Ketorolac Tromethamine
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Questions & Answers
Side Effects & Adverse Reactions
(See also Boxed WARNING)
The total combined duration of use of oral ketorolac tromethamine and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine injection is not indicated for use in pediatric patients.
The most serious risks associated with ketorolac tromethamine are:
Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with ketorolac tromethamine.
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with, ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days. However, even short-term therapy is not without risk. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.
Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet aggregation as well, use of ketorolac tromethamine in patients who have coagulation disorders should be undertaken very cautiously, and those patients should be carefully monitored. Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given ketorolac tromethamine concurrently; therefore, physicians should administer such concomitant therapy only extremely cautiously. The concurrent use of ketorolac tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2,500 to 5,000 units q12h), warfarin and dextrans have not been studied extensively, but may also be associated with an increased risk of bleeding. 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. Patients receiving therapy that affects hemostasis should be monitored closely.
In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of IV or IM dosing of ketorolac tromethamine. Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see PRECAUTIONS).
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Ketorolac tromethamine and its metabolites are eliminated primarily by the kidneys, which, in patients with reduced creatinine clearance, will result in diminished clearance of the drug (see CLINICAL PHARMACOLOGY). Therefore, ketorolac tromethamine should be used with caution in patients with impaired renal function (see DOSAGE AND ADMINISTRATION) and such patients should be followed closely. With the use of ketorolac tromethamine, there have been reports of acute renal failure, interstitial nephritis and nephrotic syndrome.
Ketorolac tromethamine is contraindicated in patients with serum creatinine concentrations indicating advanced renal impairment (see CONTRAINDICATIONS). 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. 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.
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ketorolac tromethamine. Ketorolac tromethamine should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS: Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation). Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
NSAIDs, including ketorolac tromethamine, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ketorolac tromethamine, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Fluid retention, edema, retention of NaCl, oliguria, elevations of serum urea nitrogen and creatinine have been reported in clinical trials with ketorolac tromethamine. Therefore, ketorolac tromethamine should be used only very cautiously in patients with cardiac decompensation, hypertension or similar conditions.
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. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, ketorolac tromethamine should be avoided because it may cause premature closure of the ductus arteriosus.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Carefully consider the potential benefits and risks ketorolac tromethamine injection 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 injection 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 IV or IM dosing of ketorolac tromethamine injection, 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.
Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioidsparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see DOSAGE AND ADMINISTRATION: Pharmaceutical Information for Ketorolac Tromethamine Injection).
History
There is currently no drug history available for this drug.
Other Information
Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). 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 below:
Ketorolac tromethamine, USP is a white to off-white, crystalline powder and is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40.
Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution and 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for IM administration only. 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. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.
Sources
Ketorolac Tromethamine Manufacturers
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Remedyrepack Inc.
![Ketorolac Tromethamine Injection, Solution [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ketorolac Tromethamine | Remedyrepack Inc.
Carefully consider the potential benefits and risks of ketorolac tromethamine injection 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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine injection. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
The combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
The Following Regimen Should Be Limited To Single Administration Use Only
Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥ 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS, Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
One dose of 1 mg/kg up to a maximum of 30 mg.IV Dosing:
One dose of 0.5 mg/kg up to a maximum of 15 mg.Multiple-Dose Treatment (IV or IM) In Adults:
Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg. For Patients ≥ 65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
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Blenheim Pharmacal, Inc.
Ketorolac Tromethamine | Blenheim Pharmacal, Inc.
Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
Different dose strengths and formulations (ie, tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
Although all naproxen-containing products circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action. Because naproxen delayed-release tablets dissolves in the small intestine rather than in the stomach, the absorption of the drug is delayed compared to the other naproxen formulations (see CLINICAL PHARMACOLOGY).
The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS).
Geriatric Patients
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.
Patients With Moderate to Severe Renal Impairment
Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
Naproxen Delayed-release Tablets 375 mgor500 mg twice daily
twice dailyTo maintain the integrity of the enteric coating, the naproxen delayed-release tablets should not be broken, crushed, or chewed during ingestion.
During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary.
In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk. The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY).
Juvenile Arthritis
The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (ie, 5 mg/kg given twice a day). Naproxen delayed-release tablets are not well suited to this dosage so use of naproxen oral suspension is recommended for this indication.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
Naproxen delayed-release tablets are not recommended for initial treatment of acute pain because absorption of naproxen is delayed compared to other naproxen-containing products (see CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE).
