Pred Mild 0.12% Ophth Sus 10ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Anti-inflammatory
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 work by reducing swelling, redness, and irritation in your eye caused by certain eye conditions or after eye surgery. It helps to calm 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 applying the medication, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep the container upright with the cap tightly closed.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it's 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. 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 applying the medication, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep the container upright with the cap tightly closed.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it's 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
- Shake the bottle well before each use.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- Wash your hands before and after using the eye drops.
- If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them, unless otherwise advised by your doctor.
- Do not share your eye drops with anyone else.
- Avoid rubbing your eyes, especially after application.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops in the conjunctival sac 2-4 times daily
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
severeInflammation:
1 drop every hour during the initial 24-48 hours, then taper as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and close monitoring
Child:
Similar to adult dosing, but use with caution and close monitoring of intraocular pressure (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 corticosteroid that inhibits the inflammatory response to a variety of inciting agents. 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 inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, fibroblast proliferation, and scar formation associated with inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (following topical ocular administration)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (primarily local action; systemic half-life of prednisolone is 2-3 hours)
Clearance:
Not applicable (primarily local action)
ExcretionRoute:
Systemically absorbed prednisolone and its metabolites are primarily excreted in the urine.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect)
PeakEffect:
Variable, depends on severity of inflammation
DurationOfAction:
Several hours per dose
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 notice any of the following symptoms, which could be signs of a serious reaction:
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. 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:
Change 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 notice any of the following symptoms, which could be signs of a serious reaction:
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. 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:
Change 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
- Increased redness or swelling of the eye
- Significant changes in vision (e.g., new blurring, halos around lights)
- New or worsening discharge from the eye
- Signs of a new eye infection (e.g., pus, severe pain)
- Any allergic reaction (e.g., rash, itching, severe swelling of face/throat, difficulty 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.
If you currently have a bacterial eye infection.
If you have any of the following eye conditions: fungal infection, tuberculosis (TB), or viral infection.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please inform 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 symptoms you experienced.
If you currently have a bacterial eye infection.
If you have any of the following eye conditions: fungal infection, tuberculosis (TB), or viral infection.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please inform 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. 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 are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both 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, 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 are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both 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 swallowed, drink fluids. If eye irritation occurs, rinse eye with water. For any concerning symptoms, contact a poison control center or seek medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Topical NSAIDs (concurrent use may increase risk of corneal complications in susceptible patients)
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline, especially if prolonged use (>10 days) is anticipated, due to risk of steroid-induced glaucoma.
Timing: Before initiating therapy
Slit lamp examination
Rationale: To assess corneal integrity and anterior chamber inflammation.
Timing: Before initiating therapy
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly or bi-weekly for use >10 days)
Target: Normal range (typically <21 mmHg)
Action Threshold: Significant increase above baseline or above normal range; consider discontinuing or changing therapy.
Signs of secondary infection (e.g., bacterial, fungal, viral)
Frequency: At each follow-up visit
Target: Absence of infection
Action Threshold: Presence of new or worsening infection; discontinue steroid and initiate appropriate anti-infective therapy.
Corneal integrity/healing
Frequency: At each follow-up visit
Target: Normal healing progression
Action Threshold: Delayed healing or corneal thinning/perforation; discontinue steroid.
Visual acuity
Frequency: At each follow-up visit
Target: Stable or improving
Action Threshold: Decreased vision not attributable to underlying condition; investigate for complications (e.g., cataract, glaucoma).
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or vision changes
- Discharge from the eye
- Sensitivity to light (photophobia)
Special Patient Groups
Pregnancy
Prednisolone is Pregnancy Category C. While systemic absorption from ophthalmic use is minimal, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm cannot be ruled out; use only if clearly needed.
Second Trimester:
Potential for fetal harm cannot be ruled out; use only if clearly needed.
Third Trimester:
Potential for fetal harm cannot be ruled out; use only if clearly needed.
Lactation
Systemic absorption of ophthalmic prednisolone is minimal, making the amount excreted in breast milk likely negligible. Considered low risk for the nursing infant. Use with caution and monitor the infant for any adverse effects.
Infant Risk:
Low
Pediatric Use
Use in pediatric patients requires caution, especially in infants and young children, due to the potential for increased intraocular pressure (IOP) and cataract formation. IOP should be monitored closely, particularly with prolonged use.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. However, as with all patients, monitor for increased IOP and cataract formation, especially with prolonged use.
Clinical Information
Clinical Pearls
- Always shake the suspension well before administering 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 signs of infection and may exacerbate existing viral (e.g., herpes simplex), fungal, or bacterial eye infections. Use with extreme caution in patients with a history of ocular herpes simplex.
- Corneal thinning or perforation can occur with prolonged use, especially in patients with pre-existing corneal conditions.
- This formulation (0.12%) is considered 'mild' compared to the 1% concentration, often used for less severe inflammation or for tapering therapy.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Loteprednol, Fluorometholone)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac) for non-infectious inflammation, especially when steroid-sparing is desired or IOP elevation is a concern.
- Immunomodulators (e.g., Cyclosporine ophthalmic emulsion) for chronic inflammatory conditions.
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.