Proportional increase in exposure is observed with
The renal effects of Feldene may hasten the progression of renal dysfunction in patients with preexisting renal disease.Correct volume status in dehydrated or hypovolemic patients prior to initiating Feldene. 0000006811 00000 n
The increase in CV thrombotic risk has been observed most consistently at higher doses.To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Inform patients, families, or their caregivers of the following information before initiating therapy with Feldene and periodically during the course of ongoing therapy.Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. lower incidence of minor gastrointestinal effects and FELDENE has been administered concomitantly with fixed doses of gold and These are not all the possible side effects of NSAIDs. Consider withdrawal of NSAIDs, including Feldene, in women who have difficulties conceiving or who are undergoing investigation of infertility.Feldene has not been investigated in pediatric patients. Most patients approximate steady state plasma levels within 7 to 12 days. 0000004843 00000 n
The concomitant administration of antacids (aluminum hydroxide or aluminum hydroxide with magnesium hydroxide) have been shown to have no effect on the plasma levels of orally administered piroxicam.The apparent volume of distribution of piroxicam is approximately 0.14 L/kg. Piroxicam appeared in breast milk at approximately 1% to 3% of the maternal concentration. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. approximately 1% of NSAID-treated patients in clinical trials. treatment goals [see After observing the response to initial therapy with FELDENE, the dose and frequency should be adjusted to suit
hydroxide) have been shown to have no effect on the plasma levels of orally administered piroxicam.The apparent volume of distribution of piroxicam is approximately 0.14 L/kg. The
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pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.This Medication Guide has been approved by the U.S. Food and Drug Administration.You are encouraged to report negative side effects of prescription drugs to the FDA. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. 0000005571 00000 n
The prolonged half-life (50 hours) results in the maintenance of relatively stable plasma concentrations throughout the day on once daily doses and significant accumulation upon multiple dosing. Use of piroxicam may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) Avoid the use of Feldene in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. Feldene is contraindicated in patients with previous serious skin reactions to NSAIDs Piroxicam may cause premature closure of the fetal ductus arteriosus.
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