Ceftum

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

Shows strong influence of 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 shows relatively high influence of a large number of β-lactamases produced by both gram-positive and -negative bacteria.

Indications Ceftuma

It is used for infections of a single or mixed nature associated with the action of sensitive bacteria.

Severe forms of infection:

• peritonitis, bacteremia, sepsis or meningitis;
• lesions in individuals with weakened immune systems;
• for patients in intensive care - for example, due to infected burns;
• infections in the respiratory system, including lung lesions in people with cystic fibrosis;
• lesions involving the ENT system;
• urinary tract infections;
• lesions affecting the subcutaneous tissue and epidermis;
• infections associated with the bile ducts, digestive system and peritoneum;
• lesions of joints with bones;
• infections that occur as a result of peritoneal or hemodialysis, as well as continuous outpatient peritoneal dialysis.

It is prescribed to prevent infections during operations in the prostate area (transurethral resection).

Release form

The drug is released in the form of a lyophilisate for injection liquid, inside 1.0 g vials. There are 10 such vials in a box.

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Pharmacodynamics

Ceftazidime has a high level of in vitro activity with an effect in the narrow MIC range against most infectious agents. In vitro testing has shown that the use of the drug in combination with aminoglycosides leads to the development of an additive effect, and in experiments with individual strains, symptoms of synergism were also noted.

In addition, in vitro tests have shown that ceftazidime has an effect on the following bacteria:

• gram-negative: Escherichia coli, Enterobacter, Salmonella, Klebsiella (including Klebsiella pneumoniae), Pseudomonas aeruginosa with Proteus mirabilis, Pseudomonas (including Ps. Pseudomallei), Proteus and Serratia. In addition, the list includes Shigella, Acinetobacter, Providentia Rettgerii, Morgan's bacteria, Cytobacter with Pasteurella multocida, and in addition to Providentia, Yersinia enterocolitica, Haemophilus influenzae (including strains with resistance to ampicillin), Meningococci with gonococci and Haemophilus parainfluenzae (this includes strains resistant to ampicillin);
• gram-positive: pneumococci, streptococci (except faecal streptococci), Staphylococcus aureus (methicillin-sensitive strains), micrococci, Streptococcus mitis with epidermal staphylococci (methicillin-sensitive), pyogenic streptococci (β-hemolytic from subcategory group A), as well as streptococci from subgroup B (Streptococcus agalactiae);
• anaerobes: streptococci, clostridia perfringens, peptostreptococci, fusobacteria with peptococci, propionibacteria and bacteroides (most strains of bacteroides fragilis are resistant).

When used in vitro, Ceftum had no effect on methicillin-resistant staphylococci, campylobacter, fecal streptococci (and many other enterococci), Clostridium difficile and Listeria monocytogenes.

Pharmacokinetics

After an intramuscular injection of 0.5 or 1 g, Cmax values of 18 and 37 mg/l, respectively, are quickly noted. After 5 minutes from the moment of bolus administration of 0.5, 1 or 2 g of the substance, the following average concentrations are noted in the blood serum: 46, 87 or 170 mg/l, respectively. The values of the drug that have a therapeutic effect are retained in the blood serum even after 8-12 hours from the moment of intravenous or intramuscular administration.

Intraplasmic synthesis with protein is approximately 10%. Drug levels exceeding the MIC values of most common pathogens are recorded in the heart, bones, and sputum with bile, as well as in the peritoneal, pleural, and intraocular fluids and synovium.

The drug crosses the placenta at high speed and is excreted in breast milk. The substance passes poorly through an intact BBB, so the LS level inside the CNS is quite low in people without inflammation. But if the patient has inflammation affecting the membranes of the brain, the level of the substance inside the CNS reaches 4-20+ mg/l (this is equivalent to its therapeutic indicators).

The drug does not participate in metabolic processes. When administered parenterally, stable and high serum levels of ceftazidime are observed.

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

In people with kidney problems, the elimination of Ceftum is weakened, which is why they need a lower dosage.

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

Dosing and administration

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

Adults.

Often the daily dosage is within 1-6 g, administered 2-3 times (via intramuscular or intravenous injection).

For 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 cases of extremely severe infections (especially in immunocompromised individuals, including patients with neutropenia), 2 g of the drug (or 3 g with a 12-hour interval) must be administered at 8- or 12-hour intervals.

If cystic fibrosis is observed in combination with pulmonary pseudomonas infection, 0.1-0.15 g/kg is administered per day in 3 injections.

Therapy continues for another 2 days from the moment the symptoms of infection disappear, but in severe forms of the disease the treatment period may be longer.

Administration of a dose of up to 9 g per day did not result in the development of negative consequences in adults with normal renal function.

To prevent complications during prostate surgery, 1000 mg of the drug is administered during induction of anesthesia. The second portion is used when the catheter is removed.

Infants and children over 2 months of age.

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

Newborns (age less than 2 months).

