Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Keltman Pharmaceuticals Inc.
NAPROXEN
NAPROXEN 250 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP is 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 Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen. Naproxen Tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type rea
Naproxen Tablets, USP: 250 mg : white, round, biconvex, debossed with “IP 188” on obverse and “250” on the reverse. 375 mg : white, capsule-shaped, biconvex, debossed with “IP 189” on obverse and “375” on the reverse. 500 mg : white, capsule-shaped, biconvex, debossed with “IP 190” on obverse and “500” on the reverse. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) 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: 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: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.
Abbreviated New Drug Application
NAPROXEN - NAPROXEN TABLET KELTMAN PHARMACEUTICALS INC. ---------- NAPROXEN TABLETS, USP RX ONLY CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fate. This risk may increase with duration of use. Patient with cardiovascular disease or risk factor for cardiovascular disease may be at great risk (see WARNINGS). Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri0operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK NSAIDs cause increased risk of serious gastrointestinal adverse event including, 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 proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti- inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C H O . Naproxen 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 white tablets containing 250 mg of naproxen, white tablets containing 375 mg of naproxen and white tablets containing 500 mg of naproxen for oral administration. The inactive ingredients are Croscarmellose Sodium, Povidone and Magnesium Stearate. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. 14 14 3 The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but m Διαβάστε το πλήρες έγγραφο