Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ibuprofen (UNII: WK2XYI10QM) (ibuprofen - UNII:WK2XYI10QM)
Preferred Pharmaceuticals, Inc.
ibuprofen
ibuprofen 400 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen 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, Anaph
Ibuprofen tablets are available in the following strengths : 400 mg (White to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side) Bottle of 20 - 68788-9739-2 Bottle of 21 - 68788-9739-7 Bottle of 30 - 68788-9739-3 Bottle of 50 - 68788-9739-5 Bottle of 60 - 68788-9739-6 Bottle of 90 - 68788-9739-9 Bottle of 100 - 68788-9739-1 Bottle of 120 - 68788-9739-8 600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottle of 20 - 68788-9740-2 Bottle of 21 - 68788-9740-7 Bottle of 30 - 68788-9740-3 Bottle of 50 - 68788-9740-5 Bottle of 60 - 68788-9740-6 Bottle of 90 - 68788-9740-9 Bottle of 100 - 68788-9740-1 Bottle of 120 - 68788-9740-8 800 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) Bottle of 20 - 68788-9741-2 Bottle of 21 - 68788-9741-7 Bottle of 30 - 68788-9741-3 Bottle of 50 - 68788-9741-5 Bottle of 60 - 68788-9741-6 Bottle of 90 - 68788-9741-9 Bottle of 100 - 68788-9741-1 Bottle of 120 - 68788-9741-8 Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature] Rx only Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Rev. 07/13
Abbreviated New Drug Application
Preferred Pharmaceuticals, 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 provider and pharmacist. • if you are pregnant. NSAID medic Lugege kogu dokumenti
IBUPROFEN- IBUPROFEN TABLET PREFERRED PHARMACEUTICALS, INC. ---------- IBUPROFEN TABLETS, USP CARDIOVASCULAR RISK • • GASTROINTESTINAL RISK • DESCRIPTION Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. CLINICAL PHARMACOLOGY Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have been 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). Ibuprofen tablets are contraindicated for 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 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). shown to be comparable to aspirin in controlling pai Lugege kogu dokumenti