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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Sulfacetamide Sodium, Sulfur
Brand Name
Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser
Generic Name
Sulfacetamide Sodium, Sulfur
Active Ingredient
SulfacetamideCategory
Sulfonamide Antibacterial [EPC]
Salt Form
Sodium
Variants
4
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 9.8 mg/g | LIQUID | TOPICAL | 71399-0486 |
| 98 mg/g | LIQUID | TOPICAL | 24470-955 |
| 98 mg/g | LIQUID | TOPICAL | 52187-546 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser, you must consult a qualified healthcare professional.
| 98 mg/g | LIQUID | TOPICAL | 42192-156 |
Detailed information about Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser
Sulfacetamide is a sulfonamide antibacterial agent used to treat ocular infections like conjunctivitis and dermatological conditions such as seborrheic dermatitis and acne. It works by inhibiting bacterial folic acid synthesis.
The dosage of sulfacetamide depends entirely on the formulation and the condition being treated. For Bacterial Conjunctivitis, the standard adult dose for the 10% ophthalmic solution is 1 to 2 drops instilled into the conjunctival sac of the affected eye(s) every 2 to 3 hours during the day. As the infection improves, the frequency of administration is typically reduced. For the Ophthalmic Ointment, a small ribbon (approximately 1/2 inch) is applied to the lower conjunctival sac one to four times daily and at bedtime.
In dermatology, for Seborrheic Dermatitis, sulfacetamide sodium 10% lotion is typically applied to the affected areas twice daily (morning and night). If using a Sulfacetamide Wash, the medication is usually applied to damp skin, worked into a lather, left on for 10 to 20 seconds, and then rinsed thoroughly. This process is generally repeated once or twice daily depending on the severity of the skin condition and the patient's tolerance.
Sulfacetamide is approved for use in pediatric patients, but with strict age limitations. For Ophthalmic use, it is generally considered safe for children aged 2 months and older. The dosing frequency is similar to that of adults (1-2 drops every 2-3 hours initially).
Warning: Sulfacetamide and all sulfonamides are strictly contraindicated in infants under the age of 2 months. This is because sulfonamides can displace bilirubin from albumin binding sites, leading to kernicterus (a serious form of brain damage caused by high bilirubin levels) in neonates.
Because sulfacetamide is primarily excreted by the kidneys, systemic absorption could theoretically lead to accumulation in patients with kidney failure. While topical and ocular use results in very low systemic levels, healthcare providers should exercise caution in patients with severe renal impairment, particularly if applying the medication to large areas of broken skin.
No specific dosage adjustments are typically required for hepatic (liver) impairment when using topical sulfacetamide. However, since the liver is responsible for the acetylation of absorbed sulfonamides, patients with end-stage liver disease should be monitored for signs of systemic toxicity if high-dose topical therapy is used.
Clinical studies have not identified significant differences in safety or efficacy between elderly and younger patients. However, elderly patients may have thinner skin or reduced renal function, which could slightly increase the risk of systemic absorption. Dosing should generally start at the lower end of the range.
Storage: Store sulfacetamide products at room temperature (20°C to 25°C or 68°F to 77°F). Ophthalmic solutions may darken over time; if the solution turns dark brown, it should be discarded as it may be irritating or less effective.
If you miss a dose, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Do not 'double up' or apply extra medication to make up for a missed application.
An overdose of topical or ocular sulfacetamide is unlikely to cause life-threatening symptoms. If the medication is accidentally swallowed, contact a Poison Control Center or seek emergency medical attention. Symptoms of systemic sulfonamide overdose may include nausea, vomiting, dizziness, and hematuria (blood in the urine). If the eye is over-treated, flush with lukewarm water.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not stop using the medication early, even if symptoms improve, as this can lead to a return of the infection.
The most frequently reported side effects of sulfacetamide are localized to the site of application. When used in the eye, patients commonly experience a transient stinging or burning sensation immediately after instillation. This usually lasts only a few seconds to a minute. In dermatological use, common side effects include local skin irritation, dryness, and mild redness (erythema). These effects are typically mild and often diminish as the skin adjusts to the medication. If dryness becomes bothersome, your doctor may recommend using the product less frequently or applying a non-comedogenic moisturizer.
