Tigatsil time. for solution for inf. 50 mg fl. No. 10

Tigatsil appoint to adults and children aged from 8 years for treatment:

• complicated infections of skin and soft tissues, except for the infected diabetic foot;
• complicated intraabdominal infections.

Tigatsil should be applied only in cases when other antibiotics are not acceptable to use.

Should pay attention to the official recommendations of rather corresponding use of antibacterial agents.

Structure

active ingredient: taygetsiklin;

1 bottle contains 50 mg of a taygetsiklin;

excipients: lactose monohydrate, divorced hydrochloric acid; sodium hydroxide.

Taygetsiklin, an antibiotic of a glitsiltsiklinovy row, inhibits broadcast of protein in bacteria by accession to ribosomal subunits 30S and by blocking of an entrance of molecules amino-acyl-tRNK in the website And ribosomes. It interferes with inclusion of the amino-acid remains in the increased peptide chains.

Contraindication

Hypersensitivity to active ingredient or to any of the excipients specified in the section "Structure".

Patients with hypersensitivity to antibiotics of a tetracycline row can have hypersensitivity to a taygetsiklin.

Route of administration and doses

Dosage.

Adult.

Initial recommended dose makes 100 mg, further it is necessary to apply on 50 mg everyone 12:00 within 5-14 days.

depending on disease severity, localization of an infection and the clinical answer of the patient.

Children and teenagers (aged from 8 up to 17 years).

to treatment of children aged from 8 years only after consultation with the doctor who has sufficient experience of treatment of infections.

• Children aged from 8 up to 12 years of 1.2 mg/kg to a taygetsiklin everyone 12:00 intravenously, the maximum dose - 50 mg everyone 12:00 within 5-14 days.
• Teenagers aged from 12 up to 18 years of 50 mg everyone 12:00 within 5-14 days.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy. The taygetsiklin does not have information on use to pregnant women or its quantity is limited. Researches on animals showed to reproductive toxicity. The potential risk for the person is unknown. As well as antibiotics of a tetracycline row, taygetsiklin can cause permanent damage of teeth (change of coloring and defects of enamel) and to delay processes of ossification at a fruit on exposure of in utero in the second half of pregnancy and also at children aged up to 8 years as a result of accumulation in fabrics with the high level of exchange of calcium and formation of chelate complexes, calciferous. Taygetsiklin pregnant women should not apply, except clinical cases when the woman demands use to a taygetsiklin.

feeding Period breast. It is unknown, gets taygetsiklin / metabolites into breast milk. The available pharmakodinamichesky / toxicological data obtained from researches on animals show that taygetsiklin / metabolites get into milk. It is impossible to exclude risk for newborns / babies at the person. It is necessary to make the decision to stop feeding by a breast or to stop / interrupt therapy taygetsikliny considering advantage of breastfeeding for the child and advantage of therapy for the woman.

Fertility. Taygetsiklin did not influence pairing or fertility of rats at use in doses, by 4.7 times exceeded a dose for the person on the basis of AUC value. At females of rats the effects connected with medicament on ovaries or ovarian cycles at use in doses were not observed, by 4.7 times exceeded a dose for the person on the basis of AUC value.

Children

Safety and efficiency of use of the medicament Tigatsil to children up to 8 years it was not established. Data on it are absent.

Tigatsil should not be applied to children up to 8 years because of change of coloring of teeth.

Ability to influence speed of response at control of motor transport or other mechanisms

At use to a taygetsiklin can arise dizziness that can affect ability to run motor transport and other mechanisms.

Overdose

Specific information on treatment of overdose. At single introduction of 300 mg to a taygetsiklin a course of 60 minutes to intravenously healthy volunteers observed increase in frequency of developing of nausea and vomiting.

Taygetsiklin does not leave by means of a hemodialysis in significant quantity.

Side reactions

during Only 3 and 4 phases of clinical trials to a taygetsiklin treated 2393 patients with the complicated infections of skin and soft tissues and the complicated intraabdominal infections.

During clinical trials by the most frequent side reactions connected with medicine use. These reactions were in most cases easy or average degree, usually developed in an initiation of treatment (in 1-2 days) and were reversible.

Interaction with other medicines and other types of interactions

conducted the Research of interaction only with participation of adults.

Simultaneous use and warfarin (25 mg once) to healthy volunteers led a taygetsiklina to decrease in clearance of R-warfarin and S-warfarin by 40% and 23% and to increase in AUC for 68% and 29% respectively. The mechanism of this interaction is still not known. According to the available data, it is impossible to assume that this interaction can lead to significant changes of the international normalized ratio. However as taygetsiklin can prolong both a prothrombin time, and the activated partial tromboplastinovy time, at simultaneous use the taygetsiklin with anticoagulants should control results of researches of coagulation carefully. Warfarin did not influence a pharmacokinetic profile to a taygetsiklin.

. So, it is expected that active agents which are inhibitors or inductors of CYP450 isoforms were not reflected on its clearance. Taygetsiklin in vitro does not show properties of a competitive inhibitor or inhibitor irreversible actions on CYP450 enzymes.

Taygetsiklin in the recommended doses does not influence the speed or extent of absorption or clearance of digoxin (0.5 mg, and then on 0.25 mg daily) at use to healthy adult volunteers. Digoxin does not influence a pharmacokinetic profile to a taygetsiklin. Therefore, at simultaneous use to a taygetsiklin with digoxin of need for dose adjustment is not present.

At the researches in vitro not.

Simultaneous use of antibiotics with oral contraceptives can reduce efficiency of contraceptives.

According to results of the research in vitro, taygetsiklin is R-glycoprotein substrate. The combined use with R-glycoprotein inhibitors (for example ketokonazol or cyclosporine) or R-glycoprotein inductors (for example rifampicin) can influence pharmacokinetics to a taygetsiklin.

to Store

out of children's reach at a temperature not above 25 °C.

Prepared solution needs to be used immediately.

Expiration date - 2 years.