Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Aphena Pharma Solutions - Tennessee, LLC
NAPROXEN
NAPROXEN 250 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP is indicated: - For the relief of the signs and symptoms of rheumatoid arthritis - For the relief of the signs and symptoms of osteoarthritis - For the relief of the signs and symptoms of ankylosing spondylitis - For the relief of the signs and symptoms of juvenile arthritis - For relief of the signs and symptoms of tendonitis - For relief of the signs and symptoms of bursitis - For relief of the signs and symptoms of acute gout - For the management of pain - For the management of primary dysmenorrhea Naproxen Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen. Naproxen Tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type rea
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Naproxen Tablets, USP: 250 mg : white, round, biconvex, debossed with “IP 188” on obverse and “250” on the reverse. Packaged in bottles of 100, 500 and 1000. 375 mg : white, capsule-shaped, biconvex, debossed with “IP 189” on obverse and “375” on the reverse. Packaged in bottles of 100, 500 and 1000. 500 mg : white, capsule-shaped, biconvex, debossed with “IP 190” on obverse and “500” on the reverse. Packaged in bottles of 100, 500 and 1000. Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers. Rx only
Abbreviated New Drug Application
NAPROXEN - NAPROXEN TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- NAPROXEN TABLETS, USP RX ONLY CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fate. This risk may increase with duration of use. Patient with cardiovascular disease or risk factor for cardiovascular disease may be at great risk (see WARNINGS). Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri0operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK NSAIDs cause increased risk of serious gastrointestinal adverse event including, 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 is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C H O . Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen Tablets, USP are available as white tablets containing 250 mg of naproxen, white tablets containing 375 mg of naproxen and white tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are Croscarmellose Sodium, Povidone and Magnesium Stearate. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. 14 14 3 The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely unde Read the complete document