Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Shionogi Inc.
NAPROXEN SODIUM
NAPROXEN 375 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea. NAPRELAN® is contraindicated in patients with known hypersensitivity to naproxen. NAPRELAN® should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS- Anaphylactoid Reactions, and PRECAUTIONS- Preexisting Asthma). NAPRELAN® is contraindicated for the treatment of peri-operative pain in the setting of corona
NAPRELAN® (naproxen sodium) Controlled-Release Tablets are available as follows: NAPRELAN® 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 59630-375-10. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen. NAPRELAN® 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 59630-850-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen. NAPRELAN® 750: white-capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; 59630-777-03. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen. Rx only US Patent 5,637,320 Store at controlled room temperature, 20° to 25° C (68° to 77° F). PHARMACIST: Dispense in a well-closed container. _____________________________________________________ * Registered Trademark of Alkermes Pharma Ireland Ltd. ** Registered Trademark of Alkermes Pharma Ireland Ltd. *** Naprosyn ® is a registered trademark of Syntex Pharmaceuticals International Limited Manufactured for: Shionogi Inc., Florham Park, NJ 07932 Manufactured by: Alkermes Pharma Ireland Limited, Athlone, Ireland NAP-PI -2 Rev 03/2013
New Drug Application
Shionogi Inc. ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) NAPRELAN® (naproxen sodium) CONTROLLED-RELEASE TABLETS What is the most important information I should know about medicines called Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • 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 “anti-coagulants” • 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 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 pharmacis Olvassa el a teljes dokumentumot
NAPRELAN- NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE SHIONOGI INC. ---------- NAPRELAN NAPRELAN (naproxen sodium) _CONTROLLED-RELEASE TABLETS_ Equivalent to 375 mg, 500 mg and 750 mg naproxen NAPRELAN Controlled-Release Tablets, 375 mg, 500 mg and 750 mg 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 NAPRELAN 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 PEOPLE ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL EVENTS. (SEE WARNINGS). DESCRIPTION NAPRELAN Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS (Intestinal Protective Drug Absorption System) technology. It is a rapidly disintegrating tablet system combining an immediate release component and a sustained release component of microparticles that are widely dispersed, allowing absorption of the active ingredient throughout the gastrointestinal (GI) tract, maintaining blood levels over 24 hours. The chemical name for naproxen sodium is 2-naphthaleneacetic acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following structural formula: Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and Olvassa el a teljes dokumentumot