Rofecin
Generic Name
Rofecoxib
Manufacturer
Originally Merck (Vioxx), various generic manufacturers existed.
Country
USA (original developer), various countries for generics.
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rofecin 1 gm injection | ৳ 361.08 | N/A |
| rofecin 2 gm injection | ৳ 682.05 | N/A |
| rofecin 500 mg injection | ৳ 220.66 | N/A |
Description
Overview of the medicine
Rofecoxib (marketed as Rofecin in some regions) is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It was used to treat osteoarthritis, rheumatoid arthritis, acute pain conditions, and dysmenorrhea. It was voluntarily withdrawn from the global market in 2004 by its manufacturer, Merck, due to concerns about increased risk of heart attack and stroke with long-term use.
Uses & Indications
Dosage
Adults
Osteoarthritis: 12.5 mg or 25 mg once daily. Rheumatoid Arthritis: 25 mg once daily. Acute pain/Primary Dysmenorrhea: 50 mg once daily (for short-term use).
Elderly
No specific dose adjustment recommended, but use with caution due to increased susceptibility to side effects.
Renal_impairment
Not recommended in patients with severe renal impairment (creatinine clearance <30 mL/min).
How to Take
For oral administration, can be taken with or without food.
Mechanism of Action
Rofecoxib selectively inhibits the cyclooxygenase-2 (COX-2) enzyme, which is responsible for the synthesis of prostaglandins involved in inflammation, pain, and fever. By selectively inhibiting COX-2, it was intended to reduce gastrointestinal side effects compared to non-selective NSAIDs.
Pharmacokinetics
Onset
Analgesic effects typically seen within 1-2 hours of administration.
Excretion
Primarily excreted as metabolites in urine (72%) and feces (14%).
Half life
Approximately 17 hours, allowing for once-daily dosing.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations typically reached in 2-3 hours.
Metabolism
Extensively metabolized by reduction to cis-dihydro and trans-dihydro metabolites, and subsequent oxidation; not primarily metabolized by CYP450 enzymes.
Side Effects
Contraindications
- Hypersensitivity to rofecoxib or any NSAID.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe heart failure.
- Advanced renal disease.
- Late pregnancy.
- Currently, withdrawal from market due to safety concerns makes it generally contraindicated.
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity.
Warfarin
May increase the risk of bleeding.
Diuretics
May reduce natriuretic effect.
Cyclosporine
May increase cyclosporine-induced nephrotoxicity.
Methotrexate
May increase methotrexate toxicity.
ACE Inhibitors / Angiotensin Receptor Blockers
May reduce antihypertensive effect and increase risk of renal impairment.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include lethargy, drowsiness, nausea, vomiting, epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe hypertension, acute renal failure, respiratory depression, and coma are rare but possible. Management is symptomatic and supportive; no specific antidote.
Pregnancy & Lactation
Pregnancy Category C (first two trimesters), D (third trimester). Avoid in late pregnancy due to potential for premature closure of ductus arteriosus and fetal renal dysfunction. Excreted in breast milk; advise caution during lactation.
Side Effects
Contraindications
- Hypersensitivity to rofecoxib or any NSAID.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Severe heart failure.
- Advanced renal disease.
- Late pregnancy.
- Currently, withdrawal from market due to safety concerns makes it generally contraindicated.
Drug Interactions
Lithium
May increase plasma lithium levels, leading to toxicity.
Warfarin
May increase the risk of bleeding.
Diuretics
May reduce natriuretic effect.
Cyclosporine
May increase cyclosporine-induced nephrotoxicity.
Methotrexate
May increase methotrexate toxicity.
ACE Inhibitors / Angiotensin Receptor Blockers
May reduce antihypertensive effect and increase risk of renal impairment.
Storage
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include lethargy, drowsiness, nausea, vomiting, epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe hypertension, acute renal failure, respiratory depression, and coma are rare but possible. Management is symptomatic and supportive; no specific antidote.
Pregnancy & Lactation
Pregnancy Category C (first two trimesters), D (third trimester). Avoid in late pregnancy due to potential for premature closure of ductus arteriosus and fetal renal dysfunction. Excreted in breast milk; advise caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 2-3 years from manufacturing date.
Availability
Not available worldwide due to market withdrawal.
Approval Status
Approved by FDA in 1999, voluntarily withdrawn from worldwide market in 2004 due to cardiovascular risks.
Patent Status
Patent expired, drug withdrawn from market.
Clinical Trials
Extensive clinical trials (e.g., VIGOR, APPROVe) were conducted, which initially supported its efficacy but later revealed the cardiovascular risks leading to its withdrawal.
Lab Monitoring
- Monitor renal function (creatinine, BUN) periodically.
- Monitor liver function (ALT, AST) if liver dysfunction is suspected.
- Monitor blood pressure regularly.
Doctor Notes
- Remind patients that Rofecoxib (Rofecin) was withdrawn from the market due to significant cardiovascular risks.
- Consider safer alternative NSAIDs or other pain management strategies.
- Thoroughly review patient cardiovascular and GI history before prescribing any NSAID.
- Educate patients on potential risks of all NSAIDs.
Patient Guidelines
- Do not exceed the prescribed dose or duration of treatment.
- Report any symptoms of chest pain, shortness of breath, unusual bleeding, or severe stomach pain immediately.
- Be aware that this medicine is no longer on the market due to safety concerns.
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 resume your regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness or drowsiness. Patients should be cautious when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Avoid or limit alcohol consumption as it may increase the risk of gastrointestinal adverse effects.
- Maintain a healthy lifestyle to minimize cardiovascular risks.
- If you were previously on Rofecin, consult your doctor for alternative pain management strategies.
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