Prednisolone AC 1% Ophth Susp 10ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Mar 1955
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prednisolone eye drops are a type of steroid medicine used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions or injuries. It works by calming down the body's immune response in the eye.
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. Use the medication as directed, even if your symptoms improve.
Administration
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Remove contact lenses before applying the medication. You can put them back in 15 minutes after use, but avoid doing so if your eyes are irritated or infected.
4. To prevent contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this could lead to bacterial infection and potentially severe eye problems or vision loss.
5. Shake the container well before use.
6. Tilt your head back and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep the container upright with the cap on and the lid tightly closed.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at once or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the medication as directed, even if your symptoms improve.
Administration
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Remove contact lenses before applying the medication. You can put them back in 15 minutes after use, but avoid doing so if your eyes are irritated or infected.
4. To prevent contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this could lead to bacterial infection and potentially severe eye problems or vision loss.
5. Shake the container well before use.
6. Tilt your head back and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep the container upright with the cap on and the lid tightly closed.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at once or take extra doses.
Lifestyle & Tips
- Shake the bottle well before each use to ensure the medicine is evenly mixed.
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent 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 1-2 minutes after applying the drops to allow the medicine to be absorbed.
- If using other eye drops, wait at least 5 minutes between different medications.
- Remove contact lenses before applying the drops and wait at least 10-15 minutes before reinserting them, as the preservative (benzalkonium chloride) can be absorbed by soft contact lenses.
- Do not stop using the drops suddenly, especially if used for a prolonged period, unless directed by your doctor, as this can cause a rebound of inflammation.
- Follow the prescribed dosing schedule carefully, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
- Prednisolone AC 1% Ophth Susp 10ml
- Prednisolone AC 1% Ophth Susp 5ml
- Prednisolone AC 1% Ophth Susp 15ml
- Prednisolone Sod 1% Ophthsoln 10ml
- Prednisolone Sod Phos 15mg/5ml Sol
- Prednisolone Sod Phos 5mg/5ml Sol
- Prednisolone Sod Phos 10mg/5ml Sol
- Prednisolone Sod Phos 20mg/5ml Sol
- Prednisolone 25mg/5ml Solution
- Prednisolone ODT 10mg Tablets
- Prednisolone ODT 30mg Tablets
- Prednisolone ODT 15mg Tablets
- Prednisolone 15mg/5ml Solution
- Prednisolone 5mg Tablets
- Prednisolone 5mg Tablets
- Prednisolone Sod Phos 15mg/5ml Sol
- Prednisolone 15mg/5ml Solution
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops instilled into the conjunctival sac 2 to 4 times daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
severeInflammation:
Initially, 1-2 drops every hour during waking hours, then taper to 1 drop every 4 hours. Continue for 48 hours, then 1 drop 2-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and close monitoring.
Child:
Similar to adult dosing, 1-2 drops 2-4 times daily, or more frequently for severe inflammation. Use with caution and close monitoring for IOP.
Adolescent:
Similar to adult dosing.
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
Prednisolone is a glucocorticoid that inhibits the inflammatory response to a variety of agents and may delay or slow healing. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. It also suppresses migration of polymorphonuclear leukocytes and reverses increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration.
Tmax:
Not clinically significant for ophthalmic use.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not clinically significant for ophthalmic use.
ProteinBinding:
Approximately 90-95% (systemic).
CnssPenetration:
Limited (systemic absorption is minimal).
Elimination:
HalfLife:
2-4 hours (systemic).
Clearance:
Not clinically significant for ophthalmic use.
ExcretionRoute:
Renal (systemic).
Unchanged:
Not significant for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Variable, depends on severity of inflammation and dosing frequency.
DurationOfAction:
Several hours per dose.
Confidence:
Medium
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
+ 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
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:
Change in taste
Feeling that something is in the eye
Headache
Burning or stinging
* Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, 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
+ 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
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:
Change in taste
Feeling that something is in the eye
Headache
Burning or stinging
* Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- New or worsening eye pain
- Significant vision changes or blurred vision
- Increased sensitivity to light
- Signs of a new eye infection (e.g., pus, discharge, severe redness)
- Swelling around the eye
- Headache
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.
If you currently have a bacterial eye infection.
