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Napropak
  • Professionals
  • FDA PI

Napropak

Generic name: naproxen sodium, menthol, finger cots
Dosage form: kit

Naproxen Sodium Tablets, USP 275 mg and 550 mg

Rx Only

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 Sodium 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).

Napropak Description

Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal antiinflammatory drugs.

The chemical name for naproxen sodium is (S)-6-methoxy-⟨-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure:

Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3.

Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.

Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD& C Blue #2.

Napropak - Clinical Pharmacology

Pharmacodynamics

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The sodium salt of naproxen has been developed as a more rapidl...