Betaine/Polyhexanide

Betaine/polyhexanide is used for wound irrigation for acute and chronic skin wounds.

Betaine/polyhexanide is available under the following different brand names: Prontosan.

Dosages of Betaine/Polyhexanide:

Dosing Form and Strengths

Topical Irrigation Solution

• 0.1%/0.1% in 350 mL and 40 mL

Topical Gel

• 0.1%/0.1% in 30 mL

Dosage Considerations – Should be Given as Follows:

Wound Cleansing and 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 a second bottle containing 40 mL
• Gel: Moistens and lubricates wound/bandage to assist with debridement or dressing changes; apply 3-5 mm too 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

Side effects of betaine/polyhexanide include:

• Irritation (with chronic use)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Betaine/polyhexanide has no listed severe interactions with other drugs.
• Betaine/polyhexanide has no listed serious interactions with other drugs.
• Betaine/polyhexanide has no listed moderate interactions with other drugs.
• Betaine/polyhexanide has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains betaine/polyhexanide. Do not take Prontosan if you are allergic to betaine/polyhexanide or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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 the efficacy

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Betaine/Polyhexanide?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Betaine/Polyhexanide?”

Cautions

• For external use only on skin wounds
• Do not infuse or inject
• Do not ingest

Pregnancy and Lactation

• There is no information regarding the use of betaine/polyhexanide during pregnancy. Systemic absorption is unlikely. Consult your doctor.
• It is unknown whether betaine/polyhexanide is distributed in breast milk. Systemic absorption is unlikely. Consult your doctor.