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Sprix

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Sprix

SPRIX®
(ketorolac tromethamine) Nasal Spray

WARNING

LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK

Limitations of Use

SPRIX (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug (NSAID), is indicated for short-term (up to 5 days in adults) management of moderate to moderately severe pain that requires analgesia at the opioid level. Do not exceed a total combined duration of use of SPRIX and other ketorolac formulations (IM/IV or oral) of 5 days [seeDOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

SPRIX is not indicated for use in pediatric patients and it is not indicated for minor or chronic painful conditions.

Gastrointestinal Risk

Ketorolac tromethamine, including SPRIX, 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, SPRIX is contraindicatedin 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 CONTRAINDICATIONS,WARNINGS AND PRECAUTIONS].

Bleeding Risk

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 CONTRAINDICATIONS,WARNINGS AND PRECAUTIONS].

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use.Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see WARNINGS AND PRECAUTIONS].

SPRIX Nasal spray is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS].

Renal Risk

SPRIX is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion [see CONTRAINDICATIONS, WARNINGSAND PRECAUTIONS].

DRUG DESCRIPTION

Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl2,3-dihydro-1H-pyrrolizine-1-carboxylicacid, compound with 2-amino-2-(hydroxymethyl)-1,3propanediol (1:1), and the structural formula is:

SPRIX® (ketorolac tromethamine) Structural Formula Illustration

The molecular weight of ketorolac tromethamine is 376.41. Ketorolac tromethamine is highly water-soluble, allowing its formulation in an aqueous nasal spray product at pH7.2.

SPRIX is a clear, colorless to yellow solution packaged in a glass vial with a snap on spray pump for use as an intranasal spray product. It contains the active ingredient (ketorolac tromethamine) and the excipients edetate disodium (EDTA), mono basic potassium phosphate, sodium hydroxide, and water for injection.

Last reviewed on RxList: 5/12/2014
This monograph has been modified to include the generic and brand name in many instances.

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