Country: United States
Language: English
Source: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Exelan Pharmaceuticals, Inc.
Naproxen
Naproxen 250 mg
ORAL
PRESCRIPTION DRUG
Naproxen tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets are also indicated for: the relief of signs and symptoms of: - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea Naproxen tablets are contraindicated in the following patients - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ]. - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8) ]. - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]. Risk Summary Use of NSAIDs, including naproxen tablets, during the third trimester of pr
Naproxen Tablets, USP: 250 mg: Light Yellow, Round, biconvex tablets de-bossed with ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘340’ on the other, supplied in bottles of 100’s count (NDC 76282-340-01) and 500’s count (NDC 76282-340-05). 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 100’s count (NDC 76282-341-01) and 500’s count (NDC 76282-341-05). Naproxen Tablets, USP: 500 mg: Light Yellow, Capsules shaped, biconvex tablets de-bossed with ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘342’ on the other, supplied in bottles of 100’s count (NDC 76282-342-01) and 500’s count (NDC 76282-342-05). Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container.
Abbreviated New Drug Application
Exelan Pharmaceuticals, Inc. ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Nonsteroidal 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: • any time 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 NSAIDs 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 me Read the complete document
NAPROXEN- NAPROXEN TABLET EXELAN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NAPROXEN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN TABLETS. NAPROXEN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1976 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 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. (5.1) NAPROXEN TABLETS, ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. (4, 5.1) 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. (5.2) INDICATIONS AND USAGE Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: (1) rheumatoid arthritis os te oarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis Naproxen tablets are also indicated for: (1) the relief of signs and symptoms of: (1) te ndonitis burs itis acute gout the management of: (1) pain primary dysmenorrhea DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. (2.1) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen Tablets 250 mg or 375 mg or 500 mg twice daily twice daily twice daily The dose may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses we Read the complete document