Pred Forte 1% Opth Susp 15ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pred Forte is an eye drop that contains a strong anti-inflammatory medicine called prednisolone. It's used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions or after eye surgery.
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 retain the medication.
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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use double doses or extra doses to compensate 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 retain the medication.
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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use double doses or extra doses to compensate for a missed dose.
Lifestyle & Tips
- Shake the bottle well before each use.
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface (including the eye) to prevent contamination.
- Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
- Do not share eye drops with others.
- Complete the full course of treatment as prescribed, even if symptoms improve, unless advised otherwise by your doctor.
- Avoid driving or operating machinery if vision is temporarily blurred after instillation.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops instilled into the conjunctival sac 2 to 4 times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to 2 drops every hour.
Condition-Specific Dosing:
severeInflammation:
2 drops every hour during initial 24-48 hours, then taper as inflammation subsides.
mildToModerateInflammation:
1-2 drops 2-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and under medical supervision.
Child:
Similar to adult dosing, 1-2 drops 2-4 times daily, or as directed by physician. Use with caution for prolonged periods due to risk of IOP elevation.
Adolescent:
Similar to adult dosing, 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 adjustment needed (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 acetate is a potent glucocorticoid that inhibits the inflammatory response to a variety of 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 also suppress migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration.
Tmax:
Not applicable for systemic effects; local ocular effects are rapid.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable for systemic effects due to minimal absorption.
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 applicable for systemic effects due to minimal absorption.
ExcretionRoute:
Renal (for systemically absorbed prednisolone), but minimal systemic absorption from ophthalmic route.
Unchanged:
Not significant for ophthalmic use
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular use.
DurationOfAction:
Varies with severity of inflammation and dosing frequency; typically requires multiple daily doses.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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 if you experience any of the following side effects or if they persist or bother you:
- Change in taste
- Feeling that something is in the eye
- Headache
- Burning or stinging
- 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or 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 if you experience any of the following side effects or if they persist or bother you:
- Change in taste
- Feeling that something is in the eye
- Headache
- Burning or stinging
- 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. 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
- Sudden vision changes or decreased vision
- Increased redness or swelling of the eye
- Pus or discharge from the eye
- Signs of a new eye infection (e.g., fever, severe pain)
- Headache with eye pain
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 as a result of the allergy.
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
All your health problems
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Never start, stop, or change 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 as a result of the allergy.
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
All your health problems
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Never start, stop, or change 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 while 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. Consult with your doctor to schedule these check-ups.
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, it is vital to discuss the benefits and risks of this medication with your doctor, as it may affect 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, you should have your eye pressure checked regularly. Consult with your doctor to schedule these check-ups.
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, it is vital to discuss the benefits and risks of this medication with your doctor, as it may affect 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 excessive drops are instilled, flush the eye with lukewarm water. If irritation persists or if accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for corticosteroid-induced glaucoma, especially with prolonged use (more than 10 days).
Timing: Before initiating treatment, especially if prolonged use is anticipated.
Ocular examination (slit lamp)
Rationale: To assess the initial inflammatory condition and rule out corneal defects or infections.
Timing: Before initiating treatment.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment exceeds 10 days. Frequency determined by physician based on patient risk factors.
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider tapering or discontinuing.
Signs of secondary infection (bacterial, fungal, viral)
Frequency: At each follow-up visit and if symptoms worsen.
Target: Absence of new or worsening infection signs.
Action Threshold: Presence of new or worsening redness, pain, discharge, or vision changes; consider discontinuing and initiating appropriate anti-infective therapy.
Corneal integrity
Frequency: Periodically, especially with prolonged use.
Target: Intact cornea, absence of thinning or perforation.
Action Threshold: Signs of corneal thinning or perforation; discontinue use immediately.
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or vision changes
- Discharge from the eye
- Sensitivity to light (photophobia)
- Signs of new infection (e.g., pus, fever)
Special Patient Groups
Pregnancy
Prednisolone acetate ophthalmic suspension is classified as Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but animal studies have shown corticosteroids to be teratogenic.
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. No specific adverse effects on the fetus or neonate reported with ophthalmic use.
Lactation
Prednisolone is excreted in human milk following systemic administration. However, due to minimal systemic absorption of prednisolone acetate ophthalmic suspension, the amount excreted in breast milk is expected to be negligible. Considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk to the infant due to minimal systemic exposure.
Pediatric Use
Safety and effectiveness in pediatric patients have not been fully established. Prolonged use in children should be avoided due to increased risk of corticosteroid-induced IOP elevation and cataract formation. Close monitoring of IOP is essential.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is required. However, elderly patients may be more susceptible to the ocular side effects (e.g., IOP elevation, cataract formation) with prolonged use.
Clinical Information
Clinical Pearls
- Always shake the bottle well before each use to ensure the suspension is evenly distributed.
- Pred Forte is a suspension, not a solution, which means the active ingredient is suspended in the liquid and can settle.
- Prolonged use (typically >10 days) of ophthalmic corticosteroids significantly increases the risk of elevated intraocular pressure (IOP) and secondary infections (especially fungal and viral).
- Patients should be monitored for IOP if treatment extends beyond 10 days.
- Corticosteroids can mask signs of infection; if an infection is suspected, appropriate anti-infective therapy should be initiated.
- Not for use in acute purulent untreated infections of the eye, or in most viral diseases of the cornea and conjunctiva (e.g., herpes simplex keratitis), fungal diseases of ocular structures, or mycobacterial infections of the eye.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Loteprednol, Fluorometholone)
- Topical NSAIDs (e.g., Ketorolac, Bromfenac) for ocular inflammation (less potent than corticosteroids)
- Immunomodulators (e.g., Cyclosporine ophthalmic) for chronic inflammatory conditions
Cost & Coverage
Average Cost:
$30 - $100 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name); Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 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 information about the medication taken, the amount, and the time it happened.