Naprelan

Drug Description

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NAPRELAN®
(naproxen sodium) Controlled-Release Tablets
Equivalent to 375 mg and 500 mg naproxen
NAPRELAN Controlled Release Tablets, 375 mg and 500 mg

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 NAPRELAN® 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 people are at greater risk for serous gastrointestinal events. (See WARNINGS).

DRUG DESCRIPTION

NAPRELAN®* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN® Tablets use the proprietary IPDAS®** (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula:

Naproxen sodium
Molecular Formula: C₁₄H₁₃NaO₃ Molecular Weight: 252.24

Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN® Tablets contain 412.5 mg or 550 mg of naproxen sodium, equivalent to 375 mg and 500 mg of naproxen and 37.5 mg and 50 mg sodium respectively. Each NAPRELAN® Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammo-niomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydrox-ypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

Brand Name: Naprelan
Generic Name: Naproxen Sodium

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