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COMPOSITION
Doxycycline100 mg (as hydrocloride) in one capsule.

PROPERTIES AND ANTIMICROBIAL EFFECT
The Doxycycline is a peroral wide spectrum half-synthetic antibiotic of the group of the tetracyclines with expressed bacteriostatic activity. It suppresses the synthesis of the protein in the microbe cell, connecting the tPHK and mPHK in the ribosome complex. Doxycycline possesses a wide antimicrobial spectrum, similar to this of the tetracycline. It shows high activity towards Brucella, Pasteurella, Chlamydiae, Mycoplasma pneumoniae, Rickettsia, Neisseria Gonorrheae Treponema, Spirocheta, Vibrio cholerae, Corynebacterium Acnae (Latin). The Doxycycline is applied for treatment of infections caused by Staphylococcus, Streptococcus, Pneumococcus, Salmonella typhi, Shigella, Klebsiella, Morganella morganii, Escherichia coli, Haemophilus influenzae, Clostridium, Bacteriodes, Fusobacterium, Legionel pneumophila (Latin). It is necessary to test the sensitivity to Doxycycline because of the increase of the resisting power at a lot of strains of these microorganisms when isolating the causal agent.

PHARMACOKINETICS.
The Doxycycline is absorbed quickly and almost fully (up to 90 - 100% of the dosage taken) in the gastrointestinal tract. Its admission during meals does not affect considerably the absorption. Because of the calcium contained, the dairy products considerably decrease the absorption of Doxycycline, since they lead to building of Xelate complexes, difficult for absorption. After a peroral admission of Doxycycline of a dosage of 200 mg maximum concentrations of plasma are followed, 2-4 Mg/ml from the 2nd to the 4th hour and 24 hours after the admission the plasma concentration is about 1 Mg/ml. The duration of the plasma half-life of the Doxycycline is from 15 to 22 hours; it does not change considerably if kidney function is disturbed. It connects to the plasma proteins from 85 to 96%, it penetrates well into the fabrics and fluids of the system. It reaches high concentrations in the bile, saliva, the pleural, ascite and synovial fluids. Therapeutic concentrations are kept in the lung, the ovaries, the prostate gland, the testicles, the liver. It accumulates in the bones and teeth. The Doxycycline passes the placental barrier and it excretes also with the mother's milk. With healthy meninges, it penetrates into the cerebrospinal liquor in insignificant quantities only. It is metabolized in the liver. A part of it is reabsorbed in the intestines and includes into the entero-hepatic circle. Unlike other tetracyclines, it is excreted mainly in the gastroenteric tract (up to 70%). The Doxycycline is a preparation to be chosen in cases of other than kidney infections with the presence of renal insufficiency.

INDICATIONS
The Doxycycline is suitable for treatment of infections caused by microorganisms sensible to it, i.e.:
- Infections of the respiratory tract - tonsillitis, pharyngitis, otitis, bronchitis, pneumonia, bronchopneumonia;
- Infections of the biliary tract;
- Urogenital infections - urethritis, cystitis, pyelonephritis, prostatitis;
- Infections of the small pelvis, intestinal amebiasis etc.
- Intestinal infections;
- Infection of the skin and the soft fabric - impetigo, cellulitis, furunculosis, acne, infected traumatic and postoperative wounds;
- other infections - osteomyelitis, thrombophlebitis, inflammation of the fabrics of the eye.

CONTRAINDICATIONS
Hypersensitivity to tetracyclines. Heavy violations of the liver function. Children under 8. Pregnancy and nursing.

UNDESIRED MEDICAL REACTIONS ;
The Doxycycline may provoke nausea, emesis, and diarrhea. Continuous use and in higher dosages may cause ulcer of the mucosa of the esophagus, glossitis, oral Candida. In rare cases there are damages of the liver and transitory changes in the hematologic indices. The Doxycycline may provoke photosensibility. Cutaneous hypersensitive reactions have been watched and, more rarely, other heavy manifestations of hypersensitivity: (anaohy-laxis, edema of Quinke etc.)

PREVENTIVE MEASURES
The Doxycycline is to be administered very carefully in case of disturbed liver function (danger of accumulation), to patients with disturbed esophagus mucosa, stomach ulcer and duodenum ulcer, in intensive solar radiation.

MEDICAL INTERACTIONS
Antiacide preparations, containing calcium, magnesium or aluminum and preparations containing iron may considerably decrease the absorption of the Doxycycline.

The hepathotoxic and nephrotoxic effects of the lithium salts, the general anaesthetics and other agents with similar effect may be intensified by the Doxycycline. The Doxycycline may potent anticoagulant activity of the indirect anticoagulants. The chemotherapeutic effect of the Doxycycline may be decreased by simultaneous use with enzyme inductors.

HOW TO USE?
To avoid the ulcerogenic effect of the Doxycycline on the esophagus, it is advisable to take it with more liquids and not to take it immediately before bedtime. The usual dosage of the preparation is 100 mg every 12 hours the first day and 100 mg every 24 hours in the subsequent days. At the physician's discretion, 100 mg may be taken every 12 hours during the entire course of treatment. Gonoccocal uretritis of men is treated with an initial dosage of 300 mg for the first day and supporting dosage of 200 mg two times daily for 2 to 4 additional days. For initial and secondary syphilis the treatment is carried out with a dosage of 300 mg daily, taken by 100 mg every 8 hours in the course of ten days. For children over 8 years of age the daily dosage is 4 mg per one kilogram of corporal weight. In the case of renal insufficiency, the excretion of the preparation in the urine decreases on account of the feces excretion. This allows the Doxycycline to be used also by patients suffering with renal insufficiency.

MEDICAL FORM AND PACKING
Capsules of 100 mg 6 pcs. each in PVC aluminum foil, packed in cardboard boxes.

STORAGE
To be stored in dry warehouses, protected from direct sunshine, at temperature not exceeding 30° C.

EXPIRY: Four years from the date of production.

PRODUCER
Antibiotic PLC, Bulgaria
Razgrad