KETOROLAC TROMETHAMINE injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Hikma Pharmaceuticals USA Inc.

INN (Nama Antarabangsa):

KETOROLAC TROMETHAMINE

Komposisi:

KETOROLAC TROMETHAMINE 15 mg in 1 mL

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 intravenous or intramuscular 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 to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days. (See also Boxed WARNING .) Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. 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. Ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions , and PRECAUTIONS – Pre-existing Asthma ). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS  for correction of volume depletion). Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ). Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated. Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.

Ringkasan produk:

Ketorolac Tromethamine Injection, USP is available as follows: For IV or IM Single Dose use: NDC 0641-6041-25, 2 mL vials containing 1 mL of 15 mg/mL Ketorolac Tromethamine, USP, available in boxes of 25. NDC 0641-6042-25, 2 mL vials containing 1 mL of 30 mg/mL Ketorolac Tromethamine, USP, available in boxes of 25. For IM Single Dose use only: NDC 0641-6043-25, 60 mg/2 mL, 2 mL vials containing 2 mL of 30 mg/mL Ketorolac Tromethamine, USP, (60 mg), available in boxes of 25. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Retain in carton until time of use. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
KETOROLAC TROMETHAMINE INJECTION, USP
FOR INTRAVENOUS/INTRAMUSCULAR USE (15 MG AND 30 MG)
FOR INTRAMUSCULAR USE ONLY (60 MG)
RX ONLY
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
intravenous or
intramuscular 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 is CONTRAINDICATED in the setting of
coronary artery
byp