Protect from light Mayo Clinic does not endorse companies or products. For Intramuscular Use Only 2 mL Single-Dose Vial, Rx only NDC 55150-341-01 There was no significant difference in estimates of half-life, AUC∞ and Cmax, in 7 patients with liver disease compared to healthy volunteers (see PRECAUTIONS – Hepatic Effects and Table 2). Adverse reaction rates increase with higher doses of ketorolac tromethamine. Concomitant use of ACE inhibitors and/or angiotensin II receptor antagonists may increase the risk of renal impairment, particularly in volume-depleted patients. Indications. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. Ketorolac tromethamine did not cause chromosome breakage in the in vivo mouse micronucleus assay. Distributed by: Ketorolac has side effects that can be very dangerous. 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. This risk may occur early in treatment and may increase with duration of use (see, Ketorolac tromethamine is CONTRAINDICATED in the setting of coronary artery bypass graft (CABG) surgery (see, Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see, Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see, Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection (see. The sterile solutions are clear and slightly yellow in color. [See USP Controlled Room Temperature.] Ketorolac is not a narcotic and is not habit-forming. The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1.Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. All rights reserved. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. Adult Patients The increase in volume of distribution of ketorolac tromethamine implies an increase in unbound fraction. 25 x 1 mL Single-Dose Vials For more information, ask your pharmacist about NSAIDs. Avoid the use of ketorolac tromethamine in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. IV/IM Administration. Packaged in a Carton of 25 NDC 55150-339-25 In addition to reducing inflammation, NSAIDs can also manage swelling, pain, and fevers. Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. Ketorolac Trometamol 10 mg/ml solution for injection should not be used for epidural or spinal administration. AUROMEDICS, Rx only NDC 55150-339-25 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). The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection (maximum 120 mg), Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see, Ketorolac tromethamine, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Ketorolac tromethamine is a potent NSAID and may cause serious side effects such as gastrointestinal bleeding or kidney failure, which may result in hospitalization and even fatal outcome. The maximum daily dose should not exceed 120 mg. Ketorolac tromethamine administered as an intravenous bolus, every 6 hours, for 5 days, to healthy subjects (n = 13), showed no significant difference in Cmax on Day 1 and Day 5. The dosage must be adjusted if over 65 yrs old because of decreased renal function. Packaged Individually NDC 55150-340-01 25 x 2 mL Single-Dose Vials Ketorolac Tromethamine Injection, USP 30 mg per mL For Intravenous or Intramuscular Use Dispense the enclosed Medication Guide to each patient. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. The risk of getting an ulcer or bleeding increases with: 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. In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamine intravenous as fixed intermittent boluses (e.g., 30 mg initial dose followed by 15 mg q3h), required significantly less morphine (26%) than the placebo group. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. Ketorolac Trometamol 10 mg/ml solution for injection is for administration by intramuscular or bolus intravenous injection. These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. Accumulation of ketorolac tromethamine has not been studied in special populations (geriatric, pediatric, renal failure patients, or hepatic disease patients). Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see PRECAUTIONS). Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. However, even short-term therapy is not without risk. Treatment Until data from such studies are available, physicians should carefully weigh the benefits against the risks, and use such concomitant therapy in these patients only extremely cautiously. For Intramuscular Use Only Dispense the enclosed Medication Guide to each patient. Never heard of patients coming in with nodule-like areas from injection. Medication Guide to Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Limited information is available regarding the pharmacokinetics of dosing of ketorolac tromethamine in the pediatric population. Because patients with underlying renal insufficiency are at increased risk of developing acute renal decompensation or failure, the risks and benefits should be assessed prior to giving ketorolac tromethamine to these patients. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg. Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. Pharmacokinetic differences due to race have not been identified. Store at controlled room temperature. There are no specific antidotes. Do not give NSAIDs to other people, even if they have the same symptoms that you have. Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content. The AUC∞-ratio of the ketorolac tromethamine enantiomers in healthy subjects and patients remained similar, indicating there was no selective excretion of either enantiomer in patients compared to healthy subjects (see WARNINGS – Renal Effects). Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects. The intramuscular administration should be given slowly and deeply into the muscle. The pharmacokinetics of ketorolac tromethamine, following intravenous, intramuscular and oral doses of ketorolac tromethamine are compared in Table 1. Adult: Moderate to severe: Initially, 10 mg followed by 10-30 mg every 4-6 hours as needed, may be given as often as every 2 hours in the initial postoperative period if necessary.Max: 90 mg daily. Sporadic cases of seizures have been reported during concomitant use of ketorolac tromethamine and antiepileptic drugs (phenytoin, carbamazepine). Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. This medicine should not be used for more than 5 days. it is slightly more popular than comparable drugs.It is available in multiple generic and brand versions. Following a single intravenous bolus dose of 0.5 mg/kg in 10 children 4 to 8 years old, the half-life was 5.8 ± 1.6 hours, the average clearance was 0.042 ± 0.01 L/hr/kg, the volume of distribution during the terminal phase (Vβ) was 0.34 ± 0.12 L/kg and the volume of distribution at steady state (VSS) was 0.26 ± 0.08 L/kg. If your dose is different, do not change it unless your doctor tells you to do so. 25 x 1 mL Single-Dose Vials The concurrent use of ketorolac tromethamine with muscle relaxants has not been formally studied. 4 Further, studies have illustrated that clearance of oral, IM and IV doses of ketorolac are comparable which suggests linear kinetics. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Before doctors began using the hip as an injection site, they used the … It may be given as a one-time dose or given on a regular schedule. