Faytobakt

Medication Faytobakt refers to systemic antibacterial agents, and, in particular, to the cephalosporin series of the third generation of antibiotics. International drug term: Cefoperazon. 

Indications Faytobakt

Indications for the use of Faytobakt are:

• infectious diseases of the respiratory and urinary system (upper and lower parts);
• inflammatory processes in the abdominal cavity, gall bladder, bile ducts, as well as other abdominal infections;
• sepsis;
• inflammation of the meninges;
• infectious lesions of skin and mucous membranes;
• infectious lesions of the osteoarticular system;
• - inflammatory processes in the small pelvis, including inflammation of the endometrium;
• - gonorrhea and other infections of the genitourinary system.

Release form

 The preparation is available in powder form for the manufacture of injection solutions. The powder is crystalline white, or cream white.

 Produced in the following dosages:

• 0.5 g - glass bottles, one in individual carton.
• 1 g - glass bottle, one in individual carton.
• 2 g - a glass bottle, one in an individual cardboard container.

 Faytobakt is represented by active components of sodium sulbactam and sodium cefoperazone.

• 0.5 g of drug - active substances to 0.25 g.
• 1 g of drug - active substances to 0.5 g.
• 2 g of drug - active substances per 1 g respectively. 

Pharmacodynamics

The antimicrobial substance of the drug cefoperazone is a representative of the third generation cephalosporin series, which affects bacteria sensitive to it during their reproduction by inhibiting the biological synthesis of mucopeptides of cell membranes.

The second active substance of sulbactam does not have an extensive antimicrobial effect, inhibiting the development of only β-proteobacteria and acinetobacter. Meanwhile, the inhibitory effect of sulbactam in relation to most important β-lactamases, which synthesize β-lactam resistant organisms, was proved biologically and chemically.

During experimental studies using resistant bacterial strains, sulbactam showed a friendly effect with representatives of penicillins and cephalosporins. It is noted that sulbactam is able to bind to proteins that bind penicillin. For this reason, strains are often more sensitive to the preparation of Faytobakt than to cefoperazone alone.

Faytobakt is active in all bacteria sensitive to cefoperazone. Simultaneously, the preparation also synergizes with other microorganisms, including the following:

• Haemophilus infection;
• bacteroides;
• staphylococci;
• acinetobacteria;
• enterobacteria;
• E. Coli;
• Proteus;
• Klebsiella;
• Morgana bacteria;
• citrobacter;
• Gram-positive microorganisms (staphylococci, streptococci, penicillinase and nonpenicillin-producing strains);
• Gram-negative microorganisms (colibacillus, proteus, serrations, Shigella, Pseudomonas aeruginosa, Bordetella, Yersinia, etc.).

 The list is also supplemented by clostridia, lactobacilli, peptostreptococcus, fusobacteria, etc. 

[1], [2]

Pharmacokinetics

About 85% of the sulbactam and up to 25% of the dosage of cefoperazone exits the body through the urinary system. The rest of cefoperazone can be excreted by the liver.

After entering the Faytobakt in the body, the average half-life of sulbactam can be 60 minutes, cefapperasone - 110 minutes. The level of active substances in the blood serum is directly proportional to the administered dosage of the drug.

The average maximum amounts of Faytobakt for intravenous injections of 2 g of medication over the course of five minutes are 130.2 μg / ml of sulbactam and 236.8 μg / ml of cefoperazone. This indicates a predominant distribution of sulbactam in the body.

The components of the medication penetrate well into the tissues and fluids of the body. Soon they can be found in the bile fluid, skin, the process of the cecum, the uterus and appendages.

Experimentally, pharmacokinetic differences were not found in the use of the drug in children and adult patients.

Pharmacokinetic properties of Faytobakt have been studied in elderly patients with chronic diseases of the urinary system and liver. In such patients, an elongation of the half-life, a decrease in clearance and an increase in the spread of all components of the drug were observed. The pharmacokinetics of sulbactam is in proportion to the level of renal function impairment, and the properties of cefoperazone are related to the degree of hepatic function disorder. 

[3]

Dosing and administration

 Before you begin treatment, you should make a mandatory test for the absence of an allergic reaction to the drug.

 Breeding.

 Faytobakt is bred with special water for injections.

Total dosage	Correspondence of dosages of active substances	Quantity of solvent	Maximum final concentration
0.5 g	0.25 g and 0.25 g	2 ml	125 and 125 mg / ml
1 g	0.5 g and 0.5 g	4 ml	125 and 125 mg / ml
2 grams	1 g and 1 g	8 ml	125 and 125 mg / ml

In addition to the proposed solvent, Faytobakt can be diluted with 5% glucose solution, or saline solution.

Ringer's solution with lactate.

