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GREENSTONE LLC INTRODUCES PIROXICAM CAPSULES
Authorized Generic of Feldene®

PEAPACK, N.J., March 2014 — Greenstone LLC, a U.S.-based generic pharmaceutical subsidiary of Pfizer Inc. (NYSE: PFE), is pleased to announce the introduction of Piroxicam Capsules to its ever-expanding generic pharmaceutical product line. The product is offered in dosage strengths of 10mg x 100 and 20mg x 100.

Greenstone’s Piroxicam Capsules product is the authorized generic of, and equivalent to the innovator’s product, FELDENE® (piroxicam). This new authorized generic adds to Greenstone’s consistently growing line of products, and is backed by the distribution and customer service support of Pfizer Inc., one of the world’s largest pharmaceutical companies. As a subsidiary of Pfizer, Greenstone operates under the same values and commitment to bring quality authorized generics to customers, payers, and the patients it serves.

See the Full Prescribing Information, including boxed warning, for Greenstone’s Piroxicam Capsules at http://www.greenstonellc.com/product-list.aspx. For more information about Greenstone LLC and its products, visit http://greenstonellc.com.

INDICATION:
Piroxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

IMPORTANT SAFETY INFORMATION:

Cardiovascular Risk:

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Piroxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

Piroxicam is contraindicated in patients with active gastrointestinal bleeding and in patients with known hypersensitivity to Piroxicam.

Piroxicam 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, including bronchospasm, to NSAIDs have been reported in such patients. Piroxicam should not be given to patients with the aspirin triad. Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Carefully consider the potential benefits and risks of piroxicam and other treatment options before deciding to use piroxicam. To minimize the potential risk for an adverse event, including CV and GI events, the lowest effective dose should be used for the shortest duration possible.

The concurrent use of aspirin and an NSAID including Piroxicam does increase the risk of serious GI events and can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Piroxicam should be used with caution in patients with fluid retention or heart failure.

NSAIDs including Piroxicam should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Piroxicam is not recommended in these patients with advanced renal disease.

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.

A combination of dermatological and/or allergic signs and symptoms suggestive of serum sickness have occasionally occurred in conjunction with the use of piroxicam.

In late pregnancy, as with other NSAIDs, piroxicam should be avoided because it may cause premature closure of the ductus arteriosus.

Piroxicam cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including piroxicam. 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. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, piroxicam should be discontinued.

Anemia is sometimes seen in patients receiving NSAIDs, including piroxicam. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Patients with coagulation disorders or receiving anticoagulants should be carefully monitored.

In patients taking piroxicam the most frequently reported adverse experiences are:
Edema, anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross GI bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting, anemia, increased bleeding time, dizziness, headache, pruritus, rash, tinnitus, abnormal renal function.

Please see USPI for a complete list of additional adverse experiences that have been reported.

Physicians should closely monitor patients for a change in dosage requirements when administering piroxicam to patients on other highly protein bound drugs.

Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. Piroxicam can reduce the natriuretic effect of furosemide and thiazides in some patients.

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Piroxicam has not been investigated in pediatric patients.

Patients with hepatic disease may require reduced doses of piroxicam as compared to patients with normal hepatic function. In patients who are known or suspected to be poor CYP2C9 metabolizers, piroxicam should be administered piroxicam with caution.

Studies indicate patients with mild to moderate renal impairment may not require dosing adjustments.

Piroxicam should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Piroxicam is excreted into human milk and is not recommended for use in nursing mothers.

Caution should be exercised in treating the elderly with Piroxicam.