Composition, form of production and packaging
Powder for the preparation of a solution for intravenous and / or injection of crystalline, white or white with a yellowish hue, with a weak specific odor, hygroscopic.
1 f.
cefpir (in the form of sulfate) 1 g
Excipients: sodium carbonate anhydrous.
bottles (1) - packs cardboard (10) - cardboard boxes.
Powder for the preparation of a solution for intravenous and / or injection of crystalline, white or white with a yellowish hue, with a weak specific odor, hygroscopic.
1 f.
cefpirom (in the form of sulfate) 2 g
Excipients: sodium carbonate anhydrous.
bottles (1) - packs cardboard (10) - cardboard boxes.
Powder for the preparation of a solution for intravenous and / or injection of crystalline, white or white with a yellowish hue, with a weak specific odor, hygroscopic.
1 f.
cefpir (in the form of sulphate) 250 mg
Excipients: sodium carbonate anhydrous.
bottles (1) - packs cardboard (10) - cardboard boxes.
Powder for the preparation of a solution for intravenous and / or injection of crystalline, white or white with a yellowish hue, with a weak specific odor, hygroscopic.
1 f.
cefpir (in the form of sulphate) 500 mg
Excipients: sodium carbonate anhydrous.
bottles (1) - packs cardboard (10) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Antibiotic from the group of cephalosporins of IV generation. It acts bactericidal, disrupting the synthesis of the cell wall of the microorganism. Has a wide spectrum of action against Gram-positive and Gram-negative bacteria, including strains resistant to aminoglycosides and / or cephalosporin antibiotics of the third generation.Highly resistant to the action of most beta-lactamases, within the bacterial cell, the molecular target is penicillin-binding proteins.
It is active against: Acinetobacter spp., Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Enterobacter spp., Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Hafhia alvei, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria spp. ., Peptostreptococcus spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Serratia spp., Streptococcus spp., Staphylococcus spp.
PHARMACOKINETICS
Cephpir is administered only parenterally. Penetrates into wound exudate, spinal fluid, female genital organs, prostate, kidneys, bronchial secretion, sputum and bronchial mucosa, peritoneal fluid, gallbladder tissue.
It penetrates through the placental barrier, weakly into the breast milk. In therapeutic concentrations it is found in the blood and in most tissues and liquids for 12 hours after administration. The kinetics of ceftpiroma concentration in the blood after IV and IM is linear and depends on the dose administered. After repeated IV or I / O administration at an interval of 12 hours for 3-5 days, no cumulation of the drug and changes in the main pharmacokinetic parameters were detected.
Connection with plasma proteins - 10%. T 1/2 tsfpiroma - 1.8-2.2 h. T 1/2 tsifpiroma and its total clearance are dose independent. V d - 12-21 liters.
In children, pronounced changes in the ketics of ceftirom are not observed.
In the elderly, there may be changes in pharmacokinetics, the severity of which is related to the degree of impaired renal function. Correction of ceftpirium doses is necessary for creatinine clearance (CK) below 50 ml / min.
It is not metabolized in the body, excreted by the kidneys (80-90%) and with bile.
INDICATIONS
Infectious-inflammatory diseases caused by bacteria sensitive to the drug:
sepsis / bacteremia;
- complicated urinary system infections (including pyelonephritis, pyelitis, urethritis, cystitis);
- respiratory tract infections (including pneumonia, lung abscess, pleural empyema);
- skin and soft tissue infections, wound infections; infection in patients with neutropenia.
DOSING MODE
In / in (jet or drip for 30 minutes) or in / m.
For the / m introduction, the contents of the vial with 250 mg, 500 mg, 1000 mg of IsodepВ® are dissolved in 2 ml, 5 ml, 10 ml of water for injection, respectively.
For IV infusion, the contents of the vial of 250 mg, 500 mg, 1000 mg or 2000 mg of IsodepВ® are dissolved in 2 ml, 5 ml, 10 ml or 20 ml of 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution , 5% solution of fructose.
For intravenous administration, 250 mg, 500 mg, 1000 mg or 2000 mg of the drug are dissolved respectively in 25 ml, 50 ml, 100 ml or 200 ml of 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution, 5% fructose solution .
The daily dose is administered 2 times, with an interval of 12 hours.
