Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
Caraco Pharmaceutical Laboratories, Ltd.
INDOMETHACIN
INDOMETHACIN 25 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Indomethacin has been found effective in active stages of the following: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - Moderate to severe ankylosing spondylitis. - Moderate to severe osteoarthritis. - Acute painful shoulder (bursitis and/or tendinitis). - Acute gouty arthritis. Indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION ). Indomethacin 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/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic/Anaphylactoid Reactions , and
Indomethacin Capsules, USP are available containing either 25 mg or 50 mg of indomethacin, USP. The 25 mg capsule is a hard-shell gelatin capsule, with a light green opaque colored cap and body with '119' imprinted in black ink on both cap and body. The capsule is filled with white to off-white colored granular powder blend. They are available as follows: NDC 57664-119-83 Bottles of 30 CRC NDC 57664-119-88 Bottles of 100 CRC NDC 57664-119-08 Bottles of 100 NDC 57664-119-13 Bottles of 500 NDC 57664-119-18 Bottles of 1000 The 50 mg capsule is a hard-shell gelatin capsule, with a light green opaque colored cap and body with '120' imprinted in black ink on both cap and body. The capsule is filled with white to off-white colored granular powder blend. They are available as follows: NDC 57664-120-83 Bottles of 30 CRC NDC 57664-120-88 Bottles of 100 CRC NDC 57664-120-08 Bottles of 100 NDC 57664-120-13 Bottles of 500 NDC 57664-120-18 Bottles of 1000 Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. ATTENTION : Pharmacist dispense with a Medication Guide. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Iss. 3/2011 6356T01
Abbreviated New Drug Application
Caraco Pharmaceutical Laboratories, Ltd. ---------- 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 Perskaitykite visą dokumentą
INDOMETHACIN - INDOMETHACIN CAPSULE CARACO PHARMACEUTICAL LABORATORIES, LTD. ---------- 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 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 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 Capsules, USP for oral administration are provided in two dosage strengths which contain either 25 mg or 50 mg of indomethacin. 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. The structural formula is: C H ClNO M.W.357.79 Indomethacin, USP 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. Each capsule for oral administration contains 25 mg or 50 mg of indomethacin and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The imprinting ink contains the following: black iron oxide, 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, propylene glycol, N-Butyl alcohol, shellac glaze, ethanol and methanol. CLINICAL PHARMACOLOGY In Perskaitykite visą dokumentą