Tatsillin Dzh

General characteristics. Structure:

Active ingredients: 4 g of a piperatsillin ( in the form of sodium salt), 500 mg of a tazobaktam (in the form of sodium salt).

Pharmacological properties:

Pharmacodynamics. Piperatsillin represents the semi-synthetic bactericidal antibiotic of a broad spectrum of activity showing activity concerning many gram-positive and gram-negative aerobic and anaerobic bacteria. Piperatsillin inhibits synthesis of a membrane of a cell wall of a microorganism.

Tazobaktam - sulfonic derivative triazolmethylpenicillanic acid, is powerful inhibitor of many beta лактамаз (including plasmid and chromosomal beta lactamelements) which often cause penicillin and cephalosporins resistance, including cephalosporins of the third generation. Presence of a tazobaktam as a part of the combined drug increases antimicrobic activity and expands an action spectrum of a piperatsillin due to inclusion in it of the bacteria forming beta lactamelements which are usually steady against a piperatsillin and another beta лактамным to antibiotics.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to a piperatsillinu/tazobaktam.

Adults and children are more senior than 12 years:

— lower respiratory tract infections;

— the infections of urinary tract (complicated and uncomplicated);

— intraabdomipalny infections;

— infections of skin and soft tissues;

— septicaemia;

— gynecologic infections (including an endometritis and an adnexitis in a puerperal period);

— bacterial infections at patients with a neutropenia (in a combination with aminoglycosides);

— infections of bones and joints;

— the multi-infections (caused, gram-positive/gram-negative aerobic and anaerobic microorganisms).

Children aged from 2 up to 12 years:

— intraabdominal infections;

— infections against the background of a neutropenia (in a combination with aminoglycosides).

Route of administration and doses:

Intravenously slowly struyno within not less than 3-5 minutes or kapelno within 20-30 minutes.

Duration of treatment is defined by weight of infectious process and dynamics of clinical and bacteriological indicators.

Adults and children are more senior than 12 years with normal function of kidneys: the recommended drug dose which is appointed by each 8 h makes 4.5 g (4 g piperatsillina/0.5 g of a tazobaktam). The general daily dose depends on weight and localization of an infection and can vary from 2:25 g (2 g piperatsillina/0.25 g of a tazobaktam) to 4.5 g (4 g piperatsillina/0,5 g of a tazobaktam) drug entered each 6 or 8 h.

Children aged from 2 up to 12 years. At a neutropenia: at sick children with normal function of kidneys and with a body weight less than 50 kg with the fever which arose against the background of a neutropenia, the dose of drug makes 90 mg (80 mg piperatsillina/10 mg of a tazobaktam) on kilogram of body weight which would be entered by everyone hours into combinations with the corresponding dose of aminoglycoside.

At children with body weight more than 50 kg the dose corresponds adult, and enter it into combinations with aminoglycosides.

At an intraabdominal infection: at children with body weight to 40 kg and normal function of kidneys the recommended dose makes 112.5 mg/kg of drug (100 mg piperatsillina/12.5 mg of a tazobaktam) each 8 h.

To children with body weight more than 40 kg and normal function of kidneys appoint the same dose as the adult, i.e. 4.5 g of drug (4 g piperatsillina/0.5 of a tazobaktam) each 8 h.

Treatment it is necessary to spend not less than 5 days and no more than 14 days taking into account that administration of drug is continued during, at least, 48 more h after disappearance of clinical signs of an infection.

Renal failure: the patient with a renal failure or the patient who is on a hemodialysis, it is necessary to adjust a dose and frequency of introduction taking into account degree of a renal failure.

The recommended drug doses for adults and children (body weight> of 50 kg) at a renal failure
Clearance of creatinine (ml/min.)	The recommended dosage of a piperatsillina/tazobaktam
> 40	Dose adjustment is not required
20-40	12 g / 1.5 g/days 4 g / 0.5 in each 8 h
<20	8 g / 1 g/days 4 g / 0.5 each 12 h

For the patients who are on a hemodialysis, the maximum daily dose makes 8 g / 1 of a piperatsillina/tazobaktam. Besides, as when carrying out a hemodialysis for 4 h 30-50% of a piperatsillin are removed, it is necessary to appoint one additional dose of 2 g / 0.25 of a piperatsillina/tazobaktam after each session of dialysis.

Children of 2-12 years with a renal failure: the pharmacokinetics of a piperatsillina/tazobaktam at children with a renal failure is not studied. For children of 2-12 years with a renal failure it is recommended to adjust a dose as follows:

The recommended drug doses for children (the body weight <50 kg) at a renal failure

Clearance of creatinine	The recommended dosage of a piperatsillina/tazobaktam
> 50 ml/min.	112.5 mg/kg (100 mg piperatsillina/12.5 mg of a tazobaktam) each 8 h.
<50 ml/min.	78.75 mg/kg (70 mg of a piperatsillin/8.75 of mg of a tazobaktam) each 8 h.

