KETOROLAC TROMETHAMINE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Henry Schein, Inc.

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 ). Patients sh

Bidhaa muhtasari:

Ketorolac Tromethamine Injection, USP is supplied as follows: NDC Ketorolac Tromethamine Injection, USP (30 mg per mL) Package Factor 72266-118-25 30 mg/mL Single-Dose Vial 25 vials per carton 72266-119-25* 60 mg/2 mL Single-Dose Vial 25 vials per carton *FOR IM USE ONLY Storage Conditions Store at20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India Issue date: October 2021 PSLEA-020148-02

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Henry Schein, Inc.
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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 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 the 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 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
medical conditions, including if
you:
• have liver or kidney

Tabia za bidhaa

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
HENRY SCHEIN, INC.
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KETOROLAC TROMETHAMINE INJECTION, USP
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 is CONTRAINDICATED in the setting of
coronary artery
bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
RENAL RISK
• Ketorolac tr