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. The amount of medicine that you take depends on the strength of the medicine. The risks of administering IM ketorolac include bruising, infection, hematoma, patient discomfort, and needle-stick injury.38, 39 In addition, IM administration is … Hypertension Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Last updated on Oct 1, 2020. It is used to treat moderate to severe pain for up to 5 days. Approximately 6% of a dose is excreted in the feces. Packaged Individually NDC 55150-339-01 Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions, and PRECAUTIONS – Pre-existing Asthma). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. Ketorolac Tromethamine Injection, USP 15 mg per mL For Intravenous or Intramuscular Use 1 mL Single-Dose Vial, Rx only NDC 55150-339-01 Pregnancy 10 x 1 mL Single-Dose Vials Available for Android and iOS devices. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Effects on Fertility In adults, following administration of single ORAL, INTRAMUSCULAR or INTRAVENOUS doses of ketorolac tromethamine in the recommended dosage ranges, the clearance of the racemate does not change. Therefore, concomitant use of ketorolac tromethamine and probenecid is contraindicated. You may report side effects to FDA at 1-800-FDA-1088. An 18-month study in mice with oral doses of ketorolac tromethamine tablets at 2 mg/kg/day (0.9 times the human systemic exposure at the recommended intramuscular or intravenous dose of 30 mg qid, based on area-under-the-plasma-concentration curve [AUC]), and a 24-month study in rats at 5 mg/kg/day (0.5 times the human AUC) showed no evidence of tumorigenicity. Alternate the injection site each time you inject to avoid soreness at any one sight. In patients with renal disease, the AUC∞ of each enantiomer increased by approximately 100% compared with healthy volunteers. Aurobindo Pharma Limited Hyderabad - 500038 Aspirin can cause bleeding in the brain, stomach, and intestines. Nonteratogenic Effects What are the possible side effects of NSAIDs? It is usually used before or after medical procedures or after surgery. This implies that the pharmacokinetics of ketorolac tromethamine in adults, following single or multiple intramuscular, intravenous or recommended oral doses of ketorolac tromethamine, are linear. The ketorolac tromethamine racemate has been shown to be highly protein bound (99%). The injection solutions are clear and slightly yellow in colour. The use of ketorolac tromethamine, as with any drug known to inhibit cyclooxygenase/ prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Ketorolac tromethamine is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity. of body weight (see. 60 mg/2 mL preparation for IM administration only. Emergency help should be sought in cases where an anaphylactoid reaction occurs. Packaged in a Carton of 10 NDC 55150-340-10 2 mL Single-Dose Vials, This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out. Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include: Body as a Whole: fever, infections, sepsis, Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope, Dermatologic: alopecia, photosensitivity, urticaria, Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding, Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia, Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise, Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis, Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss, Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention. There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Ketorolac Tromethamine Injection USP is a non-steroidal anti-inflammatory drug (NSAID). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine should be used with caution in patients with impaired renal function or a history of kidney disease because it is a potent inhibitor of prostaglandin synthesis. What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Max duration: 2 days. These serious events may occur without warning. AUROMEDICS, Rx only NDC 55150-340-25 Ketorolac tromethamine, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. For Intramuscular Use Only (60 mg), 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. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. AUROMEDICS, Rx only NDC 55150-341-25 This goes back to normal when ketorolac injection is stopped. 2mL is an appropriate dosage for IM injection into a well-developed adult deltoid. Ketorolac Tromethamine Injection, USP 15 mg per mL For Intravenous or Intramuscular Use Dispense the enclosed Intravenous-Administration: In normal subjects (n=37), the total clearance of 30 mg intravenous-administered ketorolac tromethamine was 0.030 (0.017 to 0.051) L/h/kg. AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. I have given Toradol 60mg IM in Vastus lateralis muscle to total knee patients and have given the same amount through deltoid route. Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Ketorolac tromethamine possesses no sedative or anxiolytic properties. Medication Guide to This site complies with the HONcode standard for trustworthy health information: verify here. Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. In adults, the extent of bioavailability following administration of the ORAL and INTRAMUSCULAR forms of ketorolac tromethamine was equal to that following an intravenous bolus. Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. Available information has not shown any specific adverse events in nursing infants; however, instruct patients to contact their infant’s healthcare provider if they note any adverse events. The terminal half-life was 5.6 (4.0 to 7.9) hours. 60 mg per 2 mL (30 mg/mL) 2 mL Single-Dose Vial, The metabolic products are hydroxylated and conjugated forms of the parent drug. NSAIDs, including ketorolac tromethamine, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Oral ketorolac tromethamine is indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. ketorolac tromethamine injection, solution, We comply with the HONcode standard for trustworthy health information -, CLINICAL PHARMACOLOGY – Kinetics in Special Populations, DOSAGE AND ADMINISTRATION – Pharmaceutical Information for Ketorolac Tromethamine Injection, WARNINGS, Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation, WARNINGS – Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation. Ketorolac is a white to off-white crystalline substance which discolours on exposure to light. Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. At 1,590 mcg/mL and at higher concentrations, ketorolac tromethamine increased the incidence of chromosomal aberrations in Chinese hamster ovarian cells. NSAIDs and some other medicines can interact with each other and cause serious side effects. Thus, the unbound fraction for each enantiomer will be constant over the therapeutic range. In summary, ketorolac clearly remains a valuable adjuvant as part of a multimodal analgesic regimen for the management of pain in the perioperative period. IV: Inject over ≥15 seconds. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. 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 postoperative setting).Therapy should always be started with Ketorolac Tromethamine IM/IV injection and Ketorolac Tromethamine oral is to be used only as continuation treatment, if necessary. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. The increase in CV thrombotic risk has been observed most consistently at higher doses. Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. This content does not have an English version. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs.
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