Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Biomes Pharmaceuticals
NAPROXEN
NAPROXEN 250 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen tablets are 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 Naproxen tablets are also indicated: - 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 are contraindicated in patients with known hypersensitivity to naproxen. Naproxen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions
Naproxen Tablets 250 mg: white to off-white, round shaped tablet with “138” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-138-16 500’s (bottle): NDC 69150-138-15 1000's (bottle): NDC 69150-138-14 375 mg: white to off-white, oval shaped tablet with “139” debossed on one side and plain on other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-139-16 500’s (bottle): NDC 69150-139-15 1000's (bottle): NDC 69150-139-14 500 mg: white to off-white, capsule-shaped tablets with “140” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-140-16 500’s (bottle): NDC 69150-140-15 1000's (bottle): NDC 69150-140-14 Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers. Rx only Manufactured for: Biomes Pharmaceuticals LLC Lansing, MI 48912, USA Manufactured by: Marksans Pharma Ltd. Verna, Goa – 403 722, India Iss. 11/11 MG #31790
Abbreviated New Drug Application
NAPROXEN- NAPROXEN TABLET BIOMES PHARMACEUTICALS ---------- NAPROXEN - 138, 139, 140 BOXED WARNINGS 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 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 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-_-methyl-2-naphthaleneacetic acid. It has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. 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 are available as white tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. CLINICAL PHARMACOLOGY PHARMACODYNAMICS PHARMACKINETICS ABS ORPTION DIS TRIBUTION METABOLIS M EXCRETION PHARMACODYNAMICS Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but may Belgenin tamamını okuyun