Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Atlantic Biologicals Corps
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, USP as naproxen sodium tablets, USP 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 contraindicated in patients with known hypersensitivity to naproxen, USP and naproxen sodium, USP. Naproxen sodium, USP
NDC:17856-0194-2 in a POUCH of 1 TABLETS
Abbreviated New Drug Application
Atlantic Biologicals Corps ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? This chance increases: NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • ·older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: • different types of arthritis • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all of your medical conditions. • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. • if you are Prečítajte si celý dokument
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET ATLANTIC BIOLOGICALS CORPS ---------- NAPROXEN SODIUM TABLETS, USP 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, 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: Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C H NaO . 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 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 14133 for Prečítajte si celý dokument