Some patients may experience more pronounced local reactions, including:
Sulfacetamide is a sulfonamide antibiotic. Patients with a known allergy to 'sulfa' drugs must inform their healthcare provider before using this medication. While topical application limits systemic exposure, fatal reactions have occurred due to hypersensitivity to sulfonamides. If any sign of a skin rash, hives, or an allergic reaction occurs, the medication must be discontinued immediately. Additionally, sulfacetamide ophthalmic products are for topical ocular use only and should never be injected into the eye.
No FDA black box warnings for Sulfacetamide. However, clinicians maintain a high level of vigilance for the rare but severe systemic reactions associated with the sulfonamide class.
Sulfacetamide must NEVER be used in the following circumstances:
Sulfacetamide is classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, or there are no adequate and well-controlled studies in humans. However, the potential benefits may warrant use of the drug in pregnant women despite potential risks. The primary concern with sulfonamides during pregnancy is their use near the time of delivery (term), as they can cross the placenta and potentially cause kernicterus in the newborn by displacing bilirubin. Most clinicians avoid prescribing sulfacetamide in the third trimester unless no safer alternative is available. During the first and second trimesters, topical or ocular use is generally considered low risk due to minimal systemic absorption, but it should still be used with caution.
Sulfonamides are excreted into human breast milk in small amounts. While the systemic absorption from the mother's eye or skin is low, there is a theoretical risk to the nursing infant, particularly if the infant is under 2 months old or has G6PD deficiency (a genetic condition that can lead to hemolytic anemia when exposed to certain drugs). For healthy, older infants, the risk is likely minimal. However, nursing mothers should consult their pediatrician before using sulfacetamide. If use is necessary, applying pressure to the tear duct (punctal occlusion) after eye drops can help minimize the amount of drug that enters the mother's bloodstream and milk.
Sulfacetamide is a competitive inhibitor of the bacterial enzyme dihydropteroate synthase. This enzyme is a critical component of the folic acid synthesis pathway in bacteria. Specifically, sulfacetamide acts as a structural analog of para-aminobenzoic acid (PABA). Bacteria use PABA to synthesize dihydrofolic acid; sulfacetamide 'tricks' the enzyme into binding with it instead of PABA, thereby halting the production of folic acid precursors. Since folic acid is a necessary cofactor for the synthesis of thymidine and purines, the bacteria become unable to produce DNA and RNA, which prevents cell growth and replication (bacteriostatic effect). This mechanism is highly specific to bacteria because human cells do not synthesize folic acid internally; instead, they absorb it from dietary sources.
The pharmacodynamics of sulfacetamide are characterized by its concentration-dependent bacteriostatic activity. The time to onset for ocular infections is usually within 24 to 48 hours, with significant symptom relief occurring as the bacterial load decreases. For skin conditions like seborrheic dermatitis, the anti-inflammatory effects may take several days to become apparent. Tolerance to sulfacetamide does not typically develop, but bacterial resistance can occur through mutations in the dihydropteroate synthase enzyme or by the bacteria increasing their production of PABA to 'outcompete' the drug.
Common questions about Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser
Sulfacetamide is primarily used to treat bacterial infections of the eye, such as conjunctivitis (pink eye) and corneal ulcers. In dermatology, it is frequently prescribed for skin conditions like seborrheic dermatitis, acne vulgaris, and acne rosacea. It works by stopping the growth of bacteria that contribute to these infections and inflammatory states. While it is effective against many types of bacteria, it is not used for viral or fungal infections. Your doctor may prescribe it as a standalone treatment or in combination with other medications like sulfur or corticosteroids.
The most common side effects are localized to the area where the medication is applied. For the eye drops, patients often report a temporary stinging or burning sensation immediately after use. For skin products, mild irritation, redness, and dryness are the most frequent complaints. These effects are usually temporary and do not require stopping the medication. However, if you experience severe itching, a widespread rash, or blistering, you should contact your doctor immediately as these could be signs of a rare but serious allergic reaction.
There is no known direct interaction between alcohol and topical or ophthalmic sulfacetamide. Unlike some oral antibiotics, sulfacetamide does not cause a 'disulfiram-like' reaction when mixed with alcohol. However, alcohol can cause flushing and inflammation in the skin, which may worsen conditions like rosacea or seborrheic dermatitis that the drug is intended to treat. For the best results, it is often recommended to limit alcohol consumption while treating inflammatory skin conditions. Always follow the specific advice provided by your healthcare professional.
