Meropenem parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations containing anhydrous meropenem as meropenem trihydrate.
Drugs List
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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