Prednisolone AC 1% Ophth Susp 15ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prednisolone eye drops are a type of medicine called a corticosteroid. They are used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions or after eye surgery. 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 Instructions
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 can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Shake the container well before each use.
6. Tilt your head back, and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply gentle 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 tightly closed to maintain the medication's integrity.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not use double doses or 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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
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 can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Shake the container well before each use.
6. Tilt your head back, and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply gentle 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 tightly closed to maintain the medication's integrity.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not use double doses or extra doses to make up for a missed dose.
Lifestyle & Tips
- Shake the bottle well before each use.
- Wash hands thoroughly before administering drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Tilt head back, pull down the lower eyelid to create a small pocket, and instill the prescribed number of drops.
- Close eyes gently for 1-2 minutes after instillation to allow the medication to be absorbed.
- If using other eye drops, wait at least 5-10 minutes between medications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not stop using the drops suddenly, especially if used for a long time, unless advised by your doctor, as this can cause the inflammation to return.
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 2-4 times daily. During the initial 24-48 hours, the dosing frequency may be increased to 2 drops every hour.
Condition-Specific Dosing:
severeInflammation:
2 drops every hour during the initial 24-48 hours, then taper frequency as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing similar to adults, typically 1-2 drops 2-4 times daily, depending on severity and physician's discretion. Use with caution.
Child:
Dosing similar to adults, typically 1-2 drops 2-4 times daily, depending on severity and physician's discretion. Use with caution.
Adolescent:
Dosing similar to adults, typically 1-2 drops 2-4 times daily.
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 for ophthalmic use (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 corticosteroid that acts by inhibiting the inflammatory response to a variety of agents. It does this 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. Corticosteroids also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after ophthalmic administration.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local peak effect is rapid.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not clinically significant systemically after ophthalmic use.
ProteinBinding:
Approximately 90-95% (for systemically absorbed prednisolone), but minimal systemic absorption from ophthalmic route.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Approximately 2-4 hours (for systemically absorbed prednisolone), but minimal systemic absorption from ophthalmic route.
Clearance:
Not clinically significant systemically after ophthalmic use.
ExcretionRoute:
Renal (for systemically absorbed prednisolone).
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of consistent use.
DurationOfAction:
Varies, typically requires multiple daily doses.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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. 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 any of the following side effects or if they persist or bother you:
Changes in taste
Feeling of something in the eye
Headache
Burning or stinging sensation
* Eye irritation
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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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. 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 any of the following side effects or if they persist or bother you:
Changes in taste
Feeling of something in the eye
Headache
Burning or stinging sensation
* Eye irritation
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:
- Worsening eye pain or discomfort
- Significant decrease in vision
- New or worsening eye discharge
- Increased sensitivity to light
- Signs of a new eye infection (e.g., pus, severe redness)
- Any new or unusual eye symptoms
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.
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, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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.
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, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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. Therefore, 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 any concerns.
Do not use this medication for a longer duration than prescribed by your doctor. Additionally, 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 are breastfeeding, it is vital to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Therefore, 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 any concerns.
Do not use this medication for a longer duration than prescribed by your doctor. Additionally, 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 are breastfeeding, it is vital to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with water. Contact a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or persistent.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause elevated IOP, especially with prolonged use (typically >10 days).
Timing: Before initiating treatment, especially if treatment duration is expected to be long.
Ophthalmic examination (e.g., slit lamp)
Rationale: To assess baseline inflammation, corneal integrity, and rule out underlying infections.
Timing: Before initiating treatment.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly or bi-weekly if used for more than 10 days).
Target: Normal range (typically 10-21 mmHg).
Action Threshold: If IOP significantly increases or exceeds normal range, consider dose reduction, discontinuation, or glaucoma management.
Signs of infection (e.g., worsening redness, discharge, pain)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of infection.
Action Threshold: If signs of infection appear or worsen, discontinue steroid and initiate appropriate antimicrobial therapy.
Corneal integrity (e.g., epithelial defects)
Frequency: Periodically, especially in patients with pre-existing corneal conditions.
Target: Intact corneal epithelium.
Action Threshold: If corneal defects develop or worsen, discontinue steroid.
Symptom Monitoring
- Blurred vision
- Eye pain or discomfort
- Increased redness or irritation
- Sensitivity to light (photophobia)
- Signs of secondary infection (e.g., purulent discharge, worsening pain)
Special Patient Groups
Pregnancy
Prednisolone is 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, caution is advised.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk due to minimal systemic absorption.
Second Trimester:
Limited data, but generally considered low risk due to minimal systemic absorption.
Third Trimester:
Limited data, but generally considered low risk due to minimal systemic absorption.
Lactation
Prednisolone is excreted in breast milk after systemic administration. However, due to minimal systemic absorption from ophthalmic use, the amount excreted into breast milk is expected to be negligible. Use with caution; monitor infant for adverse effects. Consider applying pressure to the tear duct for 1 minute after instillation to minimize systemic absorption.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have been established for ophthalmic use. However, prolonged use in children may increase the risk of elevated intraocular pressure and cataract formation. Close monitoring is essential.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustments are typically required.
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 crucial.
- Corticosteroids can mask or exacerbate existing ocular infections (bacterial, viral, fungal). Do not use in untreated acute purulent ocular infections.
- Herpes simplex keratitis is a contraindication for corticosteroid use due to the risk of corneal perforation.
- Tapering the dose gradually is often necessary for prolonged treatment to prevent rebound inflammation.
- Patients should be advised not to wear contact lenses during treatment with ophthalmic corticosteroids, especially if the eye is inflamed or infected.
Alternative Therapies
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac) for non-infectious inflammation.
- Immunomodulators (e.g., Cyclosporine ophthalmic emulsion) for chronic inflammatory conditions.
- Antibiotics/Antivirals if infection is present.
Cost & Coverage
Average Cost:
$20 - $60 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.