Ketorolac 0.5% Ophth Soln 10ml
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 Inhibitor
Pregnancy Category
Category C
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac eye drops are used to reduce pain, swelling, and inflammation in the eye, often after eye surgery or for certain eye conditions like allergic conjunctivitis.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Avoid wearing contact lenses while using this medication.
3. To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
4. Tilt your head back and gently drop the medication into your eye.
5. If you are using multiple medications in the same eye, administer each one at least 5 minutes apart.
6. 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 this medication at room temperature, protected from light. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use 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 the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Avoid wearing contact lenses while using this medication.
3. To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
4. Tilt your head back and gently drop the medication into your eye.
5. If you are using multiple medications in the same eye, administer each one at least 5 minutes apart.
6. 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 this medication at room temperature, protected from light. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use 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 the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them, unless otherwise advised by your doctor.
- If using other eye drops, wait at least 5 minutes between applications.
- Store at room temperature, away from light and moisture.
- Do not use if the solution changes color or becomes cloudy.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop to the affected eye(s) four times a day
Condition-Specific Dosing:
post-operative inflammation:
One drop to the affected eye(s) four times a day, starting 24 hours after surgery and continuing for up to 2 weeks.
allergic conjunctivitis:
One drop to the affected eye(s) four times a day for symptomatic relief.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established in pediatric patients under 2 years of age. Use in children 2 years and older is generally one drop four times a day, similar to adults, but should be based on clinical judgment.
Adolescent:
One drop to the affected eye(s) four times a day.
Dose Adjustments
Renal Impairment:
Mild:
Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate:
Not typically required for ophthalmic use due to minimal systemic absorption.
Severe:
Not typically required for ophthalmic use due to minimal systemic absorption.
Dialysis:
Not typically required for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate:
Not typically required for ophthalmic use due to minimal systemic absorption.
Severe:
Not typically required for ophthalmic use due to 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, potent mediators of inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%)
Tmax:
Not precisely quantified for ophthalmic systemic absorption, but local ocular concentrations peak within hours.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not available (primarily local ocular distribution)
ProteinBinding:
Not available (primarily local ocular distribution)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantified for ophthalmic systemic elimination (systemic half-life of oral ketorolac is 4-6 hours)
Clearance:
Not precisely quantified for ophthalmic systemic elimination
ExcretionRoute:
Not precisely quantified for ophthalmic systemic elimination (systemic excretion is primarily renal)
Unchanged:
Not precisely quantified for ophthalmic systemic elimination
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours for anti-inflammatory effect
PeakEffect:
Approximately 2-6 hours
DurationOfAction:
Approximately 4-8 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Eye irritation
Blurred eyesight
Headache
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 for medical advice. 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. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Eye irritation
Blurred eyesight
Headache
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 for medical advice. 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, increased discharge)
- Persistent or worsening eye irritation or discomfort
- Swelling of the eyelids
- Sensitivity to light
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, 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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, 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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 a current 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 performing tasks that require clear vision. Do not exceed the prescribed duration of use, as directed 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 decision for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local symptoms might include increased eye irritation, redness, or stinging.
What to Do:
If accidental ingestion occurs or if severe local irritation develops, rinse the eye with lukewarm water. Contact a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or persistent.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal adverse events)
- Topical corticosteroids (potential for delayed corneal healing)
Monitoring
Baseline Monitoring
Ocular examination
Rationale: To assess baseline ocular health and inflammation.
Timing: Prior to initiation of therapy.
Intraocular pressure (IOP)
Rationale: If used in conjunction with corticosteroids or in patients at risk for IOP elevation.
Timing: Prior to initiation and periodically during therapy if indicated.
Routine Monitoring
Ocular examination (e.g., slit lamp)
Frequency: Periodically, especially if therapy is prolonged or adverse effects are suspected.
Target: Resolution of inflammation, absence of corneal complications.
Action Threshold: Worsening inflammation, new or worsening corneal defects, signs of infection.
Patient reported symptoms (pain, discomfort, vision)
Frequency: Daily
Target: Improvement or resolution of symptoms.
Action Threshold: Persistent or worsening pain, significant vision changes, severe irritation.
Symptom Monitoring
- Eye pain
- Ocular redness
- Blurred vision
- Eye irritation
- Stinging/burning upon instillation
- Corneal changes (e.g., infiltrates, thinning, erosion)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use during late pregnancy (third trimester) due to potential for premature closure of the fetal ductus arteriosus, a known risk with systemic NSAIDs.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of NSAID-related effects.
Second Trimester:
Limited data, theoretical risk of NSAID-related effects.
Third Trimester:
Avoid use due to potential for premature closure of the fetal ductus arteriosus and inhibition of uterine contractions.
Lactation
Lactation Risk L3 (Moderately Safe). Minimal systemic absorption suggests low infant exposure. Use with caution, weighing potential benefits to the mother against potential risks to the infant.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption.
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients younger than 2 years of age. Use in children 2 years and older should be carefully considered and based on clinical judgment.
Geriatric Use
No specific dose adjustment is typically required for geriatric patients. However, elderly patients may be more susceptible to adverse effects, particularly if there is underlying corneal disease or concomitant use of other medications that may affect corneal healing.
Clinical Information
Clinical Pearls
- Ketorolac ophthalmic solution is effective for reducing ocular pain and inflammation, particularly after cataract surgery.
- It can cause transient stinging or burning upon instillation.
- Patients should be advised to avoid wearing contact lenses during treatment, especially if they have ocular inflammation or corneal defects.
- Prolonged use of topical NSAIDs, including ketorolac, may increase the risk of corneal adverse events, including corneal thinning, erosion, ulceration, and perforation, especially in patients with pre-existing corneal disease or those undergoing multiple ocular surgeries.
- It is also used off-label for pain and inflammation associated with corneal abrasions or other ocular surface conditions.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, diclofenac, nepafenac)
- Ophthalmic corticosteroids (e.g., prednisolone, dexamethasone) for more severe inflammation (note: different mechanism, different side effect profile)
- Topical antihistamines/mast cell stabilizers for allergic conjunctivitis (e.g., olopatadine, azelastine)
Cost & Coverage
Average Cost:
Varies significantly by pharmacy and insurer per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or Tier 2 for generic formulations on most prescription drug plans.
General Drug Facts
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. Some medications may come with an additional patient information leaflet, so it's a good idea 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.