KETOROLAC TROMETHAMINE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

RedPharm Drug, Inc.

SNN (starptautisko nepatentēto nosaukumu):

KETOROLAC TROMETHAMINE

Kompozīcija:

KETOROLAC TROMETHAMINE 10 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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 (NDC 0093-0314-01). 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. Distributed By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. K 7/2015

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE TABLET
REDPHARM DRUG, INC.
----------
BOXED WARNING
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
andPRECAUTIONS).
•
Ketorolac tromethamine tablets are contraindicated in the setting of
coronary artery bypass graft
(CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
RENAL RISK
•
Ketorolac tromethamine is CONTRA