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Basic Drug Info
Drug Name:Ketorolac Tromethamine
Manufacturer:Mylan Pharmaceuticals Inc.
Other Info:Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED JULY 2003KTLC:R5



Clinical Trials:


Indications and Usage

Ketorolac tromethamine is indicated for the short-term (? 5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting.

Therapy should always be initiated with ketorolac tromethamine-IV/IM, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.

Combined use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets 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.
Acute onset pain -- Pain that comes on quickly, can be severe, but lasts a relatively short time.

Absence of pain sensation --

Contraindications
(see also Boxed WARNING)Ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment, or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion).Ketorolac tromethamine is CONTRAINDICATED in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the possible adverse effects of prostaglandin-inhibiting drugs on neonates.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).Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery, and is CONTRAINDICATED intra-operatively when hemostasis is critical because of the increased risk of bleeding.Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risks of inducing serious NSAID related adverse events.The concomitant use of ketorolac tromethamine and probenecid is CONTRAINDICATED.
Peptic Ulcer -- Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

Active Peptic Ulcer --

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Gastrointestinal Hemorrhage -- Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.

Kidney Failure -- A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

Uterine hemorrhage -- Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Hemorrhagic Disorders -- spontaneous or near spontaneous bleeding caused by a defect in clotting mechanisms (blood coagulation disorders) or another abnormality causing a structural flaw in the blood vessels (vascular hemostatic disorders).

Warnings

(see also Boxed WARNING)The combined use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days.

The most serious risks associated with ketorolac tromethamine are:
Branded Drugs
The following US Branded drugs contain Ketorolac Tromethamine


TORADOL -- ROCHE PALO ALTO LLC

ACULAR -- ALLERGAN INC

ACULAR LS -- ALLERGAN

ACULAR PRESERVATIVE FREE -- ALLERGAN INC


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