NaproPax
Generic name: naproxen tablet, capsaicin menthol patch
Dosage form: kit
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Naproxen
Naproxen Label
WARNING:
Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- 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 cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
DESCRIPTION
Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.
The chemical name for naproxen, USP is (S)-6-methoxy--methyl-2- naphthaleneacetic acid. Naproxen, USP has the following structure:
Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3.
Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipidsoluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8.
Naproxen, USP is available as white tablets containing 250 mg of naproxen, USP, white tablets containing 375 mg of naproxen, USP and white tablets containing 500 mg of nap
