Acular Ls 0.4% 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
Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
Pregnancy Category
Category C (first and second trimesters); Category D (third trimester)
FDA Approved
Mar 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketorolac eye drops are used to reduce pain and swelling in your eye, especially after eye surgery like cataract removal. It belongs to a group of medicines called NSAIDs, which work by blocking substances in the eye 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 to the eye only.
Wash your hands before and after use to maintain cleanliness.
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 other 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 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 to the eye only.
Wash your hands before and after use to maintain cleanliness.
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 other 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 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 using eye drops.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Do not rub your eyes after applying the drops.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop (0.4%) to the affected eye(s) four times a day (QID) beginning 24 hours after cataract surgery and continuing for up to 2 weeks.
Dose Range:
0.4 - 0.4 mg
Condition-Specific Dosing:
post_cataract_surgery_inflammation:
One drop QID to the affected eye(s) beginning 24 hours after surgery and continuing for up to 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy have not been established in pediatric patients under 18 years of age.
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 due to 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 inhibits prostaglandin biosynthesis by decreasing the activity of cyclooxygenase (COX-1 and COX-2) enzymes, thereby inhibiting the formation of prostaglandin precursors. Prostaglandins are mediators of inflammation and pain.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5 ng/mL plasma concentration after topical ocular administration)
Tmax:
Not typically relevant for local ophthalmic action; systemic Tmax is approximately 0.5-1 hour if absorbed.
FoodEffect:
Not applicable for ophthalmic formulation.
Distribution:
Vd:
Not applicable for local ophthalmic action; systemic Vd is approximately 0.15 L/kg.
ProteinBinding:
Approximately 99% (systemic, if absorbed)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 5-7 hours (systemic, if absorbed)
Clearance:
Not applicable for local ophthalmic action; systemic clearance is approximately 0.02 L/hr/kg.
ExcretionRoute:
Renal (systemic, if absorbed)
Unchanged:
Approximately 60% (systemic, if absorbed)
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular dosing.
DurationOfAction:
Approximately 6-8 hours per dose (requires QID dosing).
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty 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 persist, contact your doctor for guidance:
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty 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 persist, contact your doctor for guidance:
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)
- Increased sensitivity to light
- Persistent or worsening eye irritation
- Signs of allergic reaction (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 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 safely with all your other 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, 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 safely with all your other 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 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 irritation may occur.
What to Do:
If an overdose is suspected, flush the eye with lukewarm water. If irritation persists or if the product is accidentally ingested, contact a poison control center or emergency medical services. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, intraocular pressure, slit lamp exam)
Rationale: To establish baseline ocular health and assess inflammation prior to treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular comfort and vision
Frequency: Daily by patient, at follow-up visits by clinician
Target: Improved comfort, stable or improving vision
Action Threshold: Worsening pain, decreased vision, or new ocular symptoms should prompt re-evaluation.
Signs of corneal complications (e.g., thinning, erosion, ulceration)
Frequency: At follow-up visits, especially with prolonged use or pre-existing corneal disease
Target: Absence of corneal defects
Action Threshold: Any signs of corneal compromise should lead to immediate discontinuation and ophthalmologic consultation.
Symptom Monitoring
- Eye pain
- Redness
- Swelling
- Photophobia
- Blurred vision
- Discharge
- Signs of infection (e.g., purulent discharge, severe pain)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided if possible, especially in the third trimester. While systemic absorption is minimal, NSAIDs can cause premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn if used in the third trimester. Category C for first and second trimesters, Category D for third trimester.
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.
Second Trimester:
Category C - Animal studies have shown adverse effects, but no adequate human studies. Use only if potential benefit justifies potential risk.
Third Trimester:
Category D - Positive evidence of human fetal risk. Contraindicated due to risk of premature closure of the ductus arteriosus and persistent pulmonary hypertension in the newborn.
Lactation
Caution is advised. While systemic absorption is minimal, ketorolac is excreted in human milk following systemic administration. The risk to the breastfed infant is considered low due to the low systemic exposure from ophthalmic use, but potential for adverse effects exists. L3 (Moderately Safe).
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption, but monitor infant for potential side effects.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established. 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 dosage adjustment is necessary. However, elderly patients may be more susceptible to corneal adverse events.
Clinical Information
Clinical Pearls
- Acular LS 0.4% is specifically formulated for lower stinging and burning compared to the 0.5% formulation, improving patient comfort and compliance.
- Primarily indicated for post-operative inflammation and pain following cataract surgery.
- Patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, previous ocular surgery) should be monitored closely for corneal adverse events.
- Prolonged use (beyond 2 weeks) of ophthalmic NSAIDs may increase the risk of corneal complications.
- Advise patients to avoid wearing contact lenses during treatment with Acular LS.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, diclofenac, nepafenac)
- Topical corticosteroids (e.g., prednisolone acetate, dexamethasone) for inflammation, often used in combination or sequentially with NSAIDs post-operatively.
Cost & Coverage
Average Cost:
Varies, typically $100-$200 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'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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.