KETOROLAC TROMETHAMINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

INN (International Name):

KETOROLAC TROMETHAMINE

Composition:

KETOROLAC TROMETHAMINE 15 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks 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 ). Pa

Product summary:

Ketorolac Tromethamine Injection, USP is available as follows: For Intravenous/Intramuscular Single-Dose Use: NDC: 68083-103-01 15 mg: 15 mg/mL, 1 mL pre-filled syringe NDC: 68083-104-01 30 mg: 30 mg/mL, 1 mL pre-filled syringe For Intramuscular Single-Dose Use: NDC: 68083-104-02 60 mg: 30 mg/mL, 2 mL pre-filled syringe Storage Conditions 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE INJECTION, SOLUTION
Gland Pharma Limited
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SPL MEDGUIDE
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NSAIDs can cause serious side effects, including:
• Increased risk of heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAID medicines should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
• 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 provider about all

Summary of Product characteristics

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE INJECTION, SOLUTION
GLAND PHARMA LIMITED
----------
KETOROLAC TROMETHAMINE INJECTION, USP
RX ONLY
FOR INTRAVENOUS /INTRAMUSCULAR USE (15 MG AND 30 MG)
FOR INTRAMUSCULAR USE ONLY (60 MG)
BOXED 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 Injection, USP is CONTRAINDICATED in the
settin