Meronem powder lyophilisate injection vial beats 500mg N10
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Active ingredients
Meropenem
Release form
Powder
Composition
1 fl.: Meropenem trihydrate 1.14 g, which corresponds to the content of Meropenem 1 g. Supplementary substances: sodium anhydrous carbonate - 208 mg.
Pharmacological effect
An antibiotic from the group of carbapenems for parenteral use, resistant to human dehydropeptidase-1 (BPH-1), does not require additional administration of the BPH-1 inhibitor. Meropenem has a bactericidal effect due to the effect on the synthesis of the bacterial cell wall. The potent bactericidal action of meropenem against a broad spectrum of aerobic and anaerobic bacteria is due to the high ability of bacteria to penetrate the cell wall, a high level of resistance to most β-lactamase, and significant affinity for penicillin-binding proteins (BSP). The minimum bactericidal concentrations (MBC) are usually the same as the minimum inhibitory concentrations (MIC). For 76% of the bacterial species tested, the MBC / MIC ratio was 2 or less. Meropenem is stable in pathogen sensitivity tests. In vitro tests show that meropenem acts synergistically with various antibiotics. It has been shown in vitro and in vivo that meropenem has a post-antibiotic effect. The only recommended criteria for susceptibility to meropenem are based on the pharmacokinetics of the drug and on the correlation of clinical and microbiological data - the diameter of the zone and the MIC determined for the corresponding pathogens.
Pharmacokinetics
Distribution B / in the administration of a single dose of the drug to healthy volunteers within 30 minutes results in a Cmax of approximately 11 μg / ml for a dose of 250 mg, 23 μg / ml for a dose of 500 mg and 49 μg / ml for a dose of 1 g. However, there is no absolute pharmacokinetic proportional to the dose administered for neither Cmax nor AUC. Moreover, there was a decrease in plasma clearance from 287 to 205 ml / min for doses from 250 mg to 2 gV / per bolus injection for 5 min of a single dose of Meronem to healthy volunteers leads to a Cmax of about 52 μg / ml for a dose 500 mg and 112 mcg / ml - for a dose of 1 g. Cmax in plasma with on / in the introduction of 1 g of the drug for 2 minutes, 3 minutes and 5 minutes were 110, 91 and 94 mcg / ml, respectively. Binding to plasma proteins is about 2%. Meropenem penetrates well into most tissues and body fluids, incl.in cerebrospinal fluid of patients with bacterial meningitis, reaching concentrations exceeding those required for suppressing most bacteria. After 6 h after i / v of 500 mg, the level of meropenem in plasma decreases to 1 mcg / ml or less. With repeated doses with an interval of 8 hours in patients with normal renal function, cumulation of meropenem does not occur. Metabolism and excretion The only metabolite of meropenem is microbiologically inactive. Approximately 70% of the administered dose is excreted in the urine unchanged during 12 hours, after which further urinary excretion insignificant. A concentration of meropenem in the urine exceeding 10 μg / ml is maintained for 5 hours after a dose of 500 mg. With the administration modes of 500 mg every 8 hours or 1 g every 6 hours, no accumulation of meropenem in plasma and urine was observed in volunteers with normal liver function. In patients with normal renal function, T1 / 2 is approximately 1 hour. The pharmacokinetics in special clinical situations. The pharmacokinetic parameters of Meronem in children are the same as in adults. T1 / 2 meropenem in children under 2 years old is approximately 1.5-2.3 hours, and linear pharmacokinetics are observed in the dose range of 10–40 mg / kg. Studies on the pharmacokinetics of the drug in patients with renal insufficiency showed that meropenem clearance correlates with creatinine clearance. In such patients, dose adjustment is necessary. Studies on the pharmacokinetics of the drug in elderly patients showed a decrease in clearance of meropenem, which correlated with a decrease in creatinine clearance associated with age. Studies on the pharmacokinetics of the drug in patients with liver diseases showed that liver disease does not affect the pharmacokinetics of meropenem.
Indications
Treatment of the following infections in children and adults caused by one or more pathogens that are sensitive to the drug: - pneumonia (including nosocomial); urinary tract infections; abdominal infections; gynecological infections (such as endometritis and pelvic inflammatory diseases ); - infections of the skin and soft tissues; - meningitis; - septicemia; - empirical therapy in cases of suspected bacterial infection in adult patients with febrile episodes with neutropenia, as monotherapy or in combination with antiviral or antifungal drugs.
