Clinical Pharmacology Details


Valdecoxib


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Indications & Dose:

Adult and Child > 16 yr


• Osteoarthritis, rheumatoid arthritis:



PO 10 mg qd


• Dysmenorrhea:



PO 20-40 mg qd or 20 mg bid


Pain:



PO 20-40 mg qd


RENAL AND HEPATIC DYSFUNCTION No change in dose in renal failure; significant increases (130%) in valdecoxib levels seen in moderate liver dysfunction; don’t exceed 10 mg qd with close monitoring for edema; avoid in patients with severe liver dysfunction

Contraindications:

Hypersensitivity; allergic to sulfa containing products; patients who have experienced asthma, urticaria or allergic-type reactions with aspirin or other NSAIDs (aspirin triad); acute peptic ulcer disease or GI bleeding; severe hepatic or renal disease 

Side Effects:

CNS: Dizziness, headache
CV: Hypertension, edema
EENT: Sinusitis
GI: Nausea, dyspepsia, abdominal pain, abdominal fullness, diarrhea, flatulence, ulceration
GU: Serum creatinine, BUN increases
HEME: Anemia
MS: Back pain,myalgia
RESP: Upper respiratory tract infection
SKIN: Rash, Steven’s Johnson syndrome

Cautions:

Precautions:

History of GI ulceration, concomitant treatment with oral corticosteroids, anticoagulants, smokers, alcoholism, older age, stress, or poor general health status (increased risk for GI ulceration, bleeding, or perforation); mild or moderate renal and liver dysfunction; concurrent diseases increasing risk for renal dysfunction (i.e., diabetes, preexisting edema, hypovolemia, sepsis); pregnancy (1st and 3rd trimesters); CHF, elderly, concurrent diuretics and ACE inhibitors, hypertension 

Interaction:

Drugs 


• Angiotensin-converting enzyme inhibitors: Diminished antihypertensive  effects


• Aspirin: Increased risk of GI ulceration; negation of cardioprotective effects of aspirin


• Diuretics (loop, thiazides): Reduced naturetic effect


• Lithium: Elevation of plasma lithium levels,potential lithium toxicity


 

Warnings:

Adverse Effects:

Lactations:

Pregnancy category C; excreted into breast milk of animals

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: