Acular 0.5% Ophth Solution 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
Ophthalmic anti-inflammatory agent
Pharmacologic Class
Nonsteroidal anti-inflammatory drug (NSAID); Cyclooxygenase (COX) inhibitor
Pregnancy Category
Category C (first and second trimesters); Category D (third trimester)
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 irritation in your eyes. They are often used after eye surgery or for certain eye conditions 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, lid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using multiple medications in the same eye, administer each one 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 safe and secure location, out of 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, lid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into the eye.
2. If you are using multiple medications in the same eye, administer each one 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 safe and secure location, out of 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 using eye drops.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- Tilt your head back, pull down your lower eyelid to form a pocket, and instill the prescribed number of drops. Close your eye gently for a few minutes.
- 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 inflamed or infected.
- Store at room temperature, away from light and moisture. Do not freeze.
- Do not use if the solution changes color or becomes cloudy.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop (0.5%) into the affected eye(s) four times a day
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
post-operative_inflammation:
1 drop (0.5%) into the affected eye(s) four times a day, starting 24 hours after surgery and continuing for up to 2 weeks.
allergic_conjunctivitis:
1 drop (0.5%) into the affected eye(s) four times a day for symptomatic relief.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in pediatric patients younger than 3 years of age. For children 3 years and older, dosing is typically similar to adults, but consult ophthalmologist.
Adolescent:
1 drop (0.5%) into the affected eye(s) four times a day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Moderate:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Severe:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Dialysis:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Moderate:
No adjustment typically required for ophthalmic use due to minimal systemic absorption.
Severe:
No adjustment 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, analgesic, and antipyretic activity. Its primary mechanism of action is thought to be inhibition of prostaglandin biosynthesis by inhibiting the cyclooxygenase (COX) enzyme pathway (both COX-1 and COX-2), thereby reducing the formation of prostaglandins, which are mediators of inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%) after ophthalmic administration.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; ocular concentrations peak within hours.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not applicable for systemic Vd due to minimal absorption.
ProteinBinding:
Not applicable for systemic protein binding due to minimal absorption.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for systemic half-life due to minimal absorption. Ocular elimination is rapid.
Clearance:
Not applicable for systemic clearance due to minimal absorption.
ExcretionRoute:
Not applicable for systemic excretion route due to minimal absorption. Ocular elimination is primarily via tear film turnover.
Unchanged:
Not applicable for systemic unchanged excretion due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Within 1 hour for pain relief.
PeakEffect:
Approximately 2-4 hours for anti-inflammatory effect.
DurationOfAction:
Up to 6-8 hours (requires QID dosing for sustained effect).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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:
- Worsening eye pain, redness, or irritation.
- New or worsening blurred vision.
- Signs of eye infection (e.g., pus, severe swelling, fever).
- Persistent foreign body sensation or severe discomfort.
- Any signs of allergic reaction (e.g., rash, itching, severe swelling of face/throat, difficulty breathing - seek immediate medical attention).
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 change 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 change 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 an existing eye infection, 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, 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 determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation or redness may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. If eye irritation occurs, rinse eye with lukewarm water. For any severe or unusual symptoms, contact a poison control center or seek medical attention. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Hypersensitivity to ketorolac tromethamine or any component of the formulation.
- Patients who have previously exhibited hypersensitivity reactions to aspirin or other NSAIDs (e.g., bronchospasm, allergic rhinitis, urticaria).
Major Interactions
- Other topical NSAIDs (concurrent use may increase risk of adverse effects, especially corneal complications).
- Topical corticosteroids (concurrent use may slow or delay healing).
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin): Although systemic absorption is minimal, theoretical increased risk of bleeding with prolonged or high-dose ophthalmic use, especially in patients with pre-existing bleeding disorders or on systemic anticoagulants.
- Antiplatelet agents (e.g., aspirin, clopidogrel): Theoretical increased risk of bleeding.
Minor Interactions
- None specifically noted for ophthalmic ketorolac due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp, intraocular pressure)
Rationale: To establish baseline ocular health and assess the condition requiring treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular examination (visual acuity, slit lamp)
Frequency: As clinically indicated, especially with prolonged use (e.g., >2 weeks)
Target: Improvement or stability of ocular condition.
Action Threshold: Worsening symptoms, signs of infection, or corneal complications (e.g., thinning, erosion, ulceration).
Intraocular pressure (IOP)
Frequency: Periodically, especially with prolonged use or in patients at risk for elevated IOP (e.g., glaucoma patients)
Target: Within normal limits or patient's baseline.
Action Threshold: Significant increase in IOP.
Symptom Monitoring
- Eye pain (worsening or new onset)
- Redness or irritation (worsening or new onset)
- Blurred vision or other vision changes
- Discharge from the eye
- Sensitivity to light (photophobia)
- Signs of infection (e.g., pus, severe swelling)
- Signs of corneal complications (e.g., persistent foreign body sensation, severe discomfort)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided if possible, especially in the third trimester. Category C for first and second trimesters, Category D for third trimester due to potential for premature closure of the fetal ductus arteriosus and inhibition of uterine contractions. Minimal systemic absorption from ophthalmic use reduces systemic risk, but caution is still advised.
Trimester-Specific Risks:
First Trimester:
Category C: Animal studies have shown adverse effects, but no adequate human studies. Use only if potential benefit justifies potential risk to the fetus.
Second Trimester:
Category C: Similar to first trimester. Risk of premature closure of ductus arteriosus increases with gestational age.
Third Trimester:
Category D: Known human fetal risk (e.g., premature closure of ductus arteriosus, persistent pulmonary hypertension, renal dysfunction, oligohydramnios, inhibition of labor). Contraindicated in late pregnancy.
Lactation
Ketorolac is excreted in human milk after systemic administration. While systemic absorption from ophthalmic use is minimal, caution should be exercised when administered to a nursing mother. L3 (Moderately Safe) - monitor infant for adverse effects.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption, but theoretical risk of NSAID-related effects (e.g., gastrointestinal, renal) in the infant. Monitor for irritability, poor feeding, or unusual bleeding.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 3 years of age. Use in children 3 years and older should be under the guidance of an ophthalmologist.
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 adverse effects, particularly if they have pre-existing conditions or are on other medications.
Clinical Information
Clinical Pearls
- Ketorolac ophthalmic is effective for reducing ocular pain and inflammation, particularly after cataract surgery.
- It is an NSAID, so it does not have the steroid-related side effects like increased IOP, but it can cause corneal complications with prolonged use.
- Patients should be advised not to wear contact lenses during treatment if they have significant ocular inflammation or infection.
- Educate patients on proper eye drop instillation technique to maximize efficacy and minimize contamination.
- Prolonged use (e.g., >2 weeks) should be carefully monitored by an ophthalmologist due to the potential for corneal adverse events (e.g., thinning, erosion, ulceration, perforation), especially in patients with pre-existing corneal disease, diabetes, or rheumatoid arthritis.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, nepafenac, diclofenac, flurbiprofen)
- Ophthalmic corticosteroids (e.g., prednisolone, dexamethasone, loteprednol) - often used in conjunction or as an alternative depending on the specific inflammatory condition and risk profile.
- Topical antihistamines/mast cell stabilizers (for allergic conjunctivitis, if applicable).
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1 or 2)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.