Sulfacet/prednisolone Oph Sol 5ml
It is used to treat or prevent eye infections.
Drug Class
Ophthalmic Anti-infective and Anti-inflammatory
Pharmacologic Class
Sulfonamide Antibiotic; Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This eye drop medicine contains two active ingredients: an antibiotic (sulfacetamide) to fight bacterial infections and a steroid (prednisolone) to reduce swelling, redness, and irritation in your eye. It's used to treat eye conditions that involve both infection and inflammation.
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 prevent infection.
3. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and lead to severe eye problems or vision loss.
4. Unless advised by your doctor, do not wear contact lenses while using this medication.
5. To administer the medication:
- Tilt your head back.
- Drop the medication into your eye.
- After use, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
6. Do not use the medication if the liquid becomes discolored.
Storage and Disposal
Store the medication at room temperature, with the lid tightly closed, and in an upright position with the cap on. Protect the medication from heat and light.
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 dosing schedule. Do not use two doses at once 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 prevent infection.
3. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and lead to severe eye problems or vision loss.
4. Unless advised by your doctor, do not wear contact lenses while using this medication.
5. To administer the medication:
- Tilt your head back.
- Drop the medication into your eye.
- After use, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
6. Do not use the medication if the liquid becomes discolored.
Storage and Disposal
Store the medication at room temperature, with the lid tightly closed, and in an upright position with the cap on. Protect the medication from heat and light.
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 dosing schedule. Do not use two doses at once 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.
- Remove contact lenses before instilling 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.
- Avoid wearing eye makeup or contact lenses during treatment for active eye infections/inflammation.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops instilled into the conjunctival sac 2-4 times daily. In severe cases, dosage may be increased to 1-2 drops every 1-2 hours until control is achieved, then gradually reduced.
Condition-Specific Dosing:
conjunctivitis:
1-2 drops 2-4 times daily
uveitis:
1-2 drops every 1-2 hours initially, then taper
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
1-2 drops instilled into the conjunctival sac 2-4 times daily (use with caution and under medical supervision)
Adolescent:
1-2 drops instilled into the conjunctival sac 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 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
Sulfacetamide is a sulfonamide antibiotic that competitively inhibits bacterial dihydropteroate synthase, an enzyme essential for the synthesis of folic acid. This action prevents bacterial growth by interfering with the synthesis of purines and pyrimidines. Prednisolone is a corticosteroid that exerts its anti-inflammatory and immunosuppressive effects by inhibiting the release of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppressing leukocyte migration, and reversing increased capillary permeability. It also reduces edema, fibrin deposition, collagen deposition, and scar formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (ophthalmic route)
Tmax:
Not applicable for systemic Tmax due to topical use; local peak effect within hours.
FoodEffect:
Not applicable (ophthalmic route)
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Not available (minimal systemic distribution)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable for systemic half-life due to topical use; local duration of action is several hours.
Clearance:
Not available (minimal systemic clearance)
ExcretionRoute:
Renal (if systemically absorbed for sulfacetamide); Renal/Biliary (for prednisolone if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory and antibacterial effects.
PeakEffect:
Within 1-2 days for significant clinical improvement.
DurationOfAction:
Several hours per dose (requiring multiple daily applications).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
Sensitivity to bright light
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Any bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye irritation
* Dizziness
This is not an exhaustive list of 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.
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 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
Sensitivity to bright light
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Any bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye irritation
* Dizziness
This is not an exhaustive list of 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:
- Worsening eye pain, redness, or discharge
- Sudden decrease in vision
- New or worsening sensitivity to light
- Signs of allergic reaction (e.g., rash, severe itching, swelling of face/throat)
- Persistent headache or eye pressure
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.
