Ketorolac 10mg Tablets
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. @ COMMON USES: It is used to manage pain.
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic
Pharmacologic Class
Cyclooxygenase (COX) inhibitor
Pregnancy Category
Category C (1st/2nd trimester), Category D (3rd trimester)
FDA Approved
Sep 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac is a strong pain reliever that belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). It works by reducing substances in the body that cause pain, fever, and inflammation. It's typically used for short-term management of moderately severe acute pain, often after surgery, and should not be used for more than 5 days due to serious risks.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Take ketorolac with food or milk to reduce stomach upset.
- Do not take more than the prescribed dose or for longer than 5 days.
- Avoid alcohol while taking ketorolac, as it can increase the risk of stomach bleeding.
- Avoid taking other NSAIDs (like ibuprofen, naproxen, aspirin) or aspirin-containing products while on ketorolac, unless directed by your doctor.
- Stay well-hydrated, especially if you are elderly or have kidney problems.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally every 4 to 6 hours as needed for pain, not to exceed 40 mg in 24 hours. Maximum duration of treatment is 5 days.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
post-operative pain:
Initial dose of 20 mg orally once, followed by 10 mg every 4 to 6 hours as needed, not to exceed 40 mg/day. Max 5 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children <17 years for oral use)
Adolescent:
Not established (generally not recommended for children <17 years for oral use)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider lower doses and monitor renal function.
Moderate:
Contraindicated in patients with moderate to severe renal impairment (serum creatinine >1.9 mg/dL or creatinine clearance <30 mL/min).
Severe:
Contraindicated.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; consider lower doses and monitor liver function. Contraindicated in patients with advanced liver disease.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activity. Its primary mechanism of action is the inhibition of prostaglandin synthesis by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandin precursors, which are involved in pain, inflammation, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 1 hour
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
0.11 to 0.3 L/kg
ProteinBinding:
Greater than 99%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 4 to 6 hours (increases with renal impairment)
Clearance:
0.02 to 0.05 L/hr/kg
ExcretionRoute:
Renal (approximately 91%), Fecal (approximately 6%)
Unchanged:
Approximately 60% (renal)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
1 to 2 hours
DurationOfAction:
4 to 6 hours
Safety & Warnings
BLACK BOX WARNING
Ketorolac has multiple Black Box Warnings:
1. **Gastrointestinal Risk**: NSAIDs, including ketorolac, cause an increased risk of 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.
2. **Cardiovascular Thrombotic Events**: NSAIDs, including ketorolac, cause an increased risk of serious cardiovascular 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 the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
3. **Renal Risk**: Ketorolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
4. **Bleeding Risk**: Ketorolac inhibits platelet function and is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or at high risk of bleeding.
5. **Hypersensitivity Reactions**: Anaphylactoid reactions may occur in patients without known prior exposure to ketorolac. Ketorolac is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs.
6. **Labor and Delivery**: Use of ketorolac is not recommended in labor and delivery because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), and the potential to inhibit uterine contractions and increase the risk of bleeding.
7. **Concomitant Use**: Concomitant use with other NSAIDs or aspirin is contraindicated.
8. **Duration of Use**: Oral ketorolac is indicated only as continuation treatment following IV or IM ketorolac, and the total combined duration of use of ketorolac (parenteral and oral) should not exceed 5 days.
1. **Gastrointestinal Risk**: NSAIDs, including ketorolac, cause an increased risk of 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.
2. **Cardiovascular Thrombotic Events**: NSAIDs, including ketorolac, cause an increased risk of serious cardiovascular 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 the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
3. **Renal Risk**: Ketorolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
4. **Bleeding Risk**: Ketorolac inhibits platelet function and is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or at high risk of bleeding.
5. **Hypersensitivity Reactions**: Anaphylactoid reactions may occur in patients without known prior exposure to ketorolac. Ketorolac is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs.
6. **Labor and Delivery**: Use of ketorolac is not recommended in labor and delivery because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), and the potential to inhibit uterine contractions and increase the risk of bleeding.
7. **Concomitant Use**: Concomitant use with other NSAIDs or aspirin is contraindicated.
8. **Duration of Use**: Oral ketorolac is indicated only as continuation treatment following IV or IM ketorolac, and the total combined duration of use of ketorolac (parenteral and oral) should not exceed 5 days.
