Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Polygen Pharmaceuticals LLC
NAPROXEN
NAPROXEN 250 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). 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 juvenilearthritis 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 patients with known hypersensitivity to naproxen. Naproxen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions
Naproxen Tablets 250 mg: white to off-white, round shaped tablet with “138” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100 & 500 100's (bottle): NDC 52605-138-01 500's (bottle): NDC 52605-138-05 375 mg: white to off-white, oval shaped tablet with “139” debossed on one side and plain on other side. Packaged in light-resistant bottles of 100 & 500 100's (bottle) : NDC 52605-139-01 500's (bottle): NDC 52605-139-05 500 mg: white to off-white, capsule-shaped tablets with “140” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100, 500 & 1000 100's (bottle): NDC 52605-140-01 500's (bottle): NDC 52605-140-05 1000's (bottle):NDC 52605-140-10 Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers. Rx only Manufactured for: PolyGen Pharmaceuticals LLC Edgewood, NY 11717, USA Manufactured by : Marksans Pharma Ltd. Verna, Goa – 403 722, India R304/13 LBS0017
Abbreviated New Drug Application
Polygen Pharmaceuticals LLC ---------- SPL MEDGUIDE Medication Guide for Non-steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescriptionNSAID 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. NSAID medicin Soma hati kamili
NAPROXEN - NAPROXEN TABLET POLYGEN PHARMACEUTICALS LLC ---------- NAPROXEN TABLETS, USP 250MG, 375MG, 500 MG BOXED WARNING 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 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 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- -methyl-2-naphthaleneacetic acid. It has the following structure: Molecular Formula: C H O MW = 230.26 Naproxen has a molecular weight of 230.26 and a molecular formula of C H O . 14 14 3 14 14 3 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 are available as white tablets containing 250 mg, 375 mg and 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. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but may be related to prost Soma hati kamili