Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
DIRECT RX
NAPROXEN SODIUM
NAPROXEN SODIUM 550 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium 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 • 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 Sodium Tablets, USP are contraind
Naproxen Sodium Tablets, USP 275 mg are blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse. They are available as follows: Bottles of 100: NDC 53746-193-01 Bottles of 500: NDC 53746-193-05 Naproxen Sodium Tablets, USP 550 mg are blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse. They are available as follows: Bottles of 100: NDC 53746-194-01 Bottles of 500: NDC 53746-194-05 Store at 15° to 30°C (59° to 86°F) in well-closed containers. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 10-2008
Abbreviated New Drug Application
DIRECT RX ---------- Revised: 1/2020 Document Id: 9ca99dc1-7125-65e1-e053-2a95a90a0be3 34391-3 Set id: 16705fc3-5379-4557-94b6-fc5bfbbbc6d1 Version: 3 Effective Time: 20200121 DIRECT RX Прочитать полный документ
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET DIRECT RX ---------- NAPROXEN SODIUM BOXED WARNING 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). DESCRIPTION SECTION Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen sodium, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structure: [Structural Formula] Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2. CLINICAL PHARMACOLOGY SECTION 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 rapidly ab Прочитать полный документ