Country: United States
Language: English
Source: NLM (National Library of Medicine)
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)
Apotheca, Inc
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. Acute Pain in Adult Patients 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 (seeWARNINGS , PRECAUTIONS , DOSAGE AND ADMINISTRATION , and ADVERSE
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: NDC 12634-809-95 Bottle of 5 NDC 12634-809-96 Bottle of 6 NDC 12634-809-00 Bottle of 10 NDC 12634-809-85 Bottle of 15 NDC 12634-809-80 Bottle of 20 NDC 12634-809-79 Bottle of 25 NDC 12634-809-71 Bottle of 30 NDC 12634-809-60 Bottle of 60 NDC 12634-809-01 Bottle of 100 NDC 12634-809-91 Blister Pack of 1 NDC 12634-809-65 Blister Card Pack of 5 NDC 12634-809-66 Blister Card Pack of 6 NDC 12634-809-61 Blister Card Pack of 10 NDC 12634-809-55 Blister Card Pack of 15 NDC 12634-809-57 Blister Card Pack of 20 NDC 12634-809-25 Blister Card Pack of 25 NDC 12634-809-59 Blister Card Pack of 30 Store at 20° to 25°C (68° to 77°F) 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. Manufactured by: TEVA PHARMACEUTICALS USA Sellersville, PA 18960
Abbreviated New Drug Application
Apotheca, 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 medicines shou Read the complete document
KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET APOTHECA, INC ---------- KETOROLAC TROMETHAMINE TABLETS, USP 10MG 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 (CABG) surgery (see WARNINGS). RENAL Read the complete document