NYSTATIN-ZDOROVYA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NYSATIN-ZDOROV'YA (NYSTATIN-ZDOROVYE)

Composition:

Active substance: nystatin;

One tablet contains|contains| nystatin equivalent to 4,500 IU/mg and dry substance 111.1 mg, or 500,000 IU|;

Excipients: lactose monohydrate, corn starch, talc, calcium stearate, methylcellulose, sodium croscarmellose, hypromellose, titanium dioxide (E 171), tartrazine (E 102), vanillin, copovidone.

Pharmaceutical form. Coated tablets.

Main physicochemical properties: coated tablets, light yellow with a greenish tint, with the smell of vanillin. Two layers are visible in cross-section.

Pharmacotherapeutic group. Antimicrobial agents used in intestinal infections. Antibiotics. ATC code A07AA02.

Pharmacological properties.

Pharmacodynamics. A polyene antibiotic produced by the actinomycete Streptomyces noursei. Exhibits antifungal activity.

The mechanism of action is due to binding with sterols of the fungal cytoplasmic membrane, incorporation into the cell membrane, and formation of multiple pores, leading to disruption of cytoplasmic membrane permeability, loss of fungal cell contents, and cell death.

Nystatin selectively acts against pathogenic yeast-like fungi of the genus Candida and Aspergillus. It exerts fungistatic, and at high doses—fungicidal effects.

Resistance to nystatin in fungi of the genus Candida and other sensitive species develops very slowly.

Inactive against bacteria, actinomycetes, and viruses. Ineffective against Trichomonas vaginalis and Gardnerella vaginalis (Haemophilus vaginalis).

Pharmacokinetics. When administered orally, nystatin is poorly absorbed from the gastrointestinal tract (bioavailability does not exceed 3–5%). Fungistatic blood concentrations and tissue concentrations close to therapeutic levels in internal organs are achieved only when the antibiotic is administered in high doses. Does not penetrate the blood-brain barrier and does not enter cerebrospinal fluid.

The majority of the orally administered antibiotic is excreted unchanged in feces, resulting in high intraluminal concentrations sufficient for therapeutic effect in mucocutaneous candidiasis of the gastrointestinal tract.

Absorbed nystatin is excreted from the body via urine.

Clinical characteristics.

Indications. Treatment of diseases caused by Candida species (Candida albicans, etc.), including candidiasis of the mucous membranes of the oral cavity|pharynx|, skin, and gastrointestinal tract.

Contraindications. Hypersensitivity to the components of the drug, peptic ulcer disease of the stomach and duodenum.

Interaction with other medicinal products and other forms of interaction. When used simultaneously|concomitantly| with|along with| clotrimazole|, the antifungal activity of the latter is reduced; when used with chloramphenicol, the antimicrobial action of both drugs is weakened; therefore, simultaneous use should be avoided. Cross-resistance may occur with certain polyene antibiotics, for example, amphotericin B.

Special considerations for use|administration|. Do not use the drug for the treatment of systemic mycoses.

Completion of the full|complete| course of therapy is required. The prescribed regimen and dosing schedule must be strictly followed throughout the entire course; the drug should be taken at regular intervals and doses must not be missed. If a dose is missed, it should be taken as soon as possible|as soon as possible|; do not take if the next|such| dose is nearly due; do not double the dose.

Nystatin may increase skin sensitivity to sunlight; therefore, direct sun exposure and artificial ultraviolet irradiation should be avoided during treatment.

The drug should be discontinued|withdrawn| if adverse reactions occur.

The drug contains tartrazine, which may cause allergic reactions.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy. If use of the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of administration|use| and dosage. Administer orally, 40–60 minutes before meals|eating|, without chewing. Individual doses should be taken at regular intervals.

Adults: 500000 IU| (1 tablet|tablet|) 3–4 times daily. Daily dose — 1500000–3000000 IU| (3–6 tablets|tablets|); in severe|severe| cases — up to 4000000–6000000 IU (8–12 tablets|tablets|).

Children aged 6 years and older: 500000 IU| (1 tablet|tablet|) 3–4 times daily; from age 13 — dosage as for adults. Maximum daily dose for children aged 6 years and older — 2000000 IU (4 tablets), from age 13 — 4000000 IU (8 tablets), in severe cases — 6000000 IU (12 tablets).

Duration of treatment — 10–14 days (depending on the severity of the disease and sensitivity to the drug).

For chronic, recurrent, and generalized| candidiasis, repeated courses should be conducted with|with| intervals of 2–3 weeks.

Dose adjustment is not required in patients with|with| renal/hepatic insufficiency.

Children. This medicinal product in the given pharmaceutical form may be administered to children aged 6 years and older.

Overdose. Symptoms: possible exacerbation of adverse effects. Oral doses of nystatin exceeding 5000000 IU per day have caused nausea and gastrointestinal disturbances.

Since gastrointestinal absorption of nystatin is negligible, overdose does not cause systemic toxicity.

Treatment: discontinue the drug, symptomatic therapy.

Adverse reactions.

Gastrointestinal system: possible bitter taste in the mouth, dyspeptic symptoms, nausea, vomiting, gastralgia, diarrhea, loss of appetite.

Allergic reactions: increased body temperature, chills, hypersensitivity reactions, including itching, skin rash, urticaria, anaphylactic reactions (e.g., angioedema, including facial swelling, bronchospasm), rarely—Stevens–Johnson syndrome.

Other: photosensitization, tachycardia, nonspecific myalgia; risk of spread of resistant fungal forms, requiring discontinuation of the drug.

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. Tablets, № 10×2 in blisters in a carton.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100.

(Limited Liability Company "FARMEKS GROUP")