Ketorolac 30mg/ml Inj, 2ml

Manufacturer FRESENIUS KABI Active Ingredient Ketorolac Injection(KEE toe role ak) Pronunciation KEE toe role ak
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.This drug is only to be used for short-term pain (up to 5 days total). It may cause unsafe side effects if taken more than 5 days.Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of severe side effects.Do not take this drug for longer than you were told by your doctor.Do not take this drug if you have ulcer disease, very bad kidney problems or a risk for kidney problems because of low blood volume, or a high chance of bleeding or any active bleeding like bleeding in the brain.Tell your doctor if you are 65 years of age or older, you have kidney problems, or you weigh less than 110 pounds (50 kilograms).Do not take if you have ever had an allergic reaction to this drug, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.Do not take before surgery to prevent pain.Do not take with aspirin or other NSAIDs like ibuprofen or naproxen.Do not take if you are pregnant and in labor.This drug is not approved for use in children. Talk with the doctor. This drug must not be given into the spine. @ COMMON USES: It is used to manage pain.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Category C (1st and 2nd trimester); Category D (3rd trimester)
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FDA Approved
Jun 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ketorolac is a strong pain reliever that belongs to a group of medicines called NSAIDs. It works by reducing substances in the body that cause pain, fever, and inflammation. It is typically used for short-term, moderate to severe pain, often after surgery, and is given as an injection.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and follow all instructions provided. This medication is administered via injection into a muscle or vein.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Do not take other NSAIDs (like ibuprofen, naproxen, or aspirin) while using ketorolac, as this increases the risk of side effects.
  • Avoid alcohol, as it can increase the risk of stomach bleeding.
  • Inform your doctor about all other medications you are taking, especially blood thinners, diuretics, or blood pressure medications.
  • This medication is for short-term use only (maximum 5 days) to avoid serious side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Single dose: IM 60 mg or IV 30 mg. Multiple dose: IM/IV 30 mg every 6 hours (max 120 mg/day). Max duration of therapy (parenteral and oral combined) is 5 days.
Dose Range: 30 - 120 mg

Condition-Specific Dosing:

singleDoseIM: 60 mg
singleDoseIV: 30 mg
multipleDoseIM_IV: 30 mg q6h
maxDailyDose: 120 mg/day
maxDuration: 5 days (combined parenteral and oral)
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Pediatric Dosing

Neonatal: Not established (contraindicated in neonates due to risk of renal failure and premature closure of ductus arteriosus)
Infant: Not established (generally not recommended for children < 16 years)
Child: Not established (generally not recommended for children < 16 years)
Adolescent: Limited data; generally not recommended for children < 16 years. If used in adolescents â‰Ĩ16 years, adult dosing may apply with caution and strict adherence to duration limits.
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Dose Adjustments

Renal Impairment:

Mild: Reduce dose by half (e.g., 15 mg q6h, max 60 mg/day).
Moderate: Contraindicated (CrCl < 30 mL/min).
Severe: Contraindicated (CrCl < 30 mL/min).
Dialysis: Contraindicated (not significantly removed by dialysis).

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests.
Moderate: Use with caution; monitor liver function tests. Consider lower doses.
Severe: Contraindicated in patients with advanced liver disease or hepatic failure.

Pharmacology

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Mechanism of Action

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activity. Its mechanism of action is thought to be due to its ability to inhibit prostaglandin synthesis by competitively inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for converting arachidonic acid to prostaglandins.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IM/IV)
Tmax: IM: 45-50 minutes; IV: 1-3 minutes (for peak plasma concentration)
FoodEffect: Not applicable for injection

Distribution:

Vd: 0.15-0.3 L/kg
ProteinBinding: >99%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 5-6 hours (can be prolonged in elderly and renally impaired patients)
Clearance: 0.02-0.05 L/hr/kg
ExcretionRoute: Primarily renal (approximately 92%), with a small amount excreted in feces (approximately 6%).
Unchanged: Approximately 60% (renal)
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Pharmacodynamics

OnsetOfAction: IM: ~10 minutes; IV: ~30 minutes (for pain relief)
PeakEffect: IM: ~45-60 minutes; IV: ~1-3 minutes (for peak plasma levels, pain relief peak may be later)
DurationOfAction: 4-6 hours