Sulfacetamide is classified as Pregnancy Category C, meaning it should only be used if the potential benefits outweigh the risks to the fetus. While topical use results in very low levels of the drug in the bloodstream, sulfonamides are generally avoided near the time of delivery. This is because they can cross the placenta and potentially cause jaundice or a serious condition called kernicterus in the newborn. If you are pregnant or planning to become pregnant, discuss the safety of sulfacetamide with your doctor. They will determine if a safer alternative is available for your specific condition.
For eye infections, most patients begin to see an improvement in redness and discharge within 24 to 48 hours of starting treatment. For skin conditions like acne or seborrheic dermatitis, it may take 1 to 2 weeks of consistent use to see a noticeable reduction in inflammation and scaling. It is crucial to continue using the medication for the full duration prescribed by your doctor, even if your symptoms seem to disappear quickly. Stopping the treatment too early can allow the infection to return or lead to antibiotic resistance.
Yes, you can stop taking sulfacetamide suddenly as it does not cause withdrawal symptoms or require a tapering period. However, you should only do so if you have completed the full course of treatment prescribed by your doctor. If you stop the medication prematurely because your symptoms have improved, the underlying bacterial infection may not be fully cleared. This can lead to a recurrence of the infection, which may then be harder to treat. Always consult your healthcare provider before deciding to discontinue an antibiotic early.
If you miss a dose of sulfacetamide, apply it as soon as you remember. If it is almost time for your next scheduled dose, simply skip the missed dose and continue with your regular routine. Do not apply a double amount of the medication to make up for the missed application, as this may increase the risk of local irritation. Consistency is key to the effectiveness of antibiotics, so try to use the medication at the same times each day. If you find yourself frequently forgetting doses, consider setting a reminder on your phone.
No, sulfacetamide is not known to cause weight gain. Because it is applied topically to the skin or eyes, very little of the medication enters the systemic circulation. Even if it were taken orally, sulfonamide antibiotics are not associated with metabolic changes or increased appetite that lead to weight gain. If you experience unusual weight changes while using this medication, it is likely due to another factor or an underlying health condition. You should discuss any unexpected physical changes with your healthcare provider for a thorough evaluation.
Sulfacetamide can interact with certain other medications, particularly those used in the same area. For example, it should not be used at the same time as silver-containing products (like silver nitrate) because they are chemically incompatible. It may also be less effective if used alongside local anesthetics like procaine or tetracaine. While it is generally safe to use with most oral medications, you should always provide your doctor with a full list of your current prescriptions, over-the-counter drugs, and supplements. This helps prevent potential interactions and ensures the safety of your treatment plan.
Yes, sulfacetamide sodium is widely available as a generic medication in various forms, including ophthalmic solutions and topical lotions. Generic versions are typically much more affordable than brand-name products and are required by the FDA to have the same active ingredient, strength, and efficacy. You may find it sold under various brand names or simply as 'Sulfacetamide Sodium.' If you have concerns about the cost of your medication, ask your pharmacist if a generic version is available for the specific formulation your doctor has prescribed.
Other drugs with the same active ingredient (Sulfacetamide)
Rare but serious systemic reactions can occur, even with topical sulfonamides, due to hypersensitivity. These include:
> Warning: Stop taking Sulfacetamide and call your doctor immediately if you experience any of these serious symptoms.
Chronic use of sulfacetamide may lead to the development of bacterial resistance, making future infections harder to treat. In the eye, long-term use may increase the risk of fungal keratitis (fungal infection of the cornea). On the skin, long-term use of sulfacetamide-sulfur products may lead to persistent dryness or a change in skin texture. Patients should be re-evaluated by their healthcare provider if the condition does not improve within a few weeks of starting therapy.
There are currently no FDA black box warnings specifically for Sulfacetamide Sodium. However, the general warnings for all sulfonamides regarding severe hypersensitivity reactions (like SJS and TEN) are included in the 'Warnings and Precautions' section of the drug label. These reactions, though rare with topical use, can be fatal and require immediate discontinuation of the drug at the first sign of a skin rash.
Report any unusual symptoms or persistent irritation to your healthcare provider to ensure the medication is being used safely.
For routine, short-term use of sulfacetamide eye drops or skin washes, intensive lab monitoring is usually not required. However, for patients on long-term therapy or those with significant systemic absorption risk, healthcare providers may monitor:
Sulfacetamide ophthalmic solution may cause temporary blurred vision immediately after application. Patients should wait until their vision clears before driving or operating heavy machinery. Topical skin applications do not typically interfere with these activities.
