KETOROLAC TROMETHAMINE injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

General Injectables and Vaccines, Inc.

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Acute Pain in Adult Patients Ketorolac tromethamine is 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 oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. The total combined duration of use of ketorolac tromethamine injection, and oral 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 be switched t

Ringkasan produk:

Ketorolac Tromethamine Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad – 500 043, India or Gland Pharma Limited Pashamylaram, Patancheru, Hyderabad – 502 307, India Distributed by: Almaject, Inc. Morristown, NJ 07960 USA Product of India Revised: May 2019 PI719-00 LEA-020271-00

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

General Injectables and Vaccines, Inc.
----------
SPL MEDGUIDE
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
Revised: 12/2022
Document Id: 8dd3ed85-3d71-4db6-864e-762b426776fa
34391-3
Set id: 605f1ae5-1424-427e-bbe1-bc1a3433fc9b
Version: 2
Effective Time: 20221222
General Injectables and Vaccines, Inc.

Karakteristik produk

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
KETOROLAC TROMETHAMINE INJECTION, USP
BOXED WARNING
WARNING
Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID),
is
indicated for the short-term (up to 5 days in adults) management of
moderately
severe acute pain that requires analgesia at the opioid level. Oral
ketorolac
tromethamine is indicated only as continuation treatment following IV
or IM dosing
of ketorolac tromethamine, if necessary. The total combined duration
of use of oral
ketorolac tromethamine and ketorolac tromethamine injection should not
exceed 5
days.
Ketorolac tromethamine is not indicated for use in pediatric patients
and it is NOT
indicated for minor or chronic painful conditions. Increasing the dose
of ketorolac
tromethamine beyond the label recommendations 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 Injection, USP is CONTRAINDICATED in the
setting of
coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
RENAL RISK
Ketoro