Dosing and uses of Prontosan (betaine-polyhexanide)
Adult dosage forms and strengths
betaine/polyhexanide
topical irrigation solution
- 0.1%/0.1% in 350 mL and 40 mL
topical geL
- 0.1%/0.1% in 30 mL
Wound Cleansing & Moistening
Physically removes debris, slough, bioburden and biofilm in wounds; indicated for wound irrigation for acute and chronic skin wounds
Available as a kit with irrigation solution and geL
Irrigation solution: Rinse first with 350 mL bottle of irrigation solution, then repeat with second bottle containing 40 mL
Gel: Moistens and lubricates wound/bandage to assist with debridement or dressing changes; apply 3-5 mm to shallow flat wound surfaces or deep wound fissures
Other Information
May warm gel to body temperature immediately before use
Store at room temperature, avoid excessive heat and protect from freezing
Pediatric dosage forms and strengths
betaine/polyhexanide
topical irrigation solution
- 0.1%/0.1% in 350 mL and 40 mL
topical geL
- 0.1%/0.1% in 30 mL
Wound Cleansing & Moistening
Physically removes debris, slough, bioburden and biofilm in wounds; indicated for wound irrigation for acute and chronic skin wounds
Available as a kit with irrigation solution and geL
Irrigation solution: Rinse first with 350 mL bottle of irrigation solution, then repeat with second bottle containing 40 mL
Gel: Moistens and lubricates wound/bandage to assist with debridement or dressing changes; apply 3-5 mm to shallow flat wound surfaces or deep wound fissures
Other Information
May warm gel to body temperature immediately before use
Store at room temperature, avoid excessive heat and protect from freezing
Prontosan (betaine-polyhexanide) adverse (side) effects
Frequency not defined
Chronic use may cause irritation
Warnings
Contraindications
Hypersensitivity
Do not use in presence of hyaline cartilage
Do not use in combination with anionic tensides (may impair preservative)
Mixing with other cleansing soaps, ointments, oils or enzymes may lower efficacy
Cautions
For external use only on skin wounds
Do not infuse or inject
Do not ingest
Pregnancy and lactation
Pregnancy category: no information; systemic absorption unlikely
Lactation: unknown whether distributed in breast milk, systemic absorption unlikely
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Prontosan (betaine-polyhexanide)
Mechanism of action
Betaine: Acts as surfactant/detergent to aid with debridement
Polyhexanide: Preservative
The combination of these 2 products provides a lower surface tension than water and improves biofilm removal in wounds