Safety & Warnings

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BLACK BOX WARNING

Ketorolac tromethamine 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. It is not indicated for use in pediatric patients and it is not indicated for chronic use. Ketorolac can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. Ketorolac can cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Ketorolac is contraindicated for peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Ketorolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. Ketorolac can cause serious hypersensitivity reactions, including anaphylaxis, which can be fatal. Ketorolac inhibits platelet function and is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and in patients at high risk of bleeding. Concomitant use with aspirin or other NSAIDs is contraindicated. Concomitant use with probenecid or pentoxifylline is contraindicated.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that increase in size
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, including:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling faint
+ Numbness or tingling
+ Shortness of breath
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Chest pain or pressure
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Feeling extremely tired or weak
Liver problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Headache
Stomach pain or heartburn
* Upset stomach

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools, or vomiting blood (signs of stomach bleeding)
  • Swelling in your hands, feet, or ankles, or sudden weight gain (signs of kidney problems or fluid retention)
  • Decreased urination
  • Chest pain, shortness of breath, weakness on one side of the body, or slurred speech (signs of heart attack or stroke)
  • Yellowing of the skin or eyes (jaundice), dark urine, or unusual tiredness (signs of liver problems)
  • Severe skin rash, blistering, or peeling
  • Any signs of an allergic reaction, such as rash, hives, difficulty breathing, or swelling of the face/throat.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you have experienced nasal polyps, swelling of the mouth, face, lips, tongue, or throat, unusual hoarseness, or breathing difficulties after taking aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney disease
+ Ulcer disease
+ Recent heart attack
+ Heart failure (weak heart)
If you are having trouble conceiving or undergoing fertility testing.
Pregnancy or plans to become pregnant: This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

Additionally, inform your doctor about any medications you are taking, including:

Pemetrexed
Pentoxifylline
Probenecid
Salicylate drugs, such as aspirin
Other NSAIDs

This is not an exhaustive list of interacting medications or health conditions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be conducted as directed by your doctor to monitor your condition.

There is a risk of developing high blood pressure while taking this drug. Your doctor will advise you on how often to have your blood pressure checked. Additionally, you may experience easier bleeding, so it is crucial to be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.

If you have asthma, consult your doctor, as you may be more sensitive to this medication. It is also important to discuss alcohol consumption with your doctor before drinking. Furthermore, if you smoke, talk to your doctor about the potential risks.

The use of this medication may increase the risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization for heart failure, and death may be higher. Your doctor will discuss these risks with you in more detail. Moreover, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death while taking this medication. In fact, studies have shown that individuals taking this medication after a first heart attack were more likely to die within a year compared to those not taking this medication. Your doctor will help you understand these risks and make informed decisions.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur with this medication. These reactions can be life-threatening and may also affect internal organs. Seek immediate medical attention if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Nonsteroidal anti-inflammatory drugs (NSAIDs) like this medication may affect ovulation, which can impact fertility. However, this effect is reversible and typically returns to normal once the medication is stopped. Discuss any concerns about fertility with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and advise you on the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Nausea
  • Vomiting
  • Drowsiness
  • Lethargy
  • GI bleeding
  • Hypertension
  • Acute renal failure
  • Respiratory depression
  • Coma (rare)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. There is no specific antidote. Treatment is supportive and symptomatic, including gastric decontamination if ingestion occurred.

Drug Interactions

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Contraindicated Interactions

  • Other NSAIDs (e.g., ibuprofen, naproxen)
  • Aspirin
  • Anticoagulants (e.g., warfarin, heparin)
  • Pentoxifylline
  • Probenecid
  • Lithium (high dose)
  • Methotrexate (high dose)
  • Diuretics (e.g., furosemide, hydrochlorothiazide) in patients with renal impairment
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Major Interactions

  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Diuretics (e.g., furosemide, hydrochlorothiazide) - risk of renal impairment
  • Cyclosporine
  • Tacrolimus
  • SSRIs/SNRIs (e.g., fluoxetine, sertraline, venlafaxine) - increased risk of GI bleeding
  • Corticosteroids (e.g., prednisone) - increased risk of GI bleeding
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Moderate Interactions

  • Antidiabetics (e.g., insulin, sulfonylureas) - may alter glucose control
  • Digoxin - may increase digoxin levels
  • Phenytoin - may increase phenytoin levels
  • Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) - increased risk of seizures
  • Pemetrexed - increased risk of myelosuppression, renal, and GI toxicity
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Minor Interactions

  • Not available (most interactions are moderate to severe due to NSAID class effects)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To assess baseline kidney function, as ketorolac is primarily renally eliminated and can cause renal impairment.

