Meropenem

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Acute exacerbation of chronic bronchitis and pneumonia due to: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, Streptococcus spp., Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenza, Pseudomonas aeruginosa, Moraxella (Branhamella) catarrhalis, Klebsiella spp., Enterobacter cloacae, Enterobacter spp., Acinetobacter spp
• Pneumonia in children due to: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, Haemophilus influenzae, Pseudomonas aeruginosa
• Urinary tract infections in adults and children, including complicating infections due to: Enterobacter cloacae, Escherichia coli, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Citrobacter freundii, Haemophilus influenzae
• Pelvic inflammatory disease (including tubo-ovarian abscess) and endometritis due to: Enterococcus faecalis, Staphylococcus aureus (methicillin-susceptible strains only), coagulase-negative Staphylococcus spp. (methicillin-susceptible strains only), Streptococcus agalactiae (Group B), Streptococcus viridans, Streptococcus spp., Escherichia coli, Neisseria gonorrhoeae, Klebsiella pneumoniae, Enterobacter aerogenes, Enterobacter cloacae, Proteus mirabilis, Acinetobacter  anitratus, Acinetobacter lwoffi, Gardnerella vaginalis, Bacteroides fragilis group, Peptostreptococcus anaerobius, Peptostreptococcus asaccharolyticus, Peptostreptococcus magmus, Pseudomonas aeruginosa, Group D Streptococcus (enterococcus and non enterococcus)
• Skin and skin structure infections in adults due to: Staphylococcus aureus (methicillin-susceptible strains only), coagulase-negative Staphylococcus spp. (methicillin-susceptible strains only), Streptococcus pyogenes, (Group A), Streptococcus agalactiae, Streptococcus viridans, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Peptostreptococcus spp., Bacteroides fragilis
• Meningitis in adults and children due to: Streptococcus pneumoniae, Haemophilus influenzae and Neisseria meningitidis
• Septicaemia in adults and children due to: Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae
• Empiric treatment, including initial monotherapy, for presumed bacterial infections in host-compromised neutropenic patients due to: Streptococcus epidermidis, Streptococcus mitis, Streptococcus sanguinis, Escherichia coli, Staphylococcus aureus, Micrococcus spp., Pseudomonas aeruginosa
• Intra-abdominal abscess and peritonitis due to: Streptococcus milleri, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Klebsiella  oxytoca, Pseudomonas aeruginosa, Bacteroides fragilis group (including Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Clostridium perfringens, Streptococcus mitior
• Polymicrobial infections

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to any other carbapenem
• Severe hypersensitivity to any other type of beta-lactam agent (e.g. penicillins or cephalosporins)

Caution

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Prevalence of resistance
• Pre-existing hepatic disorders
• Controlled sodium diet

Forms avail. in SA and covered in this monograph: inj

Dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Most aerobic and anaerobic organisms (excluding Methicillin resistant Staphylococcus spp.) 

General dosing range

• IV: 500-2000mg, 8hrly

---

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

---

See Additional Prescribing Points 

---

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities.

South African Standard Treatment Guidelines indications and dosages

Febrile neutropenia (Additional agent required)  
- If fever develops after 48hrs of hospital admission

• IV: 1g, 8hrly
  (STG, Adult 2019)

Hospital acquired pneumonia 
- With prior intravenous antibiotic use within 90 days and ventilator-associated pneumonia

• IV: 2g, 8hrly; Treatment duration: 10 days (CNS infections or known epileptics)
  (STG, Adult 2019)

Meningococcal meningitis  
- Severe penicillin allergy 

• IV: 2g, 8hrly; Treatment duration: 7 days 
  (STG, Adult 2019)

Pneumococcal meningitis 
- Severe penicillin allergy 

• IV: 2g, 8hrly; Treatment duration: 10 days 
  (STG, Adult 2019)

Haemophilus  influenzae 
- Severe penicillin allergy

• IV: 2g, 8hrly; Treatment duration: 10 days 
  (STG, Adult 2019)

---

Indications and dosages registered in other jurisdictions

Febrile neutropenia

• IV: 1g, 8hrly

Severe pneumonia (including hospital and ventilator-associated pneumonia)

• IV: 500-1000mg, 8hrly (manufacturer recommendation)

Bronchopulmonary infections in cystic fibrosis

• IV: 2g, 8hrly

Complicated urinary tract infections
Complicated intra-abdominal infections
Intra- and post-partum infections
Complicated skin and soft tissue infections

• IV: 500-1000mg, 8hrly

---

The dose administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response

---

See Additional Prescribing Points for administration directions

Paed. forms avail. in SA and covered in this monograph: inj

Paed. dosages below include:

• General dosing range
• Indications and dosages registered in other jurisdictions 

Infections caused by: Most aerobic and anaerobic organisms (excluding Methicillin resistant Staphylococcus spp.) 

