Country: United States
Language: English
Source: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)
Blenheim Pharmacal, Inc.
Diclofenac Sodium
Diclofenac Sodium 75 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac is indicated: Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac 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 is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Diclofenac sodium delayed-release tablets 75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in: Bottles of 14 (NDC 10544-189-14) Bottles of 20 (NDC 10544-189-20) Bottles of 30 (NDC 10544-189-30) Bottles of 60 (NDC 10544-189-60) Bottles of 90 (NDC 10544-189-90) Bottles of 1000 (NDC 10544-189-01) Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 USA Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131 USA Revised: February 2010 CTI-11 Rev. C Printed in USA
Abbreviated New Drug Application
DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED RELEASE Blenheim Pharmacal, Inc. ---------- 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 pr Read the complete document
DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED RELEASE BLENHEIM PHARMACAL, INC. ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP RX ONLY PRESCRIBING INFORMATION CARDIOVASCULAR RISK • • GASTROINTESTINAL RISK • DESCRIPTION Diclofenac, as the sodium salt, is a benzene-acetic acid derivative. 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 NaO , and it has the following structural formula 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 is 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.) 14 10 2 2 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; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Diclofenac sodium delayed-release tablets is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac, lik Read the complete document