KETOROLAC TROMETHAMINE injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Sun Pharmaceutical Industries, Inc.

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 REACTIO

Rezumat produs:

Ketorolac Tromethamine Injection USP is available as follows: NDC 47335-933-45 15 mg/mL, 1 mL single-dose vial , carton of 25 NDC 47335-934-45 30 mg/mL, 1 mL single-dose vial, carton of 25 *NDC 47335-935-4560 mg/2 mL, 2 mL single-dose vial, carton of 25 *FOR INTRAMUSCULAR USE ONLY Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Ketorolac Tromethamine Injection USP
(KEE-toe-ROLE-ak troe-METH-a-meen)
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 had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surger

Caracteristicilor produsului

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 WARNINGS_ and _PRECAUTIONS).
Ketorolac tromethamine is CONTRAINDICATED in the setting of coronary
artery
bypass gr