Ketorolac 0.5% Ophth Soln 5ml
It is used to treat eye irritation due to allergies.It is used to treat pain and other irritation after certain types of eye surgery.
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
Pregnancy Category
Category C
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac eye drops are a type of medicine called a nonsteroidal anti-inflammatory drug (NSAID). They work by reducing swelling, pain, and redness in your eyes. They are commonly used after eye surgery, like cataract surgery, or to relieve eye itching due to seasonal allergies.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal use:
Apply this medication only to the eye.
Wash your hands thoroughly before and after use.
Avoid wearing contact lenses while using this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to the eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
3. If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles - one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, protected from light.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal use:
Apply this medication only to the eye.
Wash your hands thoroughly before and after use.
Avoid wearing contact lenses while using this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to the eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
3. If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles - one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, protected from light.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after administering eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
- Store at room temperature, away from light and moisture.
- Do not use if the solution changes color or becomes cloudy.
- Discard the bottle 28 days after opening, even if some solution remains.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop to the affected eye(s) four times a day
Condition-Specific Dosing:
Postoperative Inflammation (Cataract Surgery):
1 drop to the affected eye(s) four times a day, starting 24 hours after surgery and continuing for up to 2 weeks.
Allergic Conjunctivitis (seasonal):
1 drop to the affected eye(s) four times a day for symptomatic relief.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients younger than 3 years of age. For children ≥3 years, dosing may be similar to adults for specific indications, but use with caution and under specialist guidance.)
Adolescent:
Dosing typically similar to adult dosing for approved indications.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory activity by inhibiting prostaglandin biosynthesis. It achieves this by inhibiting the cyclooxygenase (COX) enzymes (COX-1 and COX-2), which are responsible for converting arachidonic acid into prostaglandins. Prostaglandins are mediators of inflammation, pain, and fever. In the eye, prostaglandins are involved in the inflammatory response following trauma or surgery.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5% of topical dose)
Tmax:
Not clinically significant for systemic effects from ophthalmic administration; local ocular concentrations peak rapidly.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not clinically significant for systemic effects from ophthalmic administration.
ProteinBinding:
Approximately 99% (for systemically absorbed drug, but systemic absorption is minimal).
CnssPenetration:
Limited (not clinically relevant for ophthalmic use).
Elimination:
HalfLife:
Approximately 5-7 hours (for systemically absorbed drug, but systemic absorption is minimal).
Clearance:
Not clinically significant for systemic effects from ophthalmic administration.
ExcretionRoute:
Renal (for systemically absorbed drug).
Unchanged:
Not clinically significant for ophthalmic administration.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular dosing.
DurationOfAction:
Approximately 4-6 hours per dose.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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
Changes in eyesight, eye pain, or severe eye irritation
Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Blurred eyesight
Headache
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:
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
Changes in eyesight, eye pain, or severe eye irritation
Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Blurred eyesight
Headache
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain
- Sudden vision changes
- Signs of eye infection (e.g., pus, severe redness, swelling)
- Persistent or worsening eye irritation
- Corneal thinning or ulceration (rare, but serious)
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:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first 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. If you have an existing eye infection, have suffered an eye injury, or are scheduled to undergo eye surgery, be sure to notify your doctor. Additionally, if you experience an eye wound or irritation that does not heal, consult with your doctor promptly. When taking this medication, exercise caution when driving or engaging in activities that require clear vision. Do not exceed the prescribed duration of use, and only take the medication for the length of time specified by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. If accidentally ingested, symptoms would be similar to systemic NSAID overdose (e.g., nausea, vomiting, abdominal pain, drowsiness).
What to Do:
If accidental ingestion occurs, seek medical attention. For ocular overdose, flush the eye with lukewarm water. For systemic overdose, management is supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal complications)
- Topical corticosteroids (increased risk of corneal complications, e.g., corneal thinning, ulceration, perforation)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp exam)
Rationale: To establish baseline ocular health and assess the condition requiring treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular symptoms (pain, redness, irritation, blurred vision)
Frequency: Daily, or as advised by physician.
Target: Improvement or resolution of symptoms.
Action Threshold: Worsening symptoms, new symptoms, or lack of improvement may require re-evaluation.
Corneal integrity (e.g., signs of thinning, erosion, ulceration)
Frequency: Periodically, especially with prolonged use or in patients with pre-existing corneal disease.
Target: Intact cornea.
Action Threshold: Any signs of corneal compromise (e.g., persistent epithelial defect) require immediate discontinuation and ophthalmologic consultation.
Symptom Monitoring
- Eye pain
- Eye redness
- Eye irritation
- Blurred vision
- Photophobia
- Itching
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use in late pregnancy (third trimester) due to potential effects on fetal cardiovascular system (premature closure of ductus arteriosus) and inhibition of uterine contractions, similar to systemic NSAIDs, although systemic absorption from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of congenital malformations (low due to minimal systemic absorption).
Second Trimester:
Limited data, theoretical risk (low due to minimal systemic absorption).
Third Trimester:
Potential risk of premature closure of the fetal ductus arteriosus and inhibition of labor. Avoid use in the third trimester.
Lactation
L3 (Moderately safe). Ketorolac is excreted in human milk after systemic administration. While systemic absorption from ophthalmic use is minimal, caution should be exercised when administering to a nursing mother. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption, but theoretical risk of adverse effects on infant (e.g., gastrointestinal, renal) if significant amounts were absorbed.
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients younger than 3 years of age. Use in older children should be under the guidance of an ophthalmologist, typically for specific indications like postoperative inflammation. Risk of corneal complications may be higher in some pediatric populations.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required. However, elderly patients may be more susceptible to corneal complications, especially with prolonged use or pre-existing corneal disease.
Clinical Information
Clinical Pearls
- Ketorolac ophthalmic solution is primarily used for its anti-inflammatory and analgesic effects in the eye, particularly after surgery or for allergic conjunctivitis.
- Due to minimal systemic absorption, systemic side effects and drug interactions are rare with ophthalmic ketorolac.
- Patients should be advised to avoid wearing contact lenses during treatment, especially if they have ocular inflammation or after surgery.
- Prolonged use (beyond 2 weeks) or use in patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, recurrent erosions) may increase the risk of corneal adverse events, including thinning, erosion, ulceration, and perforation. Monitor these patients closely.
- If using multiple ophthalmic medications, administer them at least 5 minutes apart to ensure proper absorption.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., Bromfenac, Nepafenac, Diclofenac)
- Ophthalmic corticosteroids (e.g., Prednisolone, Dexamethasone - often used in combination or sequentially with NSAIDs for inflammation, but carry different side effect profiles like increased IOP and cataract risk)
- Topical antihistamines/mast cell stabilizers (for allergic conjunctivitis, e.g., Olopatadine, Azelastine)
- Topical decongestants (for symptomatic relief of redness, e.g., Naphazoline)
Cost & Coverage
Average Cost:
$30 - $100 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.