Zephthouse

Ceftum contains a component ceftazidime, which is a cephalosporin with bactericidal properties. The principle of its influence is based on the violation of the binding membranes of the microbial cell.

Demonstrates a strong influence on a relatively large range of gram-negative as well as positive microbes; among them are strains that are resistant to gentamicin and other aminoglycosides. Very high resistance indicates the effect of a large number of β-lactamases produced by both gram-positive and negative bacteria.

Indications Zephthous

It is used for infections of mono- or mixed nature, associated with the action of sensitive bacteria.

Severe forms of infection:

• peritonitis, bacteremia, sepsis or meningitis ;
• lesions in immunocompromised persons;
• for patients staying in intensive care - for example, due to infected burns;
• infections in the respiratory system, including pulmonary lesions in people with cystic fibrosis;
• lesions covering the ENT system;
• infection of the urethra;
• lesions affecting the subcutaneous tissue and epidermis;
• infections associated with the bile ducts, the digestive system and the peritoneum;
• lesions of the joints with bones;
• infections that occur as a result of peritoneal or hemodialysis, as well as carried out continuously in the outpatient setting of peritoneal dialysis.

Appointed to prevent infections during operations in the prostate (carrying out transurethral resection).

Release form

The release of drugs is implemented in the form of a lyophilisate for injection fluid, inside the vials with a volume of 1.0 g. There are 10 such bottles in a box.

[1]

Pharmacodynamics

Ceftazidime has a high level of in vitro activity with an effect in the range of a narrow spectrum of MICs on most infectious agents. In vitro testing revealed that the use of drugs in combination with aminoglycosides leads to the development of additive effects, and the symptoms of synergism were observed in experiments with individual strains.

Along with this, in vitro tests have shown that ceftazidime has influence over such bacteria:

• Gram-negative: E. Coli, enterobacteria, salmonella, Klebsiella (among them Klebsiella pneumonia), Pseudomonas bacilli with proteges Mirabilis, pseudomonads (among them Ps.Pseudomallei), regular proteas and serrations. In addition, the list of Shigella, acinetobacteria, Rettger Providences, Morgan's bacteria, cytobacters with multitocid pasteurella, and in addition, Providencia, Yersinia enterocolitica, hemophilic sticks (among them strains with resistance to ampicillin), meningococci with resistance, for example, for meningococci, for storing ampicillin-resistant meningococcus, for meninging with effects of ampicillin, for meningo, for hemophilus bacilli against ampicillin strains);
• Gram-positive: pneumococci, streptococci (except for fecal streptococcus), Staphylococcus aureus (susceptible to methicillin strains), micrococci, streptococci with epithelial staphylococcus with susceptibility to methicillin, pyogenic streptococci with epidermal staphylococci (with susceptibility to methicillin), pyogenic streptococci with epidermal staphylococcus (with susceptibility to methicillin), pyogenic streptococci with epidermal staphylococci (with susceptibility to methicillin), pyogenic streptococci with epidermal staphylococci (with susceptibility to methicillin), pyogenic streptococci with epidermal staphylococci (with susceptibility to methicillin), pyogenic streptococci with epidermal staphylococci (with susceptibility to methicillin); streptococci from subgroup B (streptococcus agalactia);
• anaerobes: streptococci, Clostridium perfringens, peptostreptokokki, fuzobakterii with peptokokkki, propionibakteriya and bacteroids (most strains of bacteroids fragilis are resistant).

When used in vitro, ceftum did not affect methicillin-resistant staphylococci, campylobacter, fecal streptococci (and many other enterococci), clostridia diffile and listeria monocytogenes.

Pharmacokinetics

After the injection of 0.5 or 1 g of the injection w / m, the Cmax indices are quickly marked, equal, respectively, to 18 and 37 mg / l. After 5 minutes from the moment of the bolus application of 0.5, 1 or 2 g of substance, inside the blood serum, respectively, such average concentrations are 46, 87 or 170 mg / l. The therapeutic effects of drug values are stored inside the blood serum even after 8-12 hours from i / v or i / m use.

Intraplasmic protein synthesis is approximately 10%. Drug indicators, which exceed the MIC values of most of the common pathogens, are recorded inside the heart, bones and sputum with bile, and in addition, inside peritoneal, pleural and intraocular fluids and synovia.

