Cefabol
Cefabol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Cefabol
ATX code: N06BX02
Active ingredient: cefotaxime (cefotaxime)
Manufacturer: ABOLmed, LLC (Russia)
Description and photo updated: 2018-26-11
Prices in pharmacies: from 41 rubles.
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Cefabol is a cephalosporin antibacterial drug with a bactericidal effect for parenteral use.
Release form and composition
Cefabol is available in the form of a powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: a mass of white with a yellow tint or white, sensitive to light (1 g each in a glass vial with a capacity of 10 ml: in a cardboard a pack of 1 or 5 bottles; in a cardboard box 1 bottle complete with 1 ampoule (5 ml) of solvent; in a blister 1 bottle complete with 1 ampoule of solvent, in a cardboard box 1 package; 5 bottles in a blister, in a cardboard pack 1 pack; in a blister strip packaging 5 bottles complete with 5 ampoules of solvent, in a cardboard box 1 or 2 packs).
The active ingredient is cefotaxime (in the form of sodium salt), its content in 1 bottle is 1 g.
Solvent: water for injection.
Pharmacological properties
Pharmacodynamics
Cefabol is an antibacterial drug for parenteral use. It has a bactericidal and broad spectrum of antimicrobial activity. The antibacterial activity of Cefabol is due to the properties of cefotaxime, which is a third generation cephalosporin.
The following gram-positive and gram-negative microorganisms resistant to other antibiotics are susceptible to cefotaxime: Staphylococcus speciales (spp.), Staphylococcus aureus (including strains that form penicillinase), Streptococcus pneumoniae, Staphylococcus pyrosis, Enterococcus epidermidis ages, Enterococcus epidermidis agp., Escherichia coli, Haemophilus parainfluenzae, Haemophilus influenzae (including strains producing penicillinase), Morganella morganii, Klebsiella spp., Klebsiella pneumoniae, Acinetobacter species, Neisseria gonorrhoeae, Eisseria gonorrhoeae (including strains producing penicillinase) penicillinase Neisseria meningitidis, Propionibacterium spp., Clostridium spp. (including Clostridium perfringens), Bacillus subtilis, Proteus indole,Proteus mirabilis, Proteus vulgaris, Citrobacter spp., Serratia spp., Providencia spp. (including Providencia rettgeri), Pseudomonas aeruginosa, Bacteroides spp. (including some strains of Bacteroides fragilis), Peptococcus spp., Fusobacterium spp. (including Fusobacterium nucleatum), Peptostreptococcus spp.
Cefabol is resistant to most beta-lactamases of gram-positive and gram-negative microorganisms, strains of Clostridium difficile, staphylococcal penicillinase.
Pharmacokinetics
The maximum concentration (C max) after a single injection of Cefabol at a dose of 1000 mg with intravenous administration is achieved after 1/12 hour and is 0.1017 mg / ml, with intramuscular injection - after 1/2 hour and is 0.021 mg / ml …
Plasma protein binding ranges from 25% to 40% of the administered dose.
Therapeutic concentrations are generated in most body tissues. The drug penetrates into bones, skin, soft tissues, myocardium, gallbladder and fluids (sputum, bile, urine, synovial, pleural, pericardial, cerebrospinal fluid), including breast milk.
The volume of distribution is 0.25-0.39 l / kg.
T 1/2 (half-life) with intravenous and intramuscular administration - 1 hour. Through the kidneys, 60–70% of cefotaxime is excreted unchanged, the rest in the form of three metabolites, one of which has bactericidal activity.
T 1/2 in chronic renal failure and in elderly patients increases 2 times. In newborns, T 1/2 is 0.75-1.5 hours, and in premature newborns, it rises to 4.6 hours. When administered intravenously at a dose of 1000 mg 4 times a day for 14 days, cumulation is not observed.