Certain health conditions, including:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
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
Natural products and vitamins you are using
* Any health problems you have
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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
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
Natural products and vitamins you are using
* Any health problems you have
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. Do not exceed the prescribed duration of use, as directed by your doctor, since prolonged use may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this potential risk with your doctor. If you are using this medication for an extended period, have your eye pressure checked regularly and consult with your doctor. Additionally, if you are pregnant, planning to become pregnant, or breastfeeding, you must discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. For ocular overdose, flush eye with lukewarm water. If irritation persists, seek medical attention. For systemic concerns, call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Topical ophthalmic NSAIDs (concurrent use with corticosteroids may increase risk of corneal healing problems)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp, fundoscopy)
Rationale: To assess baseline ocular health, extent of infection/inflammation, and rule out other conditions.
Timing: Prior to initiation of therapy
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, especially with prolonged use.
Timing: Prior to initiation of therapy, particularly if therapy is expected to exceed 10 days
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Weekly or bi-weekly if therapy exceeds 10 days
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase in IOP (e.g., >21 mmHg or >5 mmHg above baseline) warrants discontinuation or re-evaluation.
Signs of infection resolution or worsening
Frequency: Daily by patient, periodically by clinician
Target: Resolution of redness, discharge, pain, and improved vision
Action Threshold: Worsening symptoms, new symptoms, or lack of improvement after several days.
Corneal integrity (slit lamp exam)
Frequency: As clinically indicated, especially with prolonged use or pre-existing corneal disease
Target: Intact cornea, no signs of ulceration or thinning
Action Threshold: Signs of corneal thinning, ulceration, or delayed healing.
Symptom Monitoring
- Ocular pain
- Redness
- Discharge
- Blurred vision
- Photophobia
- Foreign body sensation
- Itching
- Signs of secondary infection (e.g., fungal, viral)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Prednisolone is Category C, and Sulfacetamide is Category C. Minimal systemic absorption is expected with ophthalmic use, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with systemic corticosteroids, but risk is low with topical ophthalmic use.
Second Trimester:
Low risk with topical ophthalmic use.
Third Trimester:
Low risk with topical ophthalmic use.
Lactation
Caution should be exercised when administered to a nursing mother. While systemic absorption is minimal, small amounts of corticosteroids and sulfonamides may be excreted in breast milk. Monitor infant for potential adverse effects.
Infant Risk:
Low risk, but theoretical possibility of growth suppression (corticosteroid) or sulfonamide-related effects (e.g., kernicterus in jaundiced infants, though highly unlikely with ophthalmic use).
Pediatric Use
Safety and effectiveness in pediatric patients under 2 years of age have not been established. Prolonged use of corticosteroids in children may suppress growth and cause other systemic effects. IOP monitoring is crucial if used for extended periods.
Geriatric Use
No specific dosage adjustments are typically required. Elderly patients may be more susceptible to corticosteroid-induced IOP elevation, so regular monitoring is important.
Clinical Information
Clinical Pearls
- This combination product is useful for inflammatory ocular conditions where a bacterial infection is present or there is a risk of bacterial infection.
- Prolonged use of corticosteroids can lead to increased intraocular pressure (IOP), glaucoma, optic nerve damage, posterior subcapsular cataracts, and secondary ocular infections (fungal, viral).
- Sulfonamides may cause severe hypersensitivity reactions, though rare with topical ophthalmic use. Discontinue at the first sign of rash or other hypersensitivity.
- Do not use in patients with viral diseases of the cornea and conjunctiva (e.g., herpes simplex keratitis), mycobacterial infection of the eye, or fungal diseases of ocular structures.
- Shake the bottle well before use if it's a suspension.
Alternative Therapies
- Topical ophthalmic antibiotics (e.g., Moxifloxacin, Gatifloxacin, Azithromycin)
- Topical ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone, Loteprednol)
- Oral antibiotics (for severe systemic infections affecting the eye)
- Oral corticosteroids (for severe systemic inflammation affecting the eye)
Cost & Coverage
Average Cost:
Varies, typically $30-$100+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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 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 occurred.