Prednisolone AC 1% Ophth Susp 5ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Anti-inflammatory
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jun 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 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 the eye, lid, or other skin, as this can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Shake the container well before use.
6. Tilt your head back, and gently drop the medication into the eye.
7. After application, keep your eyes closed and apply pressure to the inside corner of the eye for 1 to 2 minutes to help the medication stay in the 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 Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next 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. 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 the eye, lid, or other skin, as this can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Shake the container well before use.
6. Tilt your head back, and gently drop the medication into the eye.
7. After application, keep your eyes closed and apply pressure to the inside corner of the eye for 1 to 2 minutes to help the medication stay in the 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 Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next 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
- Shake the bottle well before each use to ensure the medicine is evenly mixed.
- Wash hands thoroughly before administering 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 create a pouch, and instill the prescribed number of drops.
- Close your eye gently for 1-2 minutes after instilling drops to allow the medicine to be absorbed.
- If using other eye drops, wait at least 5-10 minutes between different 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; follow your doctor's instructions for tapering the dose.
- Avoid wearing contact lenses during treatment if advised by your doctor, especially if you have an eye infection or inflammation.
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 1-2 drops every hour. Care should be taken not to discontinue therapy prematurely.
Condition-Specific Dosing:
severeInflammation:
1-2 drops every hour during initial 24-48 hours, then taper frequency as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and close monitoring if prescribed.
Child:
Similar to adult dosing, 1-2 drops 2-4 times daily, tapering. Close monitoring for IOP elevation is crucial.
Adolescent:
Similar to adult dosing, 1-2 drops 2-4 times daily, tapering.
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 corticosteroid 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. Corticosteroids are capable of producing a profound and varied metabolic effect and modify the body's immune responses to diverse stimuli.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption following ophthalmic administration.
Tmax:
Not well-quantified for ophthalmic use; local effect is rapid.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not well-quantified for ophthalmic use; primarily local distribution.
ProteinBinding:
Approximately 90-95% (for systemically absorbed prednisolone, but minimal for ophthalmic).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Approximately 2-4 hours (for systemically absorbed prednisolone, but minimal for ophthalmic).
Clearance:
Not well-quantified for ophthalmic use.
ExcretionRoute:
Renal (for systemically absorbed prednisolone).
Unchanged:
Not well-quantified for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours (local anti-inflammatory effect).
PeakEffect:
Within 24-48 hours of consistent dosing.
DurationOfAction:
Depends on frequency of administration; local effect lasts several hours.
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, 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 bother you or do not go away:
- Changes in taste
- Feeling of something in the eye
- Headache
- Burning or stinging sensation
- Eye irritation
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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, 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, 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 bother you or do not go away:
- Changes in taste
- Feeling of something in the eye
- Headache
- Burning or stinging sensation
- Eye irritation
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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, redness, or swelling
- New or increased discharge from the eye
- Sudden vision changes or decreased vision
- Increased sensitivity to light
- Signs of a new eye infection (e.g., pus, fever)
- 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, 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, including any previous or existing conditions
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, 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, including any previous or existing conditions
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. It is crucial to discuss this potential risk with your doctor. If you are taking this medication for an extended period, you should have your eye pressure checked regularly. Be sure to consult with your doctor about the necessary precautions.
Do not use this medication for a longer duration than prescribed by your doctor. If you have a sulfite allergy, consult with your doctor before taking this medication, as some products may contain sulfites.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must 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. It is crucial to discuss this potential risk with your doctor. If you are taking this medication for an extended period, you should have your eye pressure checked regularly. Be sure to consult with your doctor about the necessary precautions.
Do not use this medication for a longer duration than prescribed by your doctor. If you have a sulfite allergy, consult with your doctor before taking this medication, as some products may contain sulfites.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must 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 to cause systemic overdose due to minimal absorption.
- Local irritation, redness, or discomfort if excessive drops are used.
What to Do:
If excessive drops are instilled, rinse the eye with lukewarm water. If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity from ophthalmic overdose is rare.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and identify pre-existing glaucoma or ocular hypertension, as corticosteroids can elevate IOP.
Timing: Before initiating therapy, especially for prolonged use (more than 10 days).
Ophthalmic examination (slit lamp, fundoscopy)
Rationale: To assess the severity of inflammation, rule out infection, and check for pre-existing conditions like cataracts.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (more than 10 days) or in patients predisposed to IOP elevation (e.g., glaucoma patients).
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant or sustained elevation above baseline; consider discontinuation or alternative therapy.
Signs of infection (e.g., worsening redness, pain, discharge)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of signs of infection.
Action Threshold: Presence of new or worsening signs of infection; requires immediate re-evaluation and potential anti-infective therapy.
Corneal integrity/healing
Frequency: Periodically, especially in conditions involving corneal damage.
Target: Improvement or stability of corneal condition.
Action Threshold: Delayed healing or worsening corneal condition; corticosteroids can delay healing.
Symptom Monitoring
- Worsening eye pain or discomfort
- Increased redness or irritation
- Blurred vision or vision changes
- New or worsening discharge from the eye
- Sensitivity to light (photophobia)
- Signs of secondary 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, animal studies with systemic corticosteroids have shown teratogenic effects.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies with systemic corticosteroids; risk with ophthalmic use is considered low due to minimal absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
Lactation
L2 (Safely used, but some evidence of risk). Prednisolone is excreted in breast milk following systemic administration. However, due to minimal systemic absorption from ophthalmic use, the amount transferred into breast milk is expected to be negligible. Use with caution.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal maternal systemic absorption and subsequent low excretion into breast milk.
Pediatric Use
Use with caution in pediatric patients. Prolonged corticosteroid use in children may cause growth retardation and can increase the risk of elevated intraocular pressure and cataract formation. Close monitoring of IOP is essential.
Geriatric Use
Generally safe for use in geriatric patients. However, elderly patients may be more susceptible to corticosteroid-induced increases in intraocular pressure and cataract formation, especially with prolonged use. Regular ophthalmic monitoring is recommended.
Clinical Information
Clinical Pearls
- Always shake the suspension well before each use to ensure uniform distribution of the active ingredient.
- Prednisolone acetate 1% is a potent ophthalmic corticosteroid; use the lowest effective dose for the shortest duration necessary.
- Monitor intraocular pressure (IOP) frequently, especially in patients on prolonged therapy (more than 10 days) or those with a history of glaucoma.
- Corticosteroids can mask or exacerbate ocular infections (bacterial, viral, fungal). Do not use in active herpes simplex keratitis or fungal infections.
- Prolonged use can lead to posterior subcapsular cataracts, glaucoma with optic nerve damage, and secondary ocular infections.
- Patients should be advised not to wear contact lenses during treatment, especially if they have an active infection or inflammation.
Alternative Therapies
- Topical ophthalmic NSAIDs (e.g., ketorolac, bromfenac) for non-infectious inflammation, especially post-operatively.
- Immunomodulators (e.g., cyclosporine ophthalmic emulsion) for chronic inflammatory conditions like dry eye or allergic conjunctivitis (different mechanism, not direct anti-inflammatory for acute use).
Cost & Coverage
Average Cost:
$30 - $100 per 5mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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.