Doxiciclin-TEVA (doxycycline) tablets 100 mg. №10

Description

Doxiciclin-TEVA Composition
active substance: doxycycline monohydrate;

1 tablet contains doxycycline 100 mg as doxycycline monohydrate;

auxiliary substances: microcrystalline cellulose, sodium starch (type A), talc, magnesium stearate, colloidal silicon dioxide, purified water.

Doxiciclin-TEVA Dosage form
Pills.

Basic physical and chemical properties: greenish-yellow with a uniform or non-uniform color, “dotted”, round biconvex tablets with a fracture line on one side.

Doxiciclin-TEVA Pharmacotherapeutic group
Antibacterial agent for systemic use. ATX code J01A A02.

Doxiciclin-TEVA Pharmacodynamics
Doxycycline has a bacteriostatic effect; its antimicrobial effect is realized by inhibiting protein synthesis. The drug is effective against a wide range of gram-positive and gram-negative bacteria and other microorganisms.

Pharmacokinetics
Absorption. After administration, doxycycline is almost completely absorbed in the upper small intestine (> 90% of the dose). A significant concentration is reached within 30 minutes, and the maximum concentration in blood plasma – after 1-2 hours. After taking a single dose of 200 mg, the maximum concentration was 3-5.3 mg / l. When used under therapeutic conditions (200 mg on the 1st day of treatment and 100 mg on the following days), the concentration of the equilibrium state is reached quickly and almost as high as after taking a single dose of 200 mg.

The plasma half-life in a healthy person is approximately 16 ± 6 hours; it may increase slightly in patients with impaired renal function and increase significantly in patients with liver disease. The protein binding of doxycycline is 80-90%.

Distribution. The drug is quickly distributed throughout the body, while it penetrates into the central nervous system in a relatively small amount, even through the inflamed membranes of the brain. A high concentration in the gallbladder and good tissue penetration are achieved in the liver, kidneys, lungs, spleen, bones and genitals. The volume of distribution of doxycycline is approximately 0.75 L / kg.

Metabolism. Doxycycline is metabolized in the human body only to a small extent (≤10% of the dose).

Output. It is excreted mainly in the form of a microbiologically active substance through the intestines (with the help of transintestinal secretion or through the gallbladder), and 30-55% is excreted by the kidneys. Within 24 hours, approximately 41% (range: 22-60%) of the dose of doxycycline is found in urine. Due to these pharmacokinetic features, the half-life of doxycycline in patients with significant renal impairment increases slightly.

Indications
For the treatment of infections caused by susceptible strains of gram-positive and gram-negative microorganisms and some other microorganisms:

Respiratory system infections: pneumonia and other diseases of the lower respiratory tract caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, etc. Pneumonia caused by Mycoplasma pneumoniae. Chronic bronchitis, sinusitis.

Urinary tract infections: infections caused by susceptible strains of the species Klebsiella, Enterobacter, as well as bacteria Escherichia coli, Streptococcus faecalis, etc.

Sexually transmitted diseases: infections caused by Chlamydia trachomatis, including complicated urethral and endocervical infections and rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum (T-mycoplasma). Chancre, inguinal granuloma, venereal granuloma. Doxycycline is an alternative drug for the treatment of gonorrhea and syphilis.

Skin infections: acne, if necessary, antibiotic therapy.

Since doxycycline belongs to the group of tetracycline antibiotics, it can be used for infections caused by microorganisms sensitive to tetracyclines, namely:

Ophthalmic infections: infections caused by susceptible bacteria gonococci, staphylococci and Haemophilus influenzae. The infection that causes trachoma is not always cleared, which is confirmed by immunofluorescence analysis. For the treatment of paratrachoma, doxycycline can be used as monotherapy or in combination with other drugs.

Ricketsian infections: Rocky Mountain spotted fever, typhus group, Q fever, Coxiella endocarditis, tick fever.

Other infections: psittacosis, brucellosis (when used in combination with streptomycin), cholera, bubonic plague, epidemic relapsing fever; tick-borne recurrent fever, tularemia, melioidosis, tropical malaria resistant to chloroquine, and acute intestinal amebiasis (when used in combination with an amoebicide).

Doxycycline is an alternative drug for the treatment of leptospirosis, gas gangrene, and tetanus.

Doxycycline is indicated for the prevention of such conditions: Japanese river fever, traveler’s diarrhea (caused by enterotoxigenic Escherichia coli), leptospirosis, malaria. Prophylaxis malaria infection should be carried out in accordance with current practice because of the potential for resistance to develop.

Contraindications
Hypersensitivity to doxycycline or other tetracyclines or to any excipient of the drug;
severe liver dysfunction;
the period of pregnancy and lactation (see also the section “Use during pregnancy or lactation”);
children under 12 years of age (see also the section “Children”).