MYCOSTATIN Oral suspension Ref.[49859] Active ingredients: Nystatin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Substipharm, 24 rue Erlanger, 75016 Paris, France

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for topical use
ATC code: D01AA01

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

5.2. Pharmacokinetic properties

Absorption

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations. Gastrointestinal absorption of nystatin is insignificant.

Elimination

Most orally administered nystatin is passed unchanged in the stool.

5.3. Preclinical safety data

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effect on male or female fertility.

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