Анаэроцеф®

General characteristics. Structure:

Active ingredient: 0,5 g or 1,0 g of a tsefoksitin of sodium (in terms of цефокситин).
 
Tsefalosporinovy antibiotic of the II generation from group of tsefamitsin for parenteral administration.

Pharmacological properties:

Pharmacodynamics. The Tsefalosporinovy antibiotic of the II generation from group of tsefamitsin for parenteral administration. Bactericidal action is caused by blocking of bacterial transpeptidases that leads to disturbance of the final stages of synthesis of a cell wall of microorganisms. Has a wide range of antimicrobic action as concerning aerobic, and anaerobic bacteria. The unique molecular structure of a tsefoksitin defines its high resistance to bacterial beta lactamelements.

It is active concerning gram-positive aerobes - Staphylococcus aureus and Staphylococcus epidermidis (including the strains producing and not producing a penicillinase), beta and hemolitic streptococci of group A (Streptococcus pyogenes), beta and hemolitic streptococci of group In (Streptococcus agalactiae), Streptococcus pneumoniae; gram-negative aerobes - Escherichia coli, Haemophilus influenzae, Eikenella corrodens (which are not producing some beta lactamazu strains), K. pneumoniae, Neisseria gonorrhoeae (including the strains producing and not producing a penicillinase), Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri), Salmonella spp., Shigella spp., and also clinical and significant anaerobe bacterias - Actinomyces spp., Clostridium spp. (except Clostridium difficile), Peptococcus niger, Peptostreptococcus spp. mikroaerofilny streptococci, Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides spp., Prevotella bivia.

Tsefoksitin is inactive concerning metitsillinoustoychivy Staphylococcus spp., enterococci, Listeria monocytogenes, Enterobacter cloacae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Mycobacterium spp., Rickettsia spp., Chlamydia spp., Mycoplasma spp., Ureaplasma spp.

Pharmacokinetics. In 5 min. after bolyusny 1 g, intravenous (in/in) introductions, and 2 g of a tsefoksitin the maximum serumal concentration (Cmax) make 110 and 244 mg/l, respectively. In 4 hours after intravenous administration in a dose of 1 g serumal concentration make less than 1 mg/l. After intramuscular introduction (in oil) 1 g of a tsefoksitin of Cmax is observed in 20 min. and makes 30 mg/l.

Well gets into various liquids and body tissues: in pleural, ascitic and synovial liquids; bactericidal concentration are defined in bile. Distribution volume - 0,16 l/kg. Communication with proteins of plasma - 70-80%. It is allocated with breast milk in low concentration.

It is excreted preferential by kidneys in not changed in a look (85% due to glomerular filtering, 6% - canalicular secretion), at the same time in urine high concentration of drug are created. In the form of inactive metabolites only 0.2-5% of the entered dose are removed. The elimination half-life (T½) at intravenous administration makes from 41 to 59 min., at elderly - from 51 to 90 min.

Indications to use:

 The infections caused by sensitive microorganisms:
• lower respiratory tract infections, including pneumonia, a pleura empyema, abscess of lungs;
• infections of abdominal organs, including peritonitis, abscess of an abdominal cavity;
• infectious and inflammatory diseases of bodies of a small pelvis, including endometritis, pelviperitonitis, salpingo-oophoritis;
• infections of urinary tract (pyelitis, pyelonephritis);
• infections of skin and soft tissues,
• infections of bones and joints;
• uncomplicated gonorrhea;
• septicaemia.

Prevention of postoperative infectious complications

Route of administration and doses:

Clearance of creatinine,  ml/min.	Dose,	Interval between  doses
30-50	1-2	8-12 h
10-29	1-2	12-24
5-9	0,5-1	12-24 h
<5	0,5-1	24-48 h

	The bottle containing 0,5 g of Anaerotsefa®	1 ml
	The bottle containing 1,0 g of Anaerotsef ®	2 ml

	The bottle containing 0,5 g of Anaerotsefa®	5 ml
	The bottle containing 1,0 g of Anaerotsefa®	10 ml

Features of use:

Анаэроцеф® it is used as the only antibiotic (monotherapy) for treatment of the mixed aerobic-anaerobic infections of the most various localizations including caused by strains of the bacteria steady against penicillin, other cephalosporins, linkozamida and aminoglycosides.

The patients who had allergic reactions to penicillin in the anamnesis can have hypersensitivity to tsefalosporinovy antibiotics.

For treatment of newborns it is necessary to use solvent without preservatives. Use of high doses for children is followed by increase in frequency of an eosinophilia and increase in activity of asparaginamino-transferases.

Анаэроцеф® it is not recommended for treatment of bacterial meningitis.

When using a method of Jaffe the false overestimated concentration of creatinine in serum therefore it is not recommended to take away blood samples for definition of creatinine within 2 hours after introduction of a tsefoksitin are possible.

Side effects:

Allergic reactions: rash, exfoliative dermatitis, a toxic epidermal necrolysis (Lyell's disease), an eosinophilia, fever, an asthma, it is rare - anaphylactic reactions, a Quincke's disease.

Local reactions: thrombophlebitis after intravenous administration; pain, consolidation in places in oil of injections

From an urinary system: increase in level of creatinine of blood serum, intersticial nephrite, renal failure.

From the alimentary system: nausea, vomiting, dryness in a mouth, a loss of appetite, diarrhea, a pseudomembranous coloenteritis.

From system of blood: leukopenia, granulocytopenia, neutropenia, anemia, thrombocytopenia, marrow suppression, hemolitic anemia.

From cardiovascular system: arterial hypotension.

Laboratory indicators: at patients with an azotemia false positive reaction of Koombs, increase in activity of "hepatic" transaminases is possible.

Others: aggravation of a current of myastenia gravis.

Interaction with other medicines:

At simultaneous use with aminoglycosides a synergism of antimicrobic action, preferential, concerning Enterobacteriaceae is observed.

Anaerotsefa® solutions are compatible from 0,9% solution of sodium of chloride, 5% dextrose solution; the solution for infusions containing 0.45% of sodium of chloride and 5% of a dextrose; the solution for infusions containing 0,9% of sodium of chloride and 5% of a dextrose; 5% dextrose solution in Ringer's solution with a lactate, Ringer's solution with a lactate, 2,5%, 5% and 10% solution of Mannitolum, M/6 lactate sodium solution.

It is not necessary to mix in one syringe or one infusional environment Anaerotsefa® solutions and aminoglycosides.

The medicines blocking canalicular secretion increase concentration of drug in blood and duration of its action.

Simultaneous use of aminoglycosides and other cephalosporins increases risk of development of nephrotoxicity.

Contraindications:

Hypersensitivity to a tsefoksitin and other tsefalosporinovy antibiotics.

With care apply at patients with allergic reactions to penicillin in the anamnesis as the cross allergy between penicillin and cephalosporins is possible; at instructions in the anamnesis on nonspecific ulcer colitis; renal failure.

Use of Anaerotsefa® for pregnant women perhaps in cases when the estimated advantage for mother exceeds potential risk for a fruit, and has to be carried out under observation of the specialist. For treatment tsefoksitiny breastfeeding should be stopped.

Storage conditions:

List B. In the dry, protected from light place at a temperature not above 25 °C.
To store in the places unavailable to children.

Issue conditions:

According to the recipe

Packaging:

0,5 g or 1,0 g of active agent place glass with a capacity of 10 ml in bottles
1 bottle with drug and the application instruction is placed in a pack from a cardboard.