Maxipim
Maxipim: 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: Maxipime
ATX code: J01DE01
Active ingredient: cefepime (Cefepime)
Manufacturer: Corden Pharma Latina, SpA (Italy); Bristol-Myers Squibb Company (Italy)
Description and photo update: 2019-08-10
Maxipim is a broad-spectrum antibacterial drug; refers to IV generation cephalosporin antibiotics.
Release form and composition
The drug is available in the form of a powder for the preparation of a solution for intravenous and intramuscular administration, which is a white or almost white mass, sometimes with a yellowish tinge (500 mg or 1000 mg each in glass transparent vials, sealed with a stopper and an aluminum flip-off cap; in a cardboard pack (one bottle and instructions for use of Maxipim).
Composition for one bottle:
- active substance: cefepime (in the form of cefepime monohydrate hydrochloride) - 500 mg or 1000 mg;
- auxiliary components: L-arginine.
When packing the powder, the active substance is re-laid in the amount of 5%, which is required to ensure the declared dosage in full when the drug is removed from the vial.
Pharmacological properties
Pharmacodynamics
The active component of Maxipim is cefepime, an antibiotic from the cephalosporin group with a broad spectrum of action, the mechanism of which is associated with the suppression of the synthesis of proteins in the bacterial cell wall.
The drug exhibits bactericidal properties against various gram-negative and gram-positive bacteria, including most strains resistant to third generation cephalosporins (for example, ceftazidime) or aminoglycosides. Cefepime is resistant to hydrolysis by most of the beta-lactamases produced by bacteria, has a low affinity for these beta-lactamases, and can also quickly penetrate the cells of gram-negative bacteria. It was found that cefepime has a very high affinity for PSB (penicillin-binding protein) type 3, high affinity for type 2 PSP and moderate affinity for types 1a and 1b PSP.
The following microorganisms are sensitive to cefepime:
- gram-positive aerobic bacteria: Streptococcus pneumoniae (including strains with average resistance to penicillin - the minimum inhibitory concentration is 0.1-1 μg / ml), Streptococcus bovis (group D), other hemolytic Streptococcus spp. (groups F, G and C), Streptococcus spp. Viridans groups, Streptococcus agalactiae (group B streptococci), Streptococcus pyogenes (group A streptococci); Staphylococcus epidermidis and Staphylococcus aureus (including strains that produce beta-lactamases), Staphylococcus saprophyticus, other strains of Staphylococcus spp. (including Staphylococcus hominis);
- gram-negative aerobic bacteria: Salmonella spp.; Acinetobacter calcoaceticus (including the lwoffii and anitratus sub-strains); Gardnerella vaginalis; Aeromonas hydrophila; Klebsiella spp. (including Klebsiella ozaenae, Klebsiella oxytoca and Klebsiella pneumoniae); Capnocytophaga spp.; Morganella morganii; Escherichia coli; Pseudomonas spp. (including Pseudomonas stutzeri, Pseudomonas putida and Pseudomonas aeruginosa); Citrobacter spp. (including Citrobacter freundii and Citrobacter diversus); Legionella spp.; Campylobacter jejuni; Enterobacter spp. (including Enterobacter sakazakii, Enterobacter aerogenes and Enterobacter cloacae); Shigella spp.; Haemophilus influenzae and Haemophilus parainfluenzas, Haemophilus ducreyi; Yersinia enterocolitica; Hafnia alvei; Proteus spp. (including Proteus vulgaris and Proteus mirabilis);Moraxella catarrhalis (including strains that produce beta-lactamases); Providencia spp. (including Providencia stuartii and Providencia rettgeri); Neisseria meningitides and Neisseria gonorrhoeae (including strains that produce beta-lactamases); Serratia spp. (including Serratia liquefaciens and Serratia marcescens); Pantoea agglomerans (formerly known as Enterobacter agglomerans);
- anaerobic bacteria: Veillonella spp.; Bacteroides spp.; Mobiluncus spp.; Prevotella melaninogenicus (formerly known as Bacteroides melaninogenicus) Fusobacterium spp.; Peptostreptococcus spp.; Clostridium perfringens.
Clostridium difficile, Bacteroides fragilis, many strains of Stenotrophomonas maltophilia (formerly known as Pseudomonas maltophilia and Xanthomonas maltophilia) are resistant to cefepime, as well as strains of enterococci and staphylococci, resistant to methicillin and cephylococci, which are resistant to methicillin and cephalococci, and most often they are antibiotic-resistant cephalospalins (most often they are antibiotic-resistant corms).
