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  • Meronem
    / Pfizer


    Active Ingredient
    Meropenem (as Trihydrate) 500 mg, 1 g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 X 500 mg

    partial basket chart 83475 13633

    Vial

    10 X 1 g

    partial basket chart 29018 13632

    Dosage

    Adults: The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient.
    The recommended daily dosage is as follows:
    500 mg IV every 8 hours in the treatment of pneumonia, UTI, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections.
    1 g IV every 8 hours in the treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicaemia.
    In cystic fibrosis, doses up to 2 g every 8 hours have been used; most patients have been treated with 2 g every 8 hours.
    In meningitis the recommended dosage is 2 g every 8 hours.
    When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 1g every 8 hours in adults (maximum approved dose is 6g daily given in 3 divided doses) and a dose of at least 20mg/kg every 8 hours in children (maximum approved dose is 120mg/kg/ daily given in 3 divided doses) are recommended.
    Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.
    There are limited safety data available to support the administration of a 2g bolus dose in adults as an intravenous bolus injection.
    Dosage Schedule for Adults with Impaired Renal Function: Dosage should be reduced in patients with creatinine clearance less than 51 mL/min, as scheduled in table 1 at the attached doctor’s leaflet.
    Meropenem is cleared by haemodialysis and haemofiltration; if continued treatment with Meronem is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations.
    There is no experience with the use of Meronem in patients under peritoneal dialysis.
    Dosage in Adults with Hepatic Insufficiency: No dosage adjustment is necessary in patients with hepatic insufficiency.
    Elderly Patients: No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min.
    Children: For children over 3 months and up to 12 years of age the recommended dose is 10 to 20 mg/kg every 8 hours depending on type and severity of infection, susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, adult dosage should be used. In meningitis and cystic fibrosis the recommended dose is 40 mg/kg every 8 hours. There is no experience in children with renal impairment.
    Method of Administration: Meronem IV can be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes using the specific available presentations. There is limited safety data available to support the administration of a 40 mg/kg bolus dose (in children). There is limited safety data available to support the administration of a 2g bolus dose (in adults).
    Meronem IV to be used for bolus intravenous injection should be constituted with sterile Water for Injections (5 mL per 250 mg meropenem). This provides an approximate concentration of 50 mg/mL. Constituted solutions are clear, and colourless or pale yellow.
    Meronem IV for intravenous infusion may be constituted with compatible infusion fluids (50 to 200 ml).
    Meronem should not be mixed with or physically added to solutions containing other drugs.
    Solutions of meronem should not be frozen.


    Indications

    Meronem IV is indicated for treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to meropenem.
    • Pneumonias and Nosocomial Pneumonias
    • Pulmonary infections in patients with cystic fibrosis
    • Urinary Tract Infections
    • Intra abdominal Infections
    • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
    • Skin and Skin Structure Infections
    • Meningitis
    • Septicaemia
    Meronem has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections.
    There is no experience in paediatric patients with neutropenia or primary or secondary immuno deficiency.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Hypersensitivity to any other carbapenem antibacterial agent.
    Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).


    Special Precautions

    The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
    Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. resistance: Resistance to penems of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.
    Hypersensitivity reactions: As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported.
    Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
    If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
    Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.
    Antibiotic-associated colitis: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents, including meropenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
    Seizures: Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see section 4.8).
    Hepatic function monitoring: Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis).
    Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary.
    Direct antiglobulin test (Coombs test) seroconversion: A positive direct or indirect Coombs test may develop during treatment with meropenem.
    Concomitant use with valproic acid/sodium valproate/valpromide: The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended.
    Meronem contains sodium.
    Meronem 500 mg: This medicinal product contains 45 mg sodium per 500 mg vial, equivalent to 2.25% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
    Meronem 1 g: This medicinal product contains 90 mg sodium per 1 g vial, equivalent to 4.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.


    Side Effects

    In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related adverse reactions most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%).
    See prescribing information for full details.


    Drug interactions

    No specific medicinal product interaction studies other than probenecid were conducted.
    Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. Caution is required if probenecid is co-administered with meropenem.
    The potential effect of meropenem on the protein binding of other medicinal products or metabolism has not been studied. However, the protein binding is so low that no interactions with other compounds would be expected on the basis of this mechanism.
    Decreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60-100 % decrease in valproic acid levels in about two days. Due to the rapid onset and the extent of the decrease, co-administration of valproic acid/sodium valproate/valpromide with carbapenem agents is not considered to be manageable and therefore should be avoided.
    Oral anti-coagulants: Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects. There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anti-coagulant agent.
    Paediatric population: Interaction studies have only been performed in adults.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of meropenem in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
    As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
    Lactation: Small amounts of meropenem have been reported to be excreted in human milk. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby.


    Overdose

    Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2 at the attached doctor’s leaflet. Limited post-marketing experience indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8 at the attached doctor’s leaflet, are generally mild in severity and resolve on withdrawal or dose reduction. Symptomatic treatments should be considered.
    In individuals with normal renal function, rapid renal elimination will occur.
    Haemodialysis will remove meropenem and its metabolite.


    Important notes

    Storage: Do not store above 30°C. Do not freeze the reconstituted solution.


    Manufacturer
    AstraZeneca UK Ltd.
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