Indications for use
According to the instructions, Cefabol is indicated for the treatment and prevention of severe forms of the following infectious diseases caused by sensitive microorganisms:
- meningitis and other central nervous system infections;
- pneumonia, other inflammatory diseases of the otorhinolaryngological organs and the respiratory system of infectious etiology;
- acute pyelonephritis, exacerbation of the chronic form of pyelonephritis, other urinary tract infections;
- infections of the skin and soft tissues, including wound complications after surgery;
- prevention of infections after surgical interventions, including obstetric-gynecological, urological, on the organs of the gastrointestinal tract;
- infections of the genitourinary system, including chlamydia, gonorrhea;
- pelvioperitonitis, endometritis, exacerbation of chronic adnexitis, acute adnexitis, other infections of the pelvic organs;
- infectious pathologies of bones and joints;
- complicated and uncomplicated infections of the abdominal cavity - postoperative abscesses of the abdominal cavity, peritonitis, cholecystitis, cholangitis;
- borreliosis or Lyme disease;
- endocarditis;
- salmonellosis;
- infections against the background of immunodeficiency;
- sepsis.
Contraindications
- established hypersensitivity to penicillins, other cephalosporins, carbapenems;
- individual intolerance to cefotaxime.
In addition, intramuscular administration of the drug is contraindicated in children under the age of 2.5 years.
With caution, Cefabol should be prescribed for chronic renal failure, ulcerative colitis (including history), breastfeeding, during the neonatal period.
During pregnancy, the use of the drug is possible only if, in the opinion of the doctor, the expected benefit from therapy for the mother outweighs the potential threat to the fetus.
Instructions for the use of Cefabol: method and dosage
Ready solution of cefotaxime is used by intramuscular and intravenous (jet, drip) administration.
A solution for intramuscular injection is prepared by dissolving the contents of the vial (1 g) in 4 ml of sterile water for injection or 1% lidocaine solution. It should be injected deep into the gluteus muscle.
A solution for jet intravenous administration is prepared by adding 10 ml of sterile water for injection to the contents of the vial. The procedure is carried out slowly, over 3-5 minutes.
A solution for intravenous drip is prepared by dissolving 2 g of cefotaxime in 100 ml of isotonic sodium chloride solution or 5% glucose solution. The infusion should continue for 50-60 minutes.
Cefotaxime solution should not be mixed in the same syringe or dropper with solutions of other antibiotics.
The doctor sets the dose and duration of the course of treatment on the basis of clinical indications individually, taking into account the age and weight of the patient.
The recommended dosage of Cefabol for patients weighing more than 50 kg, including children:
- urinary tract infections, uncomplicated forms of infectious diseases: i / m or i / v - 1 g every 8-12 hours;
- moderate severity of infectious pathologies: i / m or i / v - 1–2 g every 12 hours;
- meningitis and other severe infectious diseases: IV - 2 g every 4–8 hours;
- uncomplicated acute gonorrhea: IM - 1 g once.
The maximum daily dose is 12 g.
Children with a body weight of up to 50 kg are prescribed Cefabol intravenously or intramuscularly. The daily dose is determined at the rate of 0.05-0.18 g per 1 kg of body weight and is divided into 4-6 injections. In case of meningitis and other severe forms of infections, the daily dose for children is increased to 0.1–0.2 g per 1 kg of weight and is also divided into 4–6 injections.
Recommended dosage for intravenous administration of Cefabol to premature infants and newborns:
- age up to 7 days: at a dose of 0.05 g per 1 kg of body weight every 12 hours;
- age 7-28 days: at a dose of 0.05 g per 1 kg of body weight every 8 hours.
In order to prevent infection during a surgical operation during an introductory general anesthesia, 1 g of Cefabol is administered once. If necessary, the dose can be repeated after 6-12 hours.
When performing a cesarean section, 1 g of cefotaxime is injected intravenously at the time of clamping the umbilical vein. 6 and 12 hours after the introduction of the first dose, an additional administration of 1 g is shown.
In case of impaired renal function, the daily dose of Cefabol should be reduced, for patients with creatinine clearance of 10 ml / min or less, it should be 1/2 of the usual dose.
Side effects
- from the nervous system: dizziness, headache;
- allergic reactions: fever, chills, rash, itching, urticaria, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), eosinophilia, angioedema, Lyell's syndrome (toxic epidermal necrolysis), anaphylactic shock;
- from the hematopoietic organs: neutropenia, leukopenia, thrombocytopenia, hemolytic anemia, hypocoagulation, granulocytopenia;
- from the digestive system: nausea, vomiting, flatulence, diarrhea, constipation, dysbiosis, abdominal pain, stomatitis, glossitis, liver dysfunction, pseudomembranous enterocolitis;
- from the urinary system: impaired renal function (oliguria, anuria, interstitial nephritis);
- on the part of the cardiovascular system: against the background of a high rate of bolus injection of the solution into the central vein - arrhythmias, potentially life-threatening;
- laboratory indicators: increased blood urea, azotemia, hypercreatininemia, false positive Coombs' test, hyperbilirubinemia, increased activity of alkaline phosphatase and liver transaminases;
- local reactions: a feeling of pain along the vein, phlebitis, with intramuscular injection - infiltration and soreness at the injection site;
- others: superinfection (including candidal vaginitis).