The drug overcomes the placenta at high speed and is excreted with the mother's milk. Through intact BBB substance passes badly, therefore, for individuals without inflammation, the indicator of drugs within the central nervous system is quite low. But if a patient has inflammation affecting the brain membranes, the level of the substance inside the CNS reaches 4–20 + mg / l (this is equivalent to its therapeutic indices).

The drug is not involved in metabolic processes. With parenteral administration, stable and high serum values of ceftazidime are noted.

The half-life term is approximately 2 hours. The drug is excreted in an active unchanged state along with urine through glomerular filtration. About 80-90% of the portion is excreted with the urine in a period of 24 hours.

People with kidney problems have a weakening of Ceftum elimination, which is why they need a lower dosage.

Less than 1% of the drug is excreted in the bile, which significantly reduces the amount of substance that enters the intestine.

Dosing and administration

The portion size is selected taking into account the sensitivity, intensity of the disease, the type and location of the infection, and in addition to this age of the patient and his renal function.

Adults.

Often the daily dosage is in the range of 1-6 g with the introduction of 2-3 times (through the / m or / in injection).

With lesions of the urogenital ducts and weaker infections, 0.5-1 g at 12-hour intervals.

For most infections: 1000 mg at 8-hour intervals, or 2000 mg at 12-hour intervals.

In the case of extremely severe infections (especially in persons with immunodeficiency, among which are patients with neutropenia), 2 g of the drug (or 3 g with a 12-hour interval) are required with 8 or 12-hour breaks.

If cystic fibrosis is observed in combination with a pulmonary pyogenous purulent lesion, 0.1-0.15 g / kg per day is administered in 3 injections.

Therapy is continued for 2 more days from the moment the symptoms of infection disappear, but with severe forms of disease, the treatment period may be longer.

The introduction of a portion of up to 9 g per day did not lead to the development of negative effects in adults with normal renal activity.

To prevent the development of complications during surgery on the prostate, with induction in anesthesia 1000 mg of drugs are injected. The second portion is used when removing the catheter.

Infants and children over 2 months of age.

Application of 0.03-0.1 g / kg (2-3 injections per day). For cystic fibrosis, immunodeficiency, or meningitis, portions of no more than 0.15 g / kg per day (maximum 6000 mg per day) in 3 administrations should be used.

Newborns (age less than 2 months).

Introduction for 2 injections 25-60 mg / kg per day. The term of serum half-life of a drug in a newborn can be three to four times as long as an adult.

Elderly faces.

Taking into account the decrease in the clearance of drugs in older people with acute infections, they are often administered no more than 3000 mg of a substance per day (especially for people over the age of 80). The duration of the therapeutic cycle is chosen individually.

Portion sizes in case of renal dysfunction.

Excretion of unchanged ceftazidime occurs through the kidneys, therefore, in patients with renal dysfunctions, the dosage of drugs should be reduced. The size of the initial portion is 1000 mg. Maintenance dosage is selected, taking into account the speed of the glomerular filtration.

Supporting portions of Ceftum with kidney failure.

Persons with severe lesions are allowed to increase 1-fold portion by 50% or increase the number of injections accordingly. In such people, it is necessary to monitor the serum values of ceftazidime, which should be less than 40 mg / l.

For a child, the KK indicator should be changed, taking into account the weight and area of the bodily surface.

With hemodialysis. The term serum half-life ceftazidime with hemodialysis is 3-5 hours. At the end of each of the hemodialysis sessions, maintenance portions of drugs are used.

During peritoneal dialysis. The drug is used according to the standard scheme. In addition to intravenous injection, the drug can be added to the dialysis fluid (0.125-0.25 g per 2 liters).

In people with kidney failure, who undergo prolonged hemodialysis of the arteriovenous type or hemofiltration at high speed in intensive care, the size of the dose per day is 1000 mg (1-fold or for several injections). With hemofiltration, which has a low speed, portions are used that are used in case of renal dysfunction.

Dosage of the drug in persons undergoing prolonged hemodialysis or hemofiltration, having a venovenous form.

It is necessary to enter the supporting portion with 12-hour breaks.

