|Manufacturer:||Hoffmann-La Roche Inc.|
Distributed by:Roche Laboratores Inc.340 Kingsland StreetNutley, New Jersey 07110–1199 Rev.
November 2007 Copyright © 1997-2007 by Roche Laboratories Inc.All rights reserved.
(see also Boxed WARNING) TORADOL is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
TORADOL 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.
TORADOL should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDS.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDS have been reported in such patients (see WARNINGS: Anaphylactoid Reactions , and PRECAUTIONS: Preexisting Asthma ).
TORADOL is contraindicated as prophylactic analgesic before any major surgery.
TORADOL is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
TORADOL 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).
TORADOL is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
The use of TORADOL is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
TORADOL inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ).
TORADOL is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.
The concomitant use of TORADOL and probenecid is contraindicated.The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
(see also Boxed WARNING) The total combined duration of use of TORADOL ORAL and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults.
TORADOL ORAL is not indicated for use in pediatric patients.The most serious risks associated with TORADOL are: