Gatispan

General characteristics. Structure:

international and chemical name: gatifloxacin; (±)-1-cyclopropyl-6-Floro-1, 4-digidro-8-metoksi-7-(3-methyl-1-piperazinil) - 4-oxo-3-kvinolinekarboksilin acids of a seskiva - hydrate;

main physical and chemical properties: tablets of white or almost white color, tear-shaped form, biconvex, coated;

Structure: 1 tablet contains a gatifloksatsin to a seskivigidrat which is equivalent a gatifloksatsina of 200 mg and 400 mg;

Excipients: silicon oxide anhydrous colloid, starch corn, cellulose microcrystallic, кросповидон, magnesium stearate;

cover: gipromelloza (Me of th ocel E 15 LVP), gidroksipropilmetil-cellulose (Me of th ocel е 5 LVP), polyethyleneglycol 4000, talc, titanium dioxide, симетикон

Emulsion of 30%).

Pharmacological properties:

Indications to use:

Gatifloksatsin is shown for treatment of the infectious and inflammatory processes caused by microorganisms, sensitive to drug;

• respiratory infections (including acute sinusitis, acute bronchitis, abscess of lungs, exacerbations of chronic diseases of pulmonary ways, cystous fibrosis, pneumonia);
• infections of kidneys and urinary system (including acute and chronic pyelonephritis, prostatitis, cystitis, persistent infections of an urinary system);
• infections of skin and soft tissues;
• infections of bones and joints;
• infections of a digestive tract;
• postoperative infectious diseases, sepsis, peritonitis;
• uncomplicated urethral gonorrhea at men;
• endocervical and rectal gonorrhea at women.

Route of administration and doses:

Acute sinusitis - 400 mg of 1 times a day or 200 mg 2 times a day within 7 - 14 days; the acute and complicated chronic bronchitis, pneumonia, infections of skin and hypodermic cellulose, acute pyelonephritis and the complicated infections of an urinary system - 400 mg of 1 times a day or on 200 mg two times a day within 7 - 10 days; uncomplicated infections of an uric path (cystitis) - 400 mg an initial dose and 200 mg once a day for 3 days; uncomplicated urethral gonorrhea at men, gonorrhea at women - 400 mg of 1 times a day.

Features of use:

Gatifloksatsin can cause increase in QT of intervals of an ECG in some patients. For insufficient гатифлоксацин patients should not appoint clinical experience with the intervals extended with QT, the patient inadequate to a hypercalcemia and the patients receiving drugs of a class 1 A (for example квинидин. процаинамид) or class III (for example Amiodaronum соталол) antiarrhythmic drugs.

Pharmacokinetic researches were not conducted for the gatifloksatsin and drugs extending QT intervals such as цисапрайд. erythromycin and tricyclic antidepressants. Gatifloksatsin has to be applied with care at parallel use with these drugs. Patients need to use drug with care with heart diseases, such as bradycardia and acute ischemia of a myocardium. Serious and fatal cases of hypersensitivity and anaphylactic reactions were observed at the patients who underwent treatment kvinolony.

Gatifloksatsin should not be applied at the first manifestations of hypersensitivity - at an enanthesis or other allergic reactions.

With care appoint to patients with epilepsy and elderly people.

It is necessary to use carefully drug during control of vehicles (possibly dizziness).

Purpose of a gatifloksatsin has to be careful in the presence of a renal failure. Careful clinical inspection and the corresponding laboratory analyses need to be carried out to and during performing treatment, in need of dependence on the level of indicators, it is necessary to lower a dose of a gatifloksatsin. For patients with an impaired renal function (clearance of creatinine of 40 ml/min.) of dose adjustment (reducing a dose) it is necessary to carry out to avoidance of accumulation of a gatifloksatsin for decreases in clearance. For patients with clearance of creatinine <reduced doses of a gatifloksatsin are recommended to Z0 of ml/min.

