Tetracycline with nystatin tablets po 100 mg + 22.2 mg -

pharmachologic effect

The drug contains tetracycline, a bacteriostatic antibiotic from the tetracycline group, and nystatin, a polyene antibiotic that has a fungistatic effect on yeast-like fungi of the genus Candida. The nystatin included in the composition helps reduce the number of side effects of tetracycline.

Tetracycline disrupts the formation of a complex between transfer RNA and the ribosome, which leads to disruption of protein synthesis.

Active against gram-positive microorganisms - Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-producing strains), Streptococcus spp. (some strains, including Streptococcus pneumoniae), Actinomyces spp., Listeria spp., Bacillus anthracis, Clostridium spp.; gram-negative microorganisms - Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, Escherichia coli, Enterobacter spp. (including Enterobacter aerogenes), Klebsiella spp., Salmonella spp., Shigella spp., Yersinia pestis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia spp., Borrelia burgdorferi, Brucella spp. (in combination with streptomycin).

Microorganisms resistant to tetracycline: Pseudomonas aeruginosa, Proteus spp., Serratia spp., most strains of Bacteroides spp. fungi, small viruses, group A beta-hemolytic streptococci (including 44% of Streptococcus pyogenes strains and 74% of Streptococcus faecalis strains).

Tetracycline with nystatin 100 thousand units 10 pcs. film-coated tablets

pharmachologic effect

Combined antibiotic.

Composition and release form Tetracycline with nystatin 100 thousand units 10 pcs. film-coated tablets

Tablets - 1 tablet:

active substances: tetracycline (in terms of the active substance) - 0.1000 g (100,000 units) and nystatin (in terms of the active substance) - 0.0222 g (100,000 units);
Excipients: gelatin, calcium stearate, lactose (milk sugar), magnesium hydrosilicate (talc), potato starch;
Shell composition: sucrose (refined sugar), magnesium hydroxycarbonate (basic magnesium carbonate), corn dextrin, sunflower oil, beeswax, solid petroleum paraffins, magnesium hydrosilicate (talc), tropeolin O dye, indigo carmine dye.

Film-coated tablets, 100 mg + 22.2 mg.

10 tablets in a blister pack.

10 tablets in an orange glass jar or in a polymer jar.

One can or 1,2, 3, 4, 5 blister packs with instructions for use are placed in a cardboard pack.

Description of the dosage form

Film-coated tablets are light green in color, round in shape with biconvex surfaces. The cross section shows two layers.

Directions for use and doses

Dosages are indicated in terms of tetracycline (one tetracycline tablet contains 0.1 g).

Orally after meals with water, 0.5 g 4 times a day or 0.5 - 1 g every 12 hours, maximum daily dose 4.0 g.

The duration of treatment is determined by the doctor.

Uncomplicated urethral, endocervical and rectal infections caused by Chlamydia trachomatis - 0.5 g 4 times a day for at least 7 days.

Pharmacodynamics

Tetracycline disrupts the formation of a complex between transfer RNA and the ribosome, which leads to disruption of protein synthesis.

Gram-negative microorganisms - Haemophilus influenzae, Haemophilus ducreyi, Bordetella pertussis, Escherichia coli, Enterobacter spp. (including Enterobacter aerogenes). Klebsiella spp., Salmonella spp., Shigella spp., Yersinia pestis, Bartonella bacilliformis, Vibrio cholerae, Vibrio fetus, Rickettsia spp., Borrelia burgdorferi, Brucella spp. (in combination with streptomycin).

Microorganisms resistant to tetracycline: Pseudomonas aeruginosa, Proteus spp.. Scrratia spp., most strains of Bacteroides spp. fungi, small viruses, group A beta-hemolytic streptococci (including 44% of Streptococcus pyogenes strains and 74% of Streptococcus faecalis strains).

Pharmacokinetics

The main pharmacokinetic parameters relate to tetracycline. Absorption - 75-77%, decreases with food intake, binding to plasma proteins - 55-65%. The time to reach maximum concentration when taken orally is 2-3 hours (it may take 2-3 days to achieve therapeutic concentrations). Over the next 8 hours, the concentration gradually decreases. The maximum concentration is 1.5-3.5 mg/l (a concentration of 1 mg/l is sufficient to achieve a therapeutic effect).

Penetrates through the placental barrier and into breast milk. Volume of distribution - 1.3-1.6 l/kg.

