Nystatin ointment

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NISTATIN CREAM (UNGUENTUM NYSTATINI)

Composition:

Active ingredient: nystatin;

1 g of cream contains 100,000 IU nystatin;

Excipients: PEG-20 cetostearyl ether (a mixture of polyethylene glycol (macrogol) and cetostearyl ether), cetostearyl alcohol, mineral oil, polyethylene oxide-400, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous mass of yellow or slightly brownish color with a weak specific odor.

Pharmacotherapeutic group.

Antifungal agents for topical use in dermatology. Antibiotics.

ATC code: D01A A01.

Pharmacological properties.

Pharmacodynamics.

Nystatin is an antifungal antibiotic of the polyene group. Its activity is expressed in international units of action (IU). Nystatin acts against pathogenic fungi, particularly against Candida species of yeast-like fungi, as well as against Aspergillus species; it is inactive against bacteria.

The drug has moderate hyperosmolar activity, resulting in anti-exudative effect.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Skin diseases caused by Candida species.

Contraindications.

Hypersensitivity to nystatin or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Cross-resistance may occur with certain polyene antibiotics, for example, amphotericin B. The activity of the drug is reduced in the presence of divalent ions and fatty acids.

Special precautions for use.

Avoid contact of the ointment with eyes and other mucous membranes. In case of contact with eyes, rinse thoroughly with running water.

Do not use Nystatin ointment in cases of tuberculosis and viral skin infections, staphylococcal pyoderma of the skin.

The medicinal product contains cetostearyl alcohol, which may cause local skin reactions such as contact dermatitis.

Use during pregnancy or breastfeeding.

Do not use the medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Administration and Dosage.

Apply nystatin ointment topically. Apply a thin layer of the ointment to the affected skin area 1–2 times daily for 7–10 days.

For chronic, relapsing, and generalized candidiasis, repeat treatment courses should be performed with 2–3 week intervals between them.

Children.

The drug is not intended for use in children.

Overdose.

Not reported.

Side effects.

Allergic reactions, including itching, rash, fever, chills.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

15 g in tubes № 1.

Prescription status.

Prescription only.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and place of business.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.