Doxycycline - instructions for use, dose, side effects, contraindications

lactose monohydrate (sugar milk) - 51,60 mg, potato starch - 19,10 mg, silicon dioxide colloid - 1,00 mg, talc - 1,00 mg, magnesium stearate - 1,90 mg. Capsule body composition:

dye quinoline yellow - 0.7500%,

titanium dioxide - 2.0000%,

dye sunset yellow - 0.0059%, gelatin - up to 100%.

Composition of cap capsule:

dye quinoline yellow - 0.7500%, titanium dioxide - 2.0000%, dye sunset yellow - 0.0059%, gelatin - up to 100%.

Description:

Hard gelatin capsules No. 2,

The body and cap capsules are opaque, yellow in color.

Contents of capsules - a mixture of powder and granules of yellow color with white impregnations. It is allowed to compact the contents of the capsule, which breaks down when pressed.

Pharmacotherapeutic group:Antibiotic, tetracycline

ATX: & nbsp

J.01.A.A.02 Doxycycline

Pharmacodynamics:

Semisynthetic tetracycline, a bacteriostatic broad-spectrum antibiotic obtained from metacycline. Penetrating into the cell, acts on intracellularly located pathogens. Inhibits the synthesis of proteins in a microbial cell, disrupting the binding of the transport aminoacyl RNA to the 30S subunits of the ribosomal membrane. Does not affect the synthesis of the bacterial cell wall.

To it are highly sensitive: Gram-positive microorganisms

Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus albus), Streptococcus spp. (including Streptococcus pneumoniae), Clostridium spp., Listeria spp .; and Gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Klebsiella spp., Entamoeba histolytica, E. coli, Shigella spp., Enterobacter, Salmonella spp., Pasterella spp., Bacteroides spp., Psyttacosis spp.,

Treponema spp. (including strains resistant to others.antibiotics, for example, to modern penicillins and cephalosporins). The most sensitive are Haemophilus influenzae (91-96%) and intracellular pathogens.

Pharmacokinetics:

Absorption is fast and high (about 100%). Has a high degree of solubility in lipids and low affinity for calcium binding.

After oral administration of 200 mg of time to maximum concentration - 2.5ch, the maximum concentration - 2.5 mg / ml, 24 hours after administration - 1.25 g / ml. The connection with plasma proteins is 80-90%.

It penetrates well into organs and tissues; 30-45 minutes after ingestion is found in therapeutic concentrations in the liver, kidneys, lungs, spleen, bones, teeth, prostate gland, eye tissues, pleural and ascitic fluids, bile, synovial exudate, exudate of maxillary sinuses and frontal sinuses. Poor penetration into the spinal cord fluid (10-20% of the plasma level). Penetrates through the placental barrier, is determined in human milk.

Metabolised in the liver 30-60%. The half-life is 16-24 hours. With repeated administration, the drug can accumulate. Accumulates in bone tissue. In bones and teeth forms insoluble complexes with calcium.

It is excreted with bile, where it is found in high concentration. It is subjected to intestinal-hepatic recirculation, it is excreted with caloric masses (20-60%); 40% of the dose is given by the kidneys for 72 hours (of which 20-50% is unchanged), in severe chronic renal failure, only 1-5%. In patients with impaired renal function or azotemia, an important route of elimination is the gastrointestinal tract.

Indications:

Infectious-inflammatory diseases caused by sensitive microorganisms: respiratory tract infections (pharyngitis, acute and chronic bronchitis, tracheitis, bronchopneumonia, lobar pneumonia, lung abscess, pleural empyema);

infection of the ENT organs (otitis media, tonsillitis, sinusitis, etc.);

infections of the genitourinary system (cystitis, pyelonephritis, prostatitis, urethritis, urethrocystitis, urogenital mycoplasmosis, endometritis, endocervicitis, acute orchypididitis, gonorrhea);

infection of biliary tract and gastrointestinal tract (cholecystitis, cholangitis, gastroenterocolitis, bacterial dysentery, diarrhea of "travelers");

infections of the skin and soft tissues (phlegmon, abscess, furunculosis, panaritium, infected burns, wounds, etc.);

infectious diseases of the eye, syphilis, yawsinosis, legionellosis, rickettsiosis, chlamydia of various localizations (including prostatitis and proctitis), fever Ky, spotty fever of the rocky mountains, typhus (including swelling, tick-borne recurrent), borreliosis , bacillary and amoebic dysentery, tularemia, cholera, Lyme disease (stage I), actinomycosis, malaria, leptospirosis, trachoma, psittacosis, ornithosis, granulocyte erlichiosis; whooping cough, brucellosis, osteomyelitis; sepsis, subacute septic endocarditis, peritonitis.

Prevention of postoperative purulent complications; malaria caused by Plasmodium falciparum, during short trips (less than 4 months) in a territory where strains resistant to chloroquine and / or pyrimethamine sulfadoxine are common.

Contraindications:Hypersensitivity, porphyria, severe hepatic insufficiency, leukopenia, pregnancy II-III trimester, lactation period, children's age (up to 8 years - the possibility of formation of insoluble complexes with calcium and deposition in the bone skeleton, enamel and dentin teeth).

Pregnancy and lactation:The use of the drug during pregnancy and lactation is contraindicated.

