Prontosan (betaine-polyhexanide) dosing, indications, interactions, adverse effects, and more

Sections

Sections betaine/polyhexanide
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosing Form & 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

Administration

May warm gel to body temperature immediately before use

Store at room temperature, avoid excessive heat and protect from freezing

Dosing Form & 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

Administration

May warm gel to body temperature immediately before use

Store at room temperature, avoid excessive heat and protect from freezing

Frequency Not Defined

Chronic use may cause irritation

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 & 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.

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

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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