Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Proficient Rx LP
DICLOFENAC SODIUM
DICLOFENAC SODIUM 50 mg
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE 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, USP, are indicated: CONTRAINDICATIONS 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 Error! Hyperlink reference not valid. , and Error! Hyperlink reference not valid. ). Diclofenac Sodium Delayed-Release Tablets, USP are contraindicated in the setting of coronary artery bypass graft
HOW SUPPLIED Diclofenac Sodium Delayed-Release Tablets, USP, for oral administration, are available as: 50 mg: round, Light brown, enteric-coated tablets P 50 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 15.....................................NDC 63187-714-15 Bottles of 30.....................................NDC 63187-714-30 Bottles of 60.....................................NDC 63187-714-60 Bottles of 90.....................................NDC 63187-714-90 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Manufactured by: UNIQUE PHARMACEUTICAL LABORATORIES. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India. Manufactured for: Rising® Rising Pharmaceuticals, Inc. Allendale, NJ 07401 1-800-521-5340 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 118063 July 2015
Abbreviated New Drug Application
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE Proficient Rx LP ---------- Diclofenac Sodium Delayed-Release Tablets, USP MEDICATION GUIDE for Non-Steroidal 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 reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Baca dokumen lengkap
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE PROFICIENT RX LP ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 25 MG, 50 MG AND 75 MG Rx only CARDIOVASCULAR THROMBOTIC EVENTS • • GASTROINTESTINAL RISK • 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 and Precautions_]. Diclofenac sodium delayed-release tablets is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see ERROR! HYPERLINK REFERENCE NOT VALID. and _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 ). DESCRIPTION Diclofenac Sodium Delayed-Release Tablets, USP are a benzene-acetic acid derivative. Diclofenac Sodium Delayed-Release Tablets are available as delayed- release (delayed-release) tablets of 25 mg, 50 mg and 75mg 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 The inactive ingredients in Diclofenac Sodium Delayed-Release Tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron 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 mod Baca dokumen lengkap