It is distributed unevenly in the body: the maximum concentration is determined in the liver, kidneys, lungs, spleen, and lymph nodes. The concentration in bile is 5-10 times higher than in blood serum. In the tissues of the thyroid and prostate glands, the concentration of tetracycline corresponds to that found in plasma; in pleural, ascitic fluid, saliva, milk of lactating women - 60 - 100% concentration in plasma. It accumulates in large quantities in bone tissue, tumor tissue, dentin and enamel of baby teeth. Penetrates poorly through the blood-brain barrier. With intact meninges, it is not detected in the cerebrospinal fluid or is detected in small quantities (5-10% of the plasma concentration). In patients with diseases of the central nervous system, especially with inflammatory processes in the meninges, the concentration in the cerebrospinal fluid is 8-36% of the concentration in plasma.

Slightly metabolized in the liver. The half-life is 6-11 hours, with anuria - 57-108 hours. It is found in urine in high concentration 2 hours after administration and persists for 6-12 hours; in the first 12 hours, up to 10-20% of the dose is excreted by the kidneys. In smaller quantities (5-10% of the total dose) it is excreted with bile into the intestine, where partial reabsorption occurs, which promotes long-term circulation of the active substance in the body (enterohepatic circulation). Excretion through the intestines - 20-50%. During hemodialysis it is removed slowly.

Nystatin is practically not absorbed from the gastrointestinal tract. Excreted through the gastrointestinal tract. Nystatin does not have cumulative properties.

Indications for use Tetracycline with nystatin 100 thousand units 10 pcs. film-coated tablets

Nystatin in the tablet aims to prevent the development of candidiasis infections.

Infectious diseases caused by tetracycline-sensitive microflora: pneumonia, bronchitis, tracheitis, pleural empyema, cholecystitis, pyelonephritis, intestinal infections, syphilis, uncomplicated gonorrhea, brucellosis, rickettsiosis, purulent infections of the skin and soft tissues, trachoma, tonsillitis, pharyngitis, furunculosis, stomatitis , gingivitis, acne.

Contraindications

Hypersensitivity to the components of the drug, pregnancy, lactation, leukopenia, liver failure, gastric and duodenal ulcers.

Children and adolescents for this dosage form.

With caution: renal failure.

Application Tetracycline with nystatin 100 thousand units 10 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated.

special instructions

Due to the possible development of photosensitivity, it is necessary to limit insolation.

To prevent irritation of the mucous membranes of the mouth, it is recommended to rinse your mouth thoroughly after taking the drug.

With long-term use, periodic monitoring of the function of the kidneys, liver, and hematopoietic organs is necessary.

It can mask the manifestations of syphilis, and therefore, if a mixed infection is possible, monthly serological analysis is necessary for 4 months.

All tetracyclines form stable complexes with calcium in any bone-forming tissue. In this regard, intake during the period of tooth development can cause long-term staining of teeth in a yellow-gray-brown color, as well as enamel hypoplasia.

To prevent hypovitaminosis, vitamins B and K and brewer's yeast should be prescribed.

Overdose

No data.

Side effects Tetracycline with nystatin 100 thousand units 10 pcs. film-coated tablets

From the digestive system: anorexia, vomiting, diarrhea, nausea, abdominal pain, glossitis, esophagitis, gastritis, ulceration of the stomach and duodenum, hypertrophy of the papillae of the tongue, discoloration of tooth enamel in children, irritation of the mucous membranes of the oral cavity, dysphagia, hepatotoxic effect , pancreatitis, increased activity of “liver” transaminases, hyperbilirubinemia.

From the nervous system: increased intracranial pressure, dizziness or unsteadiness.

From the hematopoietic organs: hemolytic anemia, thrombocytopenia, neutropenia.

From the urinary system: azotemia, hypercreatininemia.

Allergic reactions: maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug-induced lupus erythematosus.

Other: superinfection, photosensitivity, hypovitaminosis B.

Drug interactions

Absorption is reduced by antacids containing aluminum, magnesium and calcium, iron supplements and cholestyramine.

Due to the suppression of intestinal microflora, the prothrombin index decreases (requires a reduction in the dose of indirect anticoagulants).

Reduces the effectiveness of bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins).

Chymotrypsin increases the concentration and duration of circulation of the drug. Reduces the effectiveness of estrogen-containing oral contraceptives and increases the risk of breakthrough bleeding; retinol - risk of developing increased intracranial pressure.

