מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium delayed-release tablets, are indicated: Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium delayed-release tablets 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 are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see
Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 75 mg : round, Light brown, enteric-coated tablets imprinted P 75 on one side in black ink and plain on the reverse side are supplied as: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE Proficient Rx LP ---------- 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 ph קרא את המסמך השלם
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE PROFICIENT RX LP ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP, 75 MG Rx only Prescribing information CARDIOVASCULAR RISK • • GASTROINTESTINAL RISK • DESCRIPTION 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 perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). 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 ). Diclofenac sodium delayed-release tablets are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets are available as delayed-release tablets of 75 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C H Cl NNaO , and it has the following structural formula 14 10 2 2 CLINICAL PHARMACOLOGY PHARMACODYNAMICS Diclofenac sodium delayed-release tablets, are a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac sodium delayed-release tablets, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. PHARMACOKINETICS ABSORPTION TABLE 1. PHARMACOKINETIC PARAMETERS FOR DICLOFENAC NORMAL HEALTHY ADULTS (20-48 YRS.) PK PARAMETER MEAN COEFFICIENT OF MEAN VARIATI קרא את המסמך השלם