KETOROLAC TROMETHAMINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketorolac tromethamine tablets, USP are 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 IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets, USP are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine tablets, USP and 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 tablets, USP are available as follows: 10 mg: White, round, convex, unscored, film-coated tablets, debossed "93" on one side and "314" on the other side. They are available in bottles of 20 tablets (NDC 68788-8149-2) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). PROTECT FROM LIGHT AND EXCESSIVE HUMIDITY. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. N 7/2021 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Dispense with Medication Guide available at: www.tevausa.com/medguides
What is the most important information I should know about medicines
called Nonsteroidal 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
•
older age
•
•
longer use of NSAIDs
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
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 have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
----------
KETOROLAC TROMETHAMINE TABLETS USP, 10 MG
RX ONLY
WARNING
KETOROLAC TROMETHAMINE TABLETS, A NONSTEROIDAL ANTI-INFLAMMATORY DRUG
(NSAID), ARE INDICATED FOR THE SHORT-TERM (UP TO 5 DAYS IN ADULTS),
MANAGEMENT OF MODERATELY SEVERE ACUTE PAIN THAT REQUIRES ANALGESIA AT
THE OPIOID LEVEL AND ONLY AS CONTINUATION TREATMENT FOLLOWING IV OR IM
DOSING OF KETOROLAC TROMETHAMINE, IF NECESSARY. THE TOTAL COMBINED
DURATION OF USE OF KETOROLAC TROMETHAMINE TABLETS AND KETOROLAC
TROMETHAMINE SHOULD NOT EXCEED 5 DAYS.
KETOROLAC TROMETHAMINE TABLETS ARE NOT INDICATED FOR USE IN PEDIATRIC
PATIENTS AND THEY ARE NOT INDICATED FOR MINOR OR CHRONIC PAINFUL
CONDITIONS. INCREASING THE DOSE OF KETOROLAC TROMETHAMINE TABLETS
BEYOND A DAILY MAXIMUM OF 40 MG IN ADULTS WILL NOT PROVIDE BETTER
EFFICACY BUT WILL INCREASE THE RISK OF DEVELOPING SERIOUS ADVERSE
EVENTS.
GASTROINTESTINAL RISK
•
CARDIOVASCULAR THOMBOTIC EVENTS
•
•
RENAL RISK
•
RISK OF BLEEDING
•
KETOROLAC TROMETHAMINE IS CONTRAINDICATED AS PROPHYLACTIC ANALGESIC
BEFORE ANY MAJOR SURGERY.
Ketorolac tromethamine, including ketorolac tromethamine tablets 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 risk may occur early in treatment and
may
increase with duration of use (see WARNINGS and PRECAUTIONS).
Ketorol