Prednisolone Sod 1% Ophthsoln 10ml
It is used to treat eye swelling.
Drug Class
Ophthalmic Anti-inflammatory
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Prednisolone eye drops are a type of steroid medication 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 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication only in the eye.
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 introduce bacteria and lead to severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into your eye.
6. After application, keep your eyes closed and apply gentle 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, away from freezing temperatures. Keep the lid tightly closed and store all medications in a secure location, out of reach of children and pets.
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 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication only in the eye.
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 introduce bacteria and lead to severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into your eye.
6. After application, keep your eyes closed and apply gentle 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, away from freezing temperatures. Keep the lid tightly closed and store all medications in a secure location, out of reach of children and pets.
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 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
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to any surface, including the eye, 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 instilling drops to allow the medication to absorb.
- If using other eye drops, wait at least 5 minutes between medications.
- Do not wear contact lenses during treatment unless advised by your doctor.
- Do not stop using the drops suddenly, especially after prolonged use, as your doctor may want you to gradually reduce the dose.
- Avoid rubbing your eyes.
Available Forms & Alternatives
Available Strengths:
- Prednisolone AC 1% Ophth Susp 10ml
- Prednisolone AC 1% Ophth Susp 5ml
- Prednisolone AC 1% Ophth Susp 15ml
- Prednisolone Sod 1% Ophthsoln 10ml
- Prednisolone Sod Phos 15mg/5ml Sol
- Prednisolone Sod Phos 5mg/5ml Sol
- Prednisolone Sod Phos 10mg/5ml Sol
- Prednisolone Sod Phos 20mg/5ml Sol
- Prednisolone 25mg/5ml Solution
- Prednisolone ODT 10mg Tablets
- Prednisolone ODT 30mg Tablets
- Prednisolone ODT 15mg Tablets
- Prednisolone 15mg/5ml Solution
- Prednisolone 5mg Tablets
- Prednisolone 5mg Tablets
- Prednisolone Sod Phos 15mg/5ml Sol
- Prednisolone 15mg/5ml Solution
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 drops instilled into the conjunctival sac 2 to 4 times daily. In severe cases, drops may be used every 1 to 2 hours during the initial 24 to 48 hours, then tapered as inflammation subsides.
Condition-Specific Dosing:
severeInflammation:
1 to 2 drops every 1 to 2 hours initially, then taper.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and close monitoring of IOP.
Child:
Similar to adult dosing, but use with caution and close monitoring of IOP. Tapering is crucial.
Adolescent:
Similar to adult dosing.
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 synthetic glucocorticoid. It exerts its anti-inflammatory and immunosuppressive effects by binding to specific cytoplasmic glucocorticoid receptors. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines, adhesion molecules). This action reduces edema, fibrin deposition, capillary dilation, leukocyte migration, and collagen formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration.
Tmax:
Not applicable for systemic effects; local ocular concentration peaks rapidly.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not applicable for systemic effects; primarily localized in ocular tissues.
ProteinBinding:
Approximately 90-95% (for systemically absorbed prednisolone, but minimal for ophthalmic).
CnssPenetration:
Limited (for systemically absorbed prednisolone, negligible for ophthalmic).
Elimination:
HalfLife:
Approximately 2-4 hours (for systemically absorbed prednisolone, negligible for ophthalmic).
Clearance:
Not applicable for systemic effects from ophthalmic use.
ExcretionRoute:
Renal (for systemically absorbed prednisolone).
Unchanged:
Not significant for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Days to weeks depending on the severity and duration of treatment.
DurationOfAction:
Depends on frequency of administration; typically 4-6 hours per dose.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, these side effects can be life-threatening:
Signs of an allergic reaction, including:
+ 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 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 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.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, these side effects can be life-threatening:
Signs of an allergic reaction, including:
+ 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 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 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:
- Increased eye pain or discomfort
- Worsening redness or swelling
- Pus or discharge from the eye
- Sudden decrease in vision or blurred vision
- Sensitivity to light
- Signs of a new eye infection (e.g., fever, severe pain, swelling around the eye)
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.
Please note that this is not an exhaustive list of all potential interactions between this medication and other health issues.
To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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.
Please note that this is not an exhaustive list of all potential interactions between this medication and other health issues.
To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 known allergy to sulfites, 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. 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 known allergy to sulfites, 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 with ophthalmic use due to minimal systemic absorption. Local irritation or increased redness may occur with excessive use.
What to Do:
If swallowed, drink fluids. If local irritation occurs, discontinue use and consult a healthcare professional. For any concerns, call a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- None specific for ophthalmic use, but contraindications for use include acute untreated purulent ocular infections, fungal diseases of ocular structures, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye.
Major Interactions
- None significant due to minimal systemic absorption.
Moderate Interactions
- None significant due to minimal systemic absorption.
Minor Interactions
- Concurrent use with other topical ophthalmic medications: Administer at least 5 minutes apart to avoid washout.
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause elevated IOP, leading to glaucoma.
Timing: Prior to initiation of therapy.
Slit-lamp examination
Rationale: To assess baseline ocular inflammation, corneal integrity, and rule out underlying infections.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., >10 days) or in patients predisposed to elevated IOP (e.g., glaucoma patients, diabetics).
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant increase from baseline or above normal range; consider dose reduction or discontinuation.
Ocular examination (slit-lamp)
Frequency: Periodically, especially with prolonged use.
Target: Resolution of inflammation, absence of infection or corneal damage.
Action Threshold: Signs of secondary infection (bacterial, fungal, viral), persistent inflammation, or corneal defects.
Visual acuity
Frequency: Periodically.
Target: Stable or improved.
Action Threshold: Decreased vision, which could indicate cataract formation or other complications.
Symptom Monitoring
- Increased eye pain
- Persistent redness or irritation
- Blurred vision or vision changes
- Discharge from the eye
- Sensitivity to light (photophobia)
- Signs of new or worsening infection
Special Patient Groups
Pregnancy
Prednisolone is Pregnancy Category C. While systemic corticosteroids are associated with some risks, the systemic absorption from ophthalmic use 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:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Prednisolone is considered L2 (safer) for use during lactation. Systemic absorption from ophthalmic administration is minimal, and the amount excreted into breast milk is expected to be negligible. Therefore, adverse effects in a breastfed infant are unlikely.
Infant Risk:
Low risk.
Pediatric Use
Use with caution. Prolonged use in pediatric patients may increase the risk of elevated intraocular pressure and cataract formation. Close monitoring of IOP is essential.
Geriatric Use
No specific dosage adjustments are typically required. Elderly patients may be more susceptible to corticosteroid-induced elevated IOP, so regular monitoring is important.
Clinical Information
Clinical Pearls
- Always shake the bottle gently before use if it's a suspension, though prednisolone sodium phosphate is typically a solution.
- Tapering the dose is crucial to prevent rebound inflammation and to allow the eye to recover naturally. Do not stop abruptly unless directed by a physician.
- Prolonged use of ophthalmic corticosteroids can lead to increased intraocular pressure (IOP), glaucoma, optic nerve damage, posterior subcapsular cataracts, and secondary ocular infections (bacterial, fungal, viral).
- Corticosteroids can mask signs of infection or exacerbate existing infections, especially herpes simplex keratitis.
- Patients should be advised not to wear contact lenses during treatment, especially if they have an active infection or inflammation.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Loteprednol, Fluorometholone)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac) for non-infectious inflammation, especially post-operative.
- Systemic corticosteroids (for severe systemic inflammatory conditions affecting the eye, not typically for localized ocular inflammation).
Cost & Coverage
Average Cost:
$15 - $50 per 10ml bottle (generic)
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 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.