Acute Gout
Naproxen delayed-release tablets are not recommended because of the delay in absorption (see CLINICAL PHARMACOLOGY)
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Direct Rx
Ketorolac Tromethamine | Central Solutions Inc
Directions
Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands
Rub hands together briskly until dry
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Fresenius Kabi Usa, Llc
Ketorolac Tromethamine | Fresenius Kabi Usa, Llc
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS, Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
One dose of 1 mg/kg up to a maximum of 30 mg.IV Dosing:
One dose of 0.5 mg/kg up to a maximum of 15 mg.Multiple-Dose Treatment (IV or IM) In Adults:
Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg. For Patients ≥ 65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
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Mckesson Packaging Services Business Unit Of Mckesson Corporation
Ketorolac Tromethamine | Mckesson Packaging Services Business Unit Of Mckesson Corporation
THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLET IS NOT TO EXCEED FIVE (5) DAYS. THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single, or multiple dose, on a regular or "prn" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS − Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
IM Dosing:
Patients <65 years of age: One dose of 60 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
Patients <65 years of age: One dose of 30 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM):
Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg. For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
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Baxter Healthcare Corporation
Ketorolac Tromethamine | Baxter Healthcare Corporation
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED FIVE (5) DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection Adult PatientsKetorolac Tromethamine Injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS, Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed five (5) days.
When administering Ketorolac Tromethamine Injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited to Single Administration Use Only Adult Patients IM Dosing Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg. IV Dosing Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg. Pediatric Patients (2 to 16 Years of Age)The pediatric population should receive only a single dose of Ketorolac Tromethamine Injection, as follows:
IM Dosing One dose of 1 mg/kg up to a maximum of 30 mg. IV Dosing One dose of 0.5 mg/kg up to a maximum of 15 mg. Multiple-Dose Treatment (IV or IM) in Adults Patients < 65 Years of AgeThe recommended dose is 30 mg Ketorolac Tromethamine Injection every 6 hours. The maximum daily dose should not exceed 120 mg.
For Patients ≥ 65 Years of Age, Renally Impaired Patients and Patients Less Than 50 Kg (110 lbs)(see WARNINGS)
The recommended dose is 15 mg Ketorolac Tromethamine Injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Ketorolac Tromethamine Injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
Shortening the recommended dosing intervals may result in increased frequency and severity of adverse reactions.
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Keltman Pharmaceuticals Inc.
Ketorolac Tromethamine | Keltman Pharmaceuticals Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Lake Erie Medical Dba Quality Care Products Llc
Ketorolac Tromethamine | Lake Erie Medical Dba Quality Care Products Llc
DOSAGE AND ADMINISTRATIONCarefully 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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not greater than40 mg/day Patients age ≥65, renally impaired, and/or weight greater than 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not greater than40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group
-
Rebel Distributors Corp
Ketorolac Tromethamine | Rebel Distributors Corp
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLET IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
KETOROLAC TROMETHAMINE INJECTION
Adult Patients: Ketorolac tromethamine injection may be used as a single or multiple dose, on a regular or prn schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS − Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
Adult Patients:
IM Dosing:
Patients <65 years of age: One dose of 60 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
Patients <65 years of age: One dose of 30 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing:
One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM):
Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg. For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection:
Ketorolac tromethamine should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Physicians Total Care, Inc.
Ketorolac Tromethamine | Physicians Total Care, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Patients age > 65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets
(following IV or IM dosing of
ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day Adult Age > 65 years,
renally impaired and/or weight <50 kg 10 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day -
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not less then 40 mg/day Patients age less then 65, renally impaired, and/or weight greater then 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not less then 40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets
(following IV or IM dosing of
ketorolac tromethamine) Age greater then 17 years Oral not approved Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not less then 40 mg/day Adult Age less then 65 years,
renally impaired and/or weight greater then 50 kg 10 mg once, then 10 mg q4 to 6
hours prn not less then 40 mg/day
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Pd-rx Pharmaceuticals, Inc.
Ketorolac Tromethamine | Pd-rx Pharmaceuticals, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Patients age ≥65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets
(following IV or IM dosing of
ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day Adult Age ≥ 65 years,
renally impaired and/or weight <50 kg 10 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day -
Rebel Distributors Corp
Ketorolac Tromethamine | Rebel Distributors Corp
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Preferred Pharmaceuticals, Inc
Ketorolac Tromethamine | Preferred Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
-
H.j. Harkins Company, Inc.
Ketorolac Tromethamine | H.j. Harkins Company, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Wockhardt Limited
Ketorolac Tromethamine | Wockhardt Limited
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Wockhardt Usa Llc
Ketorolac Tromethamine | Wockhardt Usa Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Physicians Total Care, Inc.
