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:

Alvogen Inc.

INN (International Name):

ketorolac tromethamine

Composition:

ketorolac tromethamine 15 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). 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 to alternative analgesics a

Product summary:

Ketorolac Tromethamine Injection, USP is supplied as follows: 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 December 2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Alvogen Inc.
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical conditions, including if
you:
• have liver

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
ALVOGEN INC.
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KETOROLAC TROMETHAMINE INJECTION, USP
FOR INTRAVENOUS (IV)/ INTRAMUSCULAR (IM) USE (15 mg and 30 mg)
FOR INTRAMUSCULAR (IM) USE ONLY (60 mg)
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 INDICATED 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 of coronary
artery bypass graft (CABG)