Special water for injections is used for breeding. First, Faytobakt is diluted in injectable water, then in Ringer's lactate reagent, 5 mg / ml is made to the level of sulbactam. For example, 2 ml of the original r-ra should be diluted in 50 ml of Ringer's R-ring with lactate, or 4 ml of the original solution - in 100 ml of Ringer's R-ring with lactate.

 Lidocaine.

When using lidocaine as an additional solvent, the sample is again tested for allergic sensitivity.

First, Faytobakt is dissolved in water for injection, then diluted with 2% lidocaine until the concentration of cefoperazone is reduced to 250 mg / ml, or until the concentration of sulbactam is reached to 125 mg / ml in 0.5% of l-lidocaine.

Injection of the drug.

For intermittent infusions, the powdered substance of each vial is first dissolved in water for injection, followed by 20 ml injection for 15 to 60 minutes.

When performing IV injections, the powder from each vial is dissolved (according to the table) and injected slowly, no faster than 3 minutes.

When performing intravenous injections, the dose is administered in the same volumes every 12 hours.

With complicated and chronic infections, the daily amount of the drug can be raised to 8 g in a 1: 1 ratio (cefoperazone in a dosage of 4 g). The drug is administered in the same volumes every 12 hours.

The optimal limiting daily amount of sulbactam is 4 g.

Use in the disorders of the functionality of the urinary system.

Scheme of administration and dosage Fitobakt must be set, given the reduced clearance of sulbactam. A patient with a creatinine clearance of 15-30 ml / minute can be given a maximum of 1 g of sulbactam every 12 hours (i.e., a maximum daily amount of the drug is 2 g). A patient with a clearance of less than 15 ml / minute can receive 0.5 g of sulbactam every 12 hours (maximum per day 1 g). With a complicated infectious condition, the doctor can additionally prescribe cefoperazone.

Faytobakt can be administered after hemodialysis, but not before it.

In childhood, the following pattern of appointments is used:

The ratio of sulbactam: cefoperazone	Daily dosage of Faytobakt	Daily dosage of sulbactam	Daily dosage of cefoperazone
1: 1	40-80 mg / kg	20-40 mg / kg	20-40 mg / kg

The drug is administered in equal volumes every 6-12 hours.

In case of complicated or chronic infectious conditions, the dosage can be increased to 160 mg / kg per day, dividing it into 2-4 identical parts.

Newborn children medication is administered every 12 hours, not more than 80 mg / kg per day.

[7], [8]

Use Faytobakt during pregnancy

Faytobakt passes through the placental barrier without any problems, therefore during pregnancy it is used only when the percentage of expected benefit for a woman significantly exceeds the possible danger for a future child.

Only a small amount of active substances of the drug is found in breast milk. At the same time, women are not recommended to breastfeed against the background of treatment of Faytobakt.

Contraindications

Contraindication to the use of Faytobakt is a tendency to allergic reactions to the active substances of the drug, as well as to any representatives of the penicillin and cephalosporin series. 

[4], [5]

Side effects Faytobakt

 Side effects of Faytobakt can affect any body organs and systems:

• Gastrointestinal tract - diarrhea, attacks of nausea and vomiting, pseudomembranous enterocolitis;
• skin - a drug rash, nettle fever, malignant exudative erythema;
• blood vessels - lowering of blood pressure;
• blood - a decrease in the level of neutrophils, hemoglobin or hematocrit, a decrease in the number of leukocytes, platelets and prothrombin;
• pain in the head, febrile conditions, inflammatory reactions at the injection site, allergic manifestations, inflammation of the walls of the blood vessels, the appearance of blood in the urine.

The results of laboratory tests may indicate an increase in the number of AST, ALT, APF and bilirubin.

Contraindication to the use of Faytobakt is a tendency to allergic reactions to the active substances of the drug, as well as to any representatives of the penicillin and cephalosporin series. 

[6]

Overdose

Possible signs of an overdose may appear as severe side effects.

Sometimes the ingestion of too large amounts of β-lactam antibiotic agents can contribute to the development of neurological disorders and epileptic seizures.

The components of the drug are eliminated in hemodialysis, so hemodialysis can be used to stop signs of an overdose of Faytobakt.

Interactions with other drugs

When treating Faytobakt, the patient should be warned that it is not recommended to drink alcohol while taking the drug. Combined application of Faytobakt and alcohol can lead to reddening of the skin, increased sweating and rapid heart rate. For the same reason, simultaneous use of drugs containing ethyl alcohol should be avoided.

The use of Benedict's and Felling's can lead to a temporary appearance of glucosuria. 

[9]

Storage conditions

Keep Faytobakt in dark places at t ° to + 25 ° C. Do not allow children to the place of storage of medicinal preparations. The prepared diluted solution should be used immediately. 

Shelf life

Shelf life - up to 2 years.