Ketorolac tromethamine (injection)

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Ketorolac tromethamine (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
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 (seeWARNINGS).
  • 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 andPRECAUTIONS). 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.
  • Hypersensitivity
  • Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of Ketorolac Tromethamine Injection (seeCONTRAINDICATIONS andWARNINGS). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Intrathecal or Epidural Administration
  • Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.
    • Labor, Delivery and Nursing
  • The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and the uterus.
  • The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
  • Concomitant Use With NSAIDs
  • Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
    • Dosage and Administration
  • Ketorolac Tromethamine Tablets
  • Ketorolac tromethamine tablets are indicated only as continuation therapy to Ketorolac Tromethamine Injection, and the combined duration of use of Ketorolac Tromethamine Injection and ketorolac tromethamine tablets is not to exceed five (5) days because of the increased risk of serious adverse events.
  • The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for Ketorolac Tromethamine Injection (maximum 120 mg) (seeDOSAGE AND ADMINISTRATION).
  • Special Populations
  • Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (seeDOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS). Doses of Ketorolac Tromethamine Injection are not to exceed 60 mg (total dose per day) in these patients.

Overview

Ketorolac tromethamine (injection) is a analgesic that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include edema, hypertension, pruritus, rash, sweating, abdominal pain, constipation, diarrhea, flatulence, heartburn, indigestion, nausea, stomatitis, vomiting, anemia, purpura, dizziness, headache, somnolence, iritis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Ketorolac tromethamine (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ketorolac tromethamine (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketorolac tromethamine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ketorolac tromethamine (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ketorolac tromethamine (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketorolac tromethamine (injection) in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
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 (seeWARNINGS).
  • 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 andPRECAUTIONS). 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.
  • Hypersensitivity
  • Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of Ketorolac Tromethamine Injection (seeCONTRAINDICATIONS andWARNINGS). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Intrathecal or Epidural Administration
  • Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.
    • Labor, Delivery and Nursing
  • The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and the uterus.
  • The use of ketorolac tromethamine is CONTRAINDICATED in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
  • Concomitant Use With NSAIDs
  • Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving ASA or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
    • Dosage and Administration
  • Ketorolac Tromethamine Tablets
  • Ketorolac tromethamine tablets are indicated only as continuation therapy to Ketorolac Tromethamine Injection, and the combined duration of use of Ketorolac Tromethamine Injection and ketorolac tromethamine tablets is not to exceed five (5) days because of the increased risk of serious adverse events.
  • The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for Ketorolac Tromethamine Injection (maximum 120 mg) (seeDOSAGE AND ADMINISTRATION).
  • Special Populations
  • Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (seeDOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS). Doses of Ketorolac Tromethamine Injection are not to exceed 60 mg (total dose per day) in these patients.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ketorolac tromethamine (injection) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ketorolac tromethamine (injection) in the drug label.

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ketorolac tromethamine (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ketorolac tromethamine (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ketorolac tromethamine (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ketorolac tromethamine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ketorolac tromethamine (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ketorolac tromethamine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ketorolac tromethamine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ketorolac tromethamine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ketorolac tromethamine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ketorolac tromethamine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ketorolac tromethamine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Ketorolac tromethamine (injection) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Ketorolac tromethamine (injection) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Ketorolac tromethamine (injection) in the drug label.

Pharmacology

Template:Px
Template:Px
1 : 1 mixture (racemate)Ketorolac
Systematic (IUPAC) name
(±)-5-benzoyl-2,3-dihydro-<brF />1H-pyrrolizine-1-carboxylic acid,
2-amino-2-(hydroxymethyl)-1,3-propanediol
Identifiers
CAS number 74103-06-3
ATC code M01AB15 S01BC05 (WHO)
PubChem 3826
DrugBank DB00465
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 255.27 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 100% (All routes)
Metabolism Hepatic
Half life 3.5–9.2 hrs, young adults;
4.7–8.6 hrs, elderly (mean age 72)
Excretion Renal: 91.4% (mean)
Biliary: 6.1% (mean)
Therapeutic considerations
Licence data

US

Pregnancy cat.

C(AU) C(US)

Legal status

Prescription Only (S4)(AU) [[Prescription drug|Template:Unicode-only]](US)

Routes Oral, I.M., I.V.

Mechanism of Action

Structure

File:Ketorolac tromethamine (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ketorolac tromethamine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ketorolac tromethamine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ketorolac tromethamine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ketorolac tromethamine (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Ketorolac tromethamine (injection) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ketorolac tromethamine (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ketorolac tromethamine (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ketorolac tromethamine (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Ketorolac tromethamine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)




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