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:

Aidarex Pharmaceuticals LLC

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. 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 should

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 10, 15, 20 and 30 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 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Rev. J 4/2013

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
Rx only
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID m

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
----------
KETOROLAC TROMETHAMINE TABLETS USP, 10 MG
0314
RX ONLY
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 gr