Injection method.

The drug is used in / in the way or through a deep i / m injection. For i / m injections, the drug is injected into the area of the outer upper quadrant of the big muscle of the buttock or into the lateral femoral zone.

Prepared fluids are injected directly into the vein or through the infusion system, when the patient receives substances by parenteral administration.

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Use Zephthous during pregnancy

There is no information regarding the development of teratogenic and embryotoxic effects of drugs, but in the 1st trimester it should be prescribed very carefully.

Small volumes of Ceftum are excreted in breast milk, which is why it is used very carefully when breastfeeding.

Contraindications

It is contraindicated for people with severe intolerance towards cephalosporins, ceftazidime pentahydrate, or other elements of the medication.

Side effects Zephthous

Among the side effects:

• Invasive or infectious infections: candidiasis (this includes stomatitis with vaginitis);
• problems associated with lymph and circulatory system: thrombocyto-, leuko- or neutropenia, lymphocytosis, thrombocytosis or agranulocytosis, hemolytic anemia, and eosinophilia;
• immune disorders: anaphylaxis (this includes hypotension or bronchial spasm);
• lesions affecting the work of the National Assembly: paresthesia, and in addition to this dizziness or headaches. There are data on the development of neurological complications - myoclonia, convulsions with tremor, encephalopathy and coma in people with renal impairment who were not given the required reduction in drug dosage;
• vascular disorders: thrombophlebitis or phlebitis in the area of injection;
• disorders associated with gastrointestinal function: colitis, diarrhea, taste disorder, nausea and pain in the abdominal area. As in the case of using other cephalosporins, the developed colitis can be caused by clostridium differential and manifest itself in its pseudomembranous form;
• urinary problems: tubulointerstitial nephritis or acute renal failure;
• lesions associated with the hepatobiliary system: jaundice or a temporary increase in the values of one or several intrahepatic enzymes (AST with ALT, and in addition GGT, LDH, or alkaline phosphatase);
• violations affecting the subcutaneous layers with the epidermis: itching, SSD, urticaria or maculopapular rash, TEN, erythema multiforme and Quincke edema;
• systemic lesions and signs in the injection area: inflammation or pain at the site of injection and fever;
• change of test results: a positive Coombs reaction. As in the case of the introduction of other cephalosporins, a temporary increase in nitrogen values of blood urea or creatinine inside blood serum sometimes occurred. A positive response from the Coombs test is observed in approximately 5% of people, which can affect the process of determining the blood group.

[2]

Overdose

In case of poisoning, complications of a neurological nature are possible - convulsions, encephalopathy, and coma.

Ceftazidime serum levels can be reduced through peritoneal or hemodialysis. Symptomatic actions are also performed.

Interactions with other drugs

The use of large portions of cephalosporins together with nephrotoxic substances (for example, with aminoglycosides or with a strong diuretic effect, such as furosemide), can lead to a negative effect on renal activity. Clinical practice shows that in the case of compliance with the prescribed dosages the development of such an effect is unlikely.

When used in vitro, chloramphenicol acts as an antagonist of drugs and other cephalosporins. There is no information regarding the clinical significance of this effect, but when using these drugs in combination, the risk of antagonism must be taken into account.

The drug, as well as other antibiotics, can alter the intestinal microflora, because of which the estrogen reabsorption is weakened and the effect of complex oral contraceptives is reduced.

The drug does not change the indications in enzyme testing for the determination of glycosuria, but some effect on the test data can be observed in the case of using methods for the recovery of Cu (Fehling or Benedict or Klinitest tests).

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Storage conditions

Ceftum should be kept in a place closed to the penetration of small children. Temperature indicators - not more than 25 ° С.

[5], [6]

Shelf life

Ceftum can be used for a 24-month term from the time the therapeutic agent is manufactured.

Analogs

Analogues of the drug are the substances Norzidim, Auromitaz, Tazid with Denizid, Aurocef and Trofiz with Rumid Pharmiunion, and in addition, Zatsef, Biotum, Tulizid with Eurosidime, Fortum and Ceftarid with Zidane. Also on the list are Emzid, Lorazidim, Ceftiazidim with Orzid, Ceftadim and Fortazim.