chlorhexidine indications/contra

Stem definitionDrug idCAS RN
597 55-56-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • chlorhexidine hydrochloride
  • chlorhexidine
  • chlorohex
  • chlorohexidine
  • chlorhexidine gluconate
A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
  • Molecular weight: 505.45
  • Formula: C22H30Cl2N10
  • CLOGP: 4.81
  • LIPINSKI: 2
  • HAC: 10
  • HDO: 10
  • TPSA: 167.58
  • ALOGS: -4.29
  • ROTB: 9

Drug dosage:

DoseUnitRoute
30 mg O
30 mg O

Approvals:

DateAgencyCompanyOrphan
Sept. 17, 1976 FDA MOLNLYCKE HLTH

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 2634.08 38.85 655 2852 30459 3351893
Intentional overdose 2164.67 38.85 490 3017 14735 3367617
Toxicity to various agents 2122.99 38.85 603 2904 46451 3335901
Suicide attempt 1854.40 38.85 436 3071 15411 3366941
Overdose 1474.39 38.85 425 3082 33553 3348799
Alcohol abuse 754.31 38.85 124 3383 563 3381789
Drug abuse 751.96 38.85 221 3286 18109 3364243
Alcohol poisoning 698.26 38.85 118 3389 653 3381699
Cardio-respiratory arrest 601.04 38.85 179 3328 15261 3367091
Somnolence 501.17 38.85 187 3320 32017 3350335
Alcohol use 456.14 38.85 90 3417 1281 3381071
Intentional product misuse 453.73 38.85 138 3369 12563 3369789
Coma 391.63 38.85 123 3384 12429 3369923
Hypotension 343.86 38.85 162 3345 49352 3333000
Tachycardia 331.11 38.85 127 3380 23244 3359108
Aggression 311.38 38.85 101 3406 11284 3371068
Vomiting 271.50 38.85 169 3338 89362 3292990
Agitation 264.30 38.85 103 3404 19603 3362749
Substance abuse 259.14 38.85 55 3452 1137 3381215
Intentional self-injury 253.50 38.85 72 3435 5113 3377239
Suicidal ideation 249.67 38.85 96 3411 17609 3364743
Alcohol interaction 222.99 38.85 42 3465 457 3381895
Loss of consciousness 222.48 38.85 101 3406 28046 3354306
Drug dependence 214.91 38.85 61 3446 4315 3378037
Anaphylactic reaction 213.72 38.85 79 3428 12975 3369377
Blood alcohol increased 184.76 38.85 33 3474 260 3382092
Alcoholism 181.10 38.85 38 3469 740 3381612
Death 167.24 38.85 157 3350 152167 3230185
Sopor 164.80 38.85 48 3459 3716 3378636
Poisoning 158.59 38.85 50 3457 5062 3377290

Pharmacologic Action:

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SourceCodeDescription
ATC A01AB03 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC B05CA02 BLOOD AND BLOOD FORMING ORGANS
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
IRRIGATING SOLUTIONS
Antiinfectives
ATC D08AC02 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
ATC D09AA12 DERMATOLOGICALS
MEDICATED DRESSINGS
MEDICATED DRESSINGS
Medicated dressings with antiinfectives
ATC R02AA05 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Antiseptics
ATC S01AX09 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Other antiinfectives
ATC S02AA09 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA04 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
ATC D08AC52 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
FDA PE N0000008478 Decreased Cell Wall Integrity
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000891 Anti-Infective Agents, Local
MeSH PA D003358 Cosmetics
MeSH PA D003879 Dermatologic Agents
MeSH PA D004202 Disinfectants
MeSH PA D009067 Mouthwashes
CHEBI has role CHEBI:35441 antiinfective agent

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Gingivitis indication 66383009 DOID:3087
Mouth Infection Prevention indication
Periodontitis contraindication 41565005 DOID:824
Open wound contraindication 125643001
Front Tooth Fillings contraindication
Denture stomatitis off-label use 69254008 DOID:11875
Aphthous ulcer of mouth off-label use 426965005 DOID:9663
Dental Plaque Prevention off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.17 Basic
pKa2 10.57 Basic
pKa3 3.32 Basic
pKa4 2.72 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7595021 May 12, 2023 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7066916 Feb. 17, 2024 DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7717889 Feb. 27, 2025 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION
2% CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 Oct. 10, 2006 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7935093 Oct. 2, 2027 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
3.15% PREVANTICS MAXI SWABSTICK PROF DSPLS N021524 June 3, 2005 OTC SWAB TOPICAL Feb. 14, 2021 DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING
3.15% PREVANTICS SWAB PROF DSPLS N021524 June 3, 2005 OTC SWAB TOPICAL Feb. 14, 2021 DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING
3.15% PREVANTICS SWABSTICK PROF DSPLS N021524 June 3, 2005 OTC SWAB TOPICAL Feb. 14, 2021 DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Solute carrier family 22 member 3 Transporter IC50 6.39 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 6.68 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 6.40 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.12 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.30 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 6.15 CHEMBL
72 kDa type IV collagenase Enzyme IC50 5.12 CHEMBL
Trypanothione reductase Enzyme Ki 5.70 CHEMBL
CAAX prenyl protease 2 Unclassified AC50 5.24 CHEMBL