Contraindications
- hypersensitivity to the drug. With caution, the drug should be prescribed simultaneously with potentially nephrotoxic drugs, as well as patients with dyspepsia symptoms, especially those associated with colitis.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
The safety of Meronema during pregnancy has not been studied. Experimental studies on animals have not shown any adverse effects on the developing fetus. The only adverse event identified during animal studies on the effect of the drug on the reproductive system was the increased frequency of abortions in monkeys when given a dose 13 times higher than recommended for humans. Meronem should not be used during pregnancy, unless the potential benefits of its use justify possible risk to the fetus. In each case, the drug must be used under the direct supervision of a physician. Meropenem is determined in the breast milk of animals in very low concentrations. Meronem should not be used during lactation (breastfeeding), unless the potential benefits of its use justifies the possible risk to the child. If necessary, the use of the drug during lactation should consider stopping breastfeeding.
Dosage and administration
For adults, the dosage regimen and duration of therapy are determined depending on the type and severity of the infection and the condition of the patient. The following daily doses are recommended. When treating pneumonia, urinary tract infections, gynecological infections (endometritis and pelvic inflammatory diseases), skin and soft tissue infections - 500 mg w / every 8 hours. When treating hospital pneumonia, peritonitis, suspected bacterial infection in patients with neutropenia, as well as septicemia - 1 g i / w every 8 hours. When treating meningitis - 2 g i / w every 8 h.
Side effects
Severe side effects are rare. The following side effects were reported: Allergic reactions: rarely - angioedema, anaphylactic reactions. Dermatological reactions: itching, rash, urticaria; rarely - erythema multiforme (exudative),Stevens-Johnson syndrome and toxic epidermal necrolysis. On the part of the digestive system: abdominal pain, nausea, vomiting, diarrhea; in some cases - a reversible increase in blood levels of bilirubin, transaminases, alkaline phosphatase and LDH individually or in combination; in some cases - pseudomembranous colitis. From the hematopoietic system: reversible thrombocytosis, eosinophilia, thrombocytopenia, leukopenia and neutropenia (including very rare cases of agranulocytosis). Some patients may have a positive direct or indirect Coombs test; there are also reports of cases of reduced partial thromboplastin time. For the central nervous system and peripheral nervous system: headache, paresthesia; there are reports of the development of seizures, but a causal connection with the reception of Meronem has not been established. Local reactions: inflammation, thrombophlebitis, pain at the site of administration. Effects caused by biological effects: oral candidiasis, vaginal candidiasis.
Overdose
Accidental overdose is possible during treatment, especially in patients with impaired renal function. Treatment: symptomatic therapy is carried out. Normally, the drug is rapidly eliminated by the kidneys. In patients with renal impairment, hemodialysis effectively removes meropenem and its metabolites.
Interaction with other drugs
Probenecid competes with meropenem for active tubular secretion and, thus, inhibits renal excretion of meropenem, causing an increase in its half-life and plasma concentration. Since the effectiveness and duration of action of Meronem without probenecid are adequate, the joint introduction of probenecid with Meronem is not recommended. The possible influence of Meronem on the metabolism and protein binding of other drugs has not been studied. However, given the low binding of meropenem to plasma proteins (about 2%), it can be assumed that there should be no interaction with other drugs. Meronem was administered while taking other drugs, and no adverse pharmacological interactions were noted. Meronem may decrease serum valproic acid levels. In some patients, a level below the therapeutic level may be reached. However, there are no specific data on possible drug interactions.
special instructions
As with other antibiotics, when using meropenem as monotherapy in critically ill patients with known or suspected lower respiratory tract infection caused by Pseudomonas aeruginosa, regular determination of the sensitivity of the pathogen is recommended. from mild to life-threatening forms. Therefore, antibiotics should be administered with caution to persons with gastrointestinal complaints, especially to patients with colitis. It is important to keep in mind the diagnosis of pseudomembranous colitis in the case of diarrhea while taking antibiotics. Although studies have shown that the toxin produced by Clostridium difficile is one of the main causes of colitis associated with antibiotics, there are other reasons to keep in mind. There are clinical and laboratory signs of partial cross-sensitivity between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. Although allergic reactions with the use of beta-lactam antibiotics were quite common, hypersensitivity reactions were rarely reported during the administration of Meronem. Before starting therapy with meropenem, it is necessary to carefully interview the patient, paying particular attention to hypersensitivity reactions to beta-lactam antibiotics in history. Meronem should be used with caution in patients with a history of similar indications. If an allergic reaction occurs to meropenem, then it is necessary to stop the administration of the drug and take appropriate measures. The use of Meronem in patients with liver diseases should be carried out under careful control of the level of transaminases and bilirubin. constant monitoring of each patient is necessary. Use for infections caused by methicillin-resistant staphylococcus is not recommended. Use in pedi triiEffektivnost Meronema and tolerability in children under the age of 3 months were not established, so the drug is not recommended for use in children under 3 mes.Opyta use of the drug in pediatric practice,There are no patients with neutropenia or with primary or secondary immunodeficiency. The experience of Meronema in children with impaired liver and kidney function is not. Impact on the ability to drive motor vehicles and control mechanismsMeronem does not affect the ability to drive a car and other equipment.