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 enlarge
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden significant 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 or 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 significant weight gain
Swelling in the arms or legs
Feeling extremely tired or weak
Liver Problems: A Rare but Serious Side Effect
In rare cases, medications like this one can cause liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or 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 enlarge
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden significant 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 or 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 significant weight gain
Swelling in the arms or legs
Feeling extremely tired or weak
Liver Problems: A Rare but Serious Side Effect
In rare cases, medications like this one can cause liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Dark urine
Fatigue
Decreased appetite
Upset stomach 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, black or tarry stools, vomiting blood or material that looks like coffee grounds (signs of stomach bleeding)
- Chest pain, shortness of breath, weakness on one side of the body, slurred speech (signs of heart attack or stroke)
- Swelling in your hands, ankles, or feet, sudden weight gain (signs of kidney problems or fluid retention)
- Yellowing of the skin or eyes, dark urine, unusual tiredness (signs of liver problems)
- Rash, hives, difficulty breathing, swelling of the face/lips/tongue/throat (signs of a severe allergic reaction)
- Unusual bruising or bleeding that doesn't stop
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, 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 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 evaluation.
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. It is essential to disclose all your prescription and over-the-counter (OTC) medications, natural products, and vitamins to your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is crucial to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, 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 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 evaluation.
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. It is essential to disclose all your prescription and over-the-counter (OTC) medications, natural products, and vitamins to your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly monitor your blood work and other laboratory tests as directed by your doctor.
Be aware that medications like this one can cause high blood pressure. Therefore, it is crucial to have your blood pressure checked as advised by your doctor. Additionally, you may experience easier bleeding, so it is recommended to exercise caution and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.
If you have asthma, consult with 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 medications like this one can increase the risk of heart failure. In individuals who already have heart failure, the risk of heart attack, hospitalization for heart failure, and death is also increased. It is vital to discuss these risks with your doctor. Moreover, people taking medications like this one after a recent heart attack are at a higher risk of heart attack and heart-related death. In fact, studies have shown that individuals taking these medications after a first heart attack were more likely to die within a year compared to those not taking these medications. Therefore, it is crucial to discuss these risks with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. In some cases, these reactions can affect internal organs and be life-threatening. 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 any areas of 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 one can affect ovulation, which may impact fertility. However, this effect is reversible and typically returns to normal once the medication is stopped. It is essential to discuss this with your doctor. If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Be aware that medications like this one can cause high blood pressure. Therefore, it is crucial to have your blood pressure checked as advised by your doctor. Additionally, you may experience easier bleeding, so it is recommended to exercise caution and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.
If you have asthma, consult with 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 medications like this one can increase the risk of heart failure. In individuals who already have heart failure, the risk of heart attack, hospitalization for heart failure, and death is also increased. It is vital to discuss these risks with your doctor. Moreover, people taking medications like this one after a recent heart attack are at a higher risk of heart attack and heart-related death. In fact, studies have shown that individuals taking these medications after a first heart attack were more likely to die within a year compared to those not taking these medications. Therefore, it is crucial to discuss these risks with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. In some cases, these reactions can affect internal organs and be life-threatening. 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 any areas of 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 one can affect ovulation, which may impact fertility. However, this effect is reversible and typically returns to normal once the medication is stopped. It is essential to discuss this with your doctor. If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe stomach pain
- Nausea
- Vomiting
- Drowsiness
- Lethargy
- Blurred vision
- Dizziness
- Headache
- Tinnitus (ringing in ears)
- Acute renal failure
- Respiratory depression
- Coma (rare)
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent and significant.
Drug Interactions
Contraindicated Interactions
- Other NSAIDs (increased risk of GI adverse events)
- Aspirin (increased risk of GI adverse events)
- Pentoxifylline (increased risk of bleeding)
- Probenecid (increased ketorolac levels)
- Lithium (increased lithium levels and toxicity)
- Methotrexate (increased methotrexate levels and toxicity)
- Anticoagulants (e.g., warfarin, heparin, dabigatran) (increased risk of bleeding)
- Antiplatelet agents (e.g., clopidogrel) (increased risk of bleeding)
- SSRIs/SNRIs (increased risk of GI bleeding)
Major Interactions
- ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
- Diuretics (e.g., furosemide, hydrochlorothiazide) (reduced diuretic effect, increased risk of renal impairment)
- Corticosteroids (increased risk of GI ulceration/bleeding)
- Cyclosporine (increased risk of nephrotoxicity)
- Tacrolimus (increased risk of nephrotoxicity)
- Digoxin (increased digoxin levels)
- Phenytoin (increased phenytoin levels)
Moderate Interactions
- Oral hypoglycemics (potential for altered glucose control)
- Quinolone antibiotics (increased risk of CNS stimulation/seizures)
- Cholestyramine (reduced ketorolac absorption)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To assess for baseline anemia or other hematologic abnormalities, and to monitor for potential GI bleeding or other hematologic adverse effects.
