Sulfacetamide Sod 10% Ophth Oint
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Sulfonamide Antibiotic
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sulfacetamide sodium ophthalmic ointment is an antibiotic eye medicine used to treat bacterial eye infections. It works by stopping the growth of bacteria in your 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
This medication is for eye use only. Before and after use, wash your hands thoroughly. To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Unless advised by your doctor, avoid wearing contact lenses while using this medication. To administer the medication, gently pull down your lower eyelid and squeeze in the prescribed amount. Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Protect it from light exposure. Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose
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. Use the medication as directed, even if your symptoms improve.
Administration
This medication is for eye use only. Before and after use, wash your hands thoroughly. To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Unless advised by your doctor, avoid wearing contact lenses while using this medication. To administer the medication, gently pull down your lower eyelid and squeeze in the prescribed amount. Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Protect it from light exposure. Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose
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 the ointment.
- Do not touch the tip of the ointment tube to your eye, eyelid, or any other surface to prevent contamination.
- Remove contact lenses before applying the ointment and wait at least 15 minutes after application before reinserting them, or as advised by your doctor.
- Do not share your eye medication with others.
- Complete the full course of treatment, even if your symptoms improve, to prevent recurrence of infection.
- Avoid wearing eye makeup during treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily and at bedtime.
Condition-Specific Dosing:
severeInfections:
May apply every 3 to 4 hours initially, then reduce frequency as infection improves.
Pediatric Dosing
Neonatal:
Not established (use with caution due to theoretical risk of kernicterus in neonates, though systemic absorption is minimal).
Infant:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily and at bedtime.
Child:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily and at bedtime.
Adolescent:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 3 to 4 times daily and at bedtime.
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 inhibits bacterial growth by interfering with the synthesis of folic acid (para-aminobenzoic acid, PABA) which is essential for bacterial growth. It competitively inhibits dihydropteroate synthase, an enzyme involved in the conversion of PABA to dihydrofolic acid, a precursor of folic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from ophthalmic administration.
Tmax:
Not applicable (local action).
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable (primarily local action).
ProteinBinding:
Not significant systemically.
CnssPenetration:
No
Elimination:
HalfLife:
Not significant systemically.
Clearance:
Not significant systemically.
ExcretionRoute:
Not significant systemically.
Unchanged:
Not significant systemically.
Pharmacodynamics
OnsetOfAction:
Within hours (local antibacterial effect).
PeakEffect:
Not precisely quantified for ophthalmic use, but antibacterial effect is sustained with regular application.
DurationOfAction:
Several hours per application.
Confidence:
Medium
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 medical attention immediately:
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
Eye discharge
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
+ Cough that is new or worse
+ 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 do not experience any side effects or only have 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 attention:
Burning or stinging
* Eye irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about 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 attention immediately:
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
Eye discharge
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
+ Cough that is new or worse
+ 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 do not experience any side effects or only have 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 attention:
Burning or stinging
* Eye irritation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about 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 redness, swelling, or pain in the eye
- Worsening or new eye discharge
- Blurred vision or other vision changes
- Severe itching or burning of the eye
- Rash, hives, or swelling of the face, lips, or tongue (signs of allergic reaction)
- Fever or general malaise
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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a known sulfa allergy, as this may affect your ability to take this medication safely.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects and ensure that you can take this medication safely with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a known sulfa allergy, as this may affect your ability to take this medication safely.
To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects and ensure that you can take this medication safely with your other medications and health conditions.
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 to ensure your safety. Do not exceed the prescribed duration of use, as this may increase the risk of a secondary infection. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor 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 may occur with excessive application.
What to Do:
If excessive local irritation occurs, discontinue use and rinse eye with lukewarm water. For accidental ingestion, contact a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity is highly unlikely.
Drug Interactions
Moderate Interactions
- Silver preparations (e.g., silver nitrate): Incompatible, may precipitate.
Minor Interactions
- Local anesthetics containing PABA (e.g., procaine, tetracaine, benzocaine): May antagonize the antibacterial action of sulfacetamide.
Monitoring
Baseline Monitoring
Ocular examination (redness, discharge, swelling)
Rationale: To assess the initial severity and type of infection.
Timing: Prior to initiation of therapy.
Visual acuity
Rationale: To establish baseline and monitor for any changes.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of signs and symptoms of infection
Frequency: Daily
Target: Improvement in redness, discharge, discomfort.
Action Threshold: If no improvement within 7-10 days, or if symptoms worsen, re-evaluate diagnosis and treatment.
Signs of local irritation or hypersensitivity
Frequency: Daily
Target: Absence of increased redness, itching, swelling, or pain.
Action Threshold: Discontinue if severe irritation or allergic reaction occurs.
Symptom Monitoring
- Decreased redness of the eye
- Reduction in eye discharge
- Decreased itching or burning sensation
- Improved comfort
- Worsening pain or discomfort
- Increased redness or swelling
- New or worsening discharge
- Vision changes
- Rash or itching around the eye/face (signs of allergic reaction)
Special Patient Groups
Pregnancy
Use with caution during pregnancy (Category C). While systemic absorption from ophthalmic use is minimal, systemic sulfonamides are associated with risks (e.g., kernicterus in neonates if used near term). The benefits should outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified with ophthalmic use.
Second Trimester:
No specific increased risk identified with ophthalmic use.
Third Trimester:
Theoretical risk of kernicterus in neonates if significant systemic absorption were to occur, though highly unlikely with ophthalmic use.
Lactation
Considered low risk (L2) during breastfeeding. Systemic absorption is minimal, making infant exposure via breast milk unlikely to be significant. Monitor infant for diarrhea or rash.
Infant Risk:
Low risk.
Pediatric Use
Generally safe for use in pediatric patients, including infants, though caution is advised in neonates due to theoretical risk of kernicterus with systemic sulfonamides. Minimal systemic absorption makes this risk very low for ophthalmic use.
Geriatric Use
No specific dosage adjustments or precautions are necessary for geriatric patients. Use as per adult dosing.
Clinical Information
Clinical Pearls
- Ophthalmic ointments can cause temporary blurred vision; advise patients not to drive or operate machinery until vision clears.
- Instruct patients on proper administration technique to maximize efficacy and minimize contamination.
- If using other ophthalmic medications, apply ointments last to ensure proper absorption of drops.
- Sulfacetamide is generally effective against many common bacterial eye pathogens, but resistance can occur.
- Discontinue use if signs of hypersensitivity (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) occur, though rare with ophthalmic use.
Alternative Therapies
- Erythromycin ophthalmic ointment
- Tobramycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic solution
- Fluoroquinolone ophthalmic solutions (e.g., Moxifloxacin, Gatifloxacin)
Cost & Coverage
Average Cost:
$10 - $30 per 3.5g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 (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 overdose, including the medication taken, the amount, and the time it occurred.