Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). 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 the following patents: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin rea
strong>Naproxen Tablets, USP: 375 mg: Light Pink, Capsule shaped, biconvex tablets de-bossed with ' IG ' on one side and ' 341 ' on the other, supplied in bottles of 20 NDC 68071-3066-2 bottles of 30 NDC 68071-3066-3 bottles of 40 NDC 68071-3066-4 bottles of 60 NDC 68071-3066-6 bottles of 15 NDC 68071-3066-5 bottles of 90 NDC 68071-3066-9 Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. *All brand names mentioned are registered trademark of their respective owners and are not of Cipla Limited. Revised: 07/2016
Abbreviated New Drug Application
NuCare Pharmaceuticals, Inc. ---------- 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)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, tell your healthcare provider about all of your medical con Les hele dokumentet
NAPROXEN- NAPROXEN TABLET NUCARE PHARMACEUTICALS, INC. ---------- NAPROXEN TABLETS, USP RX ONLY WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH DURATION OF USE ( _SEE WARNINGS_ ). NAPROXEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY ( _SEE CONTRAINDICATIONS, WARNINGS_ ). GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) 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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS ( _SEE WARNINGS_ ). DESCRIPTION Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C H O . Naproxen, USP 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, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate. CLINICAL PHA Les hele dokumentet