Imipenem and cilastatin and relebactam parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of imipenem with cilastatin and relebactam.
Drugs List
Therapeutic Indications
Uses
Bacteraemia
Hospital-acquired pneumonia (HAP)
Infections caused by Gram-negative bacteria
Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
Treatment of bacteraemia that develops in association with HAP or VAP in adults.
Indicated for the treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options.
Dosage
Adults
Hospital-acquired pneumonia
500mg/500mg/250mg every 6 hours infused over 30 minutes for 7 to 14 days.
Infections due to aerobic Gram-negative organisms
500mg/500mg/250mg every 6 hours infused over 30 minutes. Duration of treatment in accordance with the site of infection.
Patients with Renal Impairment
Creatinine clearance 60 to 90mL/min
400mg/400mg/200mg every 6 hours infused over 30 minutes.
Creatinine clearance 30 to 60mL/min
300mg/300mg/150mg every 6 hours infused over 30 minutes.
Creatinine clearance 15 to 30mL/min
200mg/200mg/100mg every 6 hours infused over 30 minutes.
End stage renal disease (ESRD) on haemodialysis
200mg/200mg/100mg every 6 hours infused over 30 minutes.
Patients with a creatinine clearance of less than 15mL/min should not receive imipenem, cilastatin and relebactam unless haemodialysis is instituted within 48 hours.
Administration
For intravenous infusion only.
Contraindications
Children under 18 years
Precautions and Warnings
History of serious hypersensitivity reactions
Breastfeeding
Central nervous system disorder
Hepatic impairment
Pregnancy
Renal impairment - creatinine clearance below 90ml/minute
Not recommended in pts with CrCl <15mL/min not receiving haemodialysis
Reduce dose in patients with creatinine clearance below 90ml/min
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Monitor hepatic function regularly
Monitor renal function in patients with renal impairment
Consider C. difficile if diarrhoea occurs within 2 months of treatment
Test interference: May cause false positive Coombs test
Discontinue at once if pseudomembranous colitis occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Pregnancy and Lactation
Pregnancy
Use imipenem, cilastatin and relebactam with caution during pregnancy.
The manufacturer does not recommend using imipenem, cilastatin and relebactam during pregnancy. Animal studies have shown reproductive toxicity. Potential risk for humans is unknown.
Lactation
Use imipenem, cilastatin and relebactam with caution during breastfeeding.
The manufacturer advises that the patient either discontinues imipenem, cilastatin and relebactam or discontinues breastfeeding. Imipenem and cilastatin as excreted in breast milk in small quantities. Available data in animals has shown excretion of relebactam in milk of rats. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Acute renal failure
Agitation
Agranulocytosis
Alanine aminotransferase increased
Anaphylactic reaction
Angioedema
Aspartate aminotransferase increased
Asthenia
Bone marrow depression
Candidiasis
Chest discomfort
Clostridium difficile diarrhoea
CNS effects
Confusion
Cyanosis
Decrease in creatinine clearance
Decrease in haemoglobin
Diarrhoea
Discolouration of teeth and tongue
Discolouration of urine
Dizziness
Dyskinesia
Dyspnoea
Encephalopathy
Eosinophilia
Erythema multiforme
Exacerbation of myasthenia gravis
Exfoliative dermatitis
Fever
Flushing
Fulminant hepatitis
Gastro-enteritis
Glossitis
Haemolytic anaemia
Haemorrhagic colitis
Hallucinations
Headache
Hearing loss
Heartburn
Hepatic failure
Hepatitis
Hyperhidrosis
Hypersalivation
Hyperventilation
Hypotension
Increase in blood urea nitrogen
Increase in lactate dehydrogenase
Increase in serum alkaline phosphatase (reversible)
Increase in serum transaminases
Jaundice
Leukopenia
Local pain (injection site)
Myoclonic movements
Nausea
Oliguria
Overgrowth by non-susceptible organisms
Palpitations
Pancytopenia
Paraesthesia
Pharyngeal pain
Polyuria
Positive Coombs test
Prothrombin time increased
Pruritus
Pruritus vulvae
Pseudomembranous colitis
Rash
Seizures
Serum bilirubin increased
Serum creatinine increased
Skin texture changes
Somnolence
Stevens-Johnson syndrome
Tachycardia
Taste disturbances
Thoracic spine pain
Thrombocytopenia
Thrombocytosis
Thrombophlebitis
Tinnitus
Tongue papillae hypertrophy
Toxic epidermal necrolysis
Tremor
Urticaria
Vertigo
Vomiting
Effects on Laboratory Tests
A positive direct or indirect Coombs test may develop during treatment with imipenem, cilastatin and relebactam.
Further Information
Last Full Review Date: September 2020
Reference Sources
Summary of Product Characteristics: Recarbrio 500mg/500mg/250mg powder for solution for infusion. Merck Sharp & Dohme Limited. Revised January 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 April 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.