Ketorolac Tromethamine 15 mg/mL
Ketorolac Tromethamine · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Ketorolac Tromethamine is a nonsteroidal anti-inflammatory medication (NSAID) given by injection into the muscle to treat moderate to severe pain, typically for short-term use. It works by reducing pain and inflammation in the body.
Key Facts
- Brand Name
- Ketorolac Tromethamine
- Generic Name
- Ketorolac Tromethamine
- NDC Code (Product)
76045-107- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 15 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA203242
- Marketing Start
- 11/02/2015
Recall History
Sagent Pharmaceuticals Inc
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Fresenius Kabi USA, LLC
Presence of Particulate Matter - found in reserve sample vials at the firm.
KRS Global Biotechnology, Inc
Lack of Assurance of Sterility
Hospira Inc.
Crystallization; identified as calcium salt of Ketorolac
Akorn, Inc.
CGMP Deviations:
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Apotex Corp.
Lack of Assurance of Sterility
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Hospira Inc.
Crystallization; identified as calcium salt of Ketorolac
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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. Ketorolac tromethamine i…
Dosage & Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine. Note: Oral formulation should not be given as an initial dose. Use minimum effective dose for the individual patient. Total duration of treatment in adult patients: the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. KETOROLAC TROMETHAMINE INJECTION Ketorolac tromethamine injection ma…
Warnings
WARNINGS (See also Boxed WARNING .) The total combined duration of use of oral ketorolac tromethamine and intravenous or intramuscular dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine is not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: Gastrointestinal Effects – Risk of Ulceration, Bleeding and Perforation: Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or gastrointestinal (GI) bleeding. Ketorolac tromethamine can cause serious GI adverse events including bleeding, ulceration and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with ketorolac tromethamine. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of…
Contraindications
CONTRAINDICATIONS (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. 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, throu…
Adverse Reactions
ADVERSE REACTIONS Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI) experiences including: abdominal pain constipation/diarrhea dyspepsia flatulence GI fullness GI ulcers (gastric/duodenal) gross bleeding/perforation heartburn nausea * stomatitis vomiting Other experiences: abnormal renal function anemia dizziness drowsiness edema elevated liver enzymes headaches * hypertension increased bleeding time injection site pain pruritus purpura rashes tinnitus sweating *Incidence gr…
Frequently Asked Questions
What is Ketorolac Tromethamine used for?
Ketorolac Tromethamine is a nonsteroidal anti-inflammatory medication (NSAID) given by injection into the muscle to treat moderate to severe pain, typically for short-term use. It works by reducing pain and inflammation in the body.
Is Ketorolac Tromethamine a controlled substance?
Ketorolac Tromethamine is not classified as a controlled substance by the DEA.
What is the generic name for Ketorolac Tromethamine?
The generic name for Ketorolac Tromethamine is Ketorolac Tromethamine. There are 9 other brand versions of Ketorolac Tromethamine.
What is the NDC code for Ketorolac Tromethamine 15 mg/mL?
The NDC (National Drug Code) for Ketorolac Tromethamine 15 mg/mL is 76045-107, listed by Fresenius Kabi USA, LLC.
Other Ketorolac Tromethamine Dosages
Other Ketorolac Brands
See all →- ketorolac tromethamine15 mg/mL72266-234
- Toronova II SUIK30 mg/mL76420-252
- Toronova II SUIK30 mg/mL80425-0572
- ketorolac tromethamine30 mg/mL84549-119
- KETOROLAC TROMETHAMINE15 mg/mL31722-305
- KETOROLAC TROMETHAMINE15 mg/mL43066-049
- KETOROLAC TROMETHAMINE30 mg/mL43066-051
- ketorolac tromethamine60 mg/2mL47335-935
- ketorolac tromethamine10 mg/150090-7808
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)