Biotum

Biotum is a cephalosporin (3rd generation) that has bactericidal activity. It is used systemically; the active ingredient is ceftazidime.

The principle of the therapeutic effect of the drug is based on the destruction of the binding of bacterial membranes, which occurs under the influence of ceftazidime. The drug demonstrates high efficiency against a wide range of microbes (gram-negative, as well as -positive). It actively affects strains that are resistant to gentamicin and other aminoglycosides. [ 1 ]

The drug also demonstrates resistance to most β-lactamases.

Indications Biotum

It is used in mono- or mixed forms of infectious etiology diseases associated with the influence of bacteria that demonstrate sensitivity to ceftazidime. It is used in severe forms of infections - peritonitis, bacteremia, as well as sepsis and meningitis.

In addition, it is prescribed in case of the following violations:

• lesions of the respiratory tract and ENT organs (including pulmonary infections in people with cystic fibrosis), as well as otitis;
• urinary tract infections;
• diseases associated with the peritoneum, biliary tract and digestive system;
• lesions of the epidermis and subcutaneous layer;
• infections in the area of joints with bones;
• in people with weakened immune systems;
• in people who are in intensive care (this includes cases of infected burns).

It is effective in cases of infections caused by peritoneal hemodialysis procedures, as well as continuous outpatient peritoneal dialysis.

Along with this, the medication is prescribed for prophylaxis in case of operations in the prostate area (for example, during transurethral resection).

Ceftazidime-containing substances may be used during therapy for fever or neutropenia associated with bacterial infection.

Release form

The drug is released in the form of an injection lyophilisate - 1000 mg per vial.

Pharmacodynamics

The drug demonstrates maximum effect during therapy in a relatively antibacterial range - it has the highest activity against gram-negative aerobes.

Ceftazidime has no effect on relatively methicillin-sensitive staphylococci, as well as streptococci, clostridia, many different enterococci, etc. [ 2 ]

Pharmacokinetics

Absorption.

In case of a bolus injection of 0.5 or 1 g of the substance, it reaches plasma Cmax values at high speed (equal to 18 or 37 mg/l). After 5 minutes from the use of a single dose of 0.5, 1 or 2 g, the plasma level is 46, 87 and 170 mg/l. The pharmacokinetic parameters of the drug are linear within single doses of 0.5-2 g (after intravenous or intramuscular injection).

Distribution processes.

Protein synthesis of the drug has low rates - about 10%. The level of ceftazidime exceeds the MIC values (the minimum level that can slow the growth of pathogenic microbes) and is observed inside the heart, sputum with bones and bile, vitreous body, pleural and peritoneal fluids, and synovium.

Ceftazidime crosses the placenta without complications and is excreted with mother's milk. Passage into the cerebrospinal fluid with damaged BBB is quite weak. In the absence of inflammation, ceftazidime is determined in the cerebrospinal fluid in low concentrations. But if a person has meningitis, the LS indicator in the cerebrospinal fluid is 4-20+ mg/l. [ 3 ]

Excretion.

With parenteral administration, the plasma level of the drug decreases, and the half-life is approximately 2 hours.

Excretion of unchanged ceftazidime is achieved via the CF with urine; approximately 80-90% of the portion is excreted over a 24-hour period. Excretion with bile is less than 1% of the drug.

Elderly people.

The decrease in clearance observed in elderly people is primarily associated with an age-related decrease in intrarenal clearance rates of ceftazidime. The half-life term for a single or 7-day use of 2000 mg of the drug 2 times a day (via bolus intravenous injection) varied in elderly people (80+ years) within 3.5-4 hours.

Pediatrics.

The half-life of a 25-30 mg/kg dose of the drug in a newborn (premature or full-term) is prolonged to 4.5-7.5 hours. But up to 2 months of age, the half-life is similar to that in adults.

Dosing and administration

The required duration of therapy and dosage are selected by the attending physician, who takes into account the location and severity of the disease, the type of microbes that caused the infection, and in addition, the age and renal function of the patient.

