Tetracycline with nystatin - instructions for use, dose, side effects, contraindications

Active substanceNystatin + TetracyclineNystatin + Tetracycline

Similar drugsTo uncover

pills

Dosage form: & nbspcoated tablets

Composition:

One tablet contains active substances: tetracycline (in terms of active substance) - 0.1000 g (100,000 units) and nystatin (in terms of active substance) - 0.0222 g (100,000 units).

Excipients: gelatin, calcium stearate, lactose (sugar milk), magnesium hydrosilicate (talc), potato starch.

Sheath composition: sucrose (refined sugar), magnesium hydroxycarbonate (magnesium carbonate basic), corn dextrin, sunflower oil, beeswax, solid paraffins, magnesium hydrosilicate (talc), tropeolin dye, indigo carmine dye.

Description:coated tablets, light green, round in shape with biconvex surfaces. Two layers are visible on the cross-section.

Pharmacotherapeutic group:combined antibiotic

ATX: & nbsp

J.01.R.A Combinations of antibacterial drugs

Pharmacodynamics:

The preparation contains tetracycline - a bacteriostatic antibiotic from the group of tetracyclines and nystatin - polyene antibiotic, which exerts a fungistatic effect on yeast-like fungi of the genus Candida. Included in the nystatin can reduce the number of side effects of tetracycline.

Tetracycline - disrupts the formation of a complex between transport RNA and ribosome, which leads to a violation of protein synthesis.

It is active against gram-positive microorganisms - Staphylococcus spp. (incl. Staphylococcus aureus, including penicillinase-producing strains), Streptococcus spp. (some strains, at t. h. 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. (at combinations with streptomycin).

TO tetracycline are stable microorganisms: Pseudomonas aeruginosa, Proteus spp. Scrratia
spp., most strains Bacteroides spp. mushrooms, small viruses, beta-hemolytic streptococci groups A (including 44 % strains Streptococcus pyogenes and 74 % strains Streptococcus faecalis).

Pharmacokinetics:

The main pharmacokinetic parameters concern tetracycline. Absorption - 75-77%, with food intake decreases, communication with plasma proteins - 55-65%. The time to reach the maximum concentration with oral intake is 2-3 hours (2-3 days may be required to reach the therapeutic concentration). During the next 8 hours the concentration gradually decreases. The maximum concentration is 1.5-3.5 mg / l (enough concentration of 1 mg / l is sufficient to achieve the therapeutic effect).

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

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

It is slightly metabolized in the liver. The half-life is 6-11 hours, with anuria - 57-108 hours. In urine it is found in high concentration 2 hours after the administration and is kept for 6-12 hours; for the first 12 hours the kidneys are excreted up to 10-20% of the dose.In smaller amounts (5-10% of the total dose) is excreted with bile into the intestine, where partial reverse absorption occurs, which contributes to a prolonged circulation of the active substance in the body (intestinal-hepatic circulation). Excretion through the intestine - 20-50%. When hemodialysis is removed slowly.

Nystatin practically not absorbed from the gastrointestinal tract. It is excreted through the gastrointestinal tract. Nystatin does not possess cumulative properties.

Indications:

Nystatin in the composition of the pill is intended to prevent the development of candidal infections.

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

Contraindications:

Hypersensitivity to the components of the drug, pregnancy, lactation, leukopenia, liver failure, peptic ulcer and twelve fingersbowel.

Children and adolescence for this dosage form.

Carefully:renal insufficiency.

Pregnancy and lactation:contraindicated

Dosing and Administration:

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

Inside after eating, washed down with water, 0.5 grams 4 times a day or 0.5-1 g every 12 hours, the maximum daily dose of 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.

Side effects:

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 the tooth enamel in children, irritation of the mucous membranes of the oral cavity, dysphagia, hepatotoxic action , pancreatitis, increased activity of "liver" transaminases, hyperbilirubinemia.

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

From the hemopoiesis: hemolytic anemia, thrombocytopenia, neutropenia.

From the side of the urinary system: azotemia, hypercreatininaemia.

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

Other: superinfection, photosensitivity, hypovitaminosis B.

Overdose:

No data.

Interaction:

Absorption is reduced by antacids containing aluminum, magnesium and calcium, iron preparations and colestramine.

In connection with the suppression of the intestinal microflora, the prothrombin index decreases (requires a reduction in the dose of indirect anticoagulants).

Reduces the effectiveness of bactericidal antibiotics that disrupt the synthesis of the cell wall (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 bleeding "breakthrough"; retinol - risk of developing increased intracranial pressure.

Special instructions:

In connection with the possible development of photosensitization, it is necessary to limit the insolation.

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

With prolonged use, periodic monitoring of the function of the kidneys, liver, and hematopoiesis is necessary.

May mask the manifestations of syphilis, and therefore, with the possibility of a mixed infection, you need a monthly serological analysis for 4 months.

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

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

Effect on the ability to drive transp. cf. and fur:

Form release / dosage:

The tablets covered with a cover, 100 mg + 22,2 mg.

For 10 tablets in a planar cell package.

For 10 tablets in a can of orange glass or in a polymer can.

One bank or 1,2, 3, 4, 5, the contour of cellular packages with instructions for use placed into cardboard pack.

Packaging:10) - polymer cans (1) - packs of cardboard
(10) - cans of dark glass (1) - packs of cardboard
(10) - packings, cellular, outline (1) - packs, cardboard
(10) - packings, cellular, outline (2) - packs, cardboard
(10) - packings, cellular, outline (3) - packs, cardboard
(10) - packings, cellular, outline (4) - packs, cardboard
(10) - packings, cellular planimetric (5) - packs cardboard

Storage conditions:

List B. In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-003447/08

Date of registration:04.05.2008

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp18.08.2015

Illustrated instructions

Instructions

Tetracycline with nystatin (Tetracycline with nistatine)