Riik: Ameerika Ühendriigid
keel: inglise
Allikas: 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 extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium extended-release tablets are indicated: Diclofenac sodium extended-release tablets, USP are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release tablets should not be given to patients who have experienced asthma, urticaria, or 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, General: Preexisting Asthma ). Diclofenac sodium extended-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG
Diclofenac Sodium Extended-release Tablets, USP 100 mg - Pink round convex film coated tablet debossed with DX 41 on one side. Bottles of: 15 (NDC 63187-475-15) 15 (NDC 63187-475-20) 30 (NDC 63187-475-30) 60 (NDC 63187-475-60) 90 (NDC 63187-475-90) Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in tight container (USP). Manufactured for: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Dexcel ® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel Repackaged by: Proficient Rx LP Thousand Oaks CA, 91320
Abbreviated New Drug Application
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED 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 of 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 health Lugege kogu dokumenti
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE PROFICIENT RX LP ---------- DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP, TABLETS OF 100 MG _PRESCRIBING INFORMATION RX ONLY_ CARDIOVASCULAR RISK • • GASTROINTESTINAL RISK • DESCRIPTION Diclofenac sodium extended-release tablets, USP are benzeneacetic acid derivative. Diclofenac sodium extended-release tablets of 100 mg (pink) are available 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: 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 Extended-release Tablets, USP are contraindicated for the treatment of peri-operative 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 The inactive ingredients in diclofenac sodium extended-release tablets include: carnauba wax, cetostearyl alcohol, colloidal silicon dioxide, compressible sugar, copovidone, gum acacia, hydroxypropyl methylcellulose, iron oxide red, magnesium stearate, polyethylene glycol, povidone, sugar, talc, titanium dioxide. Meets USP Dissolution Test 2. CLINICAL PHARMACOLOGY _PHARMACODYNAMICS_ Diclofenac sodium extended-release tablets, USP are a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti- Lugege kogu dokumenti