Pharmacokinetics

The main pharmacokinetic parameters relate to tetracycline. Absorption - 75 - 77%, decreases with food intake, connection with plasma proteins - 55 - 65%. The time to reach maximum concentration when taken orally is 2-3 hours (it may take 2-3 days to reach therapeutic concentrations). Over the next 8 hours, the concentration gradually decreases. The maximum concentration is 1.5 - 3.5 mg/l (a concentration of 1 mg/l is sufficient to achieve a therapeutic effect).

Penetrates through the placental barrier and into breast milk. Volume of distribution – 1.3 – 1.6 l/kg.

It is distributed unevenly in the body: the maximum concentration is determined in the liver, kidneys, lungs, spleen, and lymph nodes. The concentration in bile is 5–10 times higher than in blood serum. In the tissues of the thyroid and prostate glands, the concentration of tetracycline corresponds to that found in plasma; in pleural, ascitic fluid, saliva, milk of lactating women - 60 - 100% concentration in plasma. It accumulates in large quantities in bone tissue, tumor tissue, dentin and enamel of baby teeth. Penetrates poorly through the blood-brain barrier. With intact meninges, it is not detected in the cerebrospinal fluid or is detected in small quantities (5–10% of the plasma concentration). In patients with diseases of the central nervous system, especially with inflammatory processes in the meninges, the concentration in the cerebrospinal fluid is 8–36% of the concentration in plasma.

Slightly metabolized in the liver. The half-life is 6 - 11 hours, with anuria - 57 - 108 hours. It is found in urine in high concentration 2 hours after administration and persists for 6 - 12 hours; in the first 12 hours, up to 10-20% of the dose is excreted by the kidneys. In smaller quantities (5 - 10% of the total dose) it is excreted with bile into the intestine, where partial reabsorption occurs, which promotes long-term circulation of the active substance in the body (enterohepatic circulation). Excretion through the intestines - 20 - 50%. During hemodialysis it is removed slowly.

Nystatin is practically not absorbed from the gastrointestinal tract. Excreted through the gastrointestinal tract. Nystatin does not have cumulative properties.

Tetracycline with nystatin tablet p/o 100 thousand units 10 pcs

Pharmacological group:

Antibacterial agents.
Pharmacodynamics:
The drug contains tetracycline, a bacteriostatic antibiotic from the tetracycline group, and nystatin, a polyene antibiotic that has a fungistatic effect on yeast-like fungi of the genus Candida. The nystatin included in the composition helps reduce the number of side effects of tetracycline.

Tetracycline disrupts the formation of a complex between transfer RNA and the ribosome, which leads to disruption of protein synthesis.

Pharmacokinetics:

Penetrates through the placental barrier and into breast milk. Volume of distribution – 1.3 – 1.6 l/kg.

Slightly metabolized in the liver. The half-life is 6 - 11 hours, with anuria - 57 - 108 hours. It is found in urine in high concentration 2 hours after administration and persists for 6 - 12 hours; in the first 12 hours, up to 10-20% of the dose is excreted by the kidneys. In smaller quantities (5 - 10% of the total dose) it is excreted with bile into the intestine, where partial reabsorption occurs, which promotes long-term circulation of the active substance in the body (enterohepatic circulation). Excretion through the intestines - 20 - 50%. During hemodialysis it is removed slowly.

Nystatin is practically not absorbed from the gastrointestinal tract. Excreted through the gastrointestinal tract. Nystatin does not have cumulative properties.

special instructions

Due to the possible development of photosensitivity, it is necessary to limit insolation.

To prevent irritation of the mucous membranes of the mouth, it is recommended to rinse your mouth thoroughly after taking the drug.

With long-term use, periodic monitoring of the function of the kidneys, liver, and hematopoietic organs is necessary.

It can mask the manifestations of syphilis, and therefore, if a mixed infection is possible, monthly serological analysis is necessary for 4 months.

To prevent hypovitaminosis, vitamins B and K and brewer's yeast should be prescribed.

Side effect

From the nervous system: increased intracranial pressure, dizziness or unsteadiness.

From the hematopoietic organs: hemolytic anemia, thrombocytopenia, neutropenia.

From the urinary system: azotemia, hypercreatininemia.

Allergic reactions: maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug-induced lupus erythematosus.

Other: superinfection, photosensitivity, hypovitaminosis B.