Such change of a dose is only approximate. Each patient has to be under observation for early detection of signs of overdose. It is necessary to adjust as appropriate a dose of drug and an interval between introduction of the next dose.

Correction of a dose at an abnormal liver function is not required.

At elderly patients dose adjustment is necessary only in the presence of a renal failure.

Way of preparation of solution. Drug is dissolved in one of the solvents provided below according to the specified volumes. The bottle is turned roundabouts before full dissolution of contents (at constant turning usually within 5-10 min.). Ready solution represents colourless or light yellow liquid.

Dosage / bottle (piperatsillin/tazobakta)	Necessary volume of solvent
2.25 (2 g / 250 mg)	10 ml
4.50 (4 g / 500 mg)	20 ml

Solvents compatible to drug of 0.9% chloride sodium solution; sterile water for injections; 5% dextrose solution.

Then the prepared solution can be divorced up to the volume, necessary for intravenous administration (for example, from 50 ml to 150 ml) by one of below the listed compatible solvents: 0.9% chloride sodium solution; sterile water for injections (most recommended volume - 50 ml); 5% dextrose solution.

Features of use:

Use at pregnancy and feeding by a breast. There are no sufficient data about use of a combination of a piperatsillina/tazobaktam or both drugs separately at pregnant women. Piperatsillin and to tazobakta get through a placental barrier. Pregnant women can only appoint drug when the expected advantage for mother surpasses possible risk for a fruit.

Piperatsillin in low concentration cosecretes with breast milk; allocation of a tazobaktam in milk is not studied. In need of use of drug in the period of a lactation it is necessary to stop breastfeeding for the period of treatment.

Use at abnormal liver functions. Correction of a dose at an abnormal liver function is not required.

Use at renal failures. The patient with a renal failure or the patient who is on a hemodialysis drug to appoint with care, the dose and frequency of introduction should be adjusted taking into account degree of a renal failure.

The recommended drug doses for adults and children (body weight> of 50 kg) at a renal failure
Clearance of creatinine (ml/min.)	The recommended dosage of a piperatsillina/tazobaktam
> 40	Dose adjustment is not required
20-40	12 g / 1.5 g/days of 4 g / 0.5 in each 8 h
<20	8 g / 1 g/days of 4 g / 0.5 each 12 h

For the patients who are on a hemodialysis, the maximum daily dose makes 8 g / 1 of a piperatsillina/tazobaktam. Besides, as when carrying out a hemodialysis for 4 h 30-50% of a piperatsillin are removed, it is necessary to appoint one additional dose of 2 g / 0.25 of a piperatsillina/tazobaktam after each session of dialysis.

Children of 2-12 years with a renal failure: the pharmacokinetics of a piperatsillina/tazobaktam at children with a renal failure is not studied. For children of 2-12 years with a renal failure it is recommended to adjust a dose as follows:

The recommended drug doses for children (the body weight <50 kg) at a renal failure:

Clearance of creatinine	The recommended dosage of a piperatsillina/tazobaktam
> 50 ml/min.	112.5 mg/kg (100 mg piperatsillina/12.5 mg of a tazobaktam) each 8 h.
<50 ml/min.	78.75 mg/kg (70 mg of a piperatsillin/8.75 of mg of a tazobaktam) each 8 h.

Such change of a dose is only approximate. Each patient has to be under observation for early detection of signs of overdose. It is necessary to adjust as appropriate a dose of drug and an interval between introduction of the next dose.

Use for children. There is no experience of use for the children who did not reach 2-year age. With care to apply at children is more senior than 2 years.

Use for elderly patients. At elderly patients dose adjustment is necessary only in the presence of a renal failure.

Before an initiation of treatment it is necessary to interview in detail the patient to reveal possible hypersensitivity reactions on penicillin, cephalosporins or other allergens. Heavy allergic reactions more likely can develop at patients with hypersensitivity to several allergens. Similar reactions demand the termination of administration of drug and purpose of Epinephrinum (adrenaline) and holding other emergency actions.

The pseudomembranous colitis caused by antibiotics can be shown by the heavy, constant diarrhea posing a threat for life. Pseudomembranous colitis can develop both during antibacterial therapy, and after its end. In such cases it is necessary to stop immediately administration of drug and to appoint the corresponding therapy (for example, inside metronidazole, Vancomycinum). The drugs inhibiting an intestines peristaltics are contraindicated.

At treatment, especially long, development of a leukopenia and neutropenia therefore it is necessary to control indicators of peripheral blood periodically is possible.

