New Drugs Approved by (DCI) Drug Controller  GENERAL -  India  For Marketing

Osteoarthritis, Rheumatoid arthritis

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.

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

Indications:

Osteoarthritis, Rheumatoid arthritis

Dosage:

Recommended dose is 10mg once daily.

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:

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

High fat meal has no effect on Cmax or AUC.

Pregnancy:

In late pregnancy, valdecoxib should be avoided because it may cause premature closure of the ductus arteriosus