Dosing and Administration:

Inside, in adults and children with a body weight of more than 45 kg, the average daily dose is 0.2 g on the first day (divided into 2 doses - 0.1 g twice a day), then 0.1 g / day (1-2 doses). In severe infections, especially with chronic infections of the urinary system - 200 mg / day throughout the period of therapy.

In the treatment of gonorrhea, one of the following regimens is prescribed: acute uncomplicated urethritis - a course dose of 0.5 g (1 dose - 0.3 g, the next two - 0.1 g at intervals of 6 hours) or 0.1 g / day until complete cure (in women) or 0.1 g 2 times a day for 7 days (in males); with complicated forms of gonorrhea, the course dose is 0.8-0.9 g, which is divided into 6-7 receptions (0.3 g - 1 reception, then at an interval of 6 hours for 5-6 follow-up).

In the treatment of syphilis - 0.3 g / day for at least 10 days (inside or

in / in).

In uncomplicated infections of the urethra, cervix and rectum caused by Cl.trachomatis, appoint 0.1 g 2 times a day for at least 7 days.

Infections of male genital organs - 0.1 g 2 times a day for 4 weeks.

Treatment of malaria resistant to chloroquine - 0.2 g / day for 7 days (in combination with shizontocidal drugs - quinine); malaria prophylaxis - 0.1 g once a day 1-2 days before the trip, then daily during the trip and within 4 weeks after the return; children, over 8 years old - 0.002 g / kg once a day.

Traveler's diarrhea (prophylaxis) - 0.2 g on the first day of the trip (1 dose or 0.1 g 2 times a day), then 0.1 g once a day during the whole stay in the region (no more than 3 weeks).

Treatment of leptospirosis - 0.01 grams orally 2 times a day for 7 days; prevention of leptospirosis - 0.02 g once a week during a stay in a dysfunctional area and 0.02 g at the end of the trip.

Prevention of infections after medical abortion - 0.1 g for 1 hour before abortion and 0.2 g - 30 minutes after.

Maximum daily doses for adults - up to 300 mg per day or up to 600 mg per day for 5 days with severe gonococcal infections.

In children 9-12 years old with a body weight of up to 45 kg, the average daily dose is 0.004 g / kg on the first day, then 0.002 g / kg per day (in 1-2 doses). In severe infections, every 12 hours, 0.004 g / kg is prescribed.

In the presence of severe hepatic insufficiency, a decrease in the daily dose of doxycycline is required, since this gradually accumulates in the body (the risk of hepatotoxic action).

Side effects:

From the nervous system:

increased intracranial pressure

(anorexia, vomiting, headache, edema of the optic nerve), toxic effects on the central nervous system (dizziness or ataxia).

From the digestive system:

nausea, diarrhea, constipation, glossitis, dysphagia, esophagitis (including erosive), gastritis, ulceration of the stomach and duodenum, inflammation in the anogenital crotch area, enterocolitis (due to the proliferation of resistant strains of staphylococci).

Allergic reactions:

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

From the side of the blood:

hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia,

Other:

photosensitivity, superinfection; persistent discoloration of tooth enamel.

Fungal infections (vaginitis, glossitis, stomatitis, proctitis), dysbiosis.

Interaction:

Absorption is reduced antatsidy containing aluminum, magnesium and calcium, food containing calcium (milk, cottage cheese), iron preparations, sodium bicarbonate, magnesium-containing laxatives, colestramine and colestipol, therefore their use should be separated by an interval of 3 hours.

In connection with the suppression of the intestinal microflora reduces the prothrombin index, which requires correction of the dose of indirect anticoagulants.

When combined with bactericidal antibiotics that disrupt the synthesis of the cell wall (penicillins, cephalosporins), a decrease in the effectiveness of the latter.

Reduces the reliability of contraception and increases the frequency of bleeding "breakthrough" against the background of taking estrogen-containing oral contraceptives.

Ethanol, barbiturates, rifampicin, carbamazepine, phenytoin and other stimulators of microsomal oxidation accelerate the metabolism of doxycycline.

With the simultaneous use of methoxyflurane, the risk of developing fatal nephrotoxicity increases.

Simultaneous use of retinol helps increase intracranial pressure.

Special instructions:

To prevent locally irritating effect (esophagitis, gastritis, ulceration of the gastrointestinal tract) it is recommended to take in the daytime hours with a lot of liquid, food.

In connection with the possible development of photosensitization, it is necessary to limit the insolation during treatment and for 4-5 days after it.

With prolonged use, periodic monitoring of the function of the kidneys (KK), liver, hematopoiesis is necessary.

May mask the manifestations of syphilis, in connection with which, with the possibility of mixed infection, a monthly serological analysis is necessary for 4 months.

The appointment during the development of teeth can cause irreversible changes in their color.

Perhaps a false increase in the level of catecholamines in urine when determined by the fluorescent method. In the study of the thyroid biopsy in patients who received long-term doxycycline, it is possible to dark brown staining of tissue in micropreparations without disturbing its function.

Form release / dosage:

Capsules 100 mg.

Packaging:

For 10, 20 capsules in a contour cell pack of film

polyvinylchloride and aluminum foil printed lacquered.

10, 20, 30, 40, 50 or 100 capsules in cans of polyethylene terephthalate. One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with instructions for use

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000168

Date of registration:17.05.2010 / 22.08.2014

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp10.02.2016

Illustrated instructions

Instructions

Doxycycline (Doxycycline )