As well as with others of a kvinolonama, disturbances of content of glucose in blood, including symptomatic: hyper-and a hypoglycemia, were revealed preferential at the patients sick with diabetes receiving simultaneous treatment by peroral hypoglycemic drugs (for example Glyburidum) or insulin. At these patients it is recommended to carry out control of level of glucose to blood.

Side effects:

The most widespread side effects of a gatifloksatsin - dizziness, vomiting, diarrhea, a vaginitis, abdominal pain, a headache. Other side effects - disturbance of flavoring feelings, allergic reactions, a fever, heat, a dorsodynia, a stethalgia, heartbeat, a lock, dyspepsia, a glossitis, candidiasis of an oral cavity, stomatitis, ulcers of an oral cavity, peripheral hypostases, an uneasy dream, sleeplessness, paresthesia, a tremor, vasodilatation, диспноэ, pharyngitis, perspiration, a vision disorder, a ring in ears, a dysuria and a hamaturia.

Kvinolona sleeplessness, nightmares or paranoia can be the cause of disturbances of the central nervous system, including nervousness, concern.

Neutropenia, increase in activity of transaminases, blood amylases.

Interaction with other medicines:

Reception of a gatifloksatsin in 1 hour after Cimetidinum (once a day orally in a dose of 200 mg) does not influence pharmacokinetics of a gatifloksatsin. These results say that absorption of a gatifloksatsin is influenced by antagonists of N 2 - receptors, such as Cimetidinum.

Use of a gatifloksatsin does not influence systematic clearance of intravenous midazolam. The daily dose of midazolam (0,0145 mg/kg) does not influence pharmacokinetics of a gatifloksatsin. These results can be considered at insufficient efficiency of a gatifloksatsin when carrying out researches on RZA4 C Y isoenzyme at people.

Simultaneous use of a gatifloksatsin and theophylline did not influence drug pharmacokinetics.

Combined use of a gatifloksatsin and warfarin did not influence drug pharmacokinetics, a prothrombin time did not change.

Simultaneous use of a gatifloksatsin and Glyburidum (at a stable state once a day) patients with the 2nd type of a diabetes mellitus had no considerable influence on placement of any drug, glucose levels on an empty stomach did not change.

Simultaneous use of a gatifloksatsin and digoxin did not give considerable effect on change of pharmacokinetics of a gatifloksatsin. The patients accepting digoxin have to be checked for signs and symptoms of toxicity. At patients, found signs or symptoms of intoxication digoxin, concentration of digoxin in serum has to be checked and the dose of digoxin is respectively modified.

System removal of a gatifloksatsin considerably increases at simultaneous use of a gatifloksatsin and probenetsid.

At the patients who received warfarin considerable changes in a blood clotting time at simultaneous use of a gatifloksatsin were not revealed.

During preclinical and clinical trials it is revealed that at combined use with non-steroidal anti-inflammatory drugs, such as квинолон, it turned out that квинолон can increase risk of frustration of TsNS and court.

Contraindications:

Gatifloksatsin is contraindicated to patients with hypersensitivity to a gatifloksatsin, kvinolonovy antibacterial components and other components of this drug, to the pregnant women nursing to children up to 18 years.

Overdose:

There is no information on overdose.

At accidental overdose of drug it is necessary to carry out a gastric lavage. The patient has to be under control and receive the symptomatic and supporting treatment. It is necessary to apply the therapy corresponding conditions of a gidratatsiyna. Gatifloksatsin is insufficiently effectively brought from an organism by a hemodialysis (about 14% during 4 h) or by means of the forced hemodialysis (about 11% in 8 days).

Storage conditions:

To store in the dry, protected from light place at a temperature not above 25 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging, on 5 blister strip packagings in a pack from a cardboard; on 5 tablets in a blister strip packaging, on 10 blister strip packagings in a pack from a cardboard; on 500 tablets in a plastic can.