Pharmacokinetics
After intravenous (intravenous) and intramuscular (intramuscular) administration, cefepime is completely absorbed. Its maximum concentration in blood plasma when administered in doses of 500 mg and 1000 mg is 39.1 ± 3.5 μg / ml and 81.7 ± 5.1 μg / ml, respectively. The time to reach the maximum plasma concentration is 1.4 ± 0.9 h and 1.6 ± 0.4 h, respectively.
In therapeutic concentrations, cefepime is found in sputum, bronchial mucosa, bile and gallbladder, appendix, bullous and peritoneal fluid, prostate and urine. The degree of binding to plasma proteins averages 16.4% and does not depend on the serum concentration of the substance.
As a result of metabolism, cefepime is converted into N-methylpyrrolidine, which undergoes further metabolism with the formation of N-methylpyrrolidine oxide.
The substance is excreted by glomerular filtration in the kidneys (average renal clearance - 110 ml / min). About 85% of unchanged cefepime, about 6.8% of N-methylpyrrolidine oxide, about 2.5% of cefepime epimer and less than 1% of N-methylpyrrolidine are excreted in the urine.
T1 / 2 of the drug after administration of doses in the range of 250-2000 mg is about 2 hours. The average value of the total clearance is 120 ml / min. In studies when healthy volunteers were injected intravenously, 2000 mg of cefepime every 8 hours (for 9 days), no cumulation was observed.
In patients with renal insufficiency, the elimination half-life increases, while there is a linear relationship between the total clearance and CC (creatinine clearance). In patients on hemodialysis, T 1/2 is about 13 hours, and during continuous peritoneal dialysis - 19 hours. If renal function is impaired, the dose of Maxipim needs to be adjusted.
In case of impaired liver function, the pharmacokinetics of the drug does not change, therefore Maxipim is used in normal doses.
In patients over 65 years of age, there was a decrease in renal clearance and an increase in AUC (area under the concentration-time curve) compared with young volunteers. In elderly patients with impaired renal function, it is necessary to adjust the dose of Maxipim.
The patient's age and gender do not significantly affect the volume of distribution and the total clearance of cefepime (taking into account the correction for the patient's body weight).
Indications for use
The antibiotic Maxipim is used in children and adults to treat infectious and inflammatory diseases caused by bacteria sensitive to cefepime:
- lower respiratory tract infections, including bronchitis and pneumonia;
- gynecological infections (in adults);
- febrile neutropenia;
- infections of the abdominal organs, including biliary tract infections and peritonitis;
- blood poisoning without metastatic abscesses (septicemia);
- bacterial meningitis (in children);
- complicated and uncomplicated urinary tract infections, including pyelonephritis;
- infections of soft tissues and skin.
In adult patients, Maxipim is used as a prophylaxis for potential infections during abdominal surgery.
Contraindications
Maxipim is contraindicated in infants under the age of 2 months, as well as in individuals with individual hypersensitivity to the ingredients of the drug and / or other beta-lactam, penicillin and cephalosporin antibiotics.
The drug is prescribed with caution in patients with renal insufficiency (CC less than 50 ml / min) and if there is a history of indications of diseases of the digestive tract (especially with colitis).
Maxipim, instructions for use: method and dosage
The solution prepared from the Maxipim powder is administered intravenously or intramuscularly. Antibiotic treatment can be started even before the pathogen is identified, since the drug has a wide spectrum of action.
The route of administration and the dose of cefepime are set individually, taking into account the severity of the infection, the sensitivity of the pathogen microorganism and the patient's renal function.
In severe or life-threatening infections, the priority is given to the intravenous route of Maxipim.
For adults and children weighing more than 40 kg (subject to normal renal function), the drug is prescribed in a dose of 500-2000 mg every 8-12 hours:
- urinary tract infections (mild to moderate severity) - 500-1000 mg intramuscularly or intravenously twice a day (every 12 hours);
- other infections (mild to moderate severity) - 1000 mg IM or IV twice a day (every 12 hours);
- severe infections - 2000 mg intravenously twice a day (every 12 hours);
- very severe, including life-threatening infections - 2000 mg IV three times a day (every 8 hours).
In order to prevent potential infections during surgical interventions, the drug is administered at a dose of 2000 mg for 30 minutes intravenously, 1 hour before the planned operation. After infusion of cefepime, the patient is additionally injected with 500 mg of metronidazole IV. Maxipime and metronidazole are administered separately without mixing. After the introduction of cefepime, it is necessary to flush the infusion system.
