KETOROLAC TROMETHAMINE injection, solution

Ketorolac Tromethamine by

Drug Labeling and Warnings

Ketorolac Tromethamine by is a Prescription medication manufactured, distributed, or labeled by Fresenius Kabi USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Do not use if package has been damaged.

  • Peel open the paper (top web) of the outer packaging that displays the product information to access the syringe. Do not pop syringe through.
  • Bend the plastic part of the outer packaging (thermoform) so as to present the plunger rod for syringe removal.

                  Figure

  • Perform visual inspection on the syringe
    Verify:
  • - absence of external particles
  • - absence of internal particles
  • - proper drug color
  • - expiration date
  • - drug name
  • - drug strength
  • - dose volume
  • - route of administration
  • - sterile field applicability
  • - integrity of the plastic wrap around the external collar
  • Do not remove plastic wrap around the external collar. Without removing the tip cap, push plunger rod slightly to break the stopper loose.
  • Do not remove plastic wrap around the external collar. Remove tip cap by twisting it off.

                  Figure

  • Discard the tip cap.
  • Expel air bubble.
  • Adjust dose by expelling extra volume (where applicable) from the syringe into sterile material prior to administration.
  • Connect the syringe to appropriate injection connection depending on route of administration. Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device.
  • Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.
  • Remove syringe from needleless luer access device (if applicable) and discard into appropriate receptacle. If delivering medication via intramuscular route, do not recap needle.
  • NOTES:

  • - All steps must be done sequentially.
  • - Do not autoclave syringe.
  • - Do not use this product on a sterile field.
  • - Do not introduce any other fluid into the syringe at any time. - This product is for single dose only.
  • For more information concerning this drug or to report an adverse event please call Fresenius Kabi USA, LLC at 1-800-551-7176.

    The brand names mentioned in this document are the trademarks of their respective owners.

  • Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    (See the end of this Medication Guide for a list of prescription NSAID medicines.)

    What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

    • with longer use of NSAID medicines
    • in people who have heart disease

    NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

    NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

    • can happen without warning symptoms
    • may cause death

    The chance of a person getting an ulcer or bleeding increases with:

    • taking medicines called “corticosteroids” and “anticoagulants”
    • longer use
    • smoking
    • drinking alcohol
    • older age
    • having poor health

    NSAID medicines should only be used:

    • exactly as prescribed
    • at the lowest dose possible for your treatment
    • for the shortest time needed

    What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

    • different types of arthritis
    • menstrual cramps and other types of short-term pain

    Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

    Do not take an NSAID medicine:

    • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
    • for pain right before or after heart bypass surgery

    Tell your healthcare provider:

    • about all of your medical conditions.
    • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects.

    Keep a list of your medicines to show to your healthcare provider and pharmacist.

    • if you are pregnant.

    NSAID medicines should not be used by pregnant women late in their pregnancy.

    • if you are breastfeeding. Talk to your doctor

    What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    Serious side effects include:

    • heart attack
    • stroke
    • high blood pressure
    • heart failure from body swelling (fluid retention)
    • kidney problems including kidney failure
    • bleeding and ulcers in the stomach and intestine
    • low red blood cells (anemia)
    • life-threatening skin reactions
    • life-threatening allergic reactions
    • liver problems including liver failure
    • asthma attacks in people who have asthma

    Other side effects include:

    • heart attack
    • stomach pain
    • constipation
    • diarrhea
    • gas
    • heartburn
    • nausea
    • vomiting
    • dizziness

    Get emergency help right away if you have any of the following symptoms:

    • shortness of breath or trouble breathing
    • chest pain
    • weakness in one part or side of your body
    • slurred speech
    • swelling of the face or throat

    Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

    • nausea
    • more tired or weaker than usual
    • itching
    • your skin or eyes look yellow
    • stomach pain
    • flu-like symptoms
    • vomit blood
    • there is blood in your bowel movement or it is black and sticky like tar
    • unusual weight gain
    • skin rash or blisters with fever
    • swelling of the arms and legs, hands and feet

    These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

    Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
    • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter).Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

    NSAID medicines that need a prescription

    * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC label warns that long term continuous use may increase the risk of heart attack or stroke.

