Meronem is an antibacterial drug of the carbapenem group.
Release form and composition
Meronem is produced in the form of a powder for preparing a solution for intravenous administration: from white with a yellowish tinge to white (0.5 g each: in bottles of 10 or 20 ml, 10 bottles in a carton pack; 1 g: in bottles of 30 ml, 10 bottles in a carton box).
One bottle contains:
- Active substance: meropenem - 500 or 1000 mg (in the form of meropenem trihydrate - 570 or 1140 mg, respectively);
- Auxiliary component: sodium carbonate (anhydrous) - 104 or 208 mg.
Indications for use
Meronem is used in the treatment of infections caused by one or more pathogens that are susceptible to meropenem:
- Infections of soft tissue and skin;
- Abdominal infections;
- Pneumonia (including nosocomial);
- Empirical treatment of suspected bacterial infection in adult patients with febrile episodes of neutropenia (as monotherapy or in combination with antifungal or antiviral drugs);
- Urinary tract infections;
- Gynecological infections (pelvic inflammatory disease, endometritis).
- Age up to 3 months (due to the lack of data on the efficacy and safety of Meronem use in this age group of patients);
- Hypersensitivity to the drug.
It should be used with caution in patients with dyspepsia (especially associated with colitis), as well as in combination with potentially nephrotoxic drugs.
The use of the drug in patients with infections caused by methicillin-resistant staphylococcus is not recommended.
During pregnancy and during the lactation period, the use of Meronema is permissible only in cases where the expected effect of therapy for the mother greatly exceeds the possible risk for the developing fetus or infant. If necessary, the use of the drug by nursing women should consider stopping breastfeeding for the period of treatment.
Dosing and Administration
The solution prepared from Meronem powder is administered in the form of an intravenous infusion over 15-30 minutes or an intravenous bolus injection for at least 5 minutes.
The dose of the drug for adults is determined individually depending on the patient's condition, the type and severity of the infection.
Recommended daily doses:
- Gynecological infections, pneumonia, infections of soft tissues, skin, urinary system: 500 mg every 8 hours;
- Hospital pneumonia, peritonitis, suspected bacterial infection in patients with neutropenia, septicemia: 1000 mg every 8 hours;
- Meningitis: 2,000 mg every 8 hours.
In cases of renal impairment with creatinine (CK) clearance of 50 ml per minute or less, Meronema doses (500, 1000 or 2000 mg) and intervals between injections, depending on the evidence, should be changed as follows:
- QC is less than 10 ml per minute: the dose is reduced by 2 times, the frequency of administration is every 24 hours;
- QC 10-25 ml per minute: the dose is reduced by 2 times, the frequency of administration - every 12 hours;
- CC 26-50 ml per minute: the dose does not change, the frequency of administration - every 12 hours.
Due to the fact that the drug is excreted during hemodialysis, if it is necessary to continue therapy, it is recommended to administer the required dose at the end of the procedure in order to restore the effective plasma concentration.
Experience with the use of the drug in patients undergoing peritoneal dialysis is absent.
Dose adjustment for patients with liver failure and elderly patients with creatinine clearance greater than 50 ml per minute or normal renal function is not required.
The recommended dose of Meronema for children aged 3 months to 12 years is determined on the basis of 10–20 mg per 1 kg of body weight every 8 hours (depending on the sensitivity of the pathogen, the type and severity of the infection, the patient’s condition). If the child’s body weight is more than 50 kg, then doses intended for adults are used.
When treating meningitis, the recommended dose is 40 mg per kg of body weight every 8 hours.
Instructions for preparing the solution:
- Intravenous bolus injections: the powder is diluted with sterile water for injection in the proportion of 5 ml of water per 250 mg of Meronema, which provides a concentration of 50 mg per 1 ml;
- Intravenous infusions: the powder is diluted with a compatible infusion fluid or sterile water for injection, and then further diluted (up to 50-200 ml) with a compatible infusion fluid.
Meronem compatible infusion fluids:
- 5% glucose solution with 0.225% sodium chloride solution for intravenous infusions;
- 0.9% sodium chloride solution for intravenous infusion;
- 2.5% or 10% mannitol solution for intravenous infusion;
- 5% glucose solution for intravenous infusions with 0.02% sodium bicarbonate solution;
- 5% glucose solution with 0.15% potassium chloride solution for intravenous infusions;
- 5% or 10% glucose solution for intravenous infusions;
- 0.9% sodium chloride solution with 5% glucose solution for intravenous infusion.
