Ketocetz

Ketocetz Special Precautions

ketorolac

Manufacturer:

Gland Pharma

Distributor:

Zuellig Pharma

Marketer:

Mega Lifesciences
Full Prescribing Info
Special Precautions
Dosage and duration of use: Ketolorac tromethamine is indicated for the short-term (not more than 5 days) management of moderately severe acute pain. Initial treatment of ketorolac tromethamine should be IV/IM administration that could be switch to oral administration, if necessary. The total combined duration of use of oral and injection ketorolac tromethamine should not exceed 5 days since increased risk of serious adverse events.
Gastrointestinal risk: Ketorolac tromethamine has known adverse effects on the gastrointestinal tract. Short-term use of the drug can cause peptic ulcers, gastrointestinal bleeding, and/or perforation of the gastrointestinal tract, which can be fatal. These adverse effects can occur at any time during use. Therefore, the drug is contraindicated in patients with active peptic ulcer disease, recent GI bleeding or perforation, and a history of peptic ulcer disease/bleeding. Close monitoring of signs and symptoms of gastrointestinal risk is highly recommended in patients receiving ketorolac tromethamine therapy.
Cardiovascular risk: NSAIDs including ketorolac tromethamine may cause an increased risk of serious thrombotic events, myocardial infarction, or stroke. Patients with preexisting cardiovascular diseases are at greater risk. Therefore, ketorolac tromethamine should not be used in elevated cardiovascular risk patients, particularly for the treatment of perioperative pain in the coronary artery bypass graft (CABG) surgery.
Risk of bleeding: Ketorolac tromethamine can inhibit platelet aggregation, which leads to increased risk of bleeding. The drug should be avoided in patients with bleeding disorders, current or history of serious hemorrhagic events, and those at high risk of bleeding. Ketorolac tromethamine is contraindicated as a prophylactic analgesic before any major surgery.
Use in renal impairment patients and renal risk: Total body clearance of ketorolac tromethamine is reduced in renal impairment patients (0.023-0.03 L/hr/kg in healthy adults and 0.015-0.016 L/hr/kg in renal insufficiency). This leads to two-fold increased elimination half-life of the drug in renal impairment patients. Therefore, ketorolac tromethamine is contraindicated in patients with severe renal impairment.
Intrathecal or epidural administration: Ketorolac tromethamine injection contains alcohol as an excipient. Therefore, the drug is contraindicated for intrathecal or epidural administration.
Special populations: The dosage of ketorolac tromethamine in elderly patients or patients weighing less than 50 kg should be adjusted. The recommended single-dose treatment in these patients is 30 mg IM or 15 mg IV. The multiple-dose treatment is 15 mg IV or IM every 6 hours. The maximum daily dose is 60 mg in these patients.
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