Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)
Northwind Pharmaceuticals, LLC
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE 10 mg
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketorolac tromethamine tablets, USP 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, USP are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets, USP 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 REACTIO
Ketorolac tromethamine tablets, USP are available as follows: 10 mg: White, round, convex, unscored, film-coated tablets, debossed "93" on one side and "314" on the other side. They are available in bottles of 15 tablets (NDC 51655-170-54), 20 tablets (NDC 51655-170-20). 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). PROTECT FROM LIGHT AND EXCESSIVE HUMIDITY. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. N 7/2021
Abbreviated New Drug Application
Northwind Pharmaceuticals, LLC ---------- MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) Dispense with Medication Guide available at: www.tevausa.com/medguides What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death.This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • older age • longer use of NSAIDs • poor health • smoking • advanced liver disease • drinking alcohol • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs 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 NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Baca dokumen lengkap
KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED NORTHWIND PHARMACEUTICALS, LLC ---------- KETOROLAC TROMETHAMINE TABLETS USP, 10 MG RX ONLY WARNING KETOROLAC TROMETHAMINE TABLETS, A NONSTEROIDAL 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 THOMBOTIC EVENTS Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGSand PRECAUTIONS). Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONSand WARNINGS). Baca dokumen lengkap