Ketorolac 60mg/2ml Inj, 2ml

Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activity. Its mechanism of action, like that of other NSAIDs, is believed to be primarily due to the inhibition of prostaglandin synthesis via the non-selective inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This 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
+ 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 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 weight gain
Swelling in the arms or legs
Feeling extremely tired or weak
Liver problems, which can be life-threatening. Seek medical help immediately if you experience:
+ 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

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.
A history of nasal polyps or 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)
Fertility issues or ongoing 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 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. Therefore, 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 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 check your blood work and other lab tests as instructed by your doctor.

Be aware that high blood pressure is a potential side effect of this medication. Monitor your blood pressure as directed by your doctor to ensure it remains within a healthy range.

This medication may increase your risk of bleeding easily. To minimize this risk, be cautious and avoid injury. Use a soft toothbrush and an electric razor to reduce the likelihood of bleeding.

If you have asthma, consult with your doctor before taking this medication, as you may be more sensitive to its effects.

Before consuming alcohol, discuss the potential risks with your doctor. Additionally, if you smoke, talk to your doctor about the potential interactions between smoking and this medication.

The use of this medication may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor to determine the best course of treatment.

People who have recently experienced a heart attack may have a higher risk of heart attack and heart-related death when taking this medication. Furthermore, individuals taking this medication after a first heart attack may be more likely to die within the year following the heart attack compared to those not taking this medication. Consult with your doctor to understand these risks and determine the best treatment plan.

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 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, 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)
• Anticoagulants (e.g., warfarin, heparin) - increased bleeding risk
• Pentoxifylline (increased bleeding risk)
• Probenecid (decreased ketorolac clearance, increased levels)
• Lithium (increased lithium levels and toxicity)
• Methotrexate (increased methotrexate levels and toxicity)
• Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced natriuretic effect, increased risk of renal impairment
• ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
• Corticosteroids (increased risk of GI ulceration/bleeding)
• SSRIs/SNRIs (increased risk of GI bleeding)

• Cyclosporine (increased risk of nephrotoxicity)
• Tacrolimus (increased risk of nephrotoxicity)
• Antiplatelet agents (e.g., clopidogrel) - increased bleeding risk
• Pemetrexed (increased pemetrexed levels and toxicity)

• Beta-blockers (reduced antihypertensive effect)
• Hydantoins (e.g., phenytoin) - increased hydantoin levels
• Sulfonylureas (increased hypoglycemic effect)
• Quinolone antibiotics (increased risk of CNS stimulation/seizures)

• Not specifically categorized as minor for Ketorolac due to its potent nature and significant interaction profile.

• Abdominal pain
• Indigestion/heartburn
• Nausea/vomiting
• Unusual bruising or bleeding
• Black, tarry stools or blood in vomit
• Swelling of hands or feet (edema)
• Decreased urine output
• Unexplained weight gain
• Shortness of breath
• Chest pain
• Weakness or numbness on one side of the body
• Slurred speech
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Flu-like symptoms

Contraindicated in the third trimester due to risk of premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Use in first and second trimesters only if potential benefit justifies 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.

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

Use with caution. Elderly patients are at increased risk for serious adverse reactions (GI bleeding, renal impairment, cardiovascular events). Lower doses (e.g., 15 mg IV/IM every 6 hours, max 60 mg/day) and shorter duration are recommended. Monitor renal function closely.

• Ketorolac is a potent NSAID intended for short-term (maximum 5 days) management of moderately severe acute pain, often as an opioid-sparing agent.
• Always assess renal function before initiating ketorolac, especially in elderly or patients with pre-existing renal impairment, dehydration, or heart failure.
• The 5-day maximum duration applies to the *total* combined parenteral and oral use.
• Avoid concomitant use with other NSAIDs, aspirin, anticoagulants, or antiplatelet agents due to increased risk of bleeding.
• Consider the patient's cardiovascular risk factors before prescribing, as NSAIDs carry a risk of thrombotic events.
• Not recommended for chronic pain management.
• Ensure adequate hydration to minimize renal adverse effects.

• Opioid analgesics (e.g., morphine, hydromorphone, oxycodone) for severe acute pain.
• Other NSAIDs (e.g., ibuprofen, naproxen, diclofenac) for less severe pain or longer-term use (with different risk profiles).
• Acetaminophen (paracetamol) for mild to moderate pain and fever.
• Local anesthetics (e.g., lidocaine, bupivacaine) for regional pain control.
• Gabapentin/Pregabalin (for neuropathic pain components).
• Non-pharmacological pain management (e.g., RICE, physical therapy, TENS).

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 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 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.