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline liver function, as ketorolac is metabolized in the liver and can rarely cause liver injury.

Timing: Prior to initiation, especially in patients with suspected hepatic impairment.

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hemoglobin/hematocrit (for potential GI bleeding risk) and platelet count (for bleeding risk).

Timing: Prior to initiation, especially if prolonged use or high risk of bleeding.

Blood pressure

Rationale: NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Prior to initiation.

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Routine Monitoring

Renal function (BUN, serum creatinine)

Frequency: Daily for the duration of therapy (max 5 days), especially in elderly or those with risk factors for renal impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase in BUN/creatinine (e.g., >20% above baseline or above upper limit of normal) warrants dose reduction or discontinuation.

Signs and symptoms of GI bleeding (e.g., melena, hematemesis, severe abdominal pain)

Frequency: Daily patient assessment.

Target: Absence of symptoms.

Action Threshold: Any sign of GI bleeding requires immediate discontinuation and medical evaluation.

Fluid retention/edema, weight gain

Frequency: Daily patient assessment.

Target: Absence of symptoms.

Action Threshold: Significant edema or rapid weight gain warrants discontinuation and medical evaluation.

Blood pressure

Frequency: Daily, especially in hypertensive patients.

Target: Within target range.

Action Threshold: Significant increase in blood pressure warrants discontinuation or adjustment of antihypertensive therapy.

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Symptom Monitoring

  • Abdominal pain
  • Indigestion (dyspepsia)
  • Nausea
  • Vomiting
  • Black, tarry stools (melena)
  • Vomiting blood (hematemesis)
  • Unusual bruising or bleeding
  • Swelling of hands, feet, or ankles (edema)
  • Decreased urine output
  • Rash or itching
  • Shortness of breath
  • Chest pain
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Yellowing of skin or eyes (jaundice)

Special Patient Groups

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Pregnancy

Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use in the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential increased risk of miscarriage and cardiac malformations (limited evidence).
Second Trimester: Potential for fetal renal dysfunction and oligohydramnios (reduced amniotic fluid).
Third Trimester: Risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and fetal renal dysfunction. May inhibit uterine contractions and increase risk of maternal and fetal bleeding.
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Lactation

Ketorolac is excreted in human milk in low concentrations. Due to the potential for serious adverse reactions in breastfed infants (e.g., GI bleeding, renal dysfunction), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe) - Low levels in milk, but potential for adverse effects in infant, especially if prolonged use or high doses. Monitor infant for GI upset, bleeding, or decreased urine output.
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Pediatric Use

Generally not recommended for children under 16 years of age due to lack of adequate studies and increased risk of adverse effects, particularly renal impairment and GI bleeding. Contraindicated in neonates.

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Geriatric Use

Elderly patients (â‰Ĩ65 years) are at increased risk for serious adverse reactions, including GI bleeding, ulceration, perforation, renal impairment, and cardiovascular events. Lower doses and shorter duration of therapy are recommended. Monitor renal function closely.

Clinical Information

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Clinical Pearls

  • Ketorolac is a potent analgesic and should only be used for short-term (maximum 5 days) management of acute, moderately severe to severe pain.
  • It is NOT indicated for chronic pain management or for minor aches and pains.
  • The combined duration of parenteral and oral ketorolac should not exceed 5 days.
  • Always assess renal function before and during therapy, especially in elderly patients or those with pre-existing renal impairment.
  • Avoid concomitant use with other NSAIDs, aspirin, or anticoagulants due to increased risk of bleeding and GI/renal toxicity.
  • Not for use in obstetric analgesia or pre-operative use due to effects on platelet aggregation and potential for premature closure of ductus arteriosus.
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Alternative Therapies

  • Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac)
  • Opioid analgesics (e.g., morphine, hydromorphone, oxycodone) for severe pain
  • Acetaminophen (for mild to moderate pain)
  • Local anesthetics (e.g., lidocaine, bupivacaine)
  • Regional nerve blocks
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Cost & Coverage

Average Cost: Varies widely, typically $5-$20 per 30mg/ml, 2ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred, as this information is crucial for receiving appropriate care.