pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Para-Aminobenzoic Acid Inhibitors.

Para-Aminobenzoic Acid

Indications

Sourced from openFDA
  • This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Contraindications

Sourced from openFDA
  • This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.contraindicated

Dosage & administration

Sourced from openFDA

Seborrheic dermatitis including seborrhea sicca - Shake well before using. Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment. Secondary cutaneous bacterial infections - Shake well before using. Apply to affected areas twice daily for eight to ten days.

Warnings & precautions

Sourced from openFDA

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.

Adverse reactions

Sourced from openFDA

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).

Overdosage

Sourced from openFDA

The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.

Approval history

Sourced from openFDA
  • Dec 28, 1994ANDAANDA040066Bausch And Lomb
  • Dec 29, 1995ANDAANDA074449Bausch And Lomb
  • Dec 23, 1996NDANDA019931Bausch
  • Mar 23, 2009ANDAANDA078649Padagis Us

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
724 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective679.3%
  2. 2Drug Hypersensitivity669.1%
  3. 3Nausea466.4%
  4. 4Pain435.9%
  5. 5Headache375.1%
  6. 6Off Label Use375.1%
  7. 7Dyspnoea365.0%
  8. 8Rash354.8%
  9. 9Fatigue304.1%
  10. 10Weight Decreased263.6%
  11. 11Erythema253.5%
  12. 12Dizziness233.2%
  13. 13Pruritus233.2%
  14. 14Vomiting233.2%
  15. 15Back Pain223.0%

Literature

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Recent PubMed references pinned to Sulfacetamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 2 most recently updated of 2 ClinicalTrials.gov registrations naming Sulfacetamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Sulfacetamide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Sulfacetamide work?
Mechanism-of-action class: Para-Aminobenzoic Acid Inhibitors.
What is Sulfacetamide used for?
According to FDA labeling, Sulfacetamide carries indications including: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sulfacetamide?
Sulfacetamide is classified as Antiinfectives for treatment of acne, Sulfonamides, Sulfonamide Antibacterial, Para-Aminobenzoic Acid Inhibitors, Cellular Growth Phase Arrest, Cellular Synthetic Activity Alteration, Decreased Folic Acid Modification.
What are the brand names for Sulfacetamide?
Sulfacetamide is marketed under brand names including Avar, BP 10-Wash, BP Cleansing Wash, Bleph-10, Blephamide, Carmol Scalp, Clenia, Klaron.
What are the contraindications for Sulfacetamide?
Sulfacetamide labeling lists contraindications including: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.. Always consult the full prescribing information and a clinician.
Note. Data for sulfacetamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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