Usually 1000-6000 mg of the drug is administered per day (in 2-3 injections). Injections are administered intravenously (via infusion) or intramuscularly.

Average portion sizes for different pathologies:

• infections of the urogenital tract and moderate forms of infections - 500-1000 mg 2 times a day (at 12-hour intervals);
• mild and moderate lesions – 1000 mg 3 times a day (with 8-hour intervals) or 2000 mg 2 times a day (with 12-hour intervals);
• severe forms of infections (also complicated by the presence of immunodeficiency), as well as neutropenia - 2000 mg 3 times a day or 3000 mg 2 times a day;
• cystic fibrosis accompanied by pulmonary pseudomonas infection - 0.1-0.15 g/kg of substance 3 times a day;
• prophylaxis before performing operations – 1000 mg together with anesthesia. The second such dose is used during removal of the catheter.

For a child, the daily portion is selected taking into account the intensity of the pathology, age and weight:

• infants under 2 months of age – 25-60 mg per day (in 2 injections);
• a child over 2 months of age – 0.03-0.1 g per day (in 2-3 injections).

With healthy renal function, no more than 9 g of the drug can be administered per day. If the kidneys are not functioning properly, the dosage is reduced, taking into account personal characteristics. The use begins with 1 g, and then the dynamics are monitored.

Elderly people (over 80 years old) can take a maximum of 3000 mg of Biotum per day.

The methods of use, proportions, solutions used and dilution portions, as well as methods of performing injections are selected by the attending physician, taking into account information from specialized medical literature.

Use Biotum during pregnancy

There is no information regarding potential harm from the drug for pregnant women, since clinical tests have not been performed in this group of patients. Biotum can be prescribed during pregnancy only in situations where the probable benefit is more expected than the risks of negative consequences. The drug is used with extreme caution in the 1st trimester.

When administered in therapeutic doses, the substance is not excreted into breast milk.

Contraindications

Contraindicated in cases of severe intolerance associated with ceftazidime or other elements of the drug. Also not prescribed if the patient has a history of hypersensitivity to cephalosporins and other β-lactam antibiotics, including carbapenems and penicillins.

Ceftazidime should not be mixed with aminoglycosides and vancomycin, which is why they are not combined in the same infusion system or syringe.

Side effects Biotum

The main side effects (listed in order of decreasing frequency of development):

• thrombocytosis or eosinophilia (thrombocyto-, leuko- or neutropenia is observed less frequently);
• thrombophlebitis with phlebitis and pain (in the injection area);
• diarrhea; less frequently vomiting, nausea and headaches occur;
• candidiasis;
• hives and rashes.

Rarely, angioedema, itching, anaphylaxis, as well as jaundice and renal failure are observed.

Overdose

Overdose may result in neurological complications, including seizures, encephalopathy and coma.

Symptomatic measures are carried out, as well as peritoneal and hemodialysis procedures.

Interactions with other drugs

Administration of large doses of ceftazidime to people using nephrotoxic agents may potentiate their negative effects on renal function.

Chloramphenicol, when administered in vitro, acts as an antagonist of ceftazidime, as well as other cephalosporins. The clinical consequences of such an effect have not been studied, but when combining Biotum with chloramphenicol, the possibility of developing an antagonistic effect must be taken into account.

Storage conditions

Biotum must be stored at a maximum temperature of 25°C. The finished liquid can be stored at a temperature of 2-8°C for a maximum of 24 hours.

Shelf life

Biotum can be used for a period of 24 months from the date of manufacture of the medicinal substance.

Analogues

Analogues of the drug are the drugs Orzid, Auromitaz, Fortum and Aurocef with Norzidim and Ceftum, and also Denizid, Trofiz and Lorazidim with Eurozidim, Fortazim with Zacef and Tulizid with Rumid Farmunion. Also on the list are Zidan, Ceftaridem and Tazid with Ceftadim, Emzid and Ceftazidim.