In some cases (most often at patients with a renal failure) emergence of the raised bleeding and the accompanying change of laboratory indicators of system of a blood coagulation is probable (a blood clotting time, aggregation of thrombocytes and a prothrombin time). At emergence of bleedings it is necessary to cancel treatment by drug and to appoint the corresponding therapy.

It must be kept in mind a possibility of emergence of steady microorganisms which can cause superinfection, especially at a long course of treatment. This drug contains 2.79 мЭкв. (64 mg) sodium on gram of a piperatsillin that can lead to total magnification of intake of sodium. At patients with a hypopotassemia or accepting drugs which promote potassium removal, during treatment the hypopotassemia can develop (it is regularly necessary to check the content of electrolytes in blood serum).

There is no experience of use for the children who did not reach 2-year age.

During use of drug the false positive result of test on glucose in urine when using the method based on recovery of ions of a bank is possible. Therefore, it is recommended to carry out the test based on enzymic oxidation of glucose (a glyukozoksidazny method).

Side effects:

Allergic reactions: urticaria, a skin itch, rash, violent dermatitis, a multiformny erythema, Stephens-Johnson's syndrome, a toxic epidermal necrolysis, anaphylactic/anaphylactoid reactions (including an acute anaphylaxis).

From the alimentary system: diarrhea, nausea, vomiting, lock, dyspepsia, jaundice, stomatitis, abdominal pain, pseudomembranous colitis, hepatitis.

From bodies of a hemopoiesis: a leukopenia, a neutropenia, thrombocytopenia, anemia, bleedings (including a purpura, nasal bleedings, increase in a bleeding time), hemolitic anemia, an agranulocytosis, false positive direct test of Koombs, a pancytopenia, increase in the activated partial tromboplastinovy time, increase in a prothrombin time, thrombocytes.

From outside мочевыделителыюй systems: intersticial nephrite, renal failure.

From a nervous system: headache, sleeplessness, spasms.

From cardiovascular system: lowering of arterial pressure, "inflows".

Laboratory indicators: a hypoalbuminemia, a hypoglycemia, a hypoproteinemia, a hypopotassemia, an eosinophilia, increase in activity of "hepatic" transaminases (alaninaminotranspherase, aspartate aminotransferase), a hyperbilirubinemia, increase in activity of an alkaline phosphatase, gamma глутамилтрансферазы, increase in concentration of creatinine and urea in blood serum.

Local reactions: phlebitis, thrombophlebitis, a hyperthermia in an injection site, a hyperemia and consolidation in an injection site.

Others: fungal superinfections, fever, arthralgia.

Interaction with other medicines:

Combined use of drug with probenetsidy increases elimination half-lives and reduces renal clearance both a piperatsillin, and a tazobaktam, however the maximum concentration in plasma of both drugs are left without change.

Simultaneous use of drug and vekuroniya of bromide can lead to longer neuromuscular blockade caused by the last (the similar effect can be observed at a combination of a piperatsillin with other not depolarizing muscle relaxants).

At the simultaneous use of high doses of heparin, indirect anticoagulants or other drugs influencing system of a blood coagulation including on function of thrombocytes, the thicket needs to control a condition of system of a blood coagulation.

Piperatsillin can detain removal of a methotrexate (in order to avoid toxic effect it is necessary to control concentration of a methotrexate in blood serum).

Pharmaceutical compatibility with other medicines. Drug should not be mixed in one syringe or a dropper with other medicines including with aminoglycosides. At use together with other antibiotics, the drugs should be administered separately; it is the most preferable to differentiate introduction of a piperatsillina/tazobaktam and aminoglycosides in time.

Drug should not be used together with the solutions containing Natrii hydrocarbonas and to add to blood preparations or hydrolyzates of albumine.

Contraindications:

— children's age up to 2 years;

— hypersensitivity to a beta laktamnym to antibiotics (including, to penicillin, cephalosporins), to other components of drug or to inhibitors beta лактамаз.

With care: heavy bleedings (including, in the anamnesis), a mucoviscidosis (the increased risk of development of a hyperthermia and skin rash), pseudomembranous colitis, children's age, a renal failure (KK less than 20 ml/min.), to the patients who are on a hemodialysis at combined use of high doses of anticoagulants, at a hypopotassemia.

Overdose:

Symptoms of overdose are nausea, vomiting, diarrhea, the increased neuromuscular excitability and spasms.

Depending on clinical manifestations the symptomatic treatment is appointed. For decrease in high concentration of a piperatsillin or a tazobaktam in serum the hemodialysis can be appointed.

Storage conditions:

To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

bottles (12) - packs cardboard.
bottles (1) - packs cardboard.
bottles (10) - packs cardboard.
bottles (100) - boxes cardboard.
bottles (25) - boxes cardboard.
bottles (48) - boxes cardboard.