ketorolac tromethamine- Ketorolac Tromethamine injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Ketorolac Tromethamine (UNII: 4EVE5946BQ) (Ketorolac Tromethamine - UNII:4EVE5946BQ)

Mevcut itibaren:

Baxter Healthcare Corporation

INN (International Adı):

Ketorolac Tromethamine

Farmasötik formu:

INJECTION, SOLUTION

Kompozisyon:

30 mg in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 Ketorolac Tromethamine Injection and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. Combined use of Ketorolac Tromethamine Injection 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 should be switched to alter

Ürün özeti:

Ketorolac Tromethamine Injection, USP is available in pre-filled syringes as follows: A syringe containing 1 mL of 15 mg/mL Ketorolac Tromethamine, USP, NDC 10019-021-09, available in boxes of 10. A syringe containing 1 mL of 30 mg/mL Ketorolac Tromethamine, USP, NDC 10019-022-09, available in boxes of 10. A syringe containing 2 mL of 30 mg/mL Ketorolac Tromethamine, USP, (60 mg), NDC 10019-022-32, available in boxes of 10. Each disposable syringe is supplied with an individually wrapped 22gauge, 1 1/2 inch needle. Peel back needle wrapping and expose needle hub; avoid touching hub. Aseptically remove rubber protective cap from the syringe. Attach needle to syringe hub with a twist, keeping needle sheath intact. Remove needle sheath and inject medication. To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand. Dispose of used syringe in accordance with applicable medical waste regulations and guidelines. Store at controlled room temperature 15°-30°C (59°-86°F). PROTECT FROM LIGHT Retain in carton until time of use. Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA by: Taylor Pharmaceuticals Decatur, IL 62525 For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) 400-657-02 MLT-01572/1.0

Ürün özellikleri

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
KETOROLAC TROMETHAMINE INJECTION, USP
RX ONLY
WARNING
KETOROLAC TROMETHAMINE, A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID),
IS INDICATED FOR
THE SHORT-TERM (UP TO 5 DAYS) MANAGEMENT OF MODERATELY SEVERE ACUTE
PAIN THAT REQUIRES
ANALGESIA AT THE OPIOID LEVEL. IT IS NOT INDICATED FOR MINOR OR
CHRONIC PAINFUL CONDITIONS.
KETOROLAC TROMETHAMINE IS A POTENT NSAID ANALGESIC, AND ITS
ADMINISTRATION CARRIES MANY
RISKS. THE RESULTING NSAID-RELATED ADVERSE EVENTS CAN BE SERIOUS IN
CERTAIN PATIENTS FOR
WHOM KETOROLAC TROMETHAMINE IS INDICATED, ESPECIALLY WHEN THE DRUG IS
USED
INAPPROPRIATELY. INCREASING THE DOSE OF KETOROLAC TROMETHAMINE BEYOND
THE LABEL
RECOMMENDATIONS WILL NOT PROVIDE BETTER EFFICACY BUT WILL RESULT IN
INCREASING THE RISK OF
DEVELOPING SERIOUS ADVERSE EVENTS.
GASTROINTESTINAL EFFECTS
Ketorolac tromethamine can cause peptic ulcers, gastrointestinal
bleeding and/or perforation.
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.
RENAL EFFECTS
Ketorolac tromethamine is CONTRAINDICATED in patients with advanced
renal impairment
and in patients at risk for renal failure due to volume depletion (see
WARNINGS).
RISK OF BLEEDING
Ketorolac tromethamine inhibits platelet function and is, therefore,
CONTRAINDICATED in
patients with suspected or confirmed cerebrovascular bleeding,
patients with hemorrhagic
diathesis, incomplete hemostasis and those at high risk of bleeding
(see WARNINGS and
PRECAUTIONS). Ketorolac tromethamine is CONTRAINDICATED as
prophylactic
analgesic before any major surgery and is CONTRAINDICATED
intra-operatively when
hemostasis is critical because of the increased risk of bleeding.
HYPERS ENS ITIVITY
Hypersensitivity reactions, ranging from bronchospasm to anaphylactic
shock, have occurred
an