KETOROLAC TROMETHAMINE- ketorolac tromethamine injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hospira, Inc.

INN (שם בינלאומי):

KETOROLAC TROMETHAMINE

הרכב:

KETOROLAC TROMETHAMINE 30 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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 switch

leaflet_short:

Ketorolac Tromethamine Injection, USP for IM and IV use is available in an iSecureTM sterile cartridge unit as follows: Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Retain in carton until time of use. PROTECT FROM LIGHT.  To Use iSecure™ Syringe             Remove the plunger rod. Insert the plunger rod into the back end of the syringe barrel and turn clockwise 2 to 3 times to attach.             BEFORE REMOVING LUER TIP CAP,             hold the syringe with tip cap upright. Press             syringe plunger until plunger moves             slightly. This motion breaks the seal             between plunger and syringe barrel. NOTE: To prevent needlestick injuries, needles and blunt cannulas should not be recapped, purposely bent, or broken by hand. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                   LAB-1295-2.0 Revised: 8/2019

מצב אישור:

Abbreviated New Drug Application

עלון מידע

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
Hospira, 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:
•
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
NSAID medicines 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 before or after heart bypass surgery.
Before taking NSAIDs, tell yo

מאפייני מוצר

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
HOSPIRA, INC.
----------
KETOROLAC
TROMETHAMINE
Injection, USP IV/IM
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 (IV) or intramuscular
(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
•
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
RENAL RISK
•
RISK OF BLEEDING
•
KETOROLAC TROMETHAMINE IS CONTRAINDICATED AS PROPHYLACTIC ANALGESIC
BEFORE ANY
MAJOR SURGERY.
HYPERSENSITIVITY
•
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).
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).
Ketoro