General dosing range

Younger than 3 months

• Not established for use

Between 3 months - 11 years or <50kg

• IV: 10-40mg/kg, 8hrly

Older than 12 years or > 50kg

• See adult dosage

---

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

---

See Additional Prescribing Points for administration directions

---

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Indications and dosages registered in other jurisdictions

Febrile neutropenia

• IV: 20mg/kg, 8hrly

Acute bacterial meningitis
Bronchopulmonary infections in cystic fibrosis

•  IV: 40mg/kg, 8hrly  

Severe pneumonia (including hospital and ventilator-associated pneumonia
Complicated urinary tract infections
Complicated intra-abdominal infections
Complicated skin and soft tissue infections

• IV: 10-20mg/kg, 8hrly

---

The dose administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response

Pregnancy

• Caution
• 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

Breastfeeding

• Caution; not recommended
• Small amounts of meropenem have been reported to be excreted in human milk. Meropenem should not be used in breastfeeding women unless the potential benefit for the mother justifies the potential risk to the baby

Renal Impairment

• Caution; dose adjustment recommended

CrCl (ml/min)	Dose
> 50	No adjustment necessary
26-50	Administer 100% of recommended dose every 12hrs
10-25	Administer 50% of recommended dose every 12hrs
< 10 or haemodialysis	Limit dose to 500mg/24hrs If CNS symptoms (confusional states and seizures) are observed, dose every 48hrs

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

•  Permitted - No warnings

Central Nervous System Disorders

• Headache
• Paraesthesia
• Seizures  
• Delirium

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting  
• Abdominal pain
• Antibiotic-associated colitis
• Pseudomembranous colitis
• Oral candidiasis

Genitourinary Disorders

• Vaginal candidiasis
• Increased blood creatinine
• Increased blood urea

Hepatobiliary Disorders

• Increased transaminases
• Increased alkaline phosphatase
• Increased lactate dehydrogenase
• Increased bilirubin

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritis
• Urticaria  
• Toxic epidermal necrolysis
• Stevens-Johnson syndrome
• Erythema multiforme
• Injection site pain

Immune, Blood and Lymphatic System Disorders

• Angioedema  
• Anaphylaxis
• Thrombocythaemia
• Eosinophilia
• DRESS Syndrome
• Thrombocytopenia
• Leukopenia
• Neutropenia
• Agranulocytosis
• Haemolytic anaemia
• Thrombophlebitis

Others

• Inflammation
• Pain

• Probenecid
• Oral anticoagulants
• Warfarin
• Valproic acid/sodium valproate
• Valpromide

• Hepatic function

None routine. Specific cases may require

• Renal function
• Full blood count
• INR

Administration directions

• IV bolus (for doses up to 20mg/kg): Solution is dissolved in water for injection to a concentration of 50mg/ml, over 5 minutes
• IV infusion: Solution is dissolved in 0.9% sodium chloride or 5% dextrose water to a solution with a concentration of 1-20mg/ml, over 15-30 minutes

Local resistance

• Prescribers should take into account the local prevalence of resistance of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. to carbapenems when treating infections
• Consideration should be given to official guidance on the appropriate use of antibacterial agents

Direct antiglobulin test (Coombs test) seroconversion

• A positive direct or indirect Coombs test may develop during treatment with meropenem

---

Injection 500mg/20ml, Injection 1000mg/30ml - EML (Hospital)

Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins.

Spectrum of activity: Most aerobic and anaerobic organisms (excluding Methicillin resistant Staphylococcus spp.)

Injection (per vial) 500mg

• Adco Meropenem (Adcock)
• Aspen Meropenem (Pharmacare)
• Carporem 500mg (Aurogen South Africa)
• Litha Meropenem (Litha Pharma)
• Mercarb (Austell)
• Mercide (Ranbaxy)
• Meroject (Pharma Dynamics)
• Meronem 500 (Pfizer Laboratories) originator
• Meropenem 500mg Fresenius (Fresenius Kabi SA)
• Meropenem Watson 500mg (Actavis Pharma)
• Ronem 500mg (Medivision)

Injection (per vial) 1000mg

• Adco Meropenem (Adcock)
• Aspen Meropenem (Pharmacare)
• Carporem 1000mg (Aurogen South Africa)
• Litha Meropenem (Litha Pharma)
• Mercarb (Austell)
• Mercide (Ranbaxy)
• Meroject 1g (Pharma Dynamics)
• Meronem 1000 (Pfizer Laboratories) originator
• Meropenem 1000mg Fresenius (Fresenius Kabi SA)
• Meropenem Watson 1g (Actavis Pharma)
• Ronem 1g (Medivision)