For long-term operations that last more than 12 hours, it is recommended to re-enter Maxipim and metronidazole at the same doses.
For children aged 2 months and older (weighing up to 40 kg), the drug is prescribed at a dose of 50 mg / kg every 12 hours (for bacterial meningitis and neutropenic fever - every 8 hours).
The average duration of the course of treatment is from 7 to 10 days, but for severe and life-threatening infections, therapy may be longer.
In patients with impaired renal function, the initial dose of Maxipim is similar to the initial dose of cefepime for patients with normal renal function, but the maintenance doses should be adjusted based on QC:
- infections of mild and moderate severity: CC 30-50 ml / min - 500-1000 mg once a day (every 24 hours); CC 11-29 ml / min - 500 mg once a day (every 24 hours); CC 10 ml / min or less - 250 mg once a day (every 24 hours);
- severe infections: CC 30-50 ml / min - 2000 mg once a day (every 24 hours); CC 11-29 ml / min - 1000 mg once a day (every 24 hours); CC 10 ml / min or less - 500 mg once a day (every 24 hours);
- very severe, including life-threatening infections: CC 30-50 ml / min - 2000 mg twice a day (every 12 hours); CC 11-29 ml / min - 2000 mg once a day (every 24 hours); CC 10 ml / min or less - 1000 mg once a day (every 24 hours).
For 3 hours of hemodialysis, about 68% of the total amount of Maxipim is removed from the patient's body. After the end of the session, a repeated dose of cefepime should be administered equal to the initial (initial) dose. In patients who are on continuous peritoneal dialysis (on an outpatient basis), cefepime can be used in doses of 500–2000 mg (based on the severity of the infection), but the interval between single doses should be at least 48 hours.
In children with impaired renal function, the dose of Maxipim is adjusted in the same way as in adults, taking into account QC.
For the preparation of solutions, depending on the route of administration, the following solutions can be used:
- IV injection: 0.9% sodium chloride solution; 5% glucose solution; water for injections;
- i / m introduction: 0.9% sodium chloride solution; 5% glucose solution; water for injections; 0.5% or 1% lidocaine hydrochloride solution; bacteriostatic water for injection with benzyl alcohol or paraben.
A solution for intravenous administration is prepared by dissolving the powder in 5 ml or 10 ml of solvent (5 ml of solvent must be added to a bottle with 500 mg of cefepime, and 10 ml of solvent must be added to a bottle with 1000 mg of cefepime). The resulting solution is injected intravenously in a stream for 3-5 minutes or for at least 30 minutes through a special infusion system (the prepared solution is mixed with other solutions for intravenous administration). Maxipim's solutions are compatible with the following solutions: 0.9% sodium chloride solution; 5% or 10% glucose solution; lactated Ringer's solution and 5% glucose solution; 0.9% sodium chloride solution and 5% glucose solution; sodium lactate, 60% solution.
To prepare a solution for intramuscular administration, 1.3 ml of solvent must be added to a bottle with 500 mg of cefepime, and 2.4 ml of solvent must be added to a bottle with 1000 mg of cefepime.
During storage, the powder in the vial with the drug may darken, but this does not affect its therapeutic properties.
Side effects
- digestive system: often - loose stools; infrequently - vomiting, nausea, pseudomembranous and other types of colitis; rarely - constipation, abdominal pain; frequency is unknown - disorders of the digestive process;
- respiratory system: rarely - shortness of breath;
- cardiovascular system: rarely - dilation of blood vessels; frequency unknown - various bleeding;
- central nervous system: infrequently - headaches; rarely - dizziness, convulsions, taste disorders, paresthesia; frequency unknown - short-term loss of consciousness, stupor, myoclonic seizures, confusion, encephalopathy, coma, hallucinations;
- urinary system: frequency unknown - toxic nephropathy, renal failure;
- allergic reactions: often - skin rash; infrequently - itchy skin, nettle rash, erythema; rarely - anaphylactic reactions; frequency unknown - erythema multiforme, anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- laboratory parameters: often - an increase in total bilirubin, eosinophilia, an increase in the activity of alkaline phosphatase and other liver enzymes, lengthening of partial thromboplastin or prothrombin time, anemia; infrequently - a decrease in the number of neutrophils, leukocytes and platelets, an increase in serum creatinine and urea nitrogen; frequency unknown - hemolytic and aplastic anemia, decreased leukocyte count;
- infectious diseases: infrequently - oral mucosa candidiasis, vaginal infections; rarely - candidiasis;
- reactions at the injection site: often - pain and phlebitis at the injection site; infrequently - inflammation and fever at the injection site;
- other reactions: rarely - change in taste, erythema, chills, genital itching, vaginitis, false positive antiglobulin test (without hemolysis).