Ketorolac Tromethamine | Physicians Total Care, Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions
Patient PopulationKetorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)Age < 17 yearsOral not approvedAdult Age 17 to 64 years20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/dayAdult Age65 years, renally impaired, and/or weight < 50 kg10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
-
Pd-rx Pharmaceuticals, Inc.
Ketorolac Tromethamine | Pd-rx Pharmaceuticals, Inc.
DO NOT EXCEED RECOMMENDED DOSAGE.
AdultsThe recommended initial dosage is two tablets four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets) daily.
Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.
ChildrenDiphenoxylate hydrochloride and atropine sulfate is not recommended in children under 2 years of age and should be used with special caution in young children (see WARNINGS and PRECAUTIONS). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use oral solution. Do not use tablets for this age group.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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General Injectables & Vaccines, Inc
Ketorolac Tromethamine | General Injectables & Vaccines, Inc
THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLET IS NOT TO EXCEED 5 DAYS. THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose, on a regular or prn schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. When administering ketorolac tromethamine the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
IM Dosing:
• Patients less than 65 years of age: One dose of 60 mg.
• Patients greater than or equal to 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
• Patients less than 65 years of age: One dose of 30 mg.
• Patients greater than or equal to 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Multiple-Dose Treatment (IV or IM):
• Patients less than 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg.
• For patients greater than or equal to 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.Pharmaceutical Information for Ketorolac Tromethamine Injection:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Ketorolac tromethamine should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution. -
Unit Dose Services
Ketorolac Tromethamine | Unit Dose Services
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
should be given Oral formulationnotas an initial dose
for the individual patient Use minimum effective dose
Do of 4 to 6 hours not shorten dosing interval
the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. Total duration of treatment in adult patients:
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Ketorolac Tromethamine | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Pfizer Laboratories Div Pfizer Inc
Ketorolac Tromethamine | Pfizer Laboratories Div Pfizer Inc
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to ketorolac tromethamine injection.
After observing the response to initial therapy with ketorolac tromethamine, the dose and frequency should be adjusted to suit an individual patient's needs.
See package insert of oral ketorolac tromethamine for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Ketorolac Tromethamine InjectionKetorolac tromethamine injection may be used as a single or multiple dose on a regular or "prn" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in approximately 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose TreatmentThe Following Regimen Should Be Limited To Single Administration Use Only
IM Dosing:
Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15mg. Multiple-Dose Treatment (IV or IM) Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥ 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids "prn" unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionKetorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
West-ward Pharmaceutical Corp.
Ketorolac Tromethamine | West-ward Pharmaceutical Corp.
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED FIVE (5) DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection ADULT PATIENTSKetorolac Tromethamine Injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - RENAL EFFECTS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed five (5) days.
When administering Ketorolac Tromethamine Injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited to Single Administration Use Only ADULT PATIENTS IM Dosing: Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg. IV Dosing: Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg. PEDIATRIC PATIENTS (2 TO 16 YEARS OF AGE):The pediatric population should receive only a single dose of Ketorolac Tromethamine Injection, as follows:
IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg. IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg. Multiple-Dose Treatment (IV or IM) in Adults Patients < 65 years of age: The recommended dose is 30 mg Ketorolac Tromethamine Injection every 6 hours. The maximum daily dose should not exceed 120 mg. For patients ≥ 65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 Kg (110 lbs): The recommended dose is 15 mg Ketorolac Tromethamine Injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Ketorolac Tromethamine Injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
Shortening the recommended dosing intervals may result in increased frequency and severity of adverse reactions.
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Bryant Ranch Prepack
Ketorolac Tromethamine | Bryant Ranch Prepack
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulationshouldnotbe givenas an initial dose
Use minimum effective dosefor the individual patient
Do not shorten dosing intervalof 4 to 6 hours
Total duration of treatment in adult patients:the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac thromethamine tablet dosing instructions in terms of age group:
TABLE 4: Summary of Dosing Instructions
Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)Age < 17 yearsOral not approvedAdult Age 17 to 64 years20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/dayAdult Age65 years, renally impaired, and/or weight < 50 kg10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
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Fresenius Kabi Usa, Llc
Ketorolac Tromethamine | Fresenius Kabi Usa, Llc
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
· Patients <65 years of age: One dose of 60 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
· Patients <65 years of age: One dose of 30 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
· One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing:
· One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM) In Adults:
· Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg.
