Drug Facts
DESCRIPTION SECTION
Each capsule contains:
Naxproxen, ESP ..........500 mg
DESCRIPTION SECTION
Dosage and Use: For dosage recommendations
and other important prescribing information, read accompanying insert.
STORAGE AND HANDLING SECTION
Store at 20 to 25 C (68 to 77 F); excursions
permitted to 15 to 30 C (59 to 86 F)[See
USP Controlled Room Temperature]
Dispense in well-closed, light-resistant containers
as defined in the USP.
BOXED WARNING SECTION
BOXED WARNING
Cardiovascular Risk
-NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal.
-Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri-operative
pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
-NSAIDs may cause an increased risk of serious gastrointestinal adverse events including
bleeding, ulceration. and perforation of the stomach or intestines, which can be fatal.
DESCRIPTION SECTION
DESCRIPTION
Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.
CLINICAL PHARMACOLOGY SECTION
CLINICAL PHARMACOLOGY
Pharmacodynamics - Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and
antipyretic properties.
CLINICAL STUDIES SECTION
CLINICAL STUDIES
General Information - Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis,
juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout.
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatments
before deciding to sue naproxen tablets, USP.
CONTRAINDICATIONS SECTION
CONTRAINDICATIONS
Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP.
WARNINGS SECTION
WARNINGS
Cardiovascular Effects - Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective
and non-selective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke, which can be fatal.
PRECAUTIONS SECTION
PRECAUTIONS
General - Naproxen - containing products such as naproxen tablets, and other naproxen products should
not be used concomitantly since they all circulate in the plasma as the naproxin anion.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis
or osteoarthritis are listed below.
OVERDOSAGE SECTION
OVERDOSAGE
Symptoms and Signs Significant naproxen overdosage may be characterized by lethargy, dizziness,
drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function,
hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment
options before deciding to use naproxen tablets, USP.
PATIENT MEDICATION INFORMATION SECTION
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)