Nystatin film-coated tablets 500,000 IU blister 20 pcs

Active ingredient: nystatin;

1 tablet contains nystatin 500,000 IU;

excipients: microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate;

film-forming coating: hydroxypropylmethylcellulose, copovidone, polyethylene glycol, medium chain triglycerides, polydextrose, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

Film-coated tablets.

Main physicochemical properties: round tablets with a biconvex surface, coated with a film coating from yellow to brownish-yellow.

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

Pharmacodynamics.

Nystatin is a polyene antibiotic produced by the actinomycetes Streptomyces noursei. It has an antifungal effect. Nystatin binds to sterols in the cell membrane of fungi, as a result of which the membrane becomes unable to function as a selective barrier, which leads to the loss of essential cell components. Nystatin selectively acts on pathogenic yeast-like fungi of the genus Candida and Aspergillus. Resistance to nystatin in fungi of the genus Candida and other sensitive species develops slowly. It has a fungistatic, and in large doses – fungicidal effect. The drug is inactive against bacteria, actinomycetes and viruses. Ineffective against Trichomonas vaginalis and Gardnerella vaginalis (Haemophilus vaginalis).

Pharmacokinetics.

When taken orally, it is poorly absorbed in the digestive tract (its bioavailability does not exceed 3-5%). Fungistatic concentrations of the antibiotic in the blood and close to therapeutic concentrations in the tissues of internal organs are achieved only when administered in large doses. The drug does not penetrate the blood-brain barrier and does not enter the cerebrospinal fluid. The bulk of the antibiotic taken orally is excreted unchanged in the feces, while high concentrations are created in the feces, sufficient to demonstrate a therapeutic effect in candidomycosis of the digestive tract mucosa. The absorbed drug is excreted from the body with urine.

Treatment of diseases of the digestive tract caused by fungi of the genus Candida (Candida albicans).

• Hypersensitivity to any of the components of the drug; liver dysfunction; pancreatitis; gastric and duodenal ulcer.

When used simultaneously with clotrimazole, the antifungal activity of clotrimazole decreases, with chloramphenicol – mutual weakening of the antimicrobial effect; their simultaneous use should be avoided. Cross-resistance is observed with a number of polyene antibiotics, for example, with amphotericin B.

The drug should not be used to treat systemic mycoses. A full course of therapy is required. The regimen and treatment regimen should be strictly followed throughout the course, the drug should be taken at regular intervals and the dose should not be missed. If a dose is missed, it should be taken as soon as possible; do not take if it is almost time for the next dose; DO NOT double the dose.

Nystatin may increase the skin’s sensitivity to sunlight, so direct sunlight and artificial ultraviolet radiation should be avoided during treatment.

If adverse reactions develop, the drug should be discontinued.

The safety of the drug for pregnant women has not been established, therefore the drug is contraindicated during pregnancy.

Breastfeeding should be discontinued during treatment.

No effect.

Nystatin tablets should be taken orally, without chewing, 40-60 minutes before meals. Adults should be prescribed a dose of 500,000 units (1 tablet) of the drug 3-4 times a day. The daily dose is 1,500,000-3,000,000 units (3-6 tablets), in severe cases – up to 4,000,000-6,000,000 units (8-12 tablets).

Children from 6 years of age should be prescribed the drug in a dose of 500,000 IU (1 tablet) 3-4 times a day. Children from 13 years of age – the dosage as for adults. The maximum daily dose for children over 6 years of age is 2,000,000 IU (4 tablets), from 13 years of age – 4,000,000 IU (8 tablets), in severe cases – 6,000,000 IU (12 tablets).

The average duration of treatment is 10-14 days (depending on the severity of the disease and sensitivity to the drug).

In case of chronic recurrent candidiasis, repeat courses of therapy should be carried out with breaks of 2-3 weeks between them.

Patients with renal or hepatic insufficiency No special dose adjustment is required.

The drug in this dosage form should not be used in children under 6 years of age.

Symptoms: possible increase in side effects. Oral doses of nystatin exceeding 5,000,000 units per day have caused nausea and gastrointestinal disorders. Since the absorption of nystatin from the gastrointestinal tract is insignificant, an overdose does not cause systemic toxicity.

Treatment: drug withdrawal, symptomatic therapy.

Digestive system: bitter taste in the mouth, dyspeptic symptoms, nausea, vomiting, diarrhea, abdominal pain, loss of appetite.

Immune system: fever, chills, hypersensitivity reactions, including itching, skin rashes, urticaria, anaphylactic reactions, for example, angioedema, including facial edema, bronchospasm, rarely – Stevens-Johnson syndrome.

Others: photosensitivity, tachycardia, nonspecific myalgia; possible risk of spreading resistant forms of fungi, which requires discontinuation of the drug.

2 years. Do not use after the expiry date stated on the packaging.

In the original packaging at a temperature not exceeding 25 ° C. Store out of the reach of children.