Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Blenheim Pharmacal,Inc.
NAPROXEN
NAPROXEN 500 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, USP 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, USP. Naproxen tablets, USP should not be given to patients who have experienced asthma, urticar
Naproxen Tablets, USP, 250 mg, are supplied as white, round, biconvex tablets, debossed with “IP 188” on obverse and “250” on the reverse. They are available as follows: Bottles of 100: NDC 53746-188-01 Bottles of 500: NDC 53746-188-05 Bottles of 1000: NDC 53746-188-10 NaproxenTablets, USP, 375 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 189” on obverse and “375” on the reverse. They are available as follows: Bottles of 100: NDC 53746-189-01 Bottles of 500: NDC 53746-189-05 Bottles of 1000: NDC 53746-189-10 Naproxen Tablets, USP, 500 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 190” on obverse and “500” on the reverse. They are available as follows: Bottles of 100: NDC 53746-190-01 Bottles of 500: NDC 53746-190-05 Bottles of 1000: NDC 53746-190-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers as defined in the USP. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 04-2015-00
Abbreviated New Drug Application
NAPROXEN- NAPROXEN TABLET BLENHEIM PHARMACAL,INC. ---------- NAPROXEN TABLETS, USP 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 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). CLINICAL PHARMACOLOGY 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 be related to prostaglandin synthetase inhibition. PHARMACOKINETICS Naproxen is rapidly and completely absorbed from the gastrointestinal tract with an _in vivo_ bioavailability of 95%. The different dosage forms of naproxen are bioequivalent in terms of extent of absorption (AUC) and peak concentration (C ); however, the products do differ in their pattern of absorption. These differences between naproxen products are related to both the chemical form of naproxen used and its formulation. Even with the observed differences in pattern of absorption, the elimination half-life of naproxen is unchanged across products ranging from 12 to 17 hours. Steady- state levels of naproxen are reached in 4 to 5 days, and the degree of naproxen accumulation is consistent with this half-life. This suggests that the differences in pattern of release play only a negligi Pročitajte cijeli dokument