Pred Forte 1% Ophth Susp 10ml
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 medicine called a corticosteroid. They work by reducing swelling, redness, and irritation in your eyes 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 use.
6. Tilt your head back, and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply 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 on and the lid 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 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 use.
6. Tilt your head back, and gently drop the medication into your eye.
7. After application, keep your eyes closed and apply 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 on and the lid 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 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 medication is evenly mixed.
- Wash your hands thoroughly before administering the 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 form a pocket, and instill the prescribed number of drops.
- Close your eye gently for 1-2 minutes after instillation to allow the medication to absorb.
- 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 (unless advised otherwise by your doctor).
- Do not stop using the drops suddenly, especially if used for a long time, unless directed by your doctor, as this can cause a rebound of inflammation.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop instilled into the conjunctival sac 2 to 4 times daily
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
severeInflammation:
During the initial 24 to 48 hours, the dosing frequency may be increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy have not been fully established in pediatric patients. Use with caution and under medical supervision, typically similar to adult dosing but adjusted based on clinical response and severity.
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 acts by inhibiting the inflammatory response to a variety of agents. It decreases inflammation by suppressing the migration of polymorphonuclear leukocytes and reversing increased capillary permeability. It also inhibits the release of lysosomal enzymes, and the synthesis of prostaglandins and related compounds.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%)
Tmax:
Not applicable for ophthalmic use (minimal systemic absorption)
FoodEffect:
Not applicable for ophthalmic use
Distribution:
Vd:
Not applicable for ophthalmic use (minimal systemic absorption)
ProteinBinding:
Not applicable for ophthalmic use (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable for ophthalmic use (minimal systemic absorption)
Clearance:
Not applicable for ophthalmic use (minimal systemic absorption)
ExcretionRoute:
Renal (for systemically absorbed drug)
Unchanged:
Not applicable for ophthalmic use
Pharmacodynamics
OnsetOfAction:
Within hours
PeakEffect:
Within 1-2 days of regular use
DurationOfAction:
Varies, typically requires multiple daily dosing
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Change in taste
Feeling that something is in the eye
Headache
Burning or stinging
* 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Change in taste
Feeling that something is in the eye
Headache
Burning or stinging
* 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, swelling, or discharge from the eye
- New or worsening blurred vision
- Sensitivity to light
- Signs of a new eye infection (e.g., pus, fever, severe pain)
- 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 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, it is recommended that you have your eye pressure checked regularly. Consult with your doctor to schedule these check-ups.
Do not exceed the prescribed duration of treatment. Only use this medication for the length of time specified by your doctor. If you have a known allergy to sulfites, 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 potential benefits and risks of this medication with your doctor. This conversation will help you understand the implications for both you and your baby, allowing you to make an informed decision about your treatment.
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, it is recommended that you have your eye pressure checked regularly. Consult with your doctor to schedule these check-ups.
Do not exceed the prescribed duration of treatment. Only use this medication for the length of time specified by your doctor. If you have a known allergy to sulfites, 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 potential benefits and risks of this medication with your doctor. This conversation will help you understand the implications for both you and your baby, allowing you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Unlikely to occur with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If swallowed, drink water. If eye 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 an increase in IOP, especially with prolonged use (typically >10 days).
Timing: Before initiating therapy, especially if prolonged use is anticipated.
Ophthalmic examination (slit lamp)
Rationale: To assess baseline inflammation, corneal integrity, and rule out pre-existing infections.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly or bi-weekly for >10 days)
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider discontinuation or alternative 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 signs of infection; discontinue steroid and initiate appropriate antimicrobial therapy.
Corneal integrity/healing
Frequency: At each follow-up visit
Target: Improvement in corneal condition, absence of ulceration
Action Threshold: Delayed healing or worsening of corneal ulceration; discontinue steroid.
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 is Pregnancy Category C. While systemic corticosteroids are associated with some risks, ophthalmic absorption is minimal. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal risk due to low systemic absorption; however, caution is advised.
Second Trimester:
Minimal risk due to low systemic absorption.
Third Trimester:
Minimal risk due to low systemic absorption.
Lactation
Prednisolone is excreted in breast milk systemically, but the amount transferred from ophthalmic use is expected to be very low due to minimal systemic absorption. L3 (Moderately Safe). Consider the risk-benefit; monitor infant for adverse effects.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption by the mother.
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients. Use with caution and under medical supervision. Prolonged use in children may increase the risk of elevated intraocular pressure and cataract formation.
Geriatric Use
No specific dosage adjustments are typically required. Use with caution in patients with pre-existing conditions that may be exacerbated by corticosteroids (e.g., glaucoma, cataracts), although systemic effects are minimal.
Clinical Information
Clinical Pearls
- Always shake the suspension well before each use to ensure uniform drug distribution.
- 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, fungal, viral, especially herpes simplex). Do not use in active herpes simplex keratitis.
- Thinning of the cornea or sclera can occur with certain eye conditions, and corticosteroids may increase the risk of perforation in these cases.
- Patients should be advised not to wear contact lenses during treatment with ophthalmic suspensions containing preservatives like benzalkonium chloride, as it can be absorbed by soft contact lenses.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Loteprednol, Fluorometholone)
- Topical NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for non-infectious inflammation, especially post-operative
- Immunomodulators (e.g., Cyclosporine ophthalmic) for chronic inflammatory conditions
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand-name Pred Forte), Tier 1 (for 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.