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FELDENE® (piroxicam)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
FELDENE® Quick Finder
Highlights
Boxed Warning
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- ...
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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
FELDENE (piroxicam) capsules:
10 mg maroon and blue #322
20 mg maroon #323
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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see Warnings and...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Use of NSAIDs,...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
FELDENE® (piroxicam) 10 mg capsules are maroon and blue #322, supplied as:
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Medication Guide
| Medication Guide for Nonsteroidal Anti-inflammatory Drugs (... |
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.