Benzalkonium chloride: Difference between revisions

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{{chembox new
{{DrugProjectFormSinglePage
| ImageFile = benzalkonium_chloride.png
|authorTag={{RB}}
| ImageSize = 220px
|genericName=Benzalkonium chloride
| IUPACName =  
|aOrAn=a
| OtherNames =  
|drugClass=[[First aid]] [[Antiseptic]]
| Abbreviations =  
|indicationType=treatment
| Appearance = white or yellow powder or gelatinous lumps colorless solution
|indication=[[minor cuts]], [[scrapes]] and [[burns]]
| Formula =  
|adverseReactions=[[Contact dermatitis|contact allergy]]
| MolarMass = (mixture)
 
| CASNo =8001-54-5
 
| Density =  
<!--Black Box Warning-->
| Solubility =  
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| MeltingPt =  
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| BoilingPt =  
 
| pKa =  
 
| pKb =  
 
| IsoelectricPt =  
<!--Adult Indications and Dosage-->
| DeltaHf =  
 
| DeltaHc =  
<!--FDA-Labeled Indications and Dosage (Adult)-->
| EINECS = 264-151-6
|fdaLIADAdult=====Indications====
| PubChem =
* [[First aid]] [[Antiseptic]] to help prevent the risk of infection in [[minor cuts]], [[scrapes]] and [[burns]]
| SMILES =
 
| InChI =  
====DIRECTIONS====
| Section2 = {{Chembox Properties
* clean the affected area
| Density = 0.98
* apply a small amount of this product to the area 1-3 times daily
| Solubility = very soluble
* may be covered with a sterile bandage when dry
| SolubleOther =  
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| Solvent =  
 
| MeltingPt =  
<!--Non–Guideline-Supported Use (Adult)-->
| BoilingPt =  
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| pKa =  
 
| pKb =  
<!--Pediatric Indications and Dosage-->
| IsoelectricPt =  
 
| SpecRotation =  
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
| RefractIndex =  
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
| Viscosity =  
 
| Dipole = }}
<!--Off-Label Use and Dosage (Pediatric)-->
| Section7 = {{Chembox Hazards
 
| EUClass = {{Hazchem_Xi}}
<!--Guideline-Supported Use (Pediatric)-->
| MainHazards =  
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| NFPA-H = 1
 
| NFPA-F = 0
<!--Non–Guideline-Supported Use (Pediatric)-->
| NFPA-R = 0
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| RPhrases = {{R21/22}}, {{R34}},
 
| SPhrases = {{S36/37/39}}, {{S45}}, {{S61}}
<!--Contraindications-->
| RSPhrases =  
|contraindications=<!--Warnings-->
| FlashPt =  
|warnings=* For external use only.
| Autoignition =  
 
| ExploLimits =  
* Do not use
| PEL =  
:* in the eyes
| RTECS = BO3150000}}
:* longer than 1 week unless directed by a doctor
}}
* Consult a doctor in case of
{{CMG}}
:* deep or puncture wounds
:* animal bites
:* serious burns
 
 
* Stop use and ask a doctorif condition persists or gets worse
 
 
* Keep out of reach of children
:* If swallowed, get medical help or contact a Poison Control Center right away.
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=* [[Contact dermatitis|contact allergy]]<ref name="pmid8654070">{{cite journal| author=Effendy I, Maibach HI| title=Surfactants and experimental irritant contact dermatitis. | journal=Contact Dermatitis | year= 1995 | volume= 33 | issue= 4 | pages= 217-25 | pmid=8654070 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=8654070  }} </ref>
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
 
 
<!--Drug Interactions-->
|drugInteractions=<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''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.
|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.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric 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.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* topical
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
 
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=: [[File:BENZALKONIUM Wiki Str.png|thumb|none|600px|This image is provided by the Wikipedia.]]
 
