Clinical Information
Gen. Code and Des.
31613 ketorolac tromethamine INTRAMUSC VIAL 60 MG/2 ML
GCN and Des.
35236 ketorolac tromethamine INTRAMUSC VIAL 60 MG/2 ML
Strength
60MG-ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS
Active Ingredients
3539 ketorolac tromethamine 74103074
Inactive Ingredients
1539 ethyl alcohol 64175
BOXED WARNING
WARNING
Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days.
Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine beyond the label recommendations will not provide better efficacy but will increase the risk of developing serious adverse events.
GASTROINTESTINAL RISK
Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
CARDIOVASCULAR THROMBOTIC EVENTS
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS)
Ketorolac tromethamine is CONTRAINDICATED in the setting of coronary artery bypass graft(CABG)surgery(see CONTRAINDICATIONS and WARNINGS).
RENAL RISK
Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS).
RISK OF BLEEDING
Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
HYPERSENSITIVITY
Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection (see CONTRAINDICATIONS and WARNINGS). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
INTRATHECAL OR EPIDURAL ADMINISTRATION
Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.
RISK DURING LABOR AND DELIVERY
The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.
CONCOMITANT USE WITH NSAIDs
Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
SPECIAL POPULATIONS
Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs.) of body weight (see DOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS). Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients.
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).
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DESCRIPTION
Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl ...
CLINICAL PHARMACOLOGY
Pharmacodynamics - Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of ...
CLINICAL STUDIES
Adult Patients - In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamine intravenous as fixed intermittent boluses (e.g., 30 mg ...
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration ...
CONTRAINDICATIONS
(see also Boxed WARNING) Ketorolac Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine is contraindicated ...
WARNINGS
(See also Boxed WARNING.) The total combined duration of use of oral ketorolac tromethamine and intravenous or intramuscular dosing of ketorolac tromethamine is not to exceed 5 days in adults ...
PRECAUTIONS
General - Ketorolac tromethamine cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease ...
ADVERSE REACTIONS
Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I ...
OVERDOSAGE
Symptoms and Signs - Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive ...
DOSAGE & 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 ...
HOW SUPPLIED
Ketorolac Tromethamine Injection, USP is a clear, colorless to slight yellow solution and supplied as follows: Unit of Sale - Each - Concentration - (mg/mL) Fill ...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ketorolac Tromethamine Injection USP, 15 mg/mL, 1 mL fill - Vial Label - Ketorolac Tromethamine Injection USP, 15 mg/mL, 1 mL fill - Carton Label - Ketorolac Tromethamine ...
INGREDIENTS AND APPEARANCE
Product Information
