Sulfacetamide (topical): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{AJ}}
|genericName=Sulfacetamide sodium
|aOrAn=a
|aOrAn=a
|hasBlackBoxWarning=Yes
|drugClass=antiacne, [[antibacterial]]
|adverseReactions=<!--Black Box Warning-->
|indicationType=treatment
|indication=[[acne vulgaris]]
|adverseReactions=application site [[irritation]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 15:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=* Sulfacetamide sodium lotion  is indicated in the topical treatment of [[acne vulgaris]].


* Dosing Information
* Apply a thin film to affected areas twice daily.
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=* Bacterial keratitis
 
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Sulfacetamide sodium lotion  is contraindicated for use by patients having known [[hypersensitivity]] to sulfonamides or any other component of this preparation.
 
|warnings=* Fatalities have occurred, although rarely, due to severe reactions to [[sulfonamides]] including [[SJS|Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]], [[fulminant hepatic necrosis]], [[agranulocytosis]], [[aplastic anemia]], and other blood dyscrasias. [[Hypersensitivity]] reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of [[sulfonamide]] [[hypersensitivity]]. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 


=====Special Senses=====
* Sulfacetamide sodium lotion  contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including [[anaphylactic]] symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of [[sulfite]] [[sensitivity]] in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in [[asthmatic]] than in non-asthmatic people.


PRECAUTIONS
====General====


* For external use only. Keep away from [[eyes]]. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. [[Hypersensitivity]] reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and [[scaling]] of the [[skin]]. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.


 
* Keep out of the reach of children.
=====Urogenital=====
|clinicalTrials=* In controlled clinical trials for the management of [[acne vulgaris]], the occurrence of adverse reactions associated with the use of Sulfacetamide sodium lotion  was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide sodium lotion  had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local [[irritation]], stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=There is limited information regarding <i>Drug Interactions</i> of {{PAGENAME}} in the drug label.
|FDAPregCat=C
|useInPregnancyFDA=* Animal reproduction studies have not been conducted with Klaron® Lotion. It is also not known whether Sulfacetamide sodium lotion  can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium lotion  should be given to a pregnant woman only if clearly needed.


=====Body as a Whole=====
* Kernicterus may occur in the newborn as a result of treatment of a [[pregnant]] woman at term with orally administered [[sulfonamide]]. There are no adequate and well controlled studies of Sulfacetamide sodium lotion  in [[pregnant]] women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sulfacetamide sodium lotion . Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Safety and effectiveness in pediatric patients under the age of 12 have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
Line 264: Line 66:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Topical
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


Line 275: Line 75:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


====Signs and Symptoms====
<!--Pharmacology-->


* Description
<!--Drug box 2-->
 
|drugBox={{Drugbox2
====Management====
| Watchedfields = changed
| verifiedrevid = 470472833
| IUPAC_name = ''N''-[(4-aminophenyl)sulfonyl]acetamide
| image = Sulfacetamide mol structure
| image2= Sulfacetamid molecule.png


* Description
<!--Clinical data-->
| tradename = Bleph-10
| Drugs.com = {{drugs.com|monograph|sulfacetamide}}
| MedlinePlus = a601114
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category = 
| legal_AU = <!-- Unscheduled / S2 / S4 / S8 -->
| legal_UK = <!-- GSL / P / POM / CD -->
| legal_US = <!-- OTC / Rx-only -->
| legal_status = 
| routes_of_administration =


===Chronic Overdose===
<!--Pharmacokinetic data-->
| bioavailability =
| protein_bound =
| metabolism =
| elimination_half-life = 7 to 12.8 hours
| excretion =


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 144-80-9
| ATC_prefix = D10
| ATC_suffix = AF06
| ATC_supplemental = {{ATC|S01|AB04}}, {{ATCvet|J01|EQ21}}
| PubChem = 5320
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00634
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 5129
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 4965G3J0F5
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D05947
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 455


<!--Pharmacology-->
<!--Chemical data-->
| C=8 | H=10 | N=2 | O=3 | S=1
| molecular_weight = 214.243 g/mol
| smiles = O=S(=O)(c1ccc(N)cc1)NC(=O)C
| InChI = 1/C8H10N2O3S/c1-6(11)10-14(12,13)8-4-2-7(9)3-5-8/h2-5H,9H2,1H3,(H,10,11)
| InChIKey = SKIVFJLNDNKQPD-UHFFFAOYAW
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C8H10N2O3S/c1-6(11)10-14(12,13)8-4-2-7(9)3-5-8/h2-5H,9H2,1H3,(H,10,11)
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = SKIVFJLNDNKQPD-UHFFFAOYSA-N
}}
|mechAction=* The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth.
|structure=* Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.


<!--Drug box 2-->
[[File:Sulfacetamide.structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|drugBox=<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=* While absorption through intact [[skin]] in humans has not been determined, in vitro studies with human cadaver skin indicated a [[percutaneous]] absorption of about 4%. Sodium sulfacetamide is readily absorbed from the [[gastrointestinal]] tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.
 
