Drug Interaction:
Interacting drugs - summary
Valdecoxib +
Aspirin
Concurrent administration of aspirin with valdecoxib result in increased risk
of GI ulceration and complications compared to valdecoxib alone
ACE
Valdecoxib diminish the antihypertensive effect of ACE inhibitors
Frusemide
Valdecoxib reduce the natriuretic effect of frusemide and thiazides in
some patients due to inhibition of poststaglandin synthesis.
Dextromethorphan
dextromethorphan plasma concentration in the presence of high doses of
valdecoxib is decreased by 5-fold than those seen in CYP 2D6 poor
metobolizers.
Lithium
Valdecoxib significantly decreases lithium serum clearance (25%) and renal
clearance (30%) with a 34% higher serum exposure.
Warfarin
Valdecoxib causes significant increases in plasma exposures of warfarin
Ketoconazole
Concomittant single dose administration of valdecoxib with multiple doses of
ketoconazole and fluconazole produced a significant increase in exposure of
valdecoxib
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Valdecoxib NSAID 01-08-2002
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Valdecoxib 20mg + 20-09-2004
Paracetamol 500mg tablet
For the treatment of pain in adults
Osteoarthritis, Rheumatoid arthritis
Adverse Reaction:
Hypertension, back pain, edema peripheral, Influenza-like symptoms, dizziness, Heartburn, headache, Abdominal fullness, abdominal pain,
Diarrheoa, dyspepsia, Flatulence, nausea, Myalgia, sinusitis, Sore throat, upper respiratory tract infections, Rashes, ear congestion, Indigestion, blood in urine, bloody black or sticky stools,
Blurred vision, chills, decreased or painful urination, Fever, nervousness, pale skin, Rapid weight gain, tingling of the hands or feet, Unusual bleeding or bruising, Unusual tiredness or weakness.
Contra-Indications:
Asthma, urticaria, or hypersensitivity
Special precautions:
Valdecoxib should be initiated with caution in patients with mild to moderate hepatic impairment and fluid retention
Toxicity such as bleeding, ulceration and perferoration of the stomach, small intestine or large intestine can occur in any time with or without warning symptoms in patients treated with valdecoxib. It should be prescribed with caution in patients with a prior history of ulcer disease or gastrointestinal bleeding
Caution should be taken when initiating treatment with valdecoxib in patients with considerable dehydration. It is advisdable to rehydrate patients first and then start therapy with valdecoxib.
Anemia is sometimes seen in patients receiving valdecoxib. Patients on long term treatment with valdecoxb should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
Valdecoxib should be used with caution in patients with fluid retention, hypertension or heart failure.
Pregnancy: In late pregnancy, valdecoxib should be avoided because it may cause premature closure of the ductus arteriosus
Dosages/ Overdosage Etc:
Indications:
Osteoarthritis, Rheumatoid arthritis
Dosage:
Recommended dose is 10mg once daily.
Other Information:
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.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Valdecoxib is NSAID that exhibit anti-inflammatory, analgesic, and antipyretic proiperties. It acts by inhibiting prostaglandin synthesis by blocking cyclooxygenase -2 (COX-2). At therapeutic plasma concentrations valdecoxib does not inhibit cyclooxygenase -1 (COX-1)
Pharmcokinetics:
Valdecoxib acheives maximal plasma concentration in approximately 3 hours. The absolute bioavailability is 83% following oral administration.High fat meal has no effect on Cmax or AUC., although Imax is delayed by 1 to 2 hours. Valdecoxib undergoes extensive hepatic metabolism involving both P450 isoenzymes and non-P450 dependent path ways. Approximately 70% of the dose is excreted in the urine as metabolites and 20% as N-gluronide. The elimination half life is approximately 8-11 hours
Interaction with Food:
High fat meal has no effect on Cmax or AUC.
Pregnancy and lactation:
Pregnancy:
In late pregnancy, valdecoxib should be avoided because it may cause premature closure of the ductus arteriosus