KETOROLAC TROMETHAMINE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

INN (Nama Antarabangsa):

KETOROLAC TROMETHAMINE

Komposisi:

KETOROLAC TROMETHAMINE 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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. NDC: 63629-2974-1: 30 Tablets in a BOTTLE NDC: 63629-2974-2: 10 Tablets in a BOTTLE NDC: 63629-2974-3: 20 Tablets in a BOTTLE NDC: 63629-2974-4: 90 Tablets in a BOTTLE NDC: 63629-2974-5: 16 Tablets in a BOTTLE NDC: 63629-2974-6: 8 Tablets in a BOTTLE NDC: 63629-2974-7: 15 Tablets in a BOTTLE NDC: 63629-2974-8: 5 Tablets in a BOTTLE NDC: 63629-2974-9: 100 Tablets in a BOTTLE NDC: 63629-2974-0: 3 Tablets in a BOTTLE 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 Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Bryant Ranch Prepack
----------
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.
Before tak

Ciri produk

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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
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 THOMBOTIC 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 RI