    Generic NameTradename
    Celecoxib Celebrex
    Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
    Diflunisal Dolobid
    Etodolac Lodine, Lodine XL
    Fenoprofen Nalfon, Nalfon 200
    Flurbirofen Ansaid
    Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
    Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
    Ketoprofen Oruvail
    Ketorolac Toradol
    Mefenamic Acid Ponstel
    Meloxicam Mobic
    Nabumetone Relafen
    Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
    Oxaprozin Daypro
    Piroxicam Feldene
    Sulindac Clinoril
    Tolmetin Tolectin, Tolectin DS, Tolectin 600

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to www.fresenius-kabi.us or call 1-800-551-7176.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.
    Revised: 04/2016

    Figure

    www.fresenius-kabi.us
    D1064P01
    Rev. 04/2016

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 1 mL Carton Panel
    Rx only NDC: 76045-104-10
    Ketorolac Tromethamine Injection, USP
    30 mg/mL
    For Intravenous or Intramuscular Use.
    24 X 1 mL prefilled single use syringes
    Discard unused portion.
    Do NOT place syringe on a Sterile Field.
    SimplistTM

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac 1 mL Carton Panel
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 1 mL Blister Pack Label
    Rx only NDC: 76045-104-10
    Ketorolac Tromethamine Injection, USP
    30 mg/mL For IV or IM use.

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 1 mL Blister Pack Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 1 mL Syringe Label
    1 mL Single-use  For IV or IM use.
    Ketorolac Tromethamine Injection, USP
    30 mg/mL
    Rx only

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 1 mL Syringe Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 2 mL Carton Panel
    Rx only NDC: 76045-105-20
    Ketorolac Tromethamine Injection, USP
    60 mg / 2 mL
    (30 mg / mL)
    For INTRAMUSCULAR use only. 
    24 X 2mL prefilled single use syringes
    Discard unused portion.
    Do NOT place syringe on a Sterile Field.
    SimplistTM

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 2 mL Carton Panel
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 2 mL Blister Pack Label
    Rx only NDC: 76045-105-20
    Ketorolac Tromethamine Injection, USP
    60 mg/2 mL
    (30 mg/mL)
    For INTRAMUSCULAR use only.

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 2 mL Blister Pack Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine 2 mL Syringe Label
    2mL Single-use.  Rx only
    Ketorolac Tromethamine Injection, USP
    60 mg/2 mL
    (30 mg/mL)
    For IM use only.

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac 2 mL Syringe Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine  1 mL Carton Panel
    Rx only NDC: 76045-107-10
    Ketorolac Tromethamine Injection, USP
    15 mg/mL
    For Intravenous or Intramuscular Use.
    24 X 1 mL prefilled single use syringes
    Discard unused portion.
    Do NOT place syringe on a Sterile Field.
    SimplistTM

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac 1 mL Carton Panel
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine  1 mL Blister Pack Label
    Rx only NDC: 76045-107-10
    Ketorolac Tromethamine Injection, USP
    For IV or IM use. 
    15 mg/mL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac 1 mL Blister Pack Label
  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine  1 mL Syringe Label
    1 mL Single-use  For IV or IM use.
    Ketorolac Tromethamine Injection, USP
    Rx only  
    15 mg/mL

    PACKAGE LABEL - PRINCIPAL DISPLAY - Ketorolac Tromethamine  1 mL Syringe Label
  • INGREDIENTS AND APPEARANCE
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 76045-104
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketorolac Tromethamine (UNII: 4EVE5946BQ) (Ketorolac - UNII:YZI5105V0L) Ketorolac Tromethamine30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Alcohol (UNII: 3K9958V90M)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 76045-104-1024 in 1 CARTON11/02/2015
    11 in 1 BLISTER PACK
    11.0 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20324211/02/2015
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 76045-105
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketorolac Tromethamine (UNII: 4EVE5946BQ) (Ketorolac - UNII:YZI5105V0L) Ketorolac Tromethamine60 mg  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Alcohol (UNII: 3K9958V90M)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 76045-105-2024 in 1 CARTON11/02/2015
    11 in 1 BLISTER PACK
    12.0 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20324211/02/2015
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 76045-107
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketorolac Tromethamine (UNII: 4EVE5946BQ) (Ketorolac - UNII:YZI5105V0L) Ketorolac Tromethamine15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Alcohol (UNII: 3K9958V90M)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 76045-107-1024 in 1 CARTON11/02/2015
    11 in 1 BLISTER PACK
    11.0 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20324211/02/2015
    Labeler - Fresenius Kabi USA, LLC (608775388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fresenius Kabi, USA LLC080381675MANUFACTURE(76045-104, 76045-105, 76045-107)

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