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OXAPROZIN Tablets (GREENSTONE LLC)

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OXAPROZIN Tablets (GREENSTONE LLC) 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

Oxaprozin is indicated:

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

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of oxaprozin and other treatment options before...

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3 DOSAGE FORMS AND STRENGTHS

Oxaprozin caplets: 600 mg caplets, white, capsule-shaped, scored, film-coated, with oxaprozin debossed on one side and 1381 on the other side.

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4 CONTRAINDICATIONS

Oxaprozin is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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...

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7 DRUG INTERACTIONS

See

...
Table 2: Clinically Significant Drug Interactions with Oxaprozin
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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 overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal...

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11 DESCRIPTION

Oxaprozin caplet is a nonsteroidal anti-inflammatory drug, available as caplets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

The mechanism of action of oxaprozin,...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Osteoarthritis

Oxaprozin was evaluated for the management of the signs and symptoms of osteoarthritis in a total of 616 patients in active...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Oxaprozin 600 mg caplets are white, capsule-shaped, scored, film-coated, with oxaprozin debossed on one side and 1381 on the other side, supplied as:

...
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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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