Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
Proficient Rx LP
INDOMETHACIN
INDOMETHACIN 50 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of indomethacin 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: 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 PRECAUTIONS - Preexisting Asthma). Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Indomethacin capsules are supplied containing 50 mg of indomethacin, USP. The 50 mg capsule is a hard-shell gelatin capsule with an opaque pink cap and an opaque white body debossed with “HP/11” on both the body and cap. They are supplied in bottles of 08, 15, 20, 30, 60 and 90 as follows: NDC 63187-697-08 bottles of 08. NDC 63187-697-15 bottles of 15. NDC 63187-697-20 bottles of 20. NDC 63187-697-30 bottles of 30. NDC 63187-697-60 bottles of 60. NDC 63187-697-90 bottles of 90. Store at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature]. Protect from light. Rx Only Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Manufactured for: Heritage Pharmaceuticals, Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India DRUGS/PY/05 13 1523 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 ______________________________________________________________________________ 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: 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: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription Celecoxib Celebrex Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbiprofen Ansaid Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethegan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600 Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Heritage Pharmaceuticals, Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India DRUGS/PY/05 13 1523 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
New Drug Application
INDOMETHACIN- INDOMETHACIN CAPSULE PROFICIENT RX LP ---------- INDOMETHACIN CAPSULES, USP 01/14- REV 05 RX ONLY BOXED WARNINGS DESCRIPTION Indomethacin Capsules, USP for oral administration contain either 25 mg or 50 mg of indomethacin and the following inactive ingredients: D & C Red #28, FD&C Blue #1, FD&C Red #3, gelatin, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, starch and titanium dioxide. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-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: C19H16CLNO4 M.W. 357.79 CLINICAL PHARMACOLOGY Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that exhibits antipyretic and analgesic properties. Its mode of action, like that of other anti-inflammatory drugs, is not known. However, its therapeutic action is not due to pituitary-adrenal stimulation. Indomethacin is a potent inhibitor of prostaglandin synthesis in vitro. Concentrations are reached during therapy which have been demonstrated to have an effect in vivo as well. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Moreover, 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 includi Citiți documentul complet