KETOROLAC TROMETHAMINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)

Available from:

General Injectables and Vaccines, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatement options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients 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 IV or IM dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine 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

Product summary:

Ketorolac Tromethamine Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Product of India Manufactured by:  Gland Pharma Limited  D.P.Pally, Dundigal Post,  Hyderabad-500 043, INDIA Distributed by:  Alvogen, Inc.  Pine Brook, NJ 07058 USA July 2017  PI583-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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KETOROLAC TROMETHAMINE INJECTION, USP
BOXED 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 IV or IM 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 INDICATE 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
Nonsteroidal anti-inflammatory drugs (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 Injection, USP is CONTRAINDICATED in the
setting or coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
RENAL RISK
Ketorolac trome