Administration in 2 injections of 25-60 mg/kg per day. The serum half-life of the drug in a newborn can be three to four times longer than in an adult.

Elderly persons.

Given the decreased drug clearance rates in elderly people with acute infections, they are often given no more than 3000 mg of the substance per day (especially for people over 80). The duration of the therapeutic cycle is selected individually.

Portion sizes for renal dysfunction.

Unchanged ceftazidime is excreted through the kidneys, so the dosage of the drug should be reduced in individuals with renal dysfunction. The initial dose is 1000 mg. The maintenance dose is selected taking into account the rate of glomerular filtration.

Maintenance doses of Ceftum in case of renal insufficiency.

In people with severe lesions, the 1-fold dose may be increased by 50% or the number of injections may be increased accordingly. In such people, serum ceftazidime values should be monitored, and should be less than 40 mg/L.

For a child, the CC indicator needs to be changed taking into account the weight and body surface area.

During hemodialysis. The serum half-life of ceftazidime during hemodialysis is 3-5 hours. At the end of each hemodialysis session, maintenance doses of the drug are used.

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

For patients with renal insufficiency undergoing continuous arteriovenous hemodialysis or high-speed hemofiltration in intensive care, the daily dose is 1000 mg (as a single dose or in several injections). For low-speed hemofiltration, the doses used in cases of renal dysfunction are administered.

Dosages of the drug in individuals undergoing long-term hemodialysis or hemofiltration, which have a venovenous form.

It is necessary to introduce a maintenance dose at 12-hour intervals.

Method of injection.

The medication is administered intravenously or through a deep intramuscular injection. With intramuscular injections, the medication is administered into the area of the outer upper quadrant of the large gluteal muscle or into the lateral femoral area.

The prepared fluids are administered directly into a vein or through an infusion system when the patient receives substances parenterally.

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Use Ceftuma during pregnancy

There is no information regarding the development of teratogenic and embryotoxic effects of the drug, but it should be prescribed with great caution in the first trimester.

Small amounts of Ceftum are excreted in breast milk, which is why it is used with extreme caution during breastfeeding.

Contraindications

Contraindicated for use by individuals with severe intolerance to cephalosporins, ceftazidime pentahydrate or other components of the drug.

Side effects Ceftuma

Side effects include:

• invasive or infectious infections: candidiasis (this includes stomatitis with vaginitis);
• problems associated with the 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 functioning of the nervous system: paresthesia, and in addition dizziness or headaches. There is evidence of the development of neurological complications - myoclonus, seizures with tremor, encephalopathy and comatose state in individuals with renal insufficiency, who did not receive the required reduction in drug dosage;
• vascular disorders: thrombophlebitis or phlebitis in the injection area;
• Gastrointestinal disorders: colitis, diarrhea, taste disturbance, nausea and abdominal pain. As with other cephalosporins, colitis may be caused by Clostridium difficile and manifest itself in its pseudomembranous form;
• problems with urination: tubulointerstitial nephritis or ARF;
• lesions associated with the hepatobiliary system: jaundice or temporary increase in the values of one or more intrahepatic enzymes (AST with ALT, and also GGT, LDH or ALP);
• disorders affecting the subcutaneous layers with the epidermis: itching, SJS, urticaria or maculopapular rashes, TEN, erythema multiforme and Quincke's edema;
• systemic lesions and signs in the injection area: inflammation or pain at the injection site and fever;
• Change in test results: positive Coombs test. As with other cephalosporins, temporary increases in blood urea nitrogen or serum creatinine have occurred at times. A positive Coombs test occurs in approximately 5% of people, which may affect blood typing.

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Overdose

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

Serum ceftazidime levels can be reduced by peritoneal or hemodialysis. Symptomatic measures are also performed.

Interactions with other drugs

The use of large doses of cephalosporins together with nephrotoxic substances (for example, with aminoglycosides or powerful diuretics such as furosemide) may lead to negative effects on renal function. Clinical practice shows that if the prescribed dosages are observed, the development of such effects is unlikely.

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

The drug, like other antibiotics, is capable of changing the intestinal microflora, which weakens estrogen reabsorption and reduces the effect of combined oral contraceptives.

The drug does not change the results of enzyme testing for glucosuria, but some effect on test data may be observed when using methods with Cu reduction (Fehling's or Benedict's tests or Clintest).

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Storage conditions

Ceftum should be stored in a place closed to small children. Temperature indicators - no more than 25°C.

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Shelf life

Ceftum can be used for a period of 24 months from the date of manufacture of the therapeutic agent.

Analogues

The analogs of the drug are Norzidim, Auromitaz, Tazid with Denizid, Aurocef and Trofiz with Rumid Farmunion, and in addition to this, Zacef, Biotum, Tulizid with Eurosidim, Fortum and Ceftaridem with Zidan. Also on the list are Emzid, Lorazidim, Ceftiazidim with Orzid, Ceftadim and Fortazim.