Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
INDOMETHACIN
INDOMETHACIN 75 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules, USP and other treatment options before deciding to use Indomethacin Extended-Release Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin Extended-Release Capsules, USP have been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to sever osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendonitis). Indomethacin Extended-Release Capsules, USP are not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more sever forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effec
Indomethacin Extended-Release Capsules, USP 75 mg are size “2” coni-snap, empty hard gelatin capsules with natural clear body imprinted “506” and blue translucent cap imprinted “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-506-03 Bottles of 60: NDC 65162-506-06 Bottles of 90: NDC 65162-506-09 Bottles of 100: NDC 65162-506-10 Bottles of 500: NDC 65162-506-50 Bottles of 1000: NDC 65162-506-11
Abbreviated New Drug Application
INDOMETHACIN - INDOMETHACIN CAPSULE, EXTENDED RELEASE LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- INDOMETHACIN EXTENDED – RELEASE CAPSULES, USP 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 a greater risk. (See WARNINGS.) Indomethacin is contraindicated for the treatment of peri-operative 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 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 Indomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended under INDICATION AND USAGE. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4- chlorobenzoyl)-5-methoxy-2-methyl-1_H_-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The structural formula is: M.W. 357.80 C H1 ClNO Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No. 3, FD&C Yellow No. 5, FD&C Red 19 6 4 No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Rel Přečtěte si celý dokument