Overdose
Symptoms: encephalopathy (against the background of the administration of high doses, especially with renal failure), convulsions, increased neuromuscular excitability, tremor.
Treatment: the appointment of symptomatic therapy.
special instructions
The appointment of Cefabol should be made taking into account the patient's allergic history, including beta-lactam antibiotics, due to the possible development of cross-allergy between cephalosporins and penicillins. If the history indicates an allergic reaction to penicillin, then the use of cefotaxime is associated with a high risk of severe anaphylactic reactions, including death.
During the first few weeks of treatment, there is an increased risk of pseudomembranous colitis, which can manifest as prolonged severe diarrhea. In this case, the use of Cefabol should be discontinued and the patient should be prescribed adequate therapy, including metronidazole or vancomycin.
If it is necessary to continue the course of treatment for more than 10 days, the patient should be provided with careful monitoring of the peripheral blood picture.
It should be borne in mind that during the period of treatment, the determination of glucose in the urine by the Benedict method can give a false positive result.
Application during pregnancy and lactation
During gestation, the use of Cefabol is possible only in cases where, in the opinion of the doctor, the expected benefit from therapy for the mother outweighs the potential threat to the fetus.
Cefotaxime is excreted in breast milk, therefore, Cefabol should be prescribed with caution during lactation. If it is necessary to use an antibiotic, breastfeeding should be discontinued during therapy.
Pediatric use
The intramuscular administration of Cefabol is contraindicated in children under the age of 2.5 years.
Care should be taken during the neonatal period.
For premature babies and newborns, Cefabol is prescribed at the rate of 0.05 g per 1 kg of body weight: at the age of 7 days, intravenous administration is performed every 12 hours, at the age of 7 to 28 days - every 8 hours.
For children with body weight up to 50 kg, the drug is prescribed intravenously or intramuscularly in a daily dose of 0.05–0.18 g per 1 kg of body weight, it is divided into 4–6 injections. For meningitis and other severe forms of infections, the daily dose is increased to 0.1–0.2 g per 1 kg of body weight and is also divided into 4–6 injections.
For children weighing 50 kg or more, use the dosage recommended for adult patients.
With impaired renal function
With caution, Cefabol should be prescribed for chronic renal failure.
In case of impaired renal function, the daily dose of the drug should be reduced, for patients with creatinine clearance of 10 ml / min or less, it should be 1/2 of the usual dose.
Drug interactions
With the simultaneous use of Cefabol:
- antiplatelet agents, non-steroidal anti-inflammatory drugs: the risk of bleeding increases;
- ethanol: does not cause the development of disulfiram-like reactions;
- aminoglycosides, "loop" diuretics, polymyxin B: increase the risk of developing functional renal disorders;
- drugs that block tubular secretion: lead to an increase in plasma concentrations of cefotaxime, causing a slowdown in its excretion.
Analogs
Analogues of Cefabol are: Intrataxime, Klaforan, Klafobrin, Kefotex, Klafotaxime, Oritax, Liforan, Resibelacta, Oritaxim, Spirozin, Talcef, Tirotax, Tarcefoksime, Cefantral, Cefotaxime Sandoz, Cefotaxime, Cefotaxime-Vial.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture and light.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Cefabol
Reviews about Cefabol are mostly positive. In the treatment of severe and moderate severity of infectious diseases, the drug has an effective therapeutic effect. If the recommended dosage regimen is observed, it is well tolerated.
The disadvantages of patients include severe pain with intramuscular injection.
Price for Cefabol in pharmacies
The price of Cefabol for a package containing 5 bottles can range from 655 rubles.
Cefabol: prices in online pharmacies
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Drug name Price Pharmacy |
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Cefabol 1 g powder for preparation of a solution for intravenous and intramuscular administration 1 pc. 41 rbl. Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