Overdose
In case of an overdose of Maxipim, the patient develops myoclonic seizures, symptoms of encephalopathy (hallucinations, confusion, coma and stupor) appear, and increased neuromuscular excitability is observed.
In the case of significant intoxication, especially in patients with impaired renal function, hemodialysis is indicated, as well as other necessary symptomatic treatment.
special instructions
In the practice of using the antibiotic Maxipim, cases of encephalopathy (usually reversible), renal failure, myoclonus and / or seizures have been noted in patients. Most often, such reactions occurred in patients with existing impaired renal function and when using cefepime in doses exceeding the recommended ones. As a rule, signs of neurotoxicity disappear after interruption of therapy and / or after hemodialysis, however, there have been isolated cases of death. Patients with impaired renal function, as well as in the presence of other risk factors that slow down the elimination of the drug, it is necessary to adjust the therapeutic dose.
Before prescribing Maxipim, you should make sure that there is no allergy to the drug, other penicillin, cephalosporin and beta-lactam antibiotics. If the patient develops an allergic reaction, cefepime should be canceled and the necessary measures should be taken to eliminate the allergy.
The sensitivity of pathogenic microorganisms to cefepime can change over time, as well as depending on geographic location, therefore, after identifying pathogenic bacteria, their sensitivity to a specific antibiotic should be determined using appropriate tests.
As with treatment with other antibiotics, cefepime therapy may be accompanied by the development of superinfection (colonization of microflora insensitive to the drug). In this case, the patient is prescribed other antibacterial drugs.
Treatment with cefepime in rare cases can lead to the occurrence of Clostridium difficile-associated diarrhea, both mild and severe (sometimes even fatal). If you suspect this disease, it is necessary to clarify the diagnosis. If CDAD (Clostridium difficile-associated diarrhea) is confirmed, Maxipim should be discontinued and other antibiotics active against Clostridium difficile should be prescribed.
Influence on the ability to drive vehicles and complex mechanisms
The effect of Maxipim on the patient's ability to drive vehicles and perform other work requiring concentration has not been studied. However, given the likelihood of some adverse reactions from the nervous system, it is advisable to refrain from this type of work during drug treatment.
Application during pregnancy and lactation
Adequate and strictly controlled studies of cefepime during pregnancy have not been conducted, therefore, in pregnant women, the use of Maxipim is possible only in cases where the expected benefit to the mother is significantly higher than the potential risk to the fetus.
Cefepime passes into breast milk in very small concentrations. During lactation, the use of Maxipim is possible after assessing the benefit to the mother / risk to the child ratio.
Pediatric use
Maxipim is not recommended for use in infants under 2 months of age. The safety profile of cefepime in children and adults is the same.
With impaired renal function
In case of impaired renal function (CC value less than 30 ml / min), the dosage regimen of Maxipim should be adjusted.
Drug interactions
Cefepime solution should not be mixed with solutions of netilmicin sulfate, tobramycin sulfate, gentamicin, vancomycin and metronidazole (due to pharmaceutical incompatibility). These antibiotics can be administered before or after cefepime by thoroughly flushing the infusion set before introducing a new drug.
According to the results of in vitro studies, the synergism of the action of Maxipim and aminoglycosides was established. In this connection, the simultaneous use of drugs can lead to the development of nephrotoxicity, the ototoxicity of aminoglycoside antibiotics also increases.
Analogs
The analogues of Maxipim are Movizar, Maxicef, Kefsepim, Efipim, Cefomax, Cefepim, Cefepim-Jodas, Cefepim-Vial, Cefepim-Alkem, Tsepim, etc.
Terms and conditions of storage
Keep out of the reach of children in a dark place at a temperature of + 15 … + 30 ° C.
The shelf life of the drug is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Maxipime
Based on the few reviews available about Maxipime, it can be concluded that the drug is very effective, especially for severe and very severe life-threatening infections. Experts note that in a number of cases, cefepime is irreplaceable, as it acts on bacteria resistant to penicillin antibiotics and third generation cephalosporins.
The disadvantages of the drug, according to patients, include the fact that the prescription drug is not always available in pharmacies and has a cost above average.
Price for Maxipim in pharmacies
The price of Maxipim in bottles of 0.5 g ranges from 55 to 170 rubles. (for one bottle). The drug in bottles of 1 g can be bought for an average of 380 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
