Nystatin rectal suppositories 500,000 units strip No. 10

Instructions Nystatin rectal suppositories 500,000 IU strip No. 10

Composition

active ingredient: nystatin;

1 suppository contains nystatin 500,000 IU (calculated as an activity of 4400 IU/mg and dry matter) – 0.111 g;

excipients: butyloxyanisole; butyloxytoluene; citric acid, monohydrate; mineral oil; hard fat.

Dosage form

Rectal suppositories.

Main physicochemical properties: suppositories of yellow or yellowish-brown color with a faint specific odor.

Pharmacotherapeutic group

Antimicrobial agents used for intestinal infections. ATX code A07A A02.

Pharmacological properties

Pharmacodynamics

Nystatin has a large number of double bonds in its structure, which determines the high tropism of the substance to the sterol formations of the cytoplasmic membrane of fungi. As a result, the molecule penetrates the cell membrane with the formation of a large number of channels that contribute to the uncontrolled transport of water, electrolytes and non-electrolytes. The cell loses resistance to the action of external osmotic forces and lyses. Nystatin is active against yeast-like fungi of the genus Candida and Aspergillus. It has a fungistatic, and in large doses - fungicidal effect. Resistance to nystatin-sensitive fungi develops very slowly.

Pharmacokinetics

When administered rectally, they are poorly absorbed through the walls of the large intestine. The resorptive effect is weakly expressed. They are excreted in the feces.

Indication

Candidiasis of the lower intestines. Prevention of fungal lesions in the pre- and postoperative period during surgical interventions on the lower intestines.

Contraindication

Hypersensitivity to the drug, liver dysfunction, pancreatitis, gastric and duodenal ulcers.

Interaction with other medicinal products and other types of interactions

When nystatin is used simultaneously with clotrimazole, the activity of the latter decreases.

Application features

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

Butyloxyanisole, butyloxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of mucous membranes.

Ability to influence reaction speed when driving vehicles or other mechanisms

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

Use during pregnancy or breastfeeding

Nystatin should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. Although the drug is absorbed in small amounts, it is not known whether it passes into breast milk, so if nystatin is necessary, the question of stopping breastfeeding should be considered.

Method of administration and doses

Adults and children over 13 years of age should be prescribed 1 suppository of 500,000 IU 2 times a day or 1 suppository of 250,000 IU 4 times a day.

The maximum daily dose is 1,000,000 IU (2 suppositories of 500,000 IU or 4 suppositories of 250,000 IU).

The duration of use is 10–14 days.

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

Children

Use for children over 13 years of age.

Overdose

Not described.

Adverse reactions

Nystatin usually does not cause side effects, but in case of hypersensitivity to it, the following side reactions are possible:

from the digestive system: nausea, vomiting, diarrhea are possible;

from the immune system: increased body temperature, chills; allergic reactions, including skin rashes, itching, urticaria; reactions at the application site, which may manifest, for example, as burning, pain, itching, tingling or irritation;

other: possible spread of resistant forms of fungi, which requires discontinuation of the drug and change of treatment tactics.

Expiration date

2 years.

Storage conditions

Store in original packaging at a temperature not exceeding 15 °C.

Keep out of reach of children.

Packaging

5 suppositories in a strip. 2 strips in a cardboard pack.

Vacation category

According to the recipe.

Producer

PJSC "Monpharm".

Location of the manufacturer and its business address

Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.