Biotum

Biotum is a cephalosporin (3rd generation) with bactericidal activity. Used systemically; the active ingredient is the substance 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). Actively affects strains that are resistant to gentamicin and other amine glycosides. [1]

Also, the drug shows resistance to most of the β-lactamases.

Indications Biotum

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

In addition, it is appointed in case of such violations:

• lesions of the respiratory tract and ENT organs (among them pulmonary infections in persons with cystic fibrosis), as well as otitis media;
• infection of the urethra;
• diseases associated with the peritoneum, gastrointestinal tract and the digestive system;
• lesions of the epidermis and subcutaneous layer;
• infections in the area of joints with bones;
• in people with weakened immunity;
• in people who are in intensive care (this includes cases with burns of an infected nature).

Effectively acts in case of infections caused by the procedures of peritoneal hemodialysis, and in addition to this continuous outpatient dialysis of the peritoneal type.

At the same time, the medication is prescribed for prophylaxis in case of operations in the prostate area (for example, during transurethral resection).

It is allowed to use substances containing ceftazidime during therapy for fever or neutropenia associated with bacterial contamination.

Release form

The drug is released in the form of an injectable lyophilisate - 1000 mg each inside the vials.

Pharmacodynamics

The drug demonstrates the maximum effect during therapy with respect to the antibacterial range - it has the highest activity against aerobes of the gram-negative type.

Ceftazidime has no effect on methicillin-sensitive staphylococci, and in addition, streptococci, clostridia, many different enterococci, etc. [2]

Pharmacokinetics

Absorption.

In the case of a bolus injection of 0.5 or 1 g of the substance, it reaches the plasma Cmax at a high speed (equal to 18 or 37 mg / l). After 5 minutes after applying a 1-fold dosage of 0.5, 1 or 2 g, the plasma level is 46, 87 and 170 mg / l. Pharmacokinetic parameters of drugs have a linear form within 1-fold dosages of 0.5-2 g (after intravenous or intramuscular injection).

Distribution processes.

The protein synthesis of the drug has low rates - about 10%. Ceftazidime levels exceed 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 humor, pleural and peritoneal fluids, and synovia.

Ceftazidime crosses the placenta without complications and is excreted in mother's milk. The passage into the cerebrospinal fluid with a damaged BBB is rather weak. In the absence of inflammation, ceftazidime is determined inside the cerebrospinal fluid in low concentrations. But if a person has meningitis, the drug value inside 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 realized through CF together with urine; about 80-90% of the serving is excreted over a 24-hour period. Bile excretion is less than 1% of drugs.

Aged people.

The decrease in the level of clearance, noted in the elderly, is primarily associated with an age-related decrease in intrarenal clearance of ceftazidime. The term half-life with 1-time or 7-day use of 2000 mg of the drug 2 times a day (through a bolus intravenous injection) fluctuated in the elderly (80+ years) within 3.5-4 hours.

Pediatrics.

The term half-life of a dosage of 25-30 mg / kg of a drug in a newborn (premature or born on time) 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 the size of the dosage are selected by the attending physician, who takes into account the location and severity of the disease, the type of microbes that provoked the infection, and in addition the age and renal function of the patient.

Usually, 1000-6000 mg of drugs are injected per day (for 2-3 injections). Injections are performed intravenously (via infusion) or intramuscularly.

Average serving sizes for various pathologies:

• infections of the urogenital ducts 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 breaks) 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 aeruginosa 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 portion is used during the 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 (2-3 injections).

With healthy kidney function, no more than 9 grams of medication can be administered per day. If the kidneys are malfunctioning, the dosage is reduced, taking into account personal characteristics. The application starts from the 1st g, and then the dynamics are monitored.

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

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

Use Biotum during pregnancy

There is no information regarding the potential harm from the medication for pregnant women, since no clinical tests have been performed on this group of patients. It is possible to prescribe Biotum during pregnancy only in situations where the likely benefits are more expected than the risks of negative consequences. With extreme caution, the medicine is used in the 1st trimester.

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

Contraindications

It is contraindicated to use in case of severe intolerance associated with ceftazidime or other elements of the drug. Also, do not prescribe if the patient has a history of hypersensitivity to cephalosporins and other β-lactam antibiotics, including carbapenems and penicillins.

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

Side effects Biotum

The main side signs (indicated in the order of decreasing the frequency of development):

• thrombocytosis or eosinophilia (thrombocytosis, leuko- or neutropenia is more rarely noted);
• thrombophlebitis with phlebitis and pain (in the area of the injection);
• diarrhea; more rarely, vomiting, nausea and headaches appear;
• candidiasis;
• hives and rashes.

Quincke's edema, itching, anaphylaxis, as well as jaundice and kidney failure are rarely observed.

Overdose

In case of an overdose, complications of a neurological nature can develop, including: convulsions, encephalopathy and coma.

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

Interactions with other drugs

The administration of large doses of ceftazidime in people who use nephrotoxic substances can lead to a potentiation of their negative effect on renal activity.

Chloramphenicol, when administered in vitro, acts as an antagonist of ceftazidime, as well as other cephalosporins. What are the clinical consequences of such an effect has not been studied, but when combining Biotum with chloramphenicol, it is necessary to take into account the possibility of developing an antagonistic effect.

Storage conditions

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

Shelf life

Biootum can be used for a 24-month term from the date of production of the medicinal substance.

Analogs

The analogues of the medication are the drugs Orzid, Auromitaz, Fortum and Aurocef with Norzidim and Ceftum, and in addition Denizid, Trophiz and Lorazidim with Eurosidime, Fortazim with Zatsef and Tulizid with Rumid Pharmunion. Also on the list are Zidane, Ceftaridem and Tazid with Ceftadim, Emzid and Ceftazidim.