There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* 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)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======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 pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--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=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing 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=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--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=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|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-->
|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=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
'''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.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
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.
<!--Look-Alike Drug Names-->
|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>
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.
<!--Drug Shortage Status-->
|drugShortage=
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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]
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Benzalkonium chloride is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
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Condition4
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Benzalkonium chloride in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
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)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Benzalkonium chloride in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Benzalkonium chloride in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzalkonium chloride in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Benzalkonium chloride 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
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Benzalkonium chloride in the drug label.
