Ketorolac 15mg/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 the inhibition of prostaglandin synthesis by reversibly inhibiting 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 immediately or seek emergency 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, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Shortness of breath, significant weight gain, or 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 use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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 medications, such as aspirin
Other NSAIDs

It is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems. Your doctor and pharmacist will help you determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose 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 monitor your 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 recommended to take precautions to avoid injury, such as using 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. 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 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.

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

• Other NSAIDs (including aspirin)
• Pentoxifylline
• Probenecid
• Methotrexate (high dose)
• Lithium
• Anticoagulants (e.g., warfarin, heparin) due to increased bleeding risk
• Renal impairment (moderate to severe)
• Active peptic ulcer disease
• Recent GI bleeding or perforation
• Advanced renal disease
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• ACE inhibitors/ARBs (increased risk of renal impairment)
• Diuretics (furosemide, hydrochlorothiazide - reduced natriuretic effect)
• Corticosteroids (increased GI risk)
• SSRIs/SNRIs (increased bleeding risk)
• Antiplatelet agents (e.g., clopidogrel - increased bleeding risk)
• Cyclosporine (increased nephrotoxicity)
• Tacrolimus (increased nephrotoxicity)

• Digoxin (increased plasma levels)
• Phenytoin (increased plasma levels)
• Sulfonylureas (potential for hypoglycemia)
• Quinolone antibiotics (increased risk of CNS stimulation/seizures)

• Not available

• Signs of GI bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of renal dysfunction (decreased urine output, edema, fatigue)
• Signs of liver injury (jaundice, dark urine, persistent nausea/vomiting, abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body)
• Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
• Unusual bruising or bleeding

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

Safety and efficacy have not been established in pediatric patients under 17 years of age. Use is generally not recommended.

Elderly patients are at increased risk for serious adverse reactions (GI bleeding, renal toxicity, cardiovascular events). Use the lowest effective dose for the shortest duration possible. Dose reduction is recommended (max 60 mg/day).

• Ketorolac is intended for short-term (up to 5 days total) management of moderately severe acute pain requiring opioid-level analgesia.
• It is NOT indicated for chronic pain management.
• The maximum daily dose for adults is 120 mg (or 60 mg for elderly, renally impaired, or <50 kg patients).
• Transition from parenteral to oral ketorolac should be done as soon as possible, and the combined duration should not exceed 5 days.
• Always assess renal function before and during therapy, especially in at-risk patients.
• Avoid concomitant use with other NSAIDs, including over-the-counter products.
• Educate patients on signs of serious adverse events, especially GI bleeding and cardiovascular issues.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib - for less severe pain or longer duration)
• Opioid analgesics (e.g., morphine, hydromorphone, oxycodone - for severe pain, but with different side effect profile and abuse potential)
• Acetaminophen (for mild to moderate pain, antipyretic)
• Regional anesthesia/nerve blocks
• Non-pharmacological pain management (e.g., ice, heat, physical therapy)

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 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.