Doloran 100 mg Suppository contains Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID), used for its analgesic, anti-inflammatory, and antipyretic properties. It is administered rectally for the relief of moderate to severe pain and inflammation.
Uses & Indications
Dosage
Adults
Usually 100 mg once daily, preferably at bedtime. In some acute cases, 50 mg twice daily may be prescribed. Max recommended daily dose is 150 mg.
Elderly
Use with caution; lower doses may be necessary due to increased risk of adverse effects, especially GI bleeding and renal impairment. Individualized dosage is recommended.
Renal_impairment
Use with caution. Dosage reduction may be required. Avoid in severe renal impairment (CrCl <30 mL/min).
How to Take
For rectal administration only. Insert the suppository deeply into the rectum. It is generally recommended to lie down for a few minutes after insertion to prevent expulsion.
Mechanism of Action
Diclofenac inhibits prostaglandin synthesis by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandins, which are mediators of inflammation, pain, and fever.
Pharmacokinetics
Onset
Onset of analgesic effect usually within 30 minutes to 1 hour.
Excretion
Approximately 60% is excreted in the urine as metabolites, and about 35% is excreted in the bile and feces.
Half life
Plasma elimination half-life is approximately 1-2 hours for the parent compound, but the active metabolites can have a longer half-life.
Absorption
Rapidly absorbed from the rectum, but absorption can be slower and less complete than oral administration. Peak plasma concentrations are achieved in approximately 1-3 hours.
Metabolism
Extensively metabolized in the liver, primarily by hydroxylation and glucuronidation. CYP2C9 and CYP3A4 enzymes are involved.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, aspirin, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe heart failure, renal failure, or hepatic failure
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic reactions to NSAIDs
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics, ACE inhibitors, beta-blockers
Reduced hypotensive effect; increased risk of renal impairment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, GI bleeding, hypotension, respiratory depression, and coma. Management is supportive and symptomatic, focusing on maintaining vital functions and treating symptoms. Gastric lavage and activated charcoal may be considered if recent oral ingestion, but less relevant for suppositories.
Pregnancy & Lactation
Pregnancy Category C (first and second trimester); Category D (third trimester). Should be avoided in the third trimester due to potential adverse effects on the fetus. Use during lactation should be done with caution, as diclofenac may be excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, aspirin, or other NSAIDs
- Active gastrointestinal bleeding or peptic ulcer
- Severe heart failure, renal failure, or hepatic failure
- Third trimester of pregnancy
- History of asthma, urticaria, or allergic reactions to NSAIDs
Drug Interactions
SSRIs
Increased risk of GI bleeding.
Lithium
Increased plasma lithium levels.
Methotrexate
Increased methotrexate toxicity.
Cyclosporine, Tacrolimus
Increased risk of nephrotoxicity.
Warfarin, other anticoagulants
Increased risk of bleeding.
Diuretics, ACE inhibitors, beta-blockers
Reduced hypotensive effect; increased risk of renal impairment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, nausea, vomiting, epigastric pain, GI bleeding, hypotension, respiratory depression, and coma. Management is supportive and symptomatic, focusing on maintaining vital functions and treating symptoms. Gastric lavage and activated charcoal may be considered if recent oral ingestion, but less relevant for suppositories.
Pregnancy & Lactation
Pregnancy Category C (first and second trimester); Category D (third trimester). Should be avoided in the third trimester due to potential adverse effects on the fetus. Use during lactation should be done with caution, as diclofenac may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, check specific packaging for details.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Diclofenac has been extensively studied in numerous clinical trials demonstrating its efficacy and safety across various pain and inflammatory conditions. Ongoing research continues to evaluate its long-term effects and comparative effectiveness.
Lab Monitoring
- Complete blood count (CBC) periodically, especially with long-term use
- Liver function tests (LFTs) periodically
- Renal function tests (e.g., serum creatinine, BUN) periodically
- Blood pressure monitoring
Doctor Notes
- Exercise caution when prescribing to elderly patients, those with a history of GI issues, cardiovascular disease, or renal/hepatic impairment.
- Advise patients on the potential risks and symptoms requiring immediate medical attention.
- Periodically monitor renal function, liver function, and blood pressure during prolonged therapy.
Patient Guidelines
- Use the lowest effective dose for the shortest possible duration to minimize adverse effects.
- Report any signs of gastrointestinal bleeding (e.g., black or bloody stools) or cardiovascular issues (e.g., chest pain, shortness of breath) immediately.
- Do not use if you are allergic to diclofenac, aspirin, or other NSAIDs.
- Avoid alcohol during treatment.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double 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 symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Maintain adequate hydration to support kidney function. Avoid excessive alcohol consumption. Follow a balanced diet.
- Regular exercise (if physical condition permits) and stress management can complement pain management.
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