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FELDENE®(piroxicam)

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FELDENE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • ...
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1 INDICATIONS AND USAGE

FELDENE is indicated:

  • For relief of the signs and symptoms of osteoarthritis.
  • For relief of the signs and symptoms of rheumatoid arthritis.
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2 DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dosage for the shortest duration consistent with...

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3 DOSAGE FORMS AND STRENGTHS

FELDENE (piroxicam) capsules:

10 mg maroon and blue #322

20 mg maroon #323

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4 CONTRAINDICATIONS

FELDENE is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product...
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5 WARNINGS AND PRECAUTIONS

5.1 Cardiovascular Thrombotic Events

Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see

    6.1 Clinical Trials...

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7 DRUG INTERACTIONS

See

...
Table 1: Clinically Significant Drug Interactions with Piroxicam
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Use of NSAIDs,...

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10 OVERDOSAGE

Symptoms following acute NSAID overdoses have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal...

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11 DESCRIPTION

FELDENE (piroxicam) capsule is a nonsteroidal anti-inflammatory drug, available as maroon and blue #322 10 mg capsules and maroon #323 20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Piroxicam has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of FELDENE,...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

In controlled clinical trials, the effectiveness of FELDENE has been established for both acute exacerbations and long term management of rheumatoid arthritis and osteoarthritis.

The therapeutic...

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16 HOW SUPPLIED/STORAGE AND HANDLING

FELDENE® (piroxicam) 10 mg capsules are maroon and blue #322, supplied as:

...
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

...

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