KETOROLAC TROMETHAMINE- 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:

General Injectables & Vaccines, Inc

INN (International Name):

Ketorolac Tromethamine

Composition:

Ketorolac Tromethamine 30 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). Patients s

Product summary:

Ketorolac Tromethamine Injection, USP is supplied as follows: 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: 7/2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
General Injectables & Vaccines, Inc
----------
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal Anit-
Inflammatory Drugs (NSAIDs)?
NSAID medicines 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
teatment 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", "anticoagulatns", "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 aree 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 o

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
KETOROLAC TROMETHAMINE INJECTION, USP
FOR IV/IM USE (15 MG AND 30 MG)
FOR IM 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) 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 a history
of peptic ulcer disease or
gastrointestinal bleeding. Elderly patients are at greater risk for
serious gastrointestinal events
(see WARNINGS).
CARDIOVASCULAR THROMBOTIC EVENTS
•NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS and PRECAUTIONS).
•Ketorolac tromethamine is CONTRAINDICATED for the treatment of
peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery
(see C