Meropenem and vaborbactam parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of meropenem and vaborbactam.
Drugs List
Therapeutic Indications
Uses
Bacteraemia
Complicated urinary tract infections
Hospital-acquired pneumonia (HAP)
Infections caused by Gram-negative bacteria
Infections intra-abdominal
Complicated urinary tract infection, including pyelonephritis.
Complicated intra-abdominal infection.
Hospital-acquired pneumonia, including ventilator associated pneumonia.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections mentioned above.
Meropenem and vaborbactam is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
Dosage
The dosage and duration of therapy shall be established depending on the type and severity of infection and the condition of patient.
Adults
Complicated urinary tract infection including pyelonephritis
2g/2g every 8 hours for 5 to 10 days. Treatment may continue up to 14 days.
Complicated intra-abdominal infection
2g/2g every 8 hours for 5 to 10 days. Treatment may continue up to 14 days.
Hospital-acquired pneumonia
2g/2g every 8 hours for 7 to 14 days.
Bacteraemia
2g/2g every 8 hours. Duration in accordance with the site of infection.
Aerobic Gram-negative infections
2g/2g every 8 hours. Duration in accordance with the site of infection.
Patients with Renal Impairment
Creatinine clearance greater than 40ml/minute: See Dosage; Adults.
Creatinine clearance 20 to 39ml/minute: 1g/1g every 8 hours.
Creatinine clearance 10 to 20ml/minute: 1g/1g every 12 hours.
Creatinine clearance less than 10ml/minute: 0.5g/0.5g every 12 hours.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Restricted sodium intake
Haemodialysis
History of seizures
Renal impairment - creatinine clearance below 40ml/minute
Contains more than 1 mmol (23 mg) sodium per dose
Haemodialysis patients: administer drug after dialysis
Advise patient ability to drive or operate machinery may be impaired
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Concentrate must be diluted and used as an infusion
Monitor hepatic function
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
May increase risk of seizure
Test interference: May cause false positive Coombs test
Discontinue and do not restart if severe cutaneous adverse reactions occur
Discontinue at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Discontinue therapy if marked diarrhoea occurs
Cases of Clostridium difficile-associated diarrhoea have been reported with meropenem and vaborbactam treatment. Consider Clostridium difficile in patients presenting with diarrhoea, and consider discontinuation of meropenem and vaborbactam treatment. Avoiding medicinal products that inhibit peristalsis in these cases.
The occurrence of seizures have been reported with meropenem and vaborbactam treatment. Patients who develop focal tremors, myoclonus or seizures should undergo neurological examination and receive anticonvulsant treatment as necessary. Dose may be adjusted according to renal function. Consider discontinuation of treatment if seizures develop.
The sodium content per 1g/1g of meropenem and vaborbactam is approximately 250mg. This should be taken into consideration with patients on a controlled sodium diet.
Pregnancy and Lactation
Pregnancy
Meropenem and vaborbactam is contraindicated during pregnancy.
The manufacturer advises as a precautionary measure to avoid the use of meropenem and vaborbactam during pregnancy.
At the time of writing there is limited published information regarding the use of meropenem and vaborbactam during pregnancy. Potential risks are unknown.
Lactation
Meropenem and vaborbactam is contraindicated during breastfeeding.
The manufacturer advises that breastfeeding should be discontinued prior to initiating treatment with meropenem and vaborbactam.
Meropenem is known to be excreted into breast milk. It is unknown whether vaborbactam is excreted in breast milk. The effects on exposed infants are unknown.
Side Effects
Abdominal distension
Abdominal pain
Acute generalised exanthematous pustulosis
Agranulocytosis
Alanine aminotransferase increased
Anaphylactic reaction
Angioedema
Aspartate aminotransferase increased
Blood urea increased
Bronchospasm
Candidiasis
Chest pain
Cholestasis
Clostridium difficile diarrhoea
Convulsions
Creatine phosphokinase increased
Cytolysis
Decreased appetite
Delirium
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Eosinophilia
Erythema at injection site
Erythema multiforme
False positive Coombs test
Haemolytic anaemia
Hallucinations
Headache
Hepatotoxicity
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypoglycaemia
Hypokalaemia
Hypotension
Incontinence
Increase in alkaline phosphatase
Increased blood lactate levels
Injection site reactions
Insomnia
Lethargy
Leucopenia
Nausea
Neutropenia
Pain
Paraesthesia
Phlebitis
Phlebitis (injection site)
Pruritus
Pyrexia
Rash
Renal impairment
Seizures
Serum bilirubin increased
Serum creatinine increased
Severe cutaneous adverse reactions
Stevens-Johnson syndrome
Thrombocythaemia
Thrombocytopenia
Thrombosis (injection site)
Toxic epidermal necrolysis
Tremor
Urticaria
Vascular pain
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 2021
Reference Sources
Summary of Product Characteristics: Vaborem 1g/1g powder for concentrate for solution for infusion. A. Menarini Farmaceutica Internazionale SRL. Revised October 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 02 June 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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