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polihexanide

Akantior · ATC code S01AX24

Also known as: Polihexanid

Key facts
Active substance
polihexanide
ATC code
S01AX24
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container
Marketing authorisation holder
SIFI SPA
Information as of
2026-10-27

Key facts

Polihexanide is an antiseptic biguanide polymer. As eye drops (AKANTIOR) it is used to treat Acanthamoeba keratitis in adults and children from 12 years of age.

What it is used for

  • Acanthamoeba keratitis in adults and children from 12 years of age

Dosing

  • 1 drop in the affected eye; start as early as possible
  • Intensive 19-day phase, daytime only: 16 times a day hourly for five days, then 8 times a day every 2 hours for seven days, then 6 times a day every 3 hours for seven days
  • Continuation phase: 4 times a day every 4 hours until cure, for no longer than 12 months
  • The intensive phase may be reinitiated if the condition deteriorates
  • Prescribed by physicians experienced in treating Acanthamoeba keratitis

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Urgent need of ocular surgery due to advanced Acanthamoeba keratitis

Important warnings

  • May cause mild to moderate eye discomfort (such as eye pain) and eye redness
  • No data in immunodeficiency or systemic immunosuppressive therapy
  • Contains phosphates: corneal calcification reported very rarely with significantly damaged corneas

Side effects

  • Most common: eye pain and ocular hyperaemia
  • Most serious: corneal perforation, corneal transplant and visual impairment, which are also part of the natural history of the disease

Interactions

  • No interaction studies; with other eye products, give AKANTIOR at least 5 minutes after the last one
  • No systemic interactions expected, as systemic absorption is negligible

Pregnancy and breastfeeding

  • Preferably avoided in pregnancy as a precaution
  • Breast-feeding: weigh the benefit of breast-feeding against the benefit of therapy

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Akantior
Norway
Akantior

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Akantior – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/akantior-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.