Nystatin (Tablets, Ointment, Suppositories) Instructions for Use

ATC Code

A07AA02 (Nystatin)

Active Substance

Nystatin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

An antifungal drug from the polyene group. By binding to sterols in the fungal cell membrane, it disrupts its permeability, which leads to the leakage of essential cellular components. It has a fungistatic effect.

Active against yeast-like fungi of the genus Candida.

Pharmacokinetics

Absorption and Distribution

After oral administration, Nystatin is poorly absorbed from the gastrointestinal tract. When applied topically, it is not absorbed into the systemic circulation. It does not accumulate.

Elimination

It is eliminated from the body with feces.

Indications

For tablets and ointment

• Candidiasis of the skin and mucous membranes;
• Candidiasis of internal organs;
• Prevention of candidiasis during long-term therapy with antimicrobial drugs, especially in debilitated and weakened patients.

For vaginal suppositories

• Vaginal candidiasis;
• Prevention of fungal complications during local antimicrobial therapy.

For rectal suppositories

• Candidiasis of the lower intestines;
• Prevention of fungal lesions in the pre- and postoperative periods.

ICD codes

Dosage Regimen

Tablets

Orally.

A single dose is 250,000-500,000 IU; the frequency and duration of administration depend on the patient’s age, indications, severity of the disease, and treatment regimen.

Ointment

For the treatment of candidiasis of internal organs, Nystatin is prescribed orally regardless of food intake.

Adults are prescribed 500,000 IU 4-8 times/day.

For generalized candidiasis, up to 6,000,000 IU/day is prescribed.

Children aged 1-3 years are prescribed 250,000 IU 3-4 times/day, over 3 years of age – 250,000-500,000 IU 4 times/day. The duration of treatment is 10-14 days. If necessary, the course of treatment is repeated after a week.

For the treatment of candidiasis of the skin and mucous membranes, the ointment is applied in a thin layer to the affected areas 2 times/day, daily for 7-10 days. The use of the ointment can be combined with oral administration of Nystatin.

Vaginal suppositories are inserted into the vagina after hygiene procedures, 1 suppository 2 times/day (morning and evening). The course of treatment is 10-14 days.

Rectal suppositories are inserted deep into the rectum, 1 suppository 2 times/day (morning and evening). The course of treatment is 10-14 days.

If necessary, repeated courses of treatment are conducted.

Suppositories

Used intravaginally.

The dose and regimen depend on the indications.

Adverse Reactions

From the digestive system: when taking the drug orally and using rectal suppositories, nausea, vomiting, and diarrhea are possible.

Allergic reactions: skin itching, chills, fever.

Other: there is a risk of spreading resistant forms of fungi, which requires discontinuation of the drug.

Contraindications

• Impaired liver function;
• Pancreatitis;
• Peptic ulcer of the stomach and duodenum;
• Pregnancy;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

Nystatin is contraindicated for use during pregnancy.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Pediatric Use

Children aged 1-3 years are prescribed 250,000 IU 3-4 times/day, over 3 years of age – 250,000-500,000 IU 4 times/day. The duration of treatment is 10-14 days. If necessary, the course of treatment is repeated after a week.

Special Precautions

If adverse reactions occur, the dose should be reduced or the drug discontinued.

Treatment with vaginal suppositories should not be interrupted during menstruation. For fungal diseases of the vagina, simultaneous treatment of the sexual partner is recommended. Sexual intercourse should be avoided during treatment.

Overdose

There are currently no reports of overdose with Nystatin.

Drug Interactions

With simultaneous use of nystatin and clotrimazole, the activity of the latter decreases.

Storage Conditions

List B. The drug in tablet form should be stored in a dry, light-protected place at a temperature of 18°-20°C (64°-68°F).

The drug in the form of ointment, vaginal suppositories, and rectal suppositories should be stored in a dry, light-protected place at a temperature not exceeding 5°C (41°F).

Shelf Life

The shelf life of the drug in the form of tablets, vaginal suppositories, and rectal suppositories is 2 years; the shelf life of the drug in the form of ointment is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.