External reference:

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IDSource
C0008199 UMLSCUI
D00858 KEGG_DRUG
DB00878 DRUGBANK_ID
CHEMBL790 ChEMBL_ID
4019673 VANDF
N0000006835 NDFRT
N0000147765 NDFRT
003674 NDDF
2358 RXNORM
373568007 SNOMEDCT_US
96316004 SNOMEDCT_US
9552079 PUBCHEM_CID
CHEMBL1628 ChEMBL_ID
CHEMBL1484251 ChEMBL_ID
D002710 MESH_DESCRIPTOR_UI
E64XL9U38K UNII
3697-42-5 SECONDARY_CAS_RN
C010882 MESH_SUPPLEMENTAL_RECORD_UI
500 INN_ID
CHEBI:3614 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
DYNA-HEX HUMAN OTC DRUG LABEL 1 0116-1021 LIQUID 2 g TOPICAL NDA 11 sections
Dyna-Hex 2 HUMAN OTC DRUG LABEL 1 0116-1022 SOLUTION 20 mg TOPICAL NDA 9 sections
DYNA-HEX 4 HUMAN OTC DRUG LABEL 1 0116-1060 LIQUID 4 g TOPICAL NDA 9 sections
ANTISEPTIC SKIN CLEANSER HUMAN OTC DRUG LABEL 1 0116-1061 SOLUTION 4 g TOPICAL NDA 9 sections
Cardinal Health Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-1130 SOLUTION 2 g TOPICAL NDA 9 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-2001 RINSE 1.20 mg ORAL ANDA 12 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-2800 SOLUTION 2 mg TOPICAL NDA 10 sections
Scrub Care HUMAN OTC DRUG LABEL 1 0116-2992 SOLUTION 2 g TOPICAL NDA 9 sections
Scrub Care HUMAN OTC DRUG LABEL 1 0116-2994 LIQUID 4 mg TOPICAL NDA 9 sections
Scrub Care HUMAN OTC DRUG LABEL 1 0116-4242 SOLUTION 2 g TOPICAL NDA 9 sections
Scrub Care HUMAN OTC DRUG LABEL 1 0116-4444 LIQUID 4 mg TOPICAL NDA 9 sections
Periogard HUMAN PRESCRIPTION DRUG LABEL 1 0126-0271 RINSE 1.20 mg BUCCAL ANDA 12 sections
PerioGard Alcohol Free HUMAN PRESCRIPTION DRUG LABEL 1 0126-0272 RINSE 1.20 mg BUCCAL ANDA 13 sections
Hibiclens HUMAN OTC DRUG LABEL 1 0234-0575 SOLUTION 213 g TOPICAL NDA 12 sections
Hibistat HUMAN OTC DRUG LABEL 2 0234-0587 SOLUTION 0.53 g TOPICAL NDA 8 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0363-1061 LIQUID 4 mg TOPICAL NDA 10 sections
CHLORHEXIDINE GLUCONATE HUMAN PRESCRIPTION DRUG LABEL 1 0374-5080 RINSE 1.20 mg ORAL ANDA 16 sections
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse HUMAN PRESCRIPTION DRUG LABEL 1 0404-4075 LIQUID 1.20 mg ORAL ANDA 15 sections
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse HUMAN PRESCRIPTION DRUG LABEL 1 0404-6720 LIQUID 1.20 mg ORAL ANDA 16 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0519-1322 SOLUTION 20 mg TOPICAL NDA 10 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0519-1344 SOLUTION 40 mg TOPICAL NDA 10 sections
Bactoshield HUMAN OTC DRUG LABEL 1 0519-1364 SPONGE 40 mg TOPICAL NDA 10 sections
Rugby Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0536-1102 LIQUID 2 g TOPICAL NDA 8 sections
PhysiciansCare Eyewash Station Additive Concentrate HUMAN OTC DRUG LABEL 2 0924-0169 SOLUTION 145.60 kg OPHTHALMIC OTC monograph not final 10 sections
Prevantics Swab HUMAN OTC DRUG LABEL 2 10819-1080 SOLUTION 31.50 mg TOPICAL NDA 8 sections
Prevantics swabstick HUMAN OTC DRUG LABEL 2 10819-4075 SOLUTION 31.50 mg TOPICAL NDA 9 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 11822-3678 LIQUID 4 mg TOPICAL NDA 10 sections
BD E-Z Scrub 107 HUMAN OTC DRUG LABEL 1 17271-107 SOLUTION 40 g TOPICAL ANDA 9 sections
BD E-Z Scrub HUMAN OTC DRUG LABEL 1 17271-505 SOLUTION 40 g TOPICAL NDA 9 sections
BD E-Z Scrub HUMAN OTC DRUG LABEL 1 17271-506 SOLUTION 20 mg TOPICAL NDA 9 sections