Drug Interaction:
Rifampicin 600mg/day caused a 50% decrease in plasma concentrations of rofecoxib
Concurrent administration of rofecoxib 75mg/day (3 times the recommended maximum dose in osteoarthiritis) with methotrexate 7.7 to 15mg/week resulted in an increase in plasma concentrations of methotrexate by 23% and caused equivalent reduction in its renal clearance.
NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme Inhibitors
Concomittant administration of low-dose aspirin with rofecoxib may result in an increased rate of GI ulceration or other compilcations. compared to refecoxib alone.
Indication:
Sprains and strains
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Rofecoxib NSAID 26-06-2000
Adverse Reaction:
Diarrhoea, headache, nausea, and upper respiratory tract infection, hypertension, dyspepsia, epigastric discomfort, heartburn, nausea, sinusitis, backpain, headache, bronchitis, urinary tract infections
Contra-Indications:
Hypersensitivity
Special Precautions:
Caution to be excercised in patients with hepatic dysfunction. No data aviailable on children below 18 years.
Pregnancy and lactation
Dosages/ Overdosage Etc:
Sprains and strains
Dosage-
Oral- 12.5mg once daily. Max dose 25mg
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
EVIDENCE BASED MEDICINE (April 2003)
Pain of Osteoarthiritis Comparative effectiveness of various interventions
Beneficial
1. Systemic simple analgesics (eg paracetamol for short term pain relief, and improvement in function)
2. Systemic NSAIDs (short term pain relief and improvement in function)
3. Topical agents (short term pain relief)
Likely to be beneficial
1. Education, dietary advice,empowerment and support ( improved knowledge of disease and pain relief)
2. Physical support (pain relief and improvement in function)
KEY POINTS
1. There is no good evidence that NSAIDs were superior to simple analgesics such as paracetamol or to suggest that any one of the many available NSAIDs had greater efficacy in relieving pain of osteoarthritis.
2. One systematic review of randomised controlled trials has found that topical agents provide pain relief in patients with osteoarthritis and offer a non-toxic alternative to systemic drug treatment. However there is no evidence to indicate whether the prescribed agents were superior to less expensive, non-prescribtion drugs over the counter (OTC) alternatives, or to other local treatments such as hot or cold packs.
Patient Information:
Caution in patients with hepatic dysfunction
Pharmacology/ Pharmacokinetics:
Pharmamcolgy:
Rofecoxib effectively inhibits COX2 activity with no significant inhibition of COX1 activity.
Pharmacokinetics:
Rofecoxib is largely eliminated by hepatic metabolism, with less than 1% recovered unchanged in the urine. Can be taken with or without food.
Interaction with Food:
Can be taken with or without food.
Pregnancy and lactation:
Caution to be excercised during pregnancy and lactation
