国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
NCS HealthCare of KY, Inc dba Vangard Labs
DICLOFENAC SODIUM
DICLOFENAC SODIUM 50 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release and other treatment options before deciding to use diclofenac sodium delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets are indicated: • For relief of signs and symptoms of osteoarthritis • For relief of signs and symptoms of rheumatoid arthritis • For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium delayed-release should not be given to patients who have experienced asthma, urticaria, or other 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)
Diclofenac Sodium Delayed-Release Tablets, USP are available as follows: 50 mg — Each white, round, enteric-coated tablet printed with Tablets are supplied in blistercards of 30 (NDC 0615-4506-39). 75 mg — Each white, round, enteric-coated tablet printed with Tablets are supplied in blistercards of 30 (NDC 0615-4507-39). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8780 Revised — January 2008
Abbreviated New Drug Application
NCS HealthCare of KY, Inc dba Vangard Labs ---------- 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: • 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 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 pregnan 阅读完整的文件
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 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). Diclofenac sodium 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 inflammation, 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 Diclofenac sodium delayed-release is a benzene-acetic acid derivative. The chemical name is 2-[(2,6- dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C H Cl NNaO , and it has the following structural formula Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Diclofenac sodium delayed-release tablets are a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities i 阅读完整的文件