Instructions Nystatin film-coated tablets 500,000 IU blister No. 20
Composition
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).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a film coating from yellow to brownish-yellow in color.
Pharmacotherapeutic group
Antimicrobial agents used for intestinal infections. ATX code A07A A02.
Pharmacological properties
Pharmacodynamics
Nystatin is a polyene antibiotic produced by the actinomycete Streptomyces noursei. It exhibits antifungal effects. Nystatin binds to sterols in the fungal cell membrane, rendering the membrane incapable of functioning as a selective barrier, leading 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 high doses - fungicidal effect.
The drug is inactive against bacteria, actinomycetes and viruses. Ineffective against Trichomonas vaginalis and Gardnerella vaginalis (Haemophilus vaginalis).
Pharmacokinetics
When taken internally, 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 internally is excreted with feces in unchanged form, while high concentrations are created in the feces, sufficient to manifest a therapeutic effect in candidomycosis of the digestive tract mucosa.
The absorbed drug is excreted from the body in the urine.
Indication
Treatment of diseases of the digestive tract caused by fungi of the genus Candida (Candida albicans).
Contraindication
Hypersensitivity to any of the components of the drug; liver dysfunction; pancreatitis; gastric and duodenal ulcer.
Interaction with other medicinal products and other types of interactions
When used simultaneously with clotrimazole, the antifungal activity of clotrimazole is reduced, and with chloramphenicol, there is a 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.
Application features
The drug should not be used to treat systemic mycoses.
It is necessary to complete the full course of therapy. You should strictly adhere to the regimen and treatment schedule throughout the course, take the drug at regular intervals and do not miss a dose. If you miss a dose, take it as soon as possible; do not take it 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
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.
Method of administration and doses
Nystatin tablets should be taken orally, without chewing, 40-60 minutes before meals.
Adults are prescribed a dose of 500,000 IU (1 tablet) of the drug 3-4 times a day. The daily dose is 1,500,000-3,000,000 IU (3-6 tablets), in severe cases - up to 4,000,000-6,000,000 IU (8-12 tablets).
Children over 6 years of age should be prescribed the drug at a dose of 500,000 IU (1 tablet) 3-4 times a day.
Children over 13 years of age - dosage as for adults.
The maximum daily dose for children aged 6 and over is 2,000,000 IU (4 tablets), for children aged 13 and over is 4,000,000 IU (8 tablets), in severe cases is 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.
No dose adjustment is required for patients with renal or hepatic insufficiency.
Children
The drug in this dosage form should not be used in children under 6 years of age.
Overdose
Since the absorption of nystatin from the gastrointestinal tract is negligible, overdose does not cause systemic toxicity.
Treatment: drug withdrawal, symptomatic therapy.
Adverse reactions
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 rash, urticaria, anaphylactic reactions, for example, angioedema, including facial edema, bronchospasm, rarely - Stevens-Johnson syndrome.
Others: photosensitivity, tachycardia, nonspecific myalgia; possible spread of resistant forms of fungi, which requires discontinuation of the drug.
Expiration date
2 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 tablets in a blister, 1 blister in a pack.
Vacation category
According to the recipe.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and its business address
Ukraine, 03134, Kyiv, Myru St., 17.
