Refain
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 |
---|---|---|
refain 75 mg injection | ৳ 9.50 | N/A |
Description
Overview of the medicine
Refain 75 mg Injection contains Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug (NSAID). It is primarily used for the rapid relief of moderate to severe pain and inflammation, particularly in conditions where oral administration is not feasible or rapid onset is required.
Uses & Indications
Dosage
Adults
Usually 75 mg once daily, administered by deep intramuscular injection. In severe cases, or in the presence of severe pain, a second 75 mg dose may be given after a few hours, preferably into the other buttock. Do not exceed 150 mg in 24 hours. The injection should not be continued for more than 2 days; switch to oral therapy as soon as possible.
Elderly
Use the lowest effective dose for the shortest duration. Monitor for adverse effects, especially gastrointestinal and renal.
Renal_impairment
Use with caution. Dose reduction may be necessary in patients with severe renal impairment. Avoid in severe renal failure.
How to Take
Refain 75 mg Injection should be administered by deep intramuscular injection into the upper outer quadrant of the gluteal region. Do not administer intravenously or subcutaneously. The injection should be given slowly. It is not intended for prolonged use; generally, treatment should be limited to 2 days.
Mechanism of Action
Diclofenac Sodium works by inhibiting the enzyme cyclooxygenase (COX-1 and COX-2), which is responsible for the synthesis of prostaglandins. Prostaglandins are inflammatory mediators that contribute to pain, fever, and inflammation. By blocking their production, Diclofenac reduces these symptoms.
Pharmacokinetics
Onset
Within 15-30 minutes for analgesic effect.
Excretion
Approximately 60% via urine (as metabolites) and 35% via bile/feces.
Half life
Approximately 1-2 hours (plasma elimination half-life).
Absorption
Rapid and complete absorption after intramuscular administration. Peak plasma concentrations are achieved within 15-30 minutes.
Metabolism
Extensive hepatic metabolism, primarily by cytochrome P450 enzymes (CYP2C9).
Side Effects
Contraindications
- Hypersensitivity to diclofenac, aspirin, or other NSAIDs.
- Active gastrointestinal bleeding or peptic ulcer.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe heart failure, severe renal impairment, or severe hepatic failure.
- Third trimester of pregnancy.
- Coronary artery bypass graft (CABG) surgery.
Drug Interactions
SSRIs and SNRIs
Increased risk of gastrointestinal bleeding.
Lithium and Methotrexate
Increased plasma levels of lithium and methotrexate, leading to toxicity.
Cyclosporine and Tacrolimus
Increased nephrotoxicity.
Diuretics and ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Other NSAIDs and Corticosteroids
Increased risk of gastrointestinal adverse effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not freeze. 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 supportive and symptomatic. Gastric lavage and activated charcoal may be considered if recent oral ingestion. No specific antidote is available.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Avoid in the third trimester due to potential premature closure of the fetal ductus arteriosus and potential inhibition of uterine contractions. Use with caution during lactation; diclofenac is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to diclofenac, aspirin, or other NSAIDs.
- Active gastrointestinal bleeding or peptic ulcer.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe heart failure, severe renal impairment, or severe hepatic failure.
- Third trimester of pregnancy.
- Coronary artery bypass graft (CABG) surgery.
Drug Interactions
SSRIs and SNRIs
Increased risk of gastrointestinal bleeding.
Lithium and Methotrexate
Increased plasma levels of lithium and methotrexate, leading to toxicity.
Cyclosporine and Tacrolimus
Increased nephrotoxicity.
Diuretics and ACE inhibitors
Reduced hypotensive effect and increased risk of renal impairment.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding.
Other NSAIDs and Corticosteroids
Increased risk of gastrointestinal adverse effects.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Do not freeze. 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 supportive and symptomatic. Gastric lavage and activated charcoal may be considered if recent oral ingestion. No specific antidote is available.
Pregnancy & Lactation
Pregnancy Category C (first and second trimesters), Category D (third trimester). Avoid in the third trimester due to potential premature closure of the fetal ductus arteriosus and potential inhibition of uterine contractions. Use with caution during lactation; diclofenac is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Diclofenac has been extensively studied in numerous clinical trials establishing its efficacy and safety profile for various pain and inflammatory conditions. As an established drug, new large-scale trials are less common, but ongoing post-marketing surveillance and comparative studies continue.
Lab Monitoring
- Complete blood count (CBC) for long-term therapy
- Liver function tests (LFTs)
- Kidney function tests (serum creatinine, BUN)
- Blood pressure monitoring
Doctor Notes
- Administer deep IM slowly to minimize injection site reactions.
- Limit parenteral use to a maximum of 2 days, then transition to oral route if possible.
- Monitor renal and hepatic function, especially in elderly or patients with comorbidities.
- Counsel patients on potential GI and CV risks associated with NSAIDs.
Patient Guidelines
- Inform your doctor about all current medications and medical conditions.
- Report any unusual bleeding, persistent stomach pain, or black/tarry stools immediately.
- Do not exceed the prescribed dose or duration of treatment.
- Avoid alcohol during treatment as it increases the risk of stomach problems.
Missed Dose Advice
If a dose is missed, administer it as soon as you remember, unless it is almost time for your next scheduled dose. Do not double the dose to catch up.
Driving Precautions
Refain 75 mg Injection may cause dizziness, drowsiness, or visual disturbances. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain adequate hydration.
- Adopt a balanced diet.
- Limit alcohol intake.
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