Pred Forte 1% Ophth Susp 5ml
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 used to reduce swelling, redness, itching, and irritation in the eye caused by certain eye conditions, injuries, or surgery. It works by calming down the body's inflammatory response.
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 could lead to bacterial infection and 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 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 could lead to bacterial infection and 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 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 wear contact lenses during treatment unless specifically advised by your doctor.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Wash hands thoroughly before and after administering drops.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Follow your doctor's instructions carefully regarding the tapering schedule; do not stop using the drops suddenly unless advised.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 drops in the conjunctival sac 2 to 4 times daily
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
severeInflammation:
1 to 2 drops every hour during waking hours, then taper frequency as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, monitor IOP)
Child:
Similar to adult dosing, 1 to 2 drops 2 to 4 times daily, tapering as inflammation subsides. Safety and efficacy established in children 2 years of age and older.
Adolescent:
Similar to adult dosing, 1 to 2 drops 2 to 4 times daily, tapering as inflammation subsides.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Prednisolone is a glucocorticoid that inhibits inflammatory responses 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. This results in reduced edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, and scar formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable (topical ophthalmic)
Distribution:
Vd:
Not applicable (primarily local)
ProteinBinding:
Not applicable (primarily local)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable (primarily local)
Clearance:
Not applicable (primarily local)
ExcretionRoute:
Renal (for systemically absorbed metabolites)
Unchanged:
Not applicable (primarily local)
Pharmacodynamics
OnsetOfAction:
Within hours (local anti-inflammatory effect)
PeakEffect:
Variable, depends on severity of inflammation and dosing frequency
DurationOfAction:
Variable, depends on severity of inflammation and dosing frequency
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 persist or bother you:
- Altered sense of taste
- Sensation of something being in the eye
- Headache
- Burning or stinging sensation
- Eye irritation
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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 persist or bother you:
- Altered sense of taste
- Sensation of something being in the eye
- Headache
- Burning or stinging sensation
- Eye irritation
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding 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:
- Increased eye pain or discomfort
- Worsening redness, swelling, or irritation of the eye
- New or increased discharge from the eye
- Blurred vision or other changes in vision
- Increased sensitivity to light
- Signs of a new eye infection (e.g., pus, fever, severe pain)
- Any new or unusual 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 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, 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 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, 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. 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 longer than the duration 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, inform your doctor. You and your doctor will need 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 any concerns.
Do not use this medication for longer than the duration 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, inform your doctor. You and your doctor will need 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, redness, or discomfort may occur with excessive application.
What to Do:
If excessive drops are applied, rinse the eye with lukewarm water. If irritation persists, contact a healthcare professional. For accidental ingestion, contact Poison Control (1-800-222-1222) or seek emergency medical attention, though systemic toxicity is unlikely due to low concentration.
Drug Interactions
Minor Interactions
- Other topical ophthalmic medications (space administration by at least 5-10 minutes)
Monitoring
Baseline Monitoring
Ocular examination
Rationale: To assess baseline inflammation and rule out contraindications (e.g., untreated infections).
Timing: Prior to initiation of therapy.
Intraocular Pressure (IOP)
Rationale: To establish baseline, especially if prolonged use (>10 days) is anticipated, due to risk of steroid-induced glaucoma.
Timing: Prior to initiation of 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 10-21 mmHg)
Action Threshold: Significant increase above baseline or normal range; consider discontinuing or changing therapy, consult ophthalmologist.
Signs of secondary infection (bacterial, fungal, viral)
Frequency: At each follow-up visit
Target: Absence of new or worsening infection signs
Action Threshold: Presence of new or worsening redness, discharge, pain, or vision changes; consider appropriate antimicrobial therapy or discontinuation.
Corneal integrity
Frequency: At each follow-up visit
Target: Intact cornea, absence of ulceration
Action Threshold: Presence of corneal ulceration or thinning; discontinue therapy and seek ophthalmologic consultation.
Healing progress of underlying condition
Frequency: At each follow-up visit
Target: Resolution or improvement of inflammation
Action Threshold: Lack of improvement or worsening of inflammation; re-evaluate diagnosis and treatment plan.
Symptom Monitoring
- Increased eye pain
- Worsening redness or irritation
- Increased discharge from the eye
- Blurred vision or other vision changes
- Sensitivity to light (photophobia)
- Signs of new infection (e.g., pus, fever)
Special Patient Groups
Pregnancy
Prednisolone is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic absorption from ophthalmic use is minimal.
Second Trimester:
Minimal risk from ophthalmic use.
Third Trimester:
Minimal risk from ophthalmic use.
Lactation
Prednisolone is considered L3 (Moderately Safe) during lactation. Minimal systemic absorption from ophthalmic use is expected, leading to minimal excretion into breast milk. Use with caution and monitor the infant for any adverse effects.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption and excretion into breast milk.
Pediatric Use
Safety and efficacy have been established in children 2 years of age and older. Use with caution in younger children. Prolonged use in pediatric patients may increase the risk of steroid-induced glaucoma and cataracts; regular monitoring of intraocular pressure is crucial.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. However, elderly patients may be more susceptible to the development of steroid-induced glaucoma and cataracts; regular monitoring of intraocular pressure and lens status is recommended.
Clinical Information
Clinical Pearls
- Shake the suspension well before each use to ensure uniform distribution of the active ingredient.
- Prolonged use of ophthalmic corticosteroids can lead to increased intraocular pressure (IOP), glaucoma with optic nerve damage, posterior subcapsular cataract formation, and secondary ocular infections (bacterial, fungal, viral).
- This medication is contraindicated in most acute untreated purulent infections of the eye, vaccinia, varicella, and other viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye, and fungal diseases of ocular structures.
- Tapering the dose gradually is crucial to prevent rebound inflammation after prolonged use.
- Patients should be advised not to wear contact lenses during treatment, especially if they have an active eye infection or inflammation.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Loteprednol, Fluorometholone)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac) for certain inflammatory conditions
- Systemic corticosteroids (for severe systemic inflammation affecting the eye, used with caution)
Cost & Coverage
Average Cost:
Check current per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.