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Nudroxipak N-500
  • Professionals
  • FDA PI

Nudroxipak N-500

Generic name: nabumetone,methyl salicylate/menthol/capsaicin
Dosage form: kit

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions].
  • Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings].

Gastrointestinal Risk

  • NSAIDs 1 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) .

1Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.

Nudroxipak N-500 Description

Nabumetone USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure:

insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4.

Each tablet, for oral administration contains eithe...