 
 
<!--Mechanism of Action-->
|mechAction=<!--Structure-->
|structure=* ACTIVE INGREDIENT
: Benzalkonium chloride .13% w/v
 
* INACTIVE INGREDIENTS
: nonoxynol-9, purified water, sodium bicarbonate
 
 
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=*
|packLabel=====POUCH INFORMATION====
 
: [[File:BENZALKONIUM PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


====Ingredients and Appearance====
: [[File:BENZALKONIUM Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


'''Benzalkonium chloride (alkyl dimethyl benzyl ammonium chloride)''' is a mixture of alkylbenzyl dimethylammonium chlorides of various alkyl chain lengths. It is commonly used as an [[antiseptic]] and [[spermicide]]. This product is a nitrogenous [[cation]]ic [[surfactant|surface-acting agent]] belonging to the [[quaternary ammonium cation|quaternary ammonium]] group. The greatest bactericidal activity is associated with the C12-C14 alkyl derivatives.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


It has been considered one of the safest synthetic [[biocide]]s known, and has a long history of efficacious use. However, conflicting studies cast doubt on its reputation for safety.<ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11575893&dopt=Abstract -- Benzalkonium chloride as a preservative in nasal solutions: re-examining the data -- Respir Med. 2001 Sep;95(9):728-33. Graf P. PMID: 11575893</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=14726922 -- Safety review of benzalkonium chloride used as a preservative in intranasal solutions: an overview of conflicting data and opinions. -- Otolaryngol Head Neck Surg. 2004 Jan;130(1):131-41.-- Marple B, Roland P, Benninger M.</ref> Some products have been reformulated in light of this research, but it is still widely used in [[eyewash]]es, hand and face washes, [[mouthwash]]es, [[Spermicide|spermicidal]] creams, and in various other cleaners, sanitizers, and [[disinfectant]]s.  It is also used as an annual treatment for the elimination of bacteria in water within [[waterbed]]s. However, manufacturers of OTC artificial tears and eye washes became concerned about chemical sensitivity from long-term daily use and have in some products substituted [[EDTA]] as a preservative and have added "for sensitive eyes" to labeling.  There has also been concern that long-term use of benzalkonium as a preservative in nose sprays may cause swelling of mucosa and lead to [[Rhinitis medicamentosa]].  Some manufacturers have put 3-day limits on safe use of such nose sprays. 
<!--Brand Names-->
|brandNames=* BZK PLUS PREP PAD®<ref>{{Cite web | title = Benzalkonium chloride  | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c06e7d6b-3696-4d5d-969d-9e8128d82a6d}}</ref>


Applications are extremely wide ranging, from disinfectant formulations to [[microbial corrosion]] [[corrosion inhibitor|inhibition]] in the oilfield sector.  It is often used to disinfect skin prior to withdrawing blood for Blood Alcohol Content ("BAC") tests because it contains no alcohol and cannot be said to taint the BAC test.
<!--Look-Alike Drug Names-->
|drugShortage=
}}
<!--Pill Image-->


Benzalkonium chloride is readily soluble in [[water]], [[alcohol]], and [[acetone]]. Formulation requires great care as Benzalkonium can be inactivated by certain [[organic compound]]s, including [[soap]], and must not be mixed with anionic surfactants. [[Hard water]] salts can also reduce biocidal activity. Although newer formulations are more resistant to deactivation, as with any disinfectant, it is recommended that surfaces are rinsed well before disinfection.


Aqueous solutions of benzalkonium chloride are neutral to slightly [[alkaline]], colorless, and nonstaining. Solutions [[foam]] profusely when shaken, have a bitter taste, and a faint almond-like odour, which is only detectable in concentrated solutions.


The mechanism of bactericidal/microbicidal action is thought to be due to disruption of intermolecular interactions. This can cause dissociation of [[cellular membrane]] bilayers, which compromises cellular permeability controls and induces leakage of cellular contents. Other biomolecular complexes within the bacterial cell can also undergo dissociation. [[Enzyme]]s, which finely control a plethora of respiratory and metabolic cellular activities, are particularly susceptible to deactivation. Critical intermolecular interactions and [[tertiary structure]]s in such highly specific biochemical systems can be readily disrupted by cationic surfactants.
<!--Label Display Image-->


Benzalkonium chloride solutions are rapidly acting anti-infective agents with a moderately long duration of action. They are active against [[bacteria]] and some [[virus]]es, [[fungi]], and [[protozoa]]. Bacterial [[spore]]s are considered to be resistant. Solutions are [[bacteriostatic]] or [[bactericidal]] according to their concentration. [[Gram-positive]] bacteria are generally more susceptible than [[gram-negative]]. Activity is not greatly affected by [[pH]], but increases substantially at higher temperatures and prolonged exposure times.


