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Valdecoxib information from DrugsUpdate  

See Available Brands of Valdecoxib in India

P - Contraindicated in pregnancy
L - Contraindicated in Lactation

Valdecoxib is a prescription drug used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory drug, or NSAID, and should not be taken by anyone allergic to these types of medications.

Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company. It was approved by the United States Food and Drug Administration on November 20, 2001, and was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke.

Pharmacodynamics

Pharmacokinetics

Valdecoxib acts by selectively inhibiting prostaglandin synthesis primarily by blocking cyclooxygenase (COX-2) enzyme. It was withdrawn worldwide in April 2005, following risk of serious skin reactions and cardiovascular side effects.

Onset
60 minutes

Absorption
Peak plasma concentrations after 2.25-3 hours (oral).

Distribution
Protein-binding: 98%

Metabolism
Extensively hepatic.

Excretion
Urine (as metabolites); 8-11 hours (elimination half-life).

Valdecoxib Indications / Valdecoxib Uses

Information Not Available

Valdecoxib Adverse Reactions / Valdecoxib Side Effects

Hypertension, back pain, myalgia, peripheral oedema, influenza-like symptoms, dizziness, headache, abdominal fullness, abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, myalgia, sinusitis.

Potentially Fatal: Toxic epidermal necrolysis, exfoliative dermatitis.

Precautions

Information Not Available

Special Precautions

Mild to moderate hepatic impairment; history of ulcer disease or GI bleeding; dehydration, hypertension, history of heart failure, left ventricular dysfunction, pre-existing oedema. Monitor Hb or haematocrit values for signs and symptoms of anaemia.

Other Drug Interactions

Concomitant admin of aspirin may result in an increased risk of GI ulceration and complications. It decreases the antihypertensive effect of antihypertensives e.g. ACE inhibitors. It increases plasma conc of dextromethorphan. It significantly decreases lithium serum clearance and renal clearance.

Other Interactions

Information Not Available

Dosage

Oral
Osteoarthritis
Adult: 10 mg once daily.
CrCl (ml/min)    Dosage Recommendation
<30                      Initiate with caution.
Hepatic impairment: Child-Pugh scale 7-9: Initiate with caution. Child-Pugh scale >10: Avoid.

Oral
Rheumatoid arthritis
Adult: 10 mg once daily.
CrCl (ml/min)    Dosage Recommendation
<30                      Initiate with caution.
Hepatic impairment: Child-Pugh scale 7-9: Initiate with caution. Child-Pugh scale >10: Avoid.

Oral
Dysmenorrhoea
Adult: 20 mg bid.
Hepatic impairment: Child-Pugh scale 7-9: Initiate with caution. Child-Pugh scale >10: Avoid.

Food(before/after)

May be taken with or without food

List of Contraindications

Valdecoxib and Pregnancy

Contraindicated in pregnancy.


Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Valdecoxib and Lactation

Contraindicated in lactation 

Valdecoxib and Children

Information Not Available

Valdecoxib and Geriatic

Information Not Available

Valdecoxib and Other Contraindications

Hypersensitivity to sulfonamides, NSAIDs and other COX 2 inhibitors; asthma, urticaria; severe hepatic impairment; pregnancy (third trimester); lactation. Active GI bleed or ulceration, severe CHF, inflammatory bowel disease.

Storage

Oral
Store below 30°C.

Lab interference

Oral
Store below 30°C.

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