Polihexanide is a broad-spectrum antiseptic with excellent cell and tissue tolerability, ability to bind to the organic matrix, low risk of contact sensitization, and wound healing promoting effect. Polihexanide interacts with acidic, negatively charged phospholipids in the bacterial membrane, leading to increased fluidity, permeability and loss of integrity, followed by the death of the organism. Polihexanide is also transferred to the cytoplasm, where it leads to disruption of the bacterial metabolism. Neutral phospholipids on the other hand are little or not affected by Polihexanide. This is commonly seen as the main reason for the low toxicity of Polihexanide against human cells and its high therapeutic range. Due to its nonspecific, strong interaction with negatively charged phospholipids, Polihexanide has a broad antimicrobial spectrum, including Gram-positive and Gramnegative bacteria, plaque-forming and biofilm-building bacteria, spore-forming bacteria (but not bacterial spores), intracellular bacteria such as chlamydiae and mycoplasma, and fungi including Candida spp. as well as Aspergillus spp. Polihexanide is classified as ‘practically nontoxic’. The therapeutic index of Polihexanide is more than 200-fold that of chlorhexidine.
Approval Year
Doses
| Dose | Population | Adverse events |
|---|---|---|
0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
Other AEs: Pain, Urinary tract infection... Other AEs: Pain (grade 1, 1 pt) Sources: Urinary tract infection (grade 1, 1 pt) Bladder discomfort (grade 1, 1 pt) Bladder irritation (grade 1, 1 pt) Bladder pain (grade 1, 2 patients) Bladder spasm (grade 1, 6 patients) Muscle spasms (grade 2, 2 patients) Bladder pain (grade 2, 2 patients) Urethral pain (grade 2, 3 patients) Bladder spasm (grade 2, 1 pt) Urinary incontinence (grade 2, 1 pt) |
AEs
| AE | Significance | Dose | Population |
|---|---|---|---|
| Bladder discomfort | grade 1, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Bladder irritation | grade 1, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Pain | grade 1, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Urinary tract infection | grade 1, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Bladder pain | grade 1, 2 patients | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Bladder spasm | grade 1, 6 patients | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Bladder spasm | grade 2, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Urinary incontinence | grade 2, 1 pt | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Bladder pain | grade 2, 2 patients | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Muscle spasms | grade 2, 2 patients | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Urethral pain | grade 2, 3 patients | 0.02 % 1 times / day multiple, intraurethral Studied dose Dose: 0.02 %, 1 times / day Route: intraurethral Route: multiple Dose: 0.02 %, 1 times / day Sources: |
unknown, ADULT Health Status: unknown Age Group: ADULT Sex: unknown Food Status: UNKNOWN Sources: |
| Substance Class |
Polymer
Created
by
admin
on
Edited
Mon Mar 31 21:46:58 GMT 2025
by
admin
on
Mon Mar 31 21:46:58 GMT 2025
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| Record UNII |
4XI6112496
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| Record Status |
Validated (UNII)
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| Record Version |
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| Classification Tree | Code System | Code | ||
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EPA PESTICIDE CODE |
111801
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admin on Mon Mar 31 21:46:58 GMT 2025 , Edited by admin on Mon Mar 31 21:46:58 GMT 2025
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EPA PESTICIDE CODE |
111802
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admin on Mon Mar 31 21:46:58 GMT 2025 , Edited by admin on Mon Mar 31 21:46:58 GMT 2025
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28757-48-4
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DBSALT002168
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1790898
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DTXSID2035726
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4XI6112496
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149534
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SUB09970MIG
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m8947
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100000091469
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27083-27-8
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ALTERNATIVE |
| Related Record | Type | Details | ||
|---|---|---|---|---|
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PARENT -> SALT/SOLVATE |
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|---|---|---|---|---|
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ACTIVE MOIETY |
| Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
|---|---|---|---|---|---|---|
| MOL_WEIGHT:WEIGHT AVERAGE(GPC) | CHEMICAL |
|