==Health concerns==
Benzalkonium chloride is an allergen.<ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10789868</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11709246</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9099278</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11233718</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10871106</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15701139</ref><ref>http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15186375</ref>


==References==
<references/>


==Further reading==
* [http://ull.chemistry.uakron.edu/erd/Chemicals/9000/8744.html Chemical database]
* Bernstein IL: Is the use of benzalkonium chloride as a preservative for nasal formulations a safety concern? J Allergy Clin Immunol 2000 Jan; 105(1 Pt 1): 39-44.
* Graf P: Adverse effects of benzalkonium chloride on the nasal mucosa: allergic rhinitis and rhinitis medicamentosa. Clin Ther 1999 Oct; 21(10): 1749-55.
* Graf P, Hallen H, Juto JE: Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995 May; 25(5): 395-400.


==External links==
<!--Category-->
* [http://www.ent-consult.com/salineadditives.html Nasal Saline Sprays - The Additives May Be the Problem]
* [http://preservative.free.fr/English/indexen.htm Use of benzalkonium in ocular preparations and eye drops, cytotoxic, allergenic and other consequences of benzalkonium use]
* [http://ull.chemistry.uakron.edu/erd/Chemicals/9000/8744.html Hazardous Chemical Database]


<br>
[[Category:Drug]]
{{Throat preparations}}
[[Category:chlorides]]
[[Category:Quaternary ammonium compounds]]
[[Category:Surfactants]]
[[Category:Antiseptics]]
[[Category:Disinfectants]]
<br>
[[de:Benzalkoniumchlorid]]
[[it:Cloruro di benzalconio]]
[[he:בנזלקוניום]]
[[hu:Benzalkónium-klorid]]
[[pt:Cloreto de benzalcônio]]
{{jb1}}
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Latest revision as of 20:15, 13 March 2015

Benzalkonium chloride
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: Rabin Bista, M.B.B.S. [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

Benzalkonium chloride is a First aid Antiseptic that is FDA approved for the treatment of minor cuts, scrapes and burns. Common adverse reactions include contact allergy.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

DIRECTIONS

  • clean the affected area
  • apply a small amount of this product to the area 1-3 times daily
  • may be covered with a sterile bandage when dry

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzalkonium chloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzalkonium chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Benzalkonium chloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzalkonium chloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzalkonium chloride in pediatric patients.

Contraindications

There is limited information regarding Benzalkonium chloride Contraindications in the drug label.

Warnings

  • For external use only.
  • Do not use
  • in the eyes
  • longer than 1 week unless directed by a doctor
  • Consult a doctor in case of
  • deep or puncture wounds
  • animal bites
  • serious burns


  • Stop use and ask a doctorif condition persists or gets worse


  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Benzalkonium chloride in the drug label.

Drug Interactions

There is limited information regarding Benzalkonium chloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Benzalkonium chloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benzalkonium chloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Benzalkonium chloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Benzalkonium chloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzalkonium chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzalkonium chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzalkonium chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzalkonium chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzalkonium chloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzalkonium chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • topical

Monitoring

There is limited information regarding Monitoring of Benzalkonium chloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benzalkonium chloride in the drug label.

Overdosage

There is limited information regarding Overdose of Benzalkonium chloride in the drug label.

Pharmacology

This image is provided by the Wikipedia.

Mechanism of Action

There is limited information regarding Benzalkonium chloride Mechanism of Action in the drug label.

Structure

  • ACTIVE INGREDIENT
Benzalkonium chloride .13% w/v
  • INACTIVE INGREDIENTS
nonoxynol-9, purified water, sodium bicarbonate

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzalkonium chloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benzalkonium chloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benzalkonium chloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benzalkonium chloride in the drug label.

How Supplied

Storage

There is limited information regarding Benzalkonium chloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Benzalkonium chloride |?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

POUCH INFORMATION

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Benzalkonium chloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Benzalkonium chloride in the drug label.

Precautions with Alcohol

  • Alcohol-Benzalkonium chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • BZK PLUS PREP PAD®[2]

Look-Alike Drug Names

There is limited information regarding Benzalkonium chloride 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.

  1. ↑ Effendy I, Maibach HI (1995). "Surfactants and experimental irritant contact dermatitis". Contact Dermatitis. 33 (4): 217–25. PMID 8654070.
  2. ↑ "Benzalkonium chloride".
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