País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC TROMETHAMINE - UNII:4EVE5946BQ)
Keltman Pharmaceuticals Inc.
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE 10 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS , PRECAUTIONS , DOSAGE AND ADMINISTRATION , and ADVERSE REACTIONS ). Patients should be switched to alternative analges
Ketorolac tromethamine tablets USP, 10 mg are round, white, unscored, film-coated tablets debossed "93" on one side and "314" on the other side. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States
Abbreviated New Drug Application
Keltman Pharmaceuticals Inc. ---------- Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Rx only (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 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 Llegiu el document complet
KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE TABLET, FILM COATED KELTMAN PHARMACEUTICALS INC. ---------- KETOROLAC TROMETHAMINE TABLETS USP, 10 MG RX ONLY WARNING KETOROLAC TROMETHAMINE TABLETS, A NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID), ARE INDICATED FOR THE SHORT-TERM (UP TO 5 DAYS IN ADULTS), MANAGEMENT OF MODERATELY SEVERE ACUTE PAIN THAT REQUIRES ANALGESIA AT THE OPIOID LEVEL AND ONLY AS CONTINUATION TREATMENT FOLLOWING IV OR IM DOSING OF KETOROLAC TROMETHAMINE, IF NECESSARY. THE TOTAL COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE TABLETS AND KETOROLAC TROMETHAMINE SHOULD NOT EXCEED 5 DAYS. KETOROLAC TROMETHAMINE TABLETS ARE NOT INDICATED FOR USE IN PEDIATRIC PATIENTS AND THEY ARE NOT INDICATED FOR MINOR OR CHRONIC PAINFUL CONDITIONS. INCREASING THE DOSE OF KETOROLAC TROMETHAMINE TABLETS BEYOND A DAILY MAXIMUM OF 40 MG IN ADULTS WILL NOT PROVIDE BETTER EFFICACY BUT WILL INCREASE THE RISK OF DEVELOPING SERIOUS ADVERSE EVENTS. GASTROINTESTINAL RISK Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). 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 and CLINICAL STUDIES). Ketorolac tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft Llegiu el document complet