מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
American Health Packaging
DICLOFENAC SODIUM
DICLOFENAC SODIUM 75 mg
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: Gastrointestinal Bleeding, Ulceration and Perforation ). Diclofenac sodium delayed-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the 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 the following patients. - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS: Anaphylactic Reactions, Serious Skin Reactions ). - History of asthma, urticaria, or other allergic-type reactions after taking aspirin
Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 50 mg: round, light brown, enteric-coated tablets “ P ” over “ 50 ” imprinted on one side in black ink and plain on the reverse side are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-606-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE American Health Packaging ---------- MEDICATION GUIDE 8233301/0322F Diclofenac Sodium (dye kloe' fen ak soe' dee um) Delayed-release Tablets, USP Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you had an asthma attack, hives, or other allergic r קרא את המסמך השלם
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE AMERICAN HEALTH PACKAGING ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 8233301/0322F RX ONLY WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS CARDIOVASCULAR THROMBOTIC EVENTS Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS). Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS). DESCRIPTION Diclofenac sodium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6- dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is: C H Cl NNaO M.W. 318.14 Diclofenac sodium is a white to off-white, hygroscopic crystalline powder. It is freely 14 10 2 2 soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each enteric-coated tablet for oral administration contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients. Inactive ingredients: lactose (monohydrate), microcrystalline ce קרא את המסמך השלם