If you have any of the following eye infections: fungal, tuberculosis (TB), or viral.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. 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.
If you currently have a bacterial eye infection.
If you have any of the following eye infections: fungal, tuberculosis (TB), or viral.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. 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. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this potential risk with your doctor. If you are taking this medication for an extended period, have your eye pressure checked regularly, and consult with your doctor about the results.
Do not use this medication for a longer duration than prescribed by your doctor. If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby. Your doctor will help you weigh the advantages and disadvantages of taking this medication during this time.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this potential risk with your doctor. If you are taking this medication for an extended period, have your eye pressure checked regularly, and consult with your doctor about the results.
Do not use this medication for a longer duration than prescribed by your doctor. If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby. Your doctor will help you weigh the advantages and disadvantages of taking this medication during this time.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidental ingestion occurs, or if local irritation is severe, contact a poison control center or seek medical attention. For general advice, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline before initiating therapy, especially if prolonged use is anticipated, due to risk of steroid-induced glaucoma.
Timing: Before initiation of therapy.
Ophthalmic examination (e.g., slit lamp)
Rationale: To assess baseline ocular condition and rule out contraindications like herpes simplex keratitis.
Timing: Before initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., >10 days).
Target: Normal range (typically 10-21 mmHg).
Action Threshold: Significant increase above baseline or normal range; consider discontinuing or reducing dose, or adding IOP-lowering medication.
Signs of secondary infection (e.g., bacterial, fungal, viral)
Frequency: At each follow-up visit.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new or worsening infection; consider appropriate antimicrobial therapy and re-evaluate corticosteroid use.
Corneal integrity (e.g., ulceration, thinning)
Frequency: At each follow-up visit, especially in patients with pre-existing corneal disease.
Target: Intact cornea.
Action Threshold: Evidence of corneal thinning or ulceration; discontinue use.
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or vision changes
- Increased light sensitivity
- Discharge from the eye
- Signs of new infection (e.g., pus, fever)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from ophthalmic use is minimal, corticosteroids have been shown to be teratogenic in animal studies.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids. Risk with ophthalmic use is considered low due to minimal systemic absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption. Prolonged or repeated use near term may theoretically lead to adrenal suppression in the neonate, though highly unlikely with ophthalmic use.
Lactation
L3 (Moderately Safe). Prednisolone is excreted in breast milk after systemic administration, but the amount transferred with ophthalmic use is expected to be very low and unlikely to cause adverse effects in the infant. Use with caution.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption by the mother.
Pediatric Use
Safety and efficacy in pediatric patients have not been fully established, but ophthalmic prednisolone is commonly used. Prolonged use in children, especially infants, should be avoided due to increased risk of steroid-induced IOP elevation and potential for systemic effects (though rare with ophthalmic use). Close monitoring of IOP is crucial.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The risk of steroid-induced IOP elevation may be higher in this population, requiring careful monitoring.
Clinical Information
Clinical Pearls
- Always shake the suspension well before use to ensure uniform distribution of the active ingredient.
- Prolonged use (typically >10 days) of ophthalmic corticosteroids can lead to increased intraocular pressure (IOP) and potentially glaucoma, as well as posterior subcapsular cataracts. Regular IOP monitoring is essential.
- Corticosteroids can mask signs of infection and may exacerbate existing viral (especially herpes simplex), fungal, or bacterial eye infections. Do not use in active herpes simplex keratitis.
- Thinning of the cornea or sclera can occur with certain eye conditions; corticosteroids can further thin these structures, increasing the risk of perforation.
- Patients should be advised not to wear contact lenses during treatment with ophthalmic prednisolone, especially if the eye is inflamed or infected, and due to the preservative (benzalkonium chloride) which can be absorbed by soft lenses.
Alternative Therapies
- Dexamethasone ophthalmic (e.g., Maxidex)
- Loteprednol etabonate ophthalmic (e.g., Lotemax)
- Fluorometholone ophthalmic (e.g., FML)
- Difluprednate ophthalmic (e.g., Durezol)
- Topical NSAIDs (e.g., Ketorolac, Bromfenac) for non-infectious inflammation, especially post-operative.
Cost & Coverage
Average Cost:
$15 - $50 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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 this 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.