Azawounds

Azawounds – a wide range of bactericidal action the antibiotic of group of cephalosporins (the III generation) intended for parenteral administration.

Form of release and structure

Dosage form of Azaran – powder for preparation of solution for intravenous and intramuscular administration: powdery weight from white with a yellowish shade till white color (on 1,0 g in the bottles of colourless glass corked by the combined cover from plastic, rubber and metal with function of control of the first opening; 1, 10 or 50 bottles in a cardboard pack).

1 bottle contains active ingredient: цефтриаксон sodium (in terms of цефтриаксон) – 1,0 g.

Indications to use

Azawounds apply to therapy of the following infectious and inflammatory diseases caused by the microorganisms sensitive to a tseftriakson:

• Respiratory infections (upper and lower parts), including pneumonia, abscess of lungs, a pleura empyema;
• Infections of bones and joints;
• Infections of skin and soft tissues;
• Infections of urinary tract, including pyelonephritis;
• Infections of bodies of a small pelvis;
• Inflammations of the digestive tract (DT) and bilious channels, including a cholangitis and an empyema of a gall bladder;
• Bacterial meningitis;
• Bacterial endocarditis;
• Peritonitis;
• Sepsis;
• Lyme's disease;
• Salmonellosis;
• Acute uncomplicated gonorrhea;
• Shigellosis.

Also drug is used in postoperative practice for prevention and treatment of infectious complications.

Contraindications

Absolute:

• Hypersensitivity to other penicillin, cephalosporins, and karbapenema;
• Hypersensitivity to Azaran's components.

Relative (drug is used with care, in connection with the increased risk of side effects):

• Abnormal liver functions and/or kidneys;
• Hyperbilirubinemia at newborns, especially premature;
• Nonspecific Ulcer Colitis (NUC);
• The enteritis or colitis connected using antibiotics.

As цефтриаксон gets through a placenta, at pregnancy therapy by Azaran is possible only according to indications, in case of exceeding of estimated advantage for mother over potential risk for a fruit.

In need of use of drug in the period of a lactation it is required to resolve an issue of breastfeeding interruption since цефтриаксон it is allocated with maternal milk.

Route of administration and dosage

The solution received from powder is entered intramusculary (in oil), either intravenously (in/in) struyno or kapelno, 1 time a day if there are no other appointments.

The recommended average daily dose:

• Newborns and children up to 14 days – 20-50 mg/kg, as much as possible to 50 mg/kg;
• Children from 15 days to 12 years – 20-80 mg/kg;
• Children of 12 years and adult – 1000-2000 mg, as much as possible to 4000 mg.

To children 12 years with the body weight of ≥50 kg are younger apply adult doses.

Solution in a daily dose of 50 mg/kg and is more entered infusionally for half an hour.

Therapy course duration usually no more than 10 days. After removal of symptoms of a disease and normalization of temperature it is necessary to continue administration of drug 2-3 more days.

The recommended dosing in special cases:

• Prevention of infections in the postoperative period: 1000-2000 mg in 30-90 min. prior to operation once (the dose depends on degree of infectious risk); at operations on thick and a rectum it is recommended to administer in addition the drug from group 5 of nitroimidazoles;
• Bacterial meningitis at children of chest and younger age: 100 mg/kg of 1 times a day, as much as possible to 4000 mg; duration of a course depends on the activator and can be from 4 days (the meningitis caused by Neisseria meningitidis) to 10-14 days (the meningitis caused by sensitive strains of Enterobacteriaceae);
• Acute uncomplicated gonorrhea: 250 mg in oil once;
• Lyme's disease: 50 mg/kg of 1 times a day (adults and children), as much as possible to 2000 mg; course duration – 14 days.

Dose adjustment is required at heavy degree of a renal failure with the clearance of creatinine (CC) of ≤10 ml/min., the daily dose of a tseftriakson at the same time should not exceed 2000 mg.

In dose adjustment of a tseftriakson patients have no need: with a moderate renal failure at normal function of a liver; with abnormal liver functions at normally functioning kidneys.

At a combination of a renal and liver failure regular control of concentration of a tseftriakson in plasma, and according to indications correction of its dose is carried out.

After carrying out dialysis patients do not need additional administration of drug as holding a procedure does not promote removal of a tseftriakson. But the hemodialysis can change the speed of its removal therefore control of concentration of drug in a blood plasma is important for possible dose adjustment.

Solution for introduction in oil can be prepared for one of two recommended ways:

1. To dissolve 1000 mg of a tseftriakson in 3,6 ml of water for injections, 1 ml of the received solution contains ~ 250 mg of a tseftriakson if it is necessary, it is possible to apply less strong solution;
2. To dissolve 1000 mg of a tseftriakson in 3,5 ml 1% of solution of lidocaine of chloride for introduction no more than 1000 mg in one muscle are deep in quite large muscles (buttock or a muscle of a hip), but; solution of lidocaine of chloride cannot be entered in/in.

