Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
Keltman Pharmaceuticals Inc.
INDOMETHACIN
INDOMETHACIN 75 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin extended-release capsules 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 severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules is not recommended for the treatment of acute gouty arthritis. Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects. The use of ind
Indomethacin extended-release capsules 75 mg is supplied as green and clear capsules, imprinted E 720. They are supplied by Keltman Pharmaceuticals Inc. as follows: Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
Keltman 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 a 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 healthcare provider and pharmacist. • if you are pregnant. NSAID medicines should no Lesen Sie das vollständige Dokument
INDOMETHACIN EXTENDED-RELEASE - INDOMETHACIN EXTENDED-RELEASE CAPSULE KELTMAN PHARMACEUTICALS INC. ---------- INDOMETHACIN EXTENDED-RELEASE CAPSULES USP 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). • 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 INDICATIONS AND USAGE. Indomethacin is a nonsteroidal, 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: Each extended-release capsule, for oral administration contains 75 mg of indomethacin. In addition, each capsule contains the following inactive ingredients: D&C yellow No. 10, D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, FD&C blue No. 2 aluminum lake, FD&C red No. 40 aluminum lake, FD&C green No. 3, ethylcellulose, gelatin, lactose monohydrate, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose, talc and titanium dioxide. This product meets USP Drug Release Test 2 Specifications. Lesen Sie das vollständige Dokument