Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Hikma Pharmaceutical
NAPROXEN SODIUM
NAPROXEN SODIUM 275 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of naproxen sodium tablets and other treatment options before deciding to use naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen sodium 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 juvenile arthritis Naproxen sodium 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 sodium is contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium. Naproxen sodium should not be given to patients who have expe
Naproxen Sodium Tablets USP, 275 mg is available as white, unscored, capsule shaped, film coated tablets imprinted "H 1" Bottles of 100 tablets. Naproxen Sodium Tablets USP, 550 mg is available as white, unscored, capsule shaped, film coated tablets imprinted "H 2" Bottles of 100 tablets. Bottles of 500 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Revised September 2009
Abbreviated New Drug Application
Hikma Pharmaceutical ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDSS) (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. NSAID medicines should not b Prečítajte si celý dokument
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET HIKMA PHARMACEUTICAL ---------- NAPROXEN SODIUM TABLETS, USP RX ONLY 09/09 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 sodium 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 sodium is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (-)-Sodium 6-methoxy-α-methyl-2-naphthaleneacetate. It has the following structural formula: Naproxen sodium is a white to creamy, crystalline solid, freely soluble in water at neutral pH. Each film coated tablet, for oral administration, contains 275 mg or 550 mg naproxen sodium, equivalent to 250 mg or 500 mg naproxen with 25 mg (about 1 mEq) or 50 mg (about 2 mEq) of sodium respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium hydrogenated vegetable oil, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K-30) and sodium lauryl sulfate. The film coating contains: hydroxypropyl methylcellulose 2910, methacrylic acid copolymer, povidone (K-30), simethicone emulsion, talc and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Prečítajte si celý dokument