Solution for in/in introductions prepares as follows:

• Injections: To dissolve 1000 mg of drug in 9,6 ml of sterile water for injections, 1 ml of the received solution contains ~ 100 mg of a tseftriakson; it is necessary to enter solution in/in slowly for 2-4 min.;
• Infusions: 2000 mg of powder dissolve in 40 ml of one of the following solutions which are not containing calcium – 0,9% chloride sodium solution; 0,45% chloride sodium solution from 2,5% dextrose solution; 6% dextran solution in 5% dextrose solution; 5% or 10% dextrose solution; 6-10% solution of hydroxyethylated starch; duration in/in infusion has to make not less than half an hour.

Freshly cooked solutions from powder Azaran are stable at the room temperature during 6 h and no more than 24 h at a temperature of 2-8 °C (storage in the refrigerator).

Side effects

• Central Nervous System (CNS): dizziness, headache;
• Urinary system: renal failure (increase in content in urea blood, azotemia, giperkreatininemiya, cylindruria, hamaturia, glucosuria, oliguria, anury);
• Alimentary system: an abdominal pain, taste disturbance, nausea, vomiting, dysbacteriosis, a meteorism, a glossitis, stomatitis, a lock or diarrhea, a pseudo-cholelithiasis ("sludge" - a syndrome), a pseudomembranous coloenteritis, increase in activity of hepatic transaminases and an alkaline phosphatase, cholestatic jaundice, a hyperbilirubinemia;
• System of a hemopoiesis: leukopenia, anemia, leukocytosis, neutropenia, lymphopenia, granulocytopenia, thrombocytosis, thrombocytopenia, hemolitic anemia, basophilia;
• Coagulant system of blood: decrease in plasma blood-coagulation factors (namely, II, VII, IX, X), hypocoagulation, increase in a prothrombin time, nasal bleeding;
• Hypersensitivity reactions: acute anaphylaxis, rash, itch, small tortoiseshell, fever, fever; seldom – hypostases, an eosinophilia, a bronchospasm, an exudative mnogoformny erythema (including a malignant exudative erythema or Stephens-Johnson's syndrome), a serum disease;
• Local reactions: in/in introduction – morbidity on the vein course, phlebitis; introduction in oil – pains in an injection site;
• Others: superinfections, including candidiasis.

Special instructions

Azawounds it is applied only in the conditions of a hospital!

In case of long therapy it is necessary to carry out regular control of a picture of peripheral blood, and also indicators of a functional condition of kidneys and a liver.

Occasionally, at ultrasound examination (ultrasonography) of a gall bladder blackouts which disappear independently after drug withdrawal (even are visible if this phenomenon is followed by pain in right hypochondrium, it is recommended to carry out a symptomatic treatment and to continue use of an antibiotic).

It is impossible to use ethanol at therapy by Azaran as there is a probability of development of the following disulfiramopodobny reactions: nausea, vomiting, rush of blood to the person, spastic pains in epigastric area, a headache, a lowering of arterial pressure (ABP), an asthma, tachycardia.

The elderly and weakened patients need in a complex with tseftriaksony purpose of vitamin K.

Before Azaran's use (as well as other cephalosporins) detailed collecting the anamnesis, but, despite its results is carried out, it is impossible to exclude a possibility of development of an acute anaphylaxis. The state demands immediate treatment: at first in/in introductions of Epinephrinum, and then glucocorticosteroids.

According to the researches in vitro it is revealed that цефтриаксон (as well as other cephalosporins) the blood serum bilirubin connected with albumine is capable to force out. Thereof at newborns with a hyperbilirubinemia, especially premature, it is required to apply цефтриаксон with a bigger care.

Medicinal interaction

• Aminoglycosides – work synergistically with tseftriaksony for many gram-negative bacteria (including Pseudomonas aeruginosa), they need to be entered in the recommended doses separately;
• The drugs reducing aggregation of thrombocytes (non-steroidal anti-inflammatory drugs, Sulfinpyrazonum, salicylates) – цефтриаксон suppresses an indestinal flora, interfering with vitamin K synthesis, thereby increasing risk of development of bleedings;
• Anticoagulants – their anticoagulating action amplifies;
• "Loopback" diuretics and other nefrotoksichny drugs – the risk of their nephrotoxic influence increases;
• Ethanol – Azaran is incompatible with the means containing alcohol;
• The solutions containing other antibiotics (including aminoglycosides and Vancomycinum), and the solutions containing флуконазол – pharmaceutical are incompatible with Azaran;
• Solutions, calciferous (including Ringer's solution) – it is impossible to mix with tseftriaksony.

Terms and storage conditions

To store in the dark place, at a temperature of 15-25 °C. To protect from children.

Period of validity – 3 years.