Ketorolac 0.4% Opth Soln5ml
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
Ophthalmic Anti-inflammatory Agent
Pharmacologic Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Cyclooxygenase Inhibitor
Pregnancy Category
C (D in 3rd trimester for systemic NSAIDs; minimal systemic absorption with ophthalmic use)
FDA Approved
Jan 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac eye drops are used to reduce pain and swelling in the eye, often after eye surgery like cataract removal. It works by blocking natural substances in your body that cause inflammation.
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, administer each medication at least 5 minutes apart.
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 this medication at room temperature, protected from light.
Keep all medications in a 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 the same time or take extra doses.
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, administer each medication at least 5 minutes apart.
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 this medication at room temperature, protected from light.
Keep all medications in a 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 the same time or take extra doses.
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 instilling drops and wait at least 15 minutes before reinserting them.
- Do not wear contact lenses if your eye is red or inflamed.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop (0.4%) to the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing for 2 weeks.
Dose Range:
0.4 - 0.4 mg
Condition-Specific Dosing:
post_cataract_surgery_inflammation_and_pain:
One drop (0.4%) to the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established in pediatric patients under 18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required 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 its effect by inhibiting the cyclooxygenase enzyme (COX-1 and COX-2), which is essential for the biosynthesis of prostaglandins from arachidonic acid. Prostaglandins are mediators of inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% of topical dose)
Tmax:
Ocular: Approximately 1-2 hours (aqueous humor concentration); Systemic: Not clinically relevant for ophthalmic use.
FoodEffect:
Not applicable for ophthalmic formulation.
Distribution:
Vd:
Not clinically relevant for ophthalmic use due to minimal systemic absorption.
ProteinBinding:
Not clinically relevant for ophthalmic use (systemic: >99% bound to plasma proteins).
CnssPenetration:
Limited/Negligible (for ophthalmic use).
Elimination:
HalfLife:
Systemic: Approximately 5-7 hours (for systemically absorbed portion).
Clearance:
Not clinically relevant for ophthalmic use.
ExcretionRoute:
Renal (for systemically absorbed portion).
Unchanged:
Not clinically relevant for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular dosing for maximal anti-inflammatory effect.
DurationOfAction:
Approximately 12 hours (with BID dosing).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, this medication can cause severe and potentially life-threatening side effects. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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 is not an exhaustive list of potential side effects. 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, this medication can cause severe and potentially life-threatening side effects. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:
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 is not an exhaustive list of potential side effects. 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 or discomfort that worsens
- Sudden vision changes or loss of vision
- Signs of eye infection (e.g., pus, discharge, severe redness, swelling)
- Persistent or worsening eye irritation
- Allergic reaction symptoms (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 identify potential interactions between this medication and other substances.
* 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 identify potential interactions between this medication and other substances.
* 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 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, and only take the medication for the length of time advised 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 determine the best course of action 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, contact a poison control center immediately (e.g., 1-800-222-1222). For ocular overdose, flush the eye with lukewarm water.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of adverse effects)
- Topical corticosteroids (potential to mask signs of infection or delay healing)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp exam)
Rationale: To assess baseline ocular health and inflammation prior to treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular examination (visual acuity, slit lamp exam)
Frequency: As clinically indicated, typically at follow-up visits post-surgery.
Target: Improvement in inflammation and pain.
Action Threshold: Lack of improvement, worsening symptoms, or development of new adverse effects.
Intraocular pressure (IOP)
Frequency: As clinically indicated, especially in post-operative period.
Target: Normal range for patient.
Action Threshold: Significant increase in IOP.
Symptom Monitoring
- Eye pain
- Eye redness
- Photophobia
- Blurred vision
- Ocular irritation or discomfort
- Signs of infection (e.g., discharge, severe pain, worsening redness)
Special Patient Groups
Pregnancy
Use with caution. While systemic absorption is minimal, NSAIDs are generally avoided in late pregnancy (third trimester) due to the risk of premature closure of the fetal ductus arteriosus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk, but use only if clearly needed.
Second Trimester:
Low risk, but use only if clearly needed.
Third Trimester:
Avoid due to potential risk of premature closure of the fetal ductus arteriosus and inhibition of uterine contractions.
Lactation
Considered low risk. Minimal systemic absorption means very little drug is expected to pass into breast milk. Use with caution and monitor infant for adverse effects.
Infant Risk:
Low
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended in this population.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Ketorolac 0.4% (Acuvail) is specifically approved for post-operative pain and inflammation following cataract surgery, typically dosed BID.
- Other concentrations (e.g., 0.5%) may have different indications and dosing frequencies (e.g., QID for allergic conjunctivitis or general post-op inflammation). Ensure correct concentration and dosing for the specific product.
- Patients should be advised to avoid wearing contact lenses during treatment, especially if the eye is inflamed or infected.
- While systemic side effects are rare due to minimal absorption, patients should be monitored for ocular adverse effects such as irritation, stinging, or corneal issues.
- Prolonged use of topical NSAIDs may increase the risk of corneal adverse events, including corneal thinning, erosion, ulceration, or perforation, especially in patients with compromised corneas or other risk factors.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, nepafenac, diclofenac)
- Ophthalmic corticosteroids (e.g., prednisolone acetate, dexamethasone)
- Combination ophthalmic products (e.g., antibiotic/corticosteroid combinations)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 this medication, don't hesitate to discuss them with your doctor, nurse, 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.