Meronem can not be mixed with solutions containing other drugs.
When diluting the drug must follow the standard rules of asepsis. Shake the prepared solution before use. All vials are for single use only.
During the period of therapy with Meronem, side effects may occur on the part of some body systems:
- Digestive system: nausea, diarrhea, vomiting, abdominal pain; in some cases - a reversible increase in blood levels of lactate dehydrogenase, alkaline phosphatase, bilirubin, transaminases individually or in combination; in some cases - pseudomembranous colitis;
- Hematopoietic system: neutropenia (including very rare cases of agranulocytosis), leukopenia, thrombocytopenia, eosinophilia, reversible thrombocytosis; in some cases, a positive direct or indirect Coombs test; there are also reports of a decrease in partial thromboplastin time;
- Central and peripheral nervous system: paresthesias, headache; there are reports of the development of seizures, however, the connection with taking the drug has not been established;
- Effects caused by biological effects: oral candidiasis, vaginal candidiasis;
- Dermatological reactions: urticaria, rash, itching; rarely, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme;
- Allergic reactions: rarely - anaphylactic reactions, angioedema;
- Local reactions: pain at the injection site, thrombophlebitis, inflammation.
When using Meronema (as well as other antibacterial drugs) as monotherapy in critically ill patients with suspected or known infection of the lower respiratory tract, caused by blue pus bacillus, it is necessary to regularly determine the sensitivity of the pathogen.
In case of liver diseases, treatment with Meronem should be carried out under careful control of the level of bilirubin and transaminases.
There are laboratory and clinical signs of partial hypersensitivity between cephalosporins and penicillins, beta-lactam antibiotics and other carbapenems. With the use of beta-lactam antibiotics, allergic reactions are quite common, however, during the administration of Meronem, hypersensitivity reactions were rarely reported. Before starting treatment, the patient should be carefully interviewed, paying particular attention to hypersensitivity reactions to beta-lactam antibiotics in history. The drug should be used with caution when instructed in the history of similar phenomena. If allergic reactions occur to meropenem, the administration of the drug should be stopped and appropriate measures should be taken.
As with the use of other antibiotics, during the period of therapy, the prevailing growth of insensitive microorganisms is possible, which requires constant monitoring of each patient.
The drug is not recommended for children under 3 months, as the tolerability and efficacy of use in children of this age have not been established. Experience with Meronema in children with impaired renal or hepatic function, neutropenia, or primary or secondary immunodeficiency is absent.
Probenecid inhibits renal excretion of meropenem, increases its plasma concentration and half-life, as it competes with it for active tubular secretion. Due to the fact that the duration of the action and the effectiveness of Meronema without probenecid are adequate, the simultaneous use of these drugs is not recommended.
The potential effect of Meronem on 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 during the use of other drugs, with no adverse pharmacological interactions noted.
The drug can reduce the level of valproic acid in the serum. In some patients, it may fall below therapeutic. Despite this, there are no specific data on possible drug interactions.
Terms and conditions of storage
Keep out of reach of children at temperature up to 30 ° C.
Shelf life - 4 years.
The solution prepared from powder cannot be frozen. It is recommended to use it in a freshly prepared form, but it maintains a satisfactory efficiency when stored at temperatures up to 25 ° C or in a refrigerator at temperatures up to 4 ° C.
The shelf life of the prepared solution, depending on the solvent used and the storage temperature:
- Water for injection, 0.9% sodium chloride solution: 15-25 ° C - 8 hours; 4 ° C - 48 hours;
- 5% glucose solution, 2.5% or 10% mannitol solution for intravenous infusions, 5% glucose solution with 0.225% sodium chloride solution, 5% glucose solution with 0.15% potassium chloride solution, 5% glucose solution with 0.9 % solution of sodium chloride: 15-25 ° C - 3 hours; 4 ° C - 14 hours;
- 10% glucose solution, 5% glucose solution with 0.02% sodium bicarbonate solution for intravenous injection: 15-25 ° C - 2 hours; 4 ° C - 8 hours.