· For Patients ≥65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (eg, in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
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Cardinal Health
Ketorolac Tromethamine | Cardinal Health
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
Ketorolac Tromethamine Injection
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use OnlyIM Dosing:
• Patients < 65 years of age: One dose of 60 mg.
• Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
• Patients < 65 years of age: One dose of 30 mg.
• Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Multiple-Dose Treatment (IV or IM)
• Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg.
• For patients ≥ 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs):
The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionKetorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Cardinal Health
Ketorolac Tromethamine | Cardinal Health
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
· Patients <65 years of age: One dose of 60 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
· Patients <65 years of age: One dose of 30 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
· One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing:
· One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM) In Adults:
· Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg.
· For Patients ≥65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (eg, in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
-
Cardinal Health
Ketorolac Tromethamine | Cardinal Health
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
· Patients <65 years of age: One dose of 60 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
· Patients <65 years of age: One dose of 30 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
· One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing:
· One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM) In Adults:
· Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg.
· For Patients ≥65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (eg, in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
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Mylan Pharmaceuticals Inc.
Ketorolac Tromethamine | Mylan Pharmaceuticals Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Patients age ≥65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4 Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets
(following IV or IM dosing of
ketorolac tromethamine)Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/dayAdult Age ≥ 65 years,
renally impaired and/or weight <50 kg10 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day -
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Cardinal Health
Ketorolac Tromethamine | Pharmacia And Upjohn Company
The suspension is intended for intramuscular administration only.
When multi-dose vials are used, special care to prevent contamination of the contents is essential [see WARNINGS and PRECAUTIONS].
Endometrial or Renal CarcinomaDoses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
Geriatric Use Renal CarcinomaOf the 349 subjects in a clinical study of Depo Provera in renal carcinoma, 30 percent were 65 and over, while 5 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Endometrial CarcinomaThis product has been used primarily in post-menopausal women for the treatment of endometrial carcinoma. Clinical experience has not identified differences in safety or effectiveness between elderly and younger patients.
Hepatic ImpairmentDEPO-PROVERA Sterile Aqueous Suspension should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur [see PRECAUTIONS].
Renal ImpairmentThe effect of renal impairment on DEPO-PROVERA pharmacokinetics has not been studied.
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General Injectables & Vaccines, Inc
Ketorolac Tromethamine | General Injectables & Vaccines, Inc
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note: Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or "prn" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only
IM Dosing
Patients <65 years of age: One dose of 60 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing
Patients <65 years of age: One dose of 30 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Clinical Solutions Wholesale
Ketorolac Tromethamine | Clinical Solutions Wholesale
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
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Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Aidarex Pharmaceuticals Llc
Ketorolac Tromethamine | Aidarex Pharmaceuticals Llc
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Apotheca, Inc
Ketorolac Tromethamine | Apotheca, Inc
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/dayPatients age >65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/dayNote:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions
Patient Population
Ketorolac Tromethamine Tablets(following IV or IM dosing ofketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/dayAdult Age > 65 years,
renally impaired and/or weight <50 kg10 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day -
Teva Pharmaceuticals Usa Inc
Ketorolac Tromethamine | Teva Pharmaceuticals Usa Inc
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
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Hospira, Inc.
Ketorolac Tromethamine | Hospira, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
NOTE: Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Adult Patients: Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
IM Dosing:
• Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing:
• Patients <65 years of age: One dose of 30 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
• Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. • For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Hospira, Inc.
Ketorolac Tromethamine | Greenstone Llc
[see Indications and Usage (1)]
Azithromycin for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.
Azithromycin for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Directions for administration of azithromycin for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin.
2.1 Sexually Transmitted DiseasesThe recommended dose of azithromycin for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1 gram (1000 mg) dose of azithromycin. This dose can be administered as one single dose packet (1 g).
2.2 Mycobacterial InfectionsPrevention of Disseminated MAC Infections
The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.
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Hospira, Inc.
Ketorolac Tromethamine | Hospira, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note: Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
IM Dosing
• Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing
• Patients <65 years of age: One dose of 30 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
• Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. • For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Hospira, Inc.
Ketorolac Tromethamine | Hospira, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note: Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
IM Dosing
• Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing
• Patients <65 years of age: One dose of 30 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
• Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. • For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Hospira, Inc.
Ketorolac Tromethamine | Hospira, Inc.
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note: Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only
IM Dosing
Patients <65 years of age: One dose of 60 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing
Patients <65 years of age: One dose of 30 mg. Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Remedyrepack Inc.
