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:

DIRECT RX

INN (International Name):

KETOROLAC TROMETHAMINE

Composition:

KETOROLAC TROMETHAMINE 10 mg

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. Acute Pain in Adult Patients 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 RE

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 100 tablets. 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. TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 4/2013

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
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.
Before taking NSAIDs, tell your healthcare provider about all of your
medical condition

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
DIRECT RX
----------
KETOROLAC TROMETHAMINE
BOXED WARNING SECTION
WARNING
Ketorolac tromethamine tablets, a non-steroidal 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
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).
CARDIOVASCULAR RISK
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
CLINICAL STUDIES).
Ketorolac tromethamine is CONTRAINDICATED for the treatment of peri-
operative pain in the setting of coronary artery bypass graft (CABG)
surgery
(see WAR