Cetalkonium

Approved Small Molecule

Cetalkonium

Cetalkonium is a C16 alkyl benzalkonium chloride derivative with an amphipathic property which allows it to be used in different types of formulations.1 It is a quaternary ammonium salt that acts as an antiseptic against a variety of bacteria and fungi.7 Cetalkonium is approved by the FDA for its use in over-the-counter products as a skin protectant.5 By Health Canada, it is also approved for its use in over-the-counter products.6 Cetalkonium is a C16 alkyl benzalkonium chloride derivative with an amphipathic property which allows it to be used in different types of formulations.1 It is a quaternary ammonium salt that acts as an antiseptic against a variety of bacteria and fungi.7 Cetalkonium is approved by the FDA for its use in over-the-counter products as a skin protectant.5 By Health Canada, it is also approved for its use in over-the-counter products.6

This compound belongs to the class of organic compounds known as phenylmethylamines. These are compounds containing a phenylmethtylamine moiety, which consists of a phenyl group substituted by an methanamine.

Structure

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Summary of Product Characteristics

Field Name Value
NameCetalkonium
TypeSmall Molecule
GroupsApproved
DescriptionCetalkonium is a C16 alkyl benzalkonium chloride derivative with an amphipathic property which allows it to be used in different types of formulations.1 It is a quaternary ammonium salt that acts as an antiseptic against a variety of bacteria and fungi.7 Cetalkonium is approved by the FDA for its use in over-the-counter products as a skin protectant.5 By Health Canada, it is also approved for its use in over-the-counter products.6
IndicationCetalkonium is used as a surfactant, germicide, fungicide, mildew preventive agents in silicone-based water repellents, emulsifier, disinfectant, topical anti-infective, and antiseptic antimicrobial for pharmaceuticals. For its chemical properties and its antiseptical characteristics, cetalkonium can be used in a wide variety of products as part of the formulations and it is also determined to be an active antiseptic ingredient in over-the-counter preparations.2
PharmacodynamicsCetalkonium is an antimicrobial agent and it has shown to be effective against both gram-positive, gram-negative bacteria and fungi. From this property, it has been shown to present a better activity against the gram-negative organisms.10
AbsorptionCetalkonium is used mainly topically and it is not absorbed.4 When administered orally and parenterally, cetalkonium absorption may happen but it is very insignificant.9
Volume of distributionAs cetalkonium is not absorbed, this pharmacokinetic property is not relevant.
Protein bindingAs cetalkonium is not absorbed, this pharmacokinetic property is not relevant.
MetabolismAs cetalkonium is not absorbed, this pharmacokinetic property is not relevant.
Route of eliminationAs cetalkonium is not absorbed, this pharmacokinetic property is not relevant. When administered orally, most of the administered dose is excreted unchanged in the feces as it is very poorly absorbed.9
Half lifeAs cetalkonium is not absorbed, this pharmacokinetic property is not relevant.
ToxicityA fatal dose is reported to be in the range of 1-3 g and the LD50 observed in different preclinical studies has been from 60-400 mg/kg depending on the animal species and route of administration.9
Affected organismsFungi Gram negative and gram positive bacteria
Taxonomy descriptionThis compound belongs to the class of organic compounds known as phenylmethylamines. These are compounds containing a phenylmethtylamine moiety, which consists of a phenyl group substituted by an methanamine.
KingdomOrganic compounds
Super classBenzenoids
ClassBenzene and substituted derivatives
Sub classPhenylmethylamines
Direct parentPhenylmethylamines
Molecular frameworkAromatic homomonocyclic compounds