Nystatin

I N S T R U C T I O N for medical use of the medicinal product N Y S T A T I N (NYSTATIN)

Composition:

Active substance: nystatinum;

1 suppository contains nystatin 250,000 IU (calculated based on activity of 4,400 IU/mg and dry substance) – 0.0555 g or 500,000 IU (calculated based on activity of 4,400 IU/mg and dry substance) – 0.111 g;

Excipients: butylhydroxyanisole; butylhydroxytoluene; citric acid monohydrate; mineral oil; hard fat.

Pharmaceutical form. Rectal suppositories.

Main physico-chemical properties: yellow or yellowish-brown suppositories with a weak specific odor.

Pharmacotherapeutic group.

Antimicrobial agents used in intestinal infections.

ATC code A07A A02.

Pharmacological Properties.

Pharmacodynamics.

Nystatin has a structure containing a large number of double bonds, which confer high affinity of the substance for sterol components of fungal cytoplasmic membranes. As a result, the molecule penetrates into the cell membrane, forming numerous channels that facilitate uncontrolled transport of water, electrolytes, and nonelectrolytes. The cell loses resistance to external osmotic forces and undergoes lysis. Nystatin is active against yeast-like fungi of the genus Candida and Aspergilli. It exerts fungistatic, and at higher doses, fungicidal effects. Resistance to nystatin in susceptible fungi develops very slowly.

Pharmacokinetics.

Poorly absorbed through the walls of the large intestine following rectal administration. Systemic absorption is weakly expressed. Excreted with feces.

Clinical characteristics.

Indications.

Intestinal candidiasis. Prevention of fungal infections in the pre- and postoperative period during surgical interventions on the lower intestinal tract.

Contraindications.

Hypersensitivity to the drug, hepatic function impairment, pancreatitis, peptic ulcer of the stomach and duodenum.

Interaction with other medicinal products and other forms of interaction.

When nystatin is used concomitantly with clotrimazole, the activity of the latter is reduced.

Special precautions.

If local irritation or allergic reaction develops, the medication should be discontinued.

Butylhydroxyanisole and butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or mucous membrane irritation.

Use during pregnancy or breastfeeding.

Nystatin may be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. Although the drug is absorbed in negligible amounts, it is unknown whether it passes into breast milk; therefore, if nystatin treatment is necessary, a decision should be made whether to discontinue breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The drug does not affect the ability to drive vehicles or operate complex machinery.

Dosage and Administration.

For adults and children aged 13 years and older: administer 1 suppository of 500,000 IU twice daily or 1 suppository of 250,000 IU four times daily.

Maximum daily dose – 1,000,000 IU (2 suppositories of 500,000 IU or 4 suppositories of 250,000 IU).

Duration of use is 10–14 days.

If necessary, repeat the course after 2–3 weeks.

Children.

To be used in children aged 13 years and older.

Overdose.

Not described.

Side effects.

Nystatin generally does not cause adverse effects; however, in case of hypersensitivity to the drug, the following side effects are possible:

Gastrointestinal system: nausea, vomiting, diarrhea;

Immune system: increased body temperature, chills; allergic reactions including skin rash, pruritus, urticaria; local reactions at the site of application, which may manifest as burning, pain, itching, tingling, or irritation;

Other: possible spread of resistant fungal strains, requiring discontinuation of the drug and change in treatment strategy.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 15 ºC.

Keep out of reach of children.

Packaging.

5 suppositories per strip. 2 strips per cardboard box.

Prescription category.

Prescription only.

Manufacturer.

JSC " Monfarm ".

Manufacturer's address and location of business activity.

8, Zavodska Street, village Avramivka, Uman district, Cherkasy region, Ukraine, 19161.