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FELDENE®(piroxicam)
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Our medical information is accurate, up to date, and scientifically balanced.
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 Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
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(800)-332-1088.