Ketorolac Tromethamine | Remedyrepack Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Readymeds
Ketorolac Tromethamine | Readymeds
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Patients age ≥65, renally impaired, and/or weight <50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not >40 mg/day Note:Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Do not shorten dosing interval of 4 to 6 hours
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:
Table 4 Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets
(following IV or IM dosing of
ketorolac tromethamine)Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/dayAdult Age ≥ 65 years,
renally impaired and/or weight <50 kg10 mg once, then 10 mg q4 to 6
hours prn not > 40 mg/day -
Proficient Rx Lp
Ketorolac Tromethamine | Proficient Rx Lp
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
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Northwind Pharmaceuticals, Llc
Ketorolac Tromethamine | Northwind Pharmaceuticals, Llc
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
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Agila Specialties Private Limited
Ketorolac Tromethamine | Agila Specialties Private Limited
DOSAGE AND ADMINISTRATION Ketorolac Tromethamine Tablets Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine injection, and the combined duration of use of ketorolac tromethamine injection and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events. The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection (maximum 120 mg) (see DOSAGE AND ADMINISTRATION ).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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note:
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
Ketorolac Tromethamine Injection
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or "prn" schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS - Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
IM Dosing:
Patients < 65 years of age : One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight : One dose of 30 mg.IV Dosing:
Patients < 65 years of age : One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
Patients < 65 years of age : The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥ 65 years of age, renally impaired patients (see WARNINGS ), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids "prn" unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection: Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Cardinal Health
Ketorolac Tromethamine | Cardinal Health
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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note: Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
KETOROLAC TROMETHAMINE INJECTION
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS – Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only
IM Dosing
• Patients <65 years of age: One dose of 60 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.IV Dosing
• Patients <65 years of age: One dose of 30 mg. • Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.Multiple-Dose Treatment (IV or IM)
• Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. • For patients ≥65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Carilion Materials Management
Ketorolac Tromethamine | Carilion Materials Management
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
should be given . Oral formulationnotas an initial dose
for the individual patient. Use minimum effective dose
Do of 4 to 6 hours. not shorten dosing interval
the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. Total duration of treatment in adult patients:
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day -
Sagent Pharmaceuticals
Ketorolac Tromethamine | Sagent Pharmaceuticals
Carefully consider the potential benefits and risks of ketorolac tromethamine injection 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. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine injection. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
Note
Oral formulation should not be given as an initial dose
Use minimum effective dose for the individual patient
Total duration of treatment in adult patients:The combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
Ketorolac Tromethamine InjectionKetorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose TreatmentThe Following Regimen Should Be Limited To Single Administration Use Only
IM Dosing: Patients < 65 years of age: One dose of 60 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg. IV Dosing: Patients < 65 years of age: One dose of 30 mg. Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg. Multiple-Dose Treatment (IV or IM) Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg. For patients ≥ 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “prn” unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine InjectionKetorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Cardinal Health
Ketorolac Tromethamine | Cardinal Health
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not> 40 mg/day
Note:
Oral formulation should not be given as an initial dose.
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing InstructionsPatient Population
Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years
Oral not approved
Adult Age 17 to 64 years
20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg
10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
-
Cardinal Health
Ketorolac Tromethamine | Cardinal Health
IN ADULTS, THE COMBINED DURATION OF USE OF KETOROLAC TROMETHAMINE INJECTION AND KETOROLAC TROMETHAMINE TABLETS IS NOT TO EXCEED 5 DAYS. IN ADULTS, THE USE OF KETOROLAC TROMETHAMINE TABLETS IS ONLY INDICATED AS CONTINUATION THERAPY TO KETOROLAC TROMETHAMINE INJECTION.
Ketorolac Tromethamine Injection
Adult Patients
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “prn” schedule for the management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see WARNINGS: Renal Effects). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
When administering ketorolac tromethamine injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in~30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only
Adult Patients
IM Dosing:
· Patients <65 years of age: One dose of 60 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
· Patients <65 years of age: One dose of 30 mg.
· Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Pediatric Patients (2 to 16 years of age): The pediatric population should receive only a single dose of ketorolac tromethamine injection as follows:
IM Dosing:
· One dose of 1 mg/kg up to a maximum of 30 mg.
IV Dosing:
· One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM) In Adults:
· Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose should not exceed 120 mg.
· For Patients ≥65 years of age, renally impaired patients (see WARNINGS) and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.
For breakthrough pain do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids prn unless otherwise contraindicated.
Pharmaceutical Information for Ketorolac Tromethamine Injection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Ketorolac tromethamine injection should not be mixed in a small volume (eg, in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
![Ketorolac Tromethamine Injection, Solution [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca7a2141-91c1-4a42-8dd3-b0fcacf87357&name=MM3.jpg)
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