<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=* The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Sulfacetamide sodium lotion  was evaluated in adult subjects (N=14) with [[acne vulgaris]]. The subjects applied Sulfacetamide sodium lotion  to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Sulfacetamide sodium lotion  excreted in the urine as [[sulfacetamide]] plus sulfanilamide, ranged from 0.08 to 0.33%.
 
<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
Line 313: Line 153:


<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=4 FL OZ (118 mL) bottles (NDC 0187-5198-04).
|packLabel=<!--Patient Counseling Information-->
|storage=* Store at Controlled Room Temperature 20 to 25°C (68 to 77°F)
 
* Shake well before using. Keep tightly closed.
|packLabel=====PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON====
 
NDC 0187-5198-04
 
Klaron®
 
sodium
sulfacetamide lotion
 
Lotion, 10%
 
FOR TOPICAL USE ONLY
 
One 4 fl oz (118 mL) Bottle
 
VALEANT
Pharmaceuticals North America LLC
 
[[File:Sulfacetamide topical drug lable01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


Line 321: Line 182:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* Carmol Scalp Treatment®
 
* Klaron®
<!--Look-Alike Drug Names-->
* Ovace®
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
* S.O.S.S.®
 
* Sodium Sulamyd®
<!--Drug Shortage Status-->
* Sulf-10®
|drugShortage=
|drugShortage=
}}
}}
Line 339: Line 200:
}}
}}
<!--Pill Image-->
<!--Pill Image-->


<!--Label Display Image-->
<!--Label Display Image-->


<!--Category-->
<!--Category-->


[[Category:Drug]]
[[Category:Drug]]

Latest revision as of 16:43, 11 May 2015

Sulfacetamide (topical)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Sulfacetamide (topical) is a antiacne, antibacterial that is FDA approved for the treatment of acne vulgaris. Common adverse reactions include application site irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Sulfacetamide sodium lotion is indicated in the topical treatment of acne vulgaris.
  • Apply a thin film to affected areas twice daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide (topical) in adult patients.

Non–Guideline-Supported Use

  • Bacterial keratitis

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Sulfacetamide (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sulfacetamide (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sulfacetamide (topical) in pediatric patients.

Contraindications

  • Sulfacetamide sodium lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation.

Warnings

  • Sulfacetamide sodium lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

PRECAUTIONS

General

  • For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
  • Keep out of the reach of children.

Adverse Reactions

Clinical Trials Experience

  • In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide sodium lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide sodium lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sulfacetamide (topical) in the drug label.

Drug Interactions

There is limited information regarding Drug Interactions of Sulfacetamide (topical) in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with Klaron® Lotion. It is also not known whether Sulfacetamide sodium lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium lotion should be given to a pregnant woman only if clearly needed.
  • Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide sodium lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sulfacetamide (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sulfacetamide (topical) during labor and delivery.

Nursing Mothers

  • It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sulfacetamide sodium lotion . Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

  • Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatic Use

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sulfacetamide (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sulfacetamide (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sulfacetamide (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sulfacetamide (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sulfacetamide (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of Sulfacetamide (topical) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Sulfacetamide (topical) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Sulfacetamide (topical) in the drug label.

Pharmacology

Template:Px
Template:Px
Sulfacetamide (topical)
Systematic (IUPAC) name
N-[(4-aminophenyl)sulfonyl]acetamide
Identifiers
CAS number 144-80-9
ATC code D10AF06 S01AB04 (WHO), Template:ATCvet
PubChem 5320
DrugBank DB00634
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 214.243 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life 7 to 12.8 hours
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

  • The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth.

Structure

  • Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.
This image is provided by the National Library of Medicine.

Pharmacodynamics

  • While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Pharmacokinetics

  • The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Sulfacetamide sodium lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Sulfacetamide sodium lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Sulfacetamide sodium lotion excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sulfacetamide (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sulfacetamide (topical) in the drug label.

How Supplied

4 FL OZ (118 mL) bottles (NDC 0187-5198-04).

Storage

  • Store at Controlled Room Temperature 20 to 25°C (68 to 77°F)
  • Shake well before using. Keep tightly closed.

Images

Drug Images

{{#ask: Page Name::Sulfacetamide (topical) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

NDC 0187-5198-04

Klaron®

sodium sulfacetamide lotion

Lotion, 10%

FOR TOPICAL USE ONLY

One 4 fl oz (118 mL) Bottle

VALEANT Pharmaceuticals North America LLC

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Sulfacetamide (topical) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sulfacetamide (topical) in the drug label.

Precautions with Alcohol

  • Alcohol-Sulfacetamide (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Carmol Scalp Treatment®
  • Klaron®
  • Ovace®
  • S.O.S.S.®
  • Sodium Sulamyd®
  • Sulf-10®

Look-Alike Drug Names

There is limited information regarding Sulfacetamide (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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