Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)
Baxter Healthcare Corporation
INTRAMUSCULAR
PRESCRIPTION DRUG
FOR INTRAMUSCULAR USE ONLY (60 mg) Rx only Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketorolac tromethamine is 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 intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection and oral 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 analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. (see also Boxed WARNING ) Ketorolac Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. 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. Ketorolac tromethamine 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-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions, and PRECAUTIONS – Pre-existing Asthma ). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ). Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated. Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
Ketorolac Tromethamine Injection, USP is supplied as follows: Unit of Sale Each Concentration (mg/mL) Fill Volume/ Container Size Total Ketorolac Tromethamine (Per Container) NDC 0338-0069-10 Carton of 10 2mL Single-Dose Glass Fliptop Vial 15 mg/mL (1 mL/2 mL) 15 mg NDC 0338-0072-25 Carton of 25 2mL Single-Dose Glass Fliptop Vial 30 mg/mL (1 mL/2 mL) 30 mg NDC * 0338-0076-10 Carton of 10 2mL Single-Dose Glass Fliptop Vial 30 mg/mL (2 mL/2 mL) 60 mg *FOR INTRAMUSCULAR USE ONLY. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light . Retain in carton until time of use. Baxter is a registered trademark of Baxter International Inc. Revised:06/2023 Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in India Lic. No.: TN/Drugs/TN00003457 22200621 07-19-00-7267
Abbreviated New Drug Application
Baxter Healthcare Corporation ---------- MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) What is the most important information I should know about medicines called Non-Steroidal 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 the use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • 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 had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, tell your healthcare provider about all of your Olvassa el a teljes dokumentumot
KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- KETOROLAC TROMETHAMINE INJECTION, USP FOR INTRAVENOUS/INTRAMUSCULAR USE (15 MG AND 30 MG) FOR INTRAMUSCULAR USE ONLY (60 MG) Rx only WARNING Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days. KETOROLAC TROMETHAMINE IS NOT INDICATED FOR USE IN PEDIATRIC PATIENTS AND IT IS NOT INDICATED FOR MINOR OR CHRONIC PAINFUL CONDITIONS. INCREASING THE DOSE OF KETOROLAC TROMETHAMINE BEYOND THE LABEL RECOMMENDATIONS WILL NOT PROVIDE BETTER EFFICACY BUT WILL INCREASE THE RISK OF DEVELOPING SERIOUS ADVERSE EVENTS. GASTROINTESTINAL RISK • CARDIOVASCULAR THROMBOTIC EVENTS • • RENAL RISK • RISK OF BLEEDING • KETOROLAC TROMETHAMINE IS CONTRAINDICATED AS PROPHYLACTIC ANALGESIC BEFORE ANY MAJOR SURGERY. HYPERSENSITIVITY Ketorolac tromethamine 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). 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 tre Olvassa el a teljes dokumentumot