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Meropenem parenteral

Updated 2 Feb 2023 | Carbapenems

Presentation

Parenteral formulations containing anhydrous meropenem as meropenem trihydrate.

Drugs List

  • MERONEM 1g powder for solution for injection
  • MERONEM 500mg powder for solution for injection
  • meropenem 1g powder for solution for injection
  • meropenem 500mg powder for solution for injection
  • Therapeutic Indications

    Uses

    Antibiotic sensitive infections in children
    Bacterial meningitis
    Complicated urinary tract infections
    Gynaecological infections
    Infections in patients with febrile neutropenia
    Infections intra-abdominal
    Pneumonia
    Septicaemia
    Skin and soft tissue infections
    Treatment of respiratory infections in patients with cystic fibrosis

    Unlicensed Uses

    Endocarditis

    Dosage

    The dosage and duration of therapy shall be established depending on the type and severity of infection and the condition of patient.

    Adults

    Intra-abdominal infection, intra- and post-partum infections, gynaecological infections, nosocomial infections, pneumonia, skin and skin structure infections and urinary tract infection
    500mg or 1g every 8 hours

    Febrile neutropenic patients
    1g every 8 hours

    Meningitis, broncho-pulmonary infections in cystic fibrosis, nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.
    2g every 8 hours.

    Endocarditis (unlicensed)
    2g every 8 hours, in combination with another antibacterial.

    Children

    Children over 50kg bodyweight
    (See Dosage; Adult).

    Children aged 1 months to 12 years with bodyweight up to 50kg (Unlicensed in children under 3 months)
    Intra-abdominal infection, gynaecological infections, nosocomial infections, pneumonia, skin and skin structure infections and urinary tract infection
    10mg/kg or 20mg/kg every 8 hours.

    Meningitis, broncho-pulmonary infections in cystic fibrosis, nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.
    40mg/kg every 8 hours.

    Management of febrile neutropenia patients
    20mg/kg every 8 hours.

    Neonates

    Gram-positive and Gram-negative infections and hospital acquired septicaemia (Unlicensed)
    Neonates 7 to 28 days
    20mg/kg every 8 hours by intravenous injection over 5 minutes or by intravenous infusion. Dose may be doubled in severe infections.
    Neonates under 7 days
    20mg/kg every 12 hours by intravenous injection over 5 minutes or by intravenous infusion. Dose may be doubled in severe infections.

    Meningitis
    Neonates 7 to 28 days
    40mg/kg every 8 hours by intravenous infusion.
    Neonates under 7 days
    40mg/kg every 12 hours by intravenous infusion.

    Patients with Renal Impairment

    Dosage should be reduced in adult or adolescent patients with creatinine clearance less than 51ml/minute. There is no experience in children with renal impairment.

    Intra-abdominal infection, pneumonia, urinary tract infection, gynaecological infection, skin and skin structure infections
    Creatinine clearance 26 to 50ml/minute: 500mg or 1g every 12 hours
    Creatinine clearance 10 to 25ml/minute: 250mg every 12 hours
    Creatinine clearance less than 10ml/minute: 250mg every 24 hours

    Febrile neutropenic patients, nosocomial pneumonias
    Creatinine clearance 26 to 50ml/minute: 1g every 12 hours
    Creatinine clearance 10 to 25ml/minute: 500mg every 12 hours
    Creatinine clearance less than 10ml/minute: 500mg every 24 hours

    Meningitis, Cystic fibrosis, nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.
    Creatinine clearance 26 to 50ml/minute: 2g every 12 hours
    Creatinine clearance 10 to 25ml/minute: 1g every 12 hours
    Creatinine clearance less than 10ml/minute: 1g every 24 hours

    Meropenem is cleared by haemodialysis and should therefore be administered at the end of the haemodialysis procedure to restore therapeutically effective plasma concentrations.

    There is no experience with the use of meropenem in patients receiving peritoneal dialysis.

    Administration

    For intravenous infusion over 15 to 30 minutes. Alternatively, doses of up to 1g in adults or 20mg/kg in children may be administered via intravenous bolus injection over 5 minutes. There are limited data available to support administration of a 2g dose in adults or a 40mg/kg dose in children as an intravenous bolus injection.

    Contraindications

    None known

    Precautions and Warnings

    Children under 3 months
    Restricted sodium intake
    Breastfeeding
    Hepatic impairment
    Pregnancy
    Renal impairment - creatinine clearance below 51ml/minute

    Not recommended for methicillin resistant staphylococci infections
    Sodium content of formulation may be significant
    Before initiating therapy enquire about previous hypersensitivity reactions
    Consult national/regional policy on the use of anti-infectives
    Monitor hepatic function
    Monitor periodically for overgrowth of non-susceptible organisms
    Reduce dose in patients with creatinine clearance below 51ml/min
    Consider pseudomembranous colitis if patient presents with diarrhoea
    Test interference: May cause false positive Coombs test
    Discontinue if severe hypersensitivity reactions occur
    Discontinue if severe skin reaction occurs
    Discontinue therapy if marked diarrhoea occurs

    The sodium content for the 500mg and 1g strengths is approximately 45mg and 90mg respectively. This should be taken into consideration when patients that are on a controlled sodium diet are administered meropenem.

    Pregnancy and Lactation

    Pregnancy

    Use meropenem with caution in pregnancy.

    Briggs suggests that animal studies have not shown any adverse effect on fertility or foetal harm, however slight changes in foetal weight have been observed in rats. The manufacturer suggests that its meropenem should be avoided in pregnancy. Safety in human pregnancy has not been established.

    Meropenem is likely to cross the placenta.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Use meropenem with caution in breastfeeding.

    The Drugs and Lactation Database (LactMed) suggests adverse effects are not expected but as with other beta-lactams, disruptions to the infants gastrointestinal flora resulting in diarrhoea may occur. These effects have not been adequately evaluated. The manufacturer suggests that a decision whether to discontinue breastfeeding or discontinue meropenem therapy should be made taking into account the benefit of therapy for the woman.

    It is unknown if meropenem is excreted in human milk, however it is detectable at very low concentrations in animal breast milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Abdominal pain
    Acute generalised exanthematous pustulosis
    Agranulocytosis
    Anaphylaxis
    Angioedema
    Antibiotic-associated colitis
    Blood urea increased
    Convulsions
    Diarrhoea
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Eosinophilia
    Erythema multiforme
    Haemolytic anaemia
    Headache
    Increase in alkaline phosphatase
    Increase in creatinine
    Increase in lactate dehydrogenase
    Increase of liver transaminases
    Increases in hepatic enzymes
    Inflammation (application site)
    Injection site reactions
    Leucopenia
    Local pain (injection site)
    Nausea
    Neutropenia
    Oropharyngeal candidiasis
    Pain
    Paraesthesia
    Positive Coombs test
    Pruritus
    Rash
    Seizures
    Serum bilirubin increased
    Stevens-Johnson syndrome
    Thrombocythaemia
    Thrombocytopenia
    Thrombocytosis
    Thrombophlebitis
    Toxic epidermal necrolysis
    Urticaria
    Vaginal candidiasis
    Vomiting

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: June 2015.

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Meronem IV 500 mg and 1 g. AstraZeneca UK Ltd. Revised January 2019.
    Summary of Product Characteristics: Meropenem 500 mg powder for solution for injection or infusion. Hospira UK Ltd. Revised January 2015.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
    Meropenem Last revised: 07 September 2013.
    Last accessed: 10 June 2015.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 September 2017

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