KETOROLAC TROMETHAMINE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Virtus Pharmaceuticals, LLC

INN (International Name):

KETOROLAC TROMETHAMINE

Sammensetning:

KETOROLAC TROMETHAMINE 30 mg in 1 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 b

Produkt oppsummering:

Ketorolac Tromethamine Injection, USP is supplied as follows: Unit of Sale Concentration (mg/mL) Fill Volume/ Container Size NDC 69543-405-15 2mL Single-Dose Glass Fliptop Vial (1 mL/2 mL) NDC 69543-386-30 2mL Single-Dose Glass Fliptop Vial (1 mL/2 mL) NDC 69543-407-60 2mL Single-Dose Glass Fliptop Vial (2 mL/2 mL) 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. Revised: 08/2018 Manufactured for: Cycle Pharmaceuticals Ltd., CB2 1RR, Cambridge, United Kingdom Manufactured by: Caplin Point Labs. Ltd., Gummidipoondi - 601 201, INDIA Lic. No.: TN/Drugs/TN00003457 Distributed by: Virtus Pharmaceuticals, LLC Newtown, PA 18940, USA For more information call Virtus Pharmaceuticals, LLC at 1-888-848-3593

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Virtus Pharmaceuticals, 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, • increasing doses of NSAIDs
or stomach or intestinal • longer use of NSAIDS
bleeding with the use of • smoking
NSAIDs • drinking alcohol
• taking medicines called • older age
“corticosteroids”, • poor health
“anticoagulants”, “SSRIs”, or • advanced liver disease
“SNRIs” • 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 surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
me

Preparatomtale

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
VIRTUS PHARMACEUTICALS, LLC
----------
KETOROLAC TROMETHAMINE
INJECTION, USP
FOR INTRAVENOUS/INTRAMUSCULAR USE (15 AND 30 MG)
FOR INTRAMUSCULAR USE ONLY (60 MG)
CYCLE PHARMACEUTICALS LTD.
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 r