Piroxicam Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Osteoarthritis

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Adult Dose for Pain

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Adult Dose for Rheumatoid Arthritis

20 mg orally once a day or 10 mg orally twice a day.

The recommended maximum daily dose is 20 mg.

Usual Pediatric Dose for Pain

0.2 to 0.3 mg/kg orally once a day. Maximum daily dose is 15 mg.

Renal Dose Adjustments

Mild to moderate renal impairment: No adjustment recommended
Severe renal impairment: Data not available

Liver Dose Adjustments

A lower dosage may be required in patients with hepatic disease.

Precautions

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of administration. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Prescribers and patients should remain vigilant for the development of such events, even in the absence of previous CV symptoms. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

Serious gastrointestinal (GI) toxicity, such as bleeding, ulceration, and perforation, can occur at any time with or without warning symptoms, in patients receiving NSAID therapy chronically. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been shown that the incidence of upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Patients should be informed about the signs and symptoms of serious GI toxicities and the steps to take if they occur. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or GI bleeding. A past history of ulcer disease, older age, and poor general health (among other factors) may increase the risk for gastrointestinal bleeding. Most spontaneous reports of fatal gastrointestinal events with nonsteroidal anti-inflammatory agents are in elderly or debilitated patients, extra caution is recommended. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be administered for the shortest duration. Prescribers and patients should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID therapy until a serious GI adverse event is ruled out. For patients at high-risk, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Piroxicam is contraindicated for the treatment of perioperative pain in patients undergoing coronary artery bypass graft (CABG) surgery. Patients with the "triad" of asthma, nasal polyps, and aspirin or other NSAID hypersensitivity (i.e. angioedema, bronchospasm, urticaria, rhinitis) may be cross-sensitive to piroxicam. The use of piroxicam is considered contraindicated in these patients.

NSAIDs, including piroxicam, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to an increased incidence of CV events. NSAIDs, including piroxicam, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID therapy and throughout the course of therapy.

Fluid retention and edema have been observed in some patients taking NSAIDs, including piroxicam. Caution should be used when using piroxicam in patients with fluid retention or heart failure.

Long-term NSAIDs use has resulted in renal papillary necrosis and other renal injury. No information is available from controlled clinical trials regarding the use of piroxicam in patients with advanced renal disease. Therefore, treatment with piroxicam is not recommended in patients with advanced renal disease. Renal function may be further compromised by the use of piroxicam in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. Renal function should be monitored in patients with impaired renal function.

NSAIDs, including piroxicam, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. A combination of dermatological and/or allergic signs and symptoms suggestive of serum sickness have occasionally occurred in conjunction with the administration of piroxicam. These include arthralgias, pruritus, fatigue, fever, and rash including vesiculobullous reactions and exfoliative dermatitis.

Borderline elevations of one or more liver tests may occur in patients taking NSAIDs, including piroxicam. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Notable elevations in ALT or AST (approximately three or more times the upper limit of normal) have been reported in clinical trials with NSAIDs. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. Patients with symptoms and/or signs suggesting liver dysfunction, or in whom abnormal liver test have occurred, should be evaluated for evidence of the development of more severe hepatic reaction while on piroxicam therapy. Piroxicam should be discontinued if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (e.g., eosinophilia, rash, etc.). Patients with hepatic disease should be carefully monitored during therapy.

Anemia has been reported in patients receiving NSAIDs, including piroxicam. This may due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including piroxicam, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggression and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving piroxicam who may be adversely affected by alterations in platelet function, such as those with coagulation disorders, should be carefully monitored.

Because of reports of adverse eye findings with NSAIDs, it is advised that patients who develop visual complaints during treatment with piroxicam have ophthalmic evaluations.

Piroxicam should be used with caution in geriatric patients 65 years of age or older since these patients may have decreased renal function. It may be necessary to monitor renal function in these patients.

Dialysis

Data not available

Other Comments

If no improvement is seen within 4 to 6 weeks of therapy, an alternative NSAID should be considered.

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