With infections of the urinary system, skin or soft tissues, the daily dose is 2 g (in severe cases, the dose may be increased to 4 g); with respiratory infections - 2-4 g; at a sepsis and infections against a background of a neutropenia - 4.
The duration of treatment depends on the severity and characteristics of the course of the infectious process, the sensitivity of the microflora and is determined individually by the attending physician, usually 5-10 days.
If the renal function is impaired, dose adjustment is performed depending on the QC. The first dose (initial) is 1-2 g, in the future, with KK 5-20 ml / min 0.5-1 g injected 1 time per day; with KK 20-50 ml / min - 0.5-1 g 2 times a day. In patients on hemodialysis, the daily dose is 0.5-1 g; after each procedure of hemodialysis, add 0.25-0.5 g.
SIDE EFFECT
Local reactions: phlebitis, pain along the vein, soreness and infiltration at the site of intramuscular injection.
Allergic reactions: urticaria, chills or fever, rash, itching, bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioedema, anaphylactic shock.
From the nervous system: headache, dizziness, encephalopathy.
From the urinary system: a violation of kidney function, oliguria, interstitial nephritis.
On the part of the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbiosis, impaired liver function, candidal stomatitis and / or glossitis, pseudomembranous colitis.
On the part of hemopoiesis: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia.
From the cardiovascular system: potentially life-threatening arrhythmias after a rapid bolus injection into the central vein.
Laboratory indicators: azotemia, increased urea concentration in the blood, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, Coombs positive reaction, hypocoagulation.
Other: superinfection (in particular, candidal vaginitis).
CONTRAINDICATIONS
Hypersensitivity (including to other beta-lactam antibiotics), pregnancy, children under 12 years, lactation period.
Carefully. Diseases of the gastrointestinal tract (including in the history: ulcerative colitis, regional enteritis or antibiotic-associated colitis), severe renal failure.
PREGNANCY AND LACTATION
During pregnancy it is contraindicated.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: severe renal failure. If the renal function is impaired, dose adjustment is performed depending on the QC.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
APPLICATION IN ELDERLY PATIENTS
In the elderly, there may be changes in pharmacokinetics, the severity of which is related to the degree of impaired renal function. Correction of ceftpirium doses is necessary for creatinine clearance (CK) below 50 ml / min.
SPECIAL INSTRUCTIONS
At the first introduction, the presence of a doctor is mandatory (the possibility of developing an anaphylactic reaction). In case of development of anaphylactic reactions, urgent therapy is carried out (epinephrine, dopamine, electrolyte balance correction, oxygen therapy, antihistamines, glucocorticosteroids).
Against the background of the introduction of ceftirom, it is necessary to take into account the possibility of developing pseudomembranous colitis, in case of its development, immediately stop the drug administration, prescribe the appropriate treatment (including vancomycin (inside) or metronidazole).
When combined severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the CK).
With long-term treatment, regular monitoring of peripheral blood (control of the number of leukocytes every 10 days), indicators of the functional state of the liver and kidneys is necessary.
With mixed aerobic-anaerobic infection before the identification of pathogens, it is advisable to add drugs that work against anaerobes.
Management of vehicles, maintenance of machines and mechanisms. Not studied. Given the likelihood of side effects from the central nervous system, care should be taken when driving vehicles and working with mechanisms.
OVERDOSE
Symptoms: convulsions, encephalopathy (especially in patients with renal insufficiency), tremor, increased neuromuscular excitability.
Treatment: symptomatic, hemodialysis.
DRUG INTERACTION
Tsefpyre is pharmaceutically incompatible with other antibiotics, with a solution of sodium bicarbonate, with heparin and most other antimicrobial medicines.
With simultaneous application with bactericidal antibiotics, cefpir shows synergism, with bacteriostatic (macrolides, chloramphenicol, tetracyclines) antagonism.
Non-steroidal anti-inflammatory drugs, diuretics, aminoglycosides, polymyxin B, other drugs blocking tubular secretion inhibit the excretion of cephalosporins, increase their serum concentration, extend T 1/2 , increase the risk of developing nephrotoxic reactions and bleeding.
Tsefpyrom increases the effect of indirect anticoagulants.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry, the dark place at a temperature of 2 to 8 В° C. Keep out of the reach of children.
Shelf life - 2 years. Do not use after the expiration date.
