ประเทศ: สหรัฐอเมริกา
ภาษา: อังกฤษ
แหล่งที่มา: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
RxChange Co.
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 contrain
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.
Abbreviated New Drug Application
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET RXCHANGE CO. ---------- NAPROXEN SODIUM TABLETS, USP 275 MG AND 550 MG RX ONLY 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 Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy- -methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure: Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2. 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 absorbed formulation of naproxen for use as an analgesic. The mechanism of action อ่านเอกสารฉบับเต็ม