Ketorolac 30mg/ml Inj, 1ml

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activity. Its primary mechanism of action is believed to be through the inhibition of prostaglandin synthesis by competitively inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition reduces the formation of prostaglandin precursors, which are involved in pain, inflammation, and fever.

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, such as:
+ 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, such as:
+ 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, 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.

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 evaluation.
Pregnancy, planned pregnancy, or pregnancy during treatment. 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 other medications you are taking, including:

Pemetrexed
Pentoxifylline
Probenecid
Salicylate drugs, such as aspirin
Other NSAIDs

It is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. This will help your doctor and pharmacist determine whether it is safe to take this medication with your other treatments. Never start, stop, or change the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood work and other laboratory tests as instructed 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 directed by your doctor. Additionally, you may experience easier bleeding, so it is vital 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 with your doctor, as you may be more sensitive to this medication. Before consuming alcohol, discuss the potential risks with your doctor. Similarly, if you smoke, talk to your doctor about the possible interactions.

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 elevated. It is crucial to discuss these risks with your doctor. Furthermore, 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 them. Therefore, it is essential to have an open discussion with your doctor about these potential risks.

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 ovulation typically returns to normal once the medication is stopped. If you are trying to conceive, discuss the potential risks with your doctor.

Finally, if you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Other NSAIDs (increased risk of GI adverse events)
• Aspirin (increased risk of GI adverse events and bleeding)
• Probenecid (decreased ketorolac clearance, increased levels)
• Pentoxifylline (increased risk of bleeding)
• Lithium (increased lithium levels and toxicity)
• Methotrexate (increased methotrexate levels and toxicity)
• Anticoagulants (e.g., warfarin, heparin) (increased risk of bleeding)
• Antiplatelet agents (e.g., clopidogrel) (increased risk of bleeding)
• SSRIs/SNRIs (increased risk of GI bleeding)

• ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
• Diuretics (reduced diuretic and antihypertensive 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)
• Hydantoins (e.g., phenytoin) (increased hydantoin levels)
• Sulfonylureas (increased risk of hypoglycemia)

• Quinolone antibiotics (increased risk of CNS stimulation/seizures)
• Selective serotonin reuptake inhibitors (SSRIs) (increased risk of GI bleeding)
• Alcohol (increased risk of GI irritation/bleeding)

• Not available

• Abdominal pain
• Indigestion
• Nausea
• Vomiting
• Black, tarry stools (melena)
• Vomiting blood (hematemesis)
• Unusual bruising or bleeding
• Swelling of ankles, feet, or hands (edema)
• Shortness of breath
• Chest pain
• Weakness or numbness on one side of the body
• Slurred speech
• Changes in urination (decreased output)
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Flu-like symptoms (fever, rash, fatigue)

Avoid use during pregnancy, especially in the third trimester due to potential for premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Use in the first and second trimesters only if the potential benefit justifies the potential risk to the fetus.

Ketorolac is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, 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. Short-term use may be acceptable with close infant monitoring.

Safety and efficacy have not been established in pediatric patients under 17 years of age. Use is generally not recommended in this population due to lack of data and potential for serious adverse effects.

Elderly patients (≥65 years) are at increased risk for serious adverse reactions, especially GI bleeding, renal impairment, and cardiovascular events. Lower doses (15 mg IV/IM every 6 hours, max 60 mg/day) are recommended, and the duration of therapy should be as short as possible.

• Ketorolac is a potent analgesic, often used as an opioid-sparing agent for acute pain.
• Strictly adhere to the maximum 5-day duration of therapy due to the high risk of serious adverse events, particularly GI and renal.
• Always assess renal function before and during therapy, especially in at-risk patients.
• Avoid concomitant use with other NSAIDs, aspirin, or anticoagulants due to increased bleeding risk.
• Not for chronic pain management.
• Consider the patient's cardiovascular risk factors before initiating therapy.
• Ensure adequate hydration to minimize renal toxicity.

• Opioid analgesics (e.g., morphine, hydromorphone, oxycodone)
• Acetaminophen (IV, oral)
• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib - typically oral or rectal)
• Local anesthetics (e.g., lidocaine, bupivacaine - for regional blocks)
• Tramadol

If your symptoms or health issues persist or worsen, it is 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.