Piroxicam
Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Piroxicam capsules are indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with piroxicam capsules, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of piroxicam capsules, steady-state blood levels are not reached for 7 to 12 days. Therefore, although the therapeutic effects of piroxicam are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
In patients taking piroxicam capsules or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are:
Cardiovas cular System: Edema.
Digestive System: Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.
Hemic and Lymphatic System: Anemia, increased bleeding time.
Nervous System: Dizziness, headache.
Skin and Appendages: Pruritus, rash.
Special Sens es: Tinnitus.
Urogenital System: Abnormal renal function.
Additional adverse experiences reported occasionally include:
Body As a Whole: Fever, infection, sepsis.
Cardiovas cular System: Congestive heart failure, hypertension, tachycardia, syncope.
Digestive System: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.
Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia.
Metabolic and Nutritional: Weight changes.
Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia,malaise, nervousness, paresthesia, somnolence, tremors, vertigo. Respiratory System: Asthma, dyspnea.
Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat.
Special Sens es: Blurred vision.
Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure.
Other adverse reactions which occur rarely are: Body As a Whole: Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness.
Cardiovas cular System: Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis.
Digestive System: Eructation, liver failure, pancreatitis.
Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.
Hypers ensitivity: Positive ANA.
Metabolic and Nutritional: Hyperglycemia, hypoglycemia.
Nervous System: Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations.
Respiratory: Respiratory depression, pneumonia.
Skin and Appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens
Johnson syndrome, urticaria, vesiculobullous reaction.
Special Sens es: Conjunctivitis, hearing impairment, swollen eyes.
Piroxicam capsules are contraindicated in patients with known hypersensitivity to piroxicam.
Piroxicam capsules should not be given to patients who have experienced asthma, urticaria, or allergictype reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma). Piroxicam capsules are contraindicated for the treatment of peri operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
See package insert for complete information