Pred Mild 0.12% Ophth Susp 5ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Corticosteroid, 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 are used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions or injuries. It works by calming down the body's natural 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, eyelid, or surrounding skin, as this can lead to bacterial infection, 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 inner 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, eyelid, or surrounding skin, as this can lead to bacterial infection, 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 inner 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.
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface, including the eye, to prevent contamination.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not stop using the drops suddenly unless advised by your doctor, as this can cause inflammation to return.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops instilled into the conjunctival sac 2 to 4 times daily. In severe cases, 1-2 drops every hour, tapering to less frequent instillation as inflammation subsides.
Condition-Specific Dosing:
severeInflammation:
1-2 drops every hour during waking hours, then taper frequency as improvement occurs.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing similar to adults, but use with caution and under strict medical supervision.
Child:
Dosing similar to adults, 1-2 drops 2 to 4 times daily, or more frequently in severe cases, tapering as inflammation subsides.
Adolescent:
Dosing similar to adults, 1-2 drops 2 to 4 times daily, or more frequently in severe cases, tapering as inflammation subsides.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Prednisolone is a corticosteroid that acts by inhibiting the inflammatory response to a variety of agents. It stabilizes lysosomal membranes, prevents release of destructive acid hydrolases from leukocytes, inhibits macrophage accumulation in inflamed areas, reduces leukocyte adhesion to capillary endothelium, reduces dilation of capillaries and permeability of the microvascular bed, and reduces edema formation. It also inhibits the synthesis of prostaglandins and related compounds by inhibiting phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from ophthalmic administration.
Tmax:
Not well characterized for ophthalmic route due to minimal systemic absorption.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not well characterized for ophthalmic route; primarily localized in ocular tissues.
ProteinBinding:
Not well characterized for ophthalmic route; minimal systemic protein binding if absorbed.
CnssPenetration:
No
Elimination:
HalfLife:
Not well characterized for ophthalmic route due to minimal systemic absorption.
Clearance:
Not well characterized for ophthalmic route due to minimal systemic absorption.
ExcretionRoute:
Primarily renal if systemically absorbed, but minimal systemic absorption from ophthalmic use.
Unchanged:
Not well characterized for ophthalmic route.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Varies depending on severity of inflammation, typically within days.
DurationOfAction:
Several hours per dose.
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, 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
- 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, contact your doctor for medical advice. 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, 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
- 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, contact your doctor for medical advice. 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
- Pus or discharge from the eye
- Significant changes in vision (e.g., blurred vision, halos, loss of vision)
- New or worsening sensitivity to light
- Signs of a new eye infection
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, 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
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. 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 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, 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
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. 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 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. Therefore, 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 taking this medication to ensure the best outcome for you and your baby.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Therefore, 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 taking this medication to ensure the best outcome for you and your baby.
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 accidentally ingested, drink fluids. If excessive topical application occurs, flush 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
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP in susceptible individuals, leading to glaucoma.
Timing: Before initiating therapy, especially if treatment duration is expected to exceed 10 days.
Ocular examination (slit lamp, fundoscopy)
Rationale: To assess baseline ocular health and identify any pre-existing conditions or infections.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment duration exceeds 10 days (e.g., weekly or bi-weekly).
Target: Normal range (typically 10-21 mmHg), individual baseline.
Action Threshold: Significant or sustained increase above baseline; consult ophthalmologist.
Signs of ocular infection (e.g., redness, discharge, pain)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of signs of infection.
Action Threshold: Worsening or new signs of infection; discontinue and re-evaluate.
Corneal integrity/healing
Frequency: Periodically, especially if corneal damage is present.
Target: Evidence of healing.
Action Threshold: Delayed healing or worsening of corneal condition.
Symptom Monitoring
- Blurred vision
- Eye pain or discomfort
- Redness or irritation
- Discharge from the eye
- Sensitivity to light (photophobia)
- Changes in vision (e.g., halos around lights)
Special Patient Groups
Pregnancy
Prednisolone is Pregnancy Category C. While systemic corticosteroids are associated with some risks, ophthalmic absorption is minimal, suggesting a low risk to the fetus. 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.
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 after systemic administration, but the amount transferred from ophthalmic use is expected to be negligible due to minimal systemic absorption. Considered compatible with breastfeeding, but monitor infant for any unusual effects.
Infant Risk:
Low risk (L3) due to minimal systemic absorption by the mother.
Pediatric Use
Safety and efficacy are generally established for pediatric use. However, prolonged use in children may increase the risk of elevated intraocular pressure and cataract formation. Close monitoring of IOP is recommended.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. The risk of increased intraocular pressure and cataract formation may be higher in this population, requiring careful monitoring.
Clinical Information
Clinical Pearls
- Always shake the bottle well before each use to ensure uniform suspension 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 or exacerbate existing ocular infections (bacterial, fungal, viral, parasitic). Use with caution in patients with active infections, especially herpes simplex keratitis.
- This lower concentration (0.12%) is often preferred for milder inflammation or for tapering from higher concentrations to minimize side effects.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation, and if they must, to remove them before instilling drops and wait 15 minutes before reinserting.
Alternative Therapies
- Dexamethasone ophthalmic suspension/solution
- Loteprednol etabonate ophthalmic suspension (less IOP elevation risk)
- Fluorometholone ophthalmic suspension
- NSAID ophthalmic drops (e.g., ketorolac, bromfenac) for non-infectious inflammation, especially post-operatively.
- Cyclosporine ophthalmic emulsion (for chronic dry eye with inflammation)
Cost & Coverage
Average Cost:
Varies, typically $20-$60 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.