KETOROLAC TROMETHAMINE injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Hospira, Inc.

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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  ADVERSE REACTIONS ). Pat

Ürün özeti:

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Retain in carton until time of use. PROTECT FROM LIGHT. Carpuject™ Single-use cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included. Instructions for Use of the Syringe Systems Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02. Carpuject™ Single-use cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                LAB-1293-6.0 Revised: 8/2021

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

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 you

Ürün özellikleri

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
HOSPIRA, INC.
----------
KETOROLAC TROMETHAMINE INJECTION, USP
FOR INTRAVENOUS or 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
•
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 an