KETOROLAC TROMETHAMINE- ketorolac tromethamine injection, solution KETOROLAC TROMETHAMINE- ketorolac tromethamine aerosol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, Inc.

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 ). 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 intravenous or intramuscular 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

Product summary:

Ketorolac tromethamine injection, USP is a sterile, clear and slightly yellow color solution and is supplied as follows: FOR INTRAMUSCULAR USE ONLY Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Protect from light. Retain in carton until time of use. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by:             Aspiro Pharma Limited                                                        Survey No. 321, Biotech Park, Phase – III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Revised: 07/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE AEROSOL
Camber Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
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:
• with increasing doses of NSAIDs
• 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:
• anytime during use
• without warning symptoms
• that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or
intestinal bleeding with the use of NSAIDs
•
taking medicines called "corticosteroids",
"anticoagulants", "SSRIs", or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
·older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• 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 had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
• right bef

Summary of Product characteristics

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE INJECTION, SOLUTION
KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE AEROSOL
CAMBER PHARMACEUTICALS, INC.
----------
KETOROLAC TROMETHAMINE INJECTION, USP
FOR INTRAVENOUS/INTRAMUSCULAR USE (15 MG AND 30 MG)
FOR INTRAMUSCULAR USE ONLY (60 MG)
RX ONLY
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
intravenous or
intramuscular 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 WARNINGSand PRECAUTIONS).
• Ketorolac trome