Overdose

No data.

Tetracycline with nystatin film-coated tablets 100 mg + 22.2 mg No. 10

pharmachologic effect

TETRACYCLINE WITH NISTATIN is a combination drug, the effect of which is determined by the properties of its constituent components. Tetracycline is a broad-spectrum bacteriostatic antibiotic. Active against gram-positive (Staphylococcus spp., including those producing penicillinase, Streptococcus, Streptococcus pneumoniae, Clostridium spp., Bacillus anthracis, Listeria monocytogenes) and gram-negative (Neisseria gonorrhoeae, Bordetella pertussis, Escherichia coli, Klebsiella spp., Salmonella spp., Shigella spp.) microorganisms, as well as Rickettsia spp., Chlamydiaceae, Mycobacterium spp., Spirochaetaceae. Most fungi and small viruses are resistant to the drug. Nystatin is an antifungal drug, an antibiotic from the group of polyenes. Changes the permeability of cell membranes of fungi and slows down their growth. Active against yeast-like fungi of the genus Candida. The addition of Nystatin to tablet dosage forms of antibiotics prevents the development of candidiasis.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug, including:

pneumonia;
bronchitis;
pleural empyema;
angina;
cholecystitis;
pyelonephritis;
intestinal infections;
endocarditis;
endometritis;
prostatitis;
syphilis;
gonorrhea;
brucellosis;
rickettsial diseases;
purulent soft tissue infections;
osteomyelitis;
trachoma;
conjunctivitis;
blepharitis;
prevention of postoperative infections.

Contraindications

Severe liver dysfunction;
leukopenia;
pregnancy;
lactation (breastfeeding);
children under 8 years of age;
hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy (II-III trimester) and lactation.

special instructions

The drug should not be prescribed to children under 8 years of age, because tetracycline, binding to calcium, is deposited in bones and teeth, causing enamel hypoplasia, persistent staining of teeth and suppression of bone tissue growth.

Nystatin, which is part of the drug, prevents the development of candidiasis infections that occur while taking antibiotics.

If it is necessary to prescribe the drug during lactation, the issue of stopping breastfeeding should be decided.

Compound

1 tablet contains:

Active ingredients: 100,000 units (100 mg) tetracycline hydrochloride, 100,000 units of nystatin.

Directions for use and doses

Doses are based on tetracycline.

Adults are prescribed 250 mg 3-4 times a day; daily dose - up to 2 g. The drug should not be prescribed at a dose of less than 800 mg per day, because development of resistant forms of microorganisms is possible.

Children over 8 years of age are prescribed a daily dose of 20-25 mg/kg body weight.

Side effects

Decreased appetite, vomiting, diarrhea, nausea, glossitis, esophagitis, gastritis, ulceration of the stomach and duodenum, dysphagia; photosensitivity, allergic reactions (maculopapular rash, skin hyperemia, angioedema, anaphylactoid reactions, drug-induced lupus erythematosus); hemolytic anemia, thrombocytopenia, neutropenia, superinfection (including fungal); intestinal dysbiosis; hypovitaminosis B; increased activity of liver transaminases, hypercreatininemia, azotemia, hyperbilirubinemia.

Drug interactions

Tetracycline is incompatible with beta-lactam antibiotics - penicillins and cephalosporins. The drug enhances the effects of indirect oral anticoagulants.

Tetracycline should not be prescribed simultaneously with antacid drugs containing aluminum, calcium, magnesium, iron-containing drugs and dairy products (forms insoluble complexes with metal ions).

Nystatin exhibits cross-resistance with a number of polyene antibiotics, such as amphotericin B.

Storage conditions

List B. In a dry place, protected from light, at a temperature not exceeding 25 °C.

Best before date

2 years

Active substance

Tetracycline, Nystatin

Interaction with other drugs

Absorption is reduced by antacids containing aluminum, magnesium and calcium, iron supplements and cholestyramine.

Due to the suppression of intestinal microflora, the prothrombin index decreases (requires a reduction in the dose of indirect anticoagulants).

Reduces the effectiveness of bactericidal antibiotics that disrupt cell wall synthesis (penicillins, cephalosporins).

Chymotrypsin increases the concentration and duration of circulation of the drug.

Reduces the effectiveness of estrogen-containing oral contraceptives and increases the risk of breakthrough bleeding; retinol – risk of developing increased intracranial pressure.