Timing: Prior to initiation of therapy.
Renal Function (Serum Creatinine, BUN, eGFR)
Rationale: To assess baseline kidney function, as ketorolac is primarily renally eliminated and can cause acute kidney injury.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: To assess baseline liver function, as ketorolac can cause elevated liver enzymes.
Timing: Prior to initiation of therapy.
Blood Pressure (BP)
Rationale: To establish baseline and monitor for potential hypertension or worsening of existing hypertension.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs/Symptoms of GI Bleeding (e.g., melena, hematemesis, severe abdominal pain)
Frequency: Daily, throughout therapy
Target: Absence of symptoms
Action Threshold: Immediately discontinue drug and seek medical attention if symptoms occur.
Renal Function (Serum Creatinine, BUN)
Frequency: Not routinely recommended for short-term use (max 5 days) in patients with normal baseline renal function. Monitor if risk factors for renal impairment are present (e.g., dehydration, heart failure, concomitant nephrotoxic drugs).
Target: Within patient's baseline range
Action Threshold: Significant increase in creatinine or decrease in urine output; discontinue drug.
Blood Pressure (BP)
Frequency: Daily, especially in patients with hypertension or cardiovascular risk factors.
Target: Within target range for patient
Action Threshold: Significant increase in BP; consider drug discontinuation or adjustment.
Signs/Symptoms of Fluid Retention/Edema
Frequency: Daily, throughout therapy
Target: Absence of symptoms
Action Threshold: Development of significant edema or weight gain; discontinue drug.
Symptom Monitoring
- Abdominal pain
- Indigestion
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Heartburn
- Black, tarry stools
- Vomiting blood or coffee-ground like material
- Unusual bruising or bleeding
- Rash or itching
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Chest pain
- Shortness of breath
- Weakness or numbness on one side of the body
- Slurred speech
- Sudden severe headache
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual fatigue
- Flu-like symptoms
Special Patient Groups
Pregnancy
Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and inhibition of uterine contractions. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest possible duration.
Trimester-Specific Risks:
First Trimester:
Category C; potential for increased risk of miscarriage and cardiac malformations (limited data).
Second Trimester:
Category C; potential for oligohydramnios and fetal renal dysfunction (rare).
Third Trimester:
Category D; risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, renal dysfunction, and inhibition of labor.
Lactation
Ketorolac is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants (e.g., GI bleeding, renal effects), 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. Generally rated L3 (moderately safe) by LactMed, but caution is advised, especially with prolonged use or in preterm infants.
Infant Risk:
Low to moderate risk; potential for GI upset, bleeding, or renal effects in the infant. Monitor infant for adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients under 17 years of age have not been established for oral use. Oral ketorolac is generally not recommended for this population due to lack of data and potential for serious adverse effects.
Geriatric Use
Elderly patients (65 years and older) are at increased risk for serious adverse reactions, especially GI bleeding, cardiovascular events, and renal impairment. Use the lowest effective dose for the shortest possible duration. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Ketorolac oral is intended for short-term (up to 5 days total for combined parenteral and oral) management of moderately severe acute pain, typically as a continuation of IV/IM therapy.
- It is NOT indicated for chronic pain management or for minor aches and pains.
- Always take with food or milk to minimize GI upset.
- Patients should be educated on the serious risks of GI bleeding, cardiovascular events, and kidney problems, and advised to seek immediate medical attention for warning signs.
- Avoid concomitant use with other NSAIDs, aspirin, anticoagulants, or antiplatelet agents due to increased risk of bleeding and other adverse effects.
- Ensure adequate hydration, especially in patients at risk for renal impairment.
Alternative Therapies
- Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
- Acetaminophen
- Opioid analgesics (for severe pain, short-term)
- Tramadol
- Local anesthetics (e.g., lidocaine patches, nerve blocks)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.