There are no known direct interactions between alcohol and topical sulfacetamide. However, alcohol can sometimes exacerbate inflammatory skin conditions like rosacea or seborrheic dermatitis, potentially counteracting the benefits of the medication. Discuss your alcohol intake with your doctor if you are treating these conditions.
Sulfacetamide does not require a tapering period. However, it is vital to complete the full course of treatment as prescribed by your doctor. Stopping the medication too early, even if symptoms have vanished, can allow the remaining bacteria to multiply and potentially develop resistance, leading to a more severe or recurrent infection.
> Important: Discuss all your medical conditions, especially any history of allergies or kidney disease, with your healthcare provider before starting Sulfacetamide.
There are no significant food interactions associated with topical or ophthalmic sulfacetamide. Unlike some oral antibiotics, its efficacy is not affected by the consumption of dairy, caffeine, or high-fat meals. However, maintaining a healthy diet supports the immune system's ability to fight infection.
Sulfacetamide may interfere with certain laboratory tests:
For each interaction, the primary management strategy is to inform your healthcare provider of all substances you are using. If an interaction is suspected, your doctor may adjust the timing of your doses or choose an alternative antibiotic that does not have the same metabolic interference.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, even those applied to the skin or eyes.
Conditions requiring a careful risk-benefit analysis by a healthcare provider include:
Patients allergic to one sulfonamide are likely to be allergic to others. There is also a theoretical risk of cross-sensitivity with other drugs containing sulfonamide moieties, such as:
While the risk of cross-reaction with non-antibiotic sulfonamides is debated in medical literature, patients with a history of severe sulfa allergy should be monitored closely if these drugs are initiated.
> Important: Your healthcare provider will evaluate your complete medical history, including all past allergic reactions, before prescribing Sulfacetamide.
Sulfacetamide is approved for use in children for bacterial conjunctivitis (2 months and older) and for certain skin conditions. It is highly effective and generally well-tolerated in the pediatric population. However, the risk of kernicterus makes it strictly contraindicated in infants younger than 2 months. Parents should be instructed on the proper administration of eye drops to ensure the child receives the correct dose and to prevent contamination of the dropper tip.
Clinical data indicates that sulfacetamide is safe for use in elderly patients. There are no specific age-related adjustments required for the standard topical or ocular dose. However, elderly patients are more likely to have co-existing conditions like chronic dry eye or reduced kidney function. They may also be taking multiple other medications (polypharmacy), increasing the theoretical risk of drug interactions. Healthcare providers should ensure that elderly patients can physically manage the administration of eye drops or lotions, as arthritis or tremors can make precise dosing difficult.
In patients with significant renal (kidney) impairment, the clearance of any absorbed sulfacetamide will be reduced. While the amount absorbed from the eye or skin is typically tiny, caution is advised if the medication is applied to large areas of broken skin or used for very long periods. In such cases, systemic accumulation of the drug's metabolites could occur. No specific GFR-based dosing scales exist for topical sulfacetamide, but clinical monitoring for systemic side effects is recommended.
Patients with hepatic (liver) impairment should use sulfacetamide with caution. The liver is responsible for the acetylation of sulfonamides. In cases of severe liver failure, the metabolism of absorbed drug may be impaired. However, like with renal impairment, this is rarely a clinical concern for standard topical or ocular therapy. Monitoring for signs of jaundice or increased liver enzymes is prudent if extensive topical therapy is used in patients with known liver disease.
> Important: Special populations require individualized medical assessment. Always disclose your full health status to your prescriber.
| Parameter | Value |
|---|---|
| Bioavailability | Minimal (Topical/Ocular); High (if Systemic) |
| Protein Binding | 10% - 25% |
| Half-life | 7 - 12 hours (Systemic) |
| Tmax | 1 - 4 hours (Systemic absorption) |
| Metabolism | Hepatic (N-acetylation) |
| Excretion | Renal (primarily as unchanged drug and metabolites) |
Sulfacetamide is classified as a Sulfonamide Antibacterial. It belongs to the same therapeutic family as sulfamethoxazole (found in Bactrim) and sulfadiazine. Within the topical category, it is often grouped with other antibacterial agents like erythromycin or bacitracin, though its mechanism of action is distinct from these macrolide and polypeptide antibiotics.