Acuvail 0.45% Opht Sol 30single Use
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
Sep 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acuvail is an eye drop that helps reduce pain and swelling in your eye after cataract surgery. It belongs to a group of medicines called NSAIDs, which work by blocking certain natural substances in your body that cause inflammation and pain.
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 during treatment with this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into your eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
Important Handling Instructions
Each vial of medication is intended for single-use only. Do not use a vial for more than one eye.
After administering your dose, discard any remaining medication and do not save it for later use.
Storage and Disposal
Store this medication at room temperature, protected from light.
Keep unused containers in their original foil pouches until you are ready to use them.
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 take two doses at once or use 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 during treatment with this medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Administration Technique
1. Tilt your head back and gently drop the medication into your eye.
2. If you are using more than one medication in the same eye, allow at least a 5-minute interval between each application.
Important Handling Instructions
Each vial of medication is intended for single-use only. Do not use a vial for more than one eye.
After administering your dose, discard any remaining medication and do not save it for later use.
Storage and Disposal
Store this medication at room temperature, protected from light.
Keep unused containers in their original foil pouches until you are ready to use them.
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 take two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Do not wear contact lenses during treatment unless advised by your doctor.
- Wash hands thoroughly before and after administering eye drops.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- If using other eye drops, wait at least 5 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop to the affected eye two times daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and for 2 weeks post-surgery.
Condition-Specific Dosing:
post-cataract_surgery_pain_and_inflammation:
One drop to the affected eye two times daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and for 2 weeks post-surgery.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
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 its effect by inhibiting the cyclooxygenase (COX) enzyme, which is responsible for the synthesis of prostaglandins from arachidonic acid. Prostaglandins are mediators of inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (ocular)
Tmax:
Not applicable for systemic Tmax due to minimal absorption; ocular concentrations peak within hours.
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not quantifiable systemically due to minimal absorption
ProteinBinding:
Not quantifiable systemically due to minimal absorption
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not quantifiable systemically due to minimal absorption
Clearance:
Not quantifiable systemically due to minimal absorption
ExcretionRoute:
Not quantifiable systemically due to minimal absorption
Unchanged:
Not quantifiable systemically due to minimal absorption
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect
PeakEffect:
Within hours
DurationOfAction:
Approximately 12 hours (based on twice-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although 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, or 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. While 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:
- Eye irritation
- Blurred eyesight
- Headache
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for guidance on managing side effects.
Although 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, or 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. While 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:
- Eye irritation
- Blurred eyesight
- Headache
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- New or worsening eye pain
- Persistent eye redness or irritation
- Changes in vision
- Signs of eye infection (e.g., discharge, pus)
- Signs of corneal damage (e.g., severe discomfort, foreign body sensation, blurred vision)
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 allergic reaction you experienced, including any symptoms that occurred.
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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 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 administration due to minimal systemic absorption. Local irritation may occur.
What to Do:
If an overdose is suspected or if the solution is accidentally ingested, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention. For ocular overdose, flush the eye with water.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal adverse events)
- Topical corticosteroids (potential to slow or delay healing, increased risk of corneal adverse events)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp)
Rationale: To establish baseline ocular health and assess suitability for treatment.
Timing: Prior to initiation of therapy
Intraocular pressure (IOP)
Rationale: Although not directly affected by ketorolac, it's a standard pre-operative and post-operative measure.
Timing: Prior to initiation of therapy
Routine Monitoring
Ocular examination (visual acuity, signs of inflammation/irritation)
Frequency: As clinically indicated, typically at post-operative visits
Target: Improvement in pain and inflammation
Action Threshold: Worsening symptoms, signs of infection, or corneal complications (e.g., thinning, erosion, ulceration)
Intraocular pressure (IOP)
Frequency: As clinically indicated post-operatively
Target: Normal range for patient
Action Threshold: Significant elevation or fluctuation
Symptom Monitoring
- Ocular pain
- Ocular redness
- Blurred vision
- Photophobia
- Signs of infection (e.g., discharge, severe pain)
- 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. Animal studies have shown adverse effects, but human data are limited. The potential benefits should outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of cardiovascular malformations (based on systemic NSAIDs).
Second Trimester:
Limited data, generally considered lower risk than first or third trimester.
Third Trimester:
Avoid use due to potential for premature closure of the fetal ductus arteriosus and inhibition of uterine contractions (based on systemic NSAIDs).
Note Trimester:
Due to minimal systemic absorption, the risk is considered lower than with systemic NSAIDs, but caution is still advised.
Lactation
Ketorolac is excreted in human milk after systemic administration. However, due to minimal systemic absorption following ophthalmic administration, the amount excreted into breast milk is expected to be negligible. Use with caution.
Infant Risk:
Low risk (L3 - Moderately safe). Monitor infant for potential adverse effects, though unlikely.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Acuvail is specifically formulated as a 0.45% solution for twice-daily dosing, offering convenience compared to other ketorolac ophthalmic formulations that may require more frequent dosing.
- Single-dose containers help maintain sterility and prevent contamination.
- Patients should be instructed on proper instillation technique to maximize efficacy and minimize contamination.
- While systemic absorption is minimal, caution should be exercised in patients with known bleeding tendencies or those on anticoagulants, though the risk of systemic bleeding is very low.
- Prolonged use of topical NSAIDs, including Acuvail, may increase the risk of corneal adverse events, especially in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, or ocular surface diseases. Discontinue if corneal breakdown occurs.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., bromfenac, diclofenac, nepafenac)
- Ophthalmic corticosteroids (e.g., prednisolone acetate, dexamethasone)
- Combination NSAID/corticosteroid ophthalmic products (if available and indicated)
Cost & Coverage
Average Cost:
$150 - $300 per 30 single-use containers
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 amount taken, the time it occurred, and any other relevant information.