País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Aidarex Pharmaceuticals LLC
NAPROXEN
NAPROXEN 375 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Naproxen Delayed-Release Tablets USP and other treatment options before deciding to use Naproxen Delayed-Release Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen Delayed-Release 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 Naproxen, USP as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen Delayed-Release Tablets USP are not recommended for initial treatment of acute pain because the absorption of naproxen, USP is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and
Naproxen Delayed-Release Tablets USP are supplied as follows: 375 mg: White to off-white, capsule-shaped, enteric-coated, unscored tablets imprinted on one side in blue ink with “93-5”. They are available in bottles of 60. 500 mg: White to off-white, capsule-shaped, enteric-coated, unscored tablets imprinted on one side in blue ink with “93-6”. They are available in bottles of 30 and 60 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. I 3/2013
Abbreviated New Drug Application
Aidarex Pharmaceuticals LLC ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only (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: • 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. NSA Leia o documento completo
NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE AIDAREX PHARMACEUTICALS LLC ---------- NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 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 delayed-release tablets are 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 (seeWARNINGS). Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti- inflammatory drug. DESCRIPTION Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of non-steroidal anti- inflammatory drugs. The chemical name for naproxen, USP is (+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the following structural formula: C H O M.W. 230.26 Naproxen, USP is a practically 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, USP at pH 7.4 is 1.6 to 1.8. Naproxen Delayed-Release Tablets USP are available as enteric-coated, white to off-white tablets containing 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are: antifoam DC 1510, corn starch, croscarmellose sodium, FD&C Blue # 2 Aluminum Lake, magnesium * * 14 14 3 stearate, methacrylic acid copolymer-dispersion, povidone, propylene glycol, shellac, talc, titani Leia o documento completo