KETOROLAC TROMETHAMINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt USA LLC.

INN (International Name):

KETOROLAC TROMETHAMINE

Composition:

KETOROLAC TROMETHAMINE 15 mg in 1 mL

Administration route:

INTRAMUSCULAR

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 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 ADVERSE REACTIONS ). Patients should be switched to alt

Product summary:

Ketorolac Tromethamine Injection, USP is supplied as follows: NDC 64679-757-01    15 mg/mL, 1 mL single-dose vial, carton of 25.  NDC 64679-757-02   15 mg/mL, 1 mL single-dose vial, carton of 10. NDC 64679-757-03    15 mg/mL, 1 mL single-dose vial, carton of 1  NDC 64679-758-01   30 mg/mL, 1 mL single-dose vial, carton of 25.  NDC 64679-758-04   30 mg/mL, 1 mL single-dose vial, carton of 10. *NDC 64679-758-02 60 mg/2 mL, 2 mL single-dose vial, carton of 25. *NDC 64679-758-06 60 mg/2 mL, 2 mL single-dose vial, carton of 10. *NDC 64679-758-05 60 mg/2 mL, 2 mL single-dose vial, carton of 1.  NDC 64679-758-03   300 mg/10 mL, 10 mL multiple-dose vial, carton of 15. *FOR INTRAMUSCULAR USE ONLY. 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. Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054, USA. Rev.240321

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAC TROMETHAMINE - KETOROLAC TROMETHAMINE INJECTION
Wockhardt USA LLC.
----------
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
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 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 prov

Summary of Product characteristics

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE INJECTION
WOCKHARDT USA LLC.
----------
KETOROLAC TROMETHAMINE INJECTION, USP
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 WARNINGS and PRECAUTIONS ).
Ketorolac tromethamine is CONTRAINDICATED in the setting of coronary
artery
bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ).
RENAL RISK
Ketorolac tromethamine is CONTRAI