KETOROLAC TROMETHAMINE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Virtus Pharmaceuticals, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets 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 ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets 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

Produkt oppsummering:

Ketorolac Tromethamine Tablets, USP are available containing 10 mg of ketorolac tromethamine, USP. The tablets are white, round, biconvex, film-coated tablets, imprinted with product identification in black color on one side and plain on other side. They are available as follows: NDC 69543-388-10 bottles of 100 tablets with child-resistant closure. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and excessive humidity. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Virtus Pharmaceuticals, LLC
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
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
•
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 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
medic

Preparatomtale

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
VIRTUS PHARMACEUTICALS, LLC
----------
KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
CYCLE PHARMACEUTICALS LTD
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 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 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 tablets are contraindicated in the setting
of coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
RENAL RISK
•Ket