Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)
Pack Pharmaceuticals, LLC
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 ). Diclofenac Sodium Delayed-release Tablets, are indicated: - For relief of signs and symptoms of osteoarthritis - For relief of 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 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 PRE
Diclofenac Sodium Delayed-release Tablets, USP, for oral administration, are available as: 25 mg : round, Light brown, enteric-coated tablets P 25 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 100 NDC 16571-203-10 50 mg : round, Light brown, enteric-coated tablets P 50 on one side in black ink and plain on the reverse side are supplied as: Bottles of 60 NDC 16571-202-06 Bottles of 100 NDC 16571-202-10 Bottles of 1000 NDC 16571-202-11 75 mg : round, Light brown, enteric-coated tablets P 75 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 60 NDC 16571-201-06 Bottles of 100 NDC 16571-201-10 Bottles of 500 NDC 16571-201-50 Bottles of 1000 NDC 16571-201-11 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. Distributed by: PACK Pharmaceuticals, LLC Buffalo Grove, IL 60089
Abbreviated New Drug Application
Pack Pharmaceuticals, LLC ---------- 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 pharmacist. • if you are pregnant. NSAID medicines s Preberite celoten dokument
DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE PACK PHARMACEUTICALS, LLC ---------- DICLOFENAC SODIUM DELAYED-RELEASE TABLETS USP, 25 MG, 50 MG AND 75 MG Rx only CARDIOVASCULAR RISK 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). GASTROINTESTINAL RISK 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 are a benzene-acetic acid derivative. Diclofenac Sodium Delayed-release Tablets are available as delayed-release (delayed-release) tablets of 25 mg or 50 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 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 oxide red, iron oxide yellow) and purified water. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Diclofenac Sodium Delayed-release Tablets, are a nonsteroidal anti-inflammatory drug (NSAID) that 14 10 2 2 exhibits anti-inflammatory, analgesic, and antipyret Preberite celoten dokument