Doxycycline-Ferein - instructions for use, doses, side effects, contraindications

Doxycycline is a semisynthetic antibiotic of the tetracycline series with a broad spectrum of antibacterialactions. Penetrating into the cell, it acts on intracellularly located pathogens. Inhibits the synthesis of proteins in a microbial cell, disrupting the binding of transport aminoacyl ribonucleic acids to the 30S subunit of the ribosomal membrane. Does not affect the synthesis of the bacterial cell wall.

It is active against most Gram-positive microorganisms: aerobic cocci - Staphylococcus spp. (including Staphylococcus aureus), Streptococcus spp. (including Streptococcus pneumoniae); aerobic spore-forming bacteria - Bacillus anthracis; aerobic non-spore-forming bacteria - Listeria monocytogenes; anaerobic spore-forming bacteria - Clostridium spp. The drug is also active against boundary motritsatelnyh microorganisms: Aerobic bacteria - Neisseria gonorrhoeae, Neisseria meningitidis, Haemophilus influenzae, Klebsiella spp, Entamoeba histolytica, Escherichia coli, Shigella spp, Treponema spp... (including strains resistant to other antibiotics, for example, to modern penicillins and cephalosporins). The most sensitive are Haemophilus influenzae (91-96%) and intracellular pathogens. It does not affect most proteic strains, Pseudomonas aeruginosa and fungi. There is cross-resistance to other tetracyclines, as well as to penicillins.

Pharmacokinetics:

With intravenous administration, the drug penetrates well into organs and tissues and is found in effective concentrations in the blood, liver, kidneys, lungs, spleen, pleural and ascitic fluids until 24 hours.

Poor penetration into the cerebrospinal 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. Undergoes intestinal-hepatic recirculation, is excreted by the intestine (20-60%).

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infection of the lower respiratory tract - bronchitis acute and chronic, bronchopneumonia, lobar pneumonia, lung abscess, empyema of the pleura;

infection of the ENT organs - otitis media, sinusitis;

- infections of the genitourinary system - cystitis, pyelonephritis, prostatitis, urethritis, urethro-cystitis, endometritis, endocervicitis, acute orchypididymitis;

- infections of the skin and soft tissues - phlegmon, abscesses, furunculosis, infected burns, wounds;

- infectious diseases of the eye, syphilis, yawsinia, legionellosis, rickettsiosis, chlamydia of various localizations (including prostatitis and proctitis), fever KU,spotted fever of the rocky mountains, typhus (including rash, tick-borne, recurrent), actinomycosis, malaria, leptospirosis, trachoma, psittacosis, ornithosis, granulocyte erlichiosis, dysentery; brucellosis, osteomyelitis; sepsis, subacute septic endocarditis, peritonitis;

- prevention of postoperative purulent complications.

Contraindications:Hypersensitivity, porphyria, severe hepatic insufficiency, leukopenia, pregnancy, lactation period, children's age (up to 12 years - the possibility of formation of insoluble complexes with calcium with deposition in the bone skeleton, enamel and dentine teeth), myasthenia gravis.

Pregnancy and lactation:Application during lactation is contraindicated.

Dosing and Administration:

Intravenously injected with severe forms of purulent-septic diseases, when it is necessary to quickly create a high concentration of the drug in the blood, as well as in cases when the intake of the drug inside is difficult or badly tolerated by patients.

Adults on the first day of treatment are given 0.2 g once a day or 0.1 g every 12 hours; in the following days of treatment - 0.1 g once a day.

Maximum daily doses for adults - up to 0.3 g / day or 0.6 g / day for 5 days with severe gonococcal infections.

Children older than 12 years of age, the drug is prescribed at a rate of 4 mg / kg on the first day of treatment, in the following days - 2 mg / kg also once a day.

Intravenous drip is administered as a solution, which is prepared ex tempore. To do this, the contents of each ampoule or vial (0.1 g of the drug) are dissolved in 5 ml of water for injection, then add to 250 ml of a 0.9% solution of sodium chloride or 5% glucose solution. The concentration of the drug in the solution should not exceed 1 mg / ml. The duration of infusion, depending on the dose administered (0.1 g or 0.2 g of the drug) is 1-2 hours at a rate of 60 to 80 drops per minute.

Duration of treatment with intravenous administration is 3-5 days, followed by a transition, if necessary, to take the drug inside.

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 and 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 Staphylococcus strains).

Allergic reactions:

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

From the side of the blood:

hemolytic anemia, thrombocytopenia, neutropenia, eosinfilia.

Other:

photosensitivity, superinfection; stable change in the color of tooth enamel, phlebitis, re-phlebitis.

Fungal infections:

vaginitis, glossitis, stomatitis, proctitis; a dysbacteriosis.

Interaction:

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 stimulants 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.

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

Pharmaceutically incompatible with other antibacterial drugs.

Special instructions:

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, liver, and hematopoiesis is necessary.

May mask the manifestations of syphilis, in connection with which, if possible, infection requires a monthly serological analysis 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.

In the experiment it was established that doxycycline can cause toxic effects on the development of the fetus - the delay in the development of the skeleton.

During infusion, the solution should be protected from light (solar and artificial).

Form release / dosage:Lyophilizate for the preparation of a solution for infusions of 100 mg.

Packaging:

To 0.1 g of the active substance into a neutral glass vial with a capacity of 5 ml.

To 0.1 g of the active substance into a neutral glass vial of 10 ml capacity, sealed with a plug of rubber compound, crimped with an aluminum cap or a combination cap made of aluminum and plastic.

5 ampoules per contour cell pack of polyvinyl chloride film.

5 ampoules per contour cell packaging made of polyvinylchloride film and aluminum foil or packaging material.

1, 2 contoured cell packs with ampoules together with instructions for use and a scarifier or a knife ampoule in a pack of cardboard.

For 5 or 10 ampoules together with the instructions for use and a scarifier or knife ampoule in a pack with an insert with cells for ampoules in 1 or 2 rows of cardboard.

When using ampoules with a notch, the ampoule knife or scarifier is not inserted into the fracture ring.

1 bottle together with the instruction for use is placed in a pack of cardboard.

5 vials into a contour mesh package made of a polyvinyl chloride film.

5 bottles in a contour mesh box made of a polyvinylchloride film and aluminum foil or packaging material.

1.2 contour mesh packages with vials along with instructions for use in a cardboard box.

For 5 or 10 bottles together with the instructions for use in a pack with an insert with cells for bottles in 1 or 2 rows of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:4 of the year. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007080/08

Date of registration:04.09.2008

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp16.02.2016

Illustrated instructions

Instructions

Doxycycline-Ferein (Doxycycline-Ferein)