Ertapenem

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:

• Complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis
• Complicated skin and skin structure infections, including diabetic lower extremity and diabetic foot infections due to Staphylococcus aureus (methicillin strains only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae,, Proteus mirabilis,  Porphyromonas asaccharolytica or Peptostreptococcus species
• Community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible strains only) including cases with concurrent bacteremia, Moraxella catarrhalis
• Complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae
• Acute pelvic infections including postpartum endomyometritis,
  septic abortion and post surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to carbapenems
• Severe hypersensitivity to any other type of beta-lactam antibacterial agent

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Severe hepatic impairment
• Elderly
• Central nervous system disorders
• Low sodium diet
• Treatment of penicillin-resistant S. pneumoniae
• Seizures
• History of colitis
• Diabetic foot infections with concurrent osteomyelitis
• Children younger than 2 years
• Coadministration with valproic acid/sodium valproate

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

Dosages below include:

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

Infections caused by: Gram-positive and Gram-negative aerobic cocci (excluding Entercocci spp., Acinetobacter spp. and methicillin-resistant Staphylococcus spp.); Gram-positive and Gram-negative aerobic bacilli (excluding C. jeikeium, Lactobacillus spp., P. aeruginosa, B. cepacia, and Legionella spp.); some anaerobes, including C. clostidioforme, Peptostreptococcus spp., Fusobacterium spp.

General dosage

• IV/IM: 1g, dly

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Not recommended for use as empiric therapy (administration of antibiotics based on the assumption of a causative organism) in community acquired infections

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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

South African Standard Treatment Guidelines indications and dosages

Surgical wound infections (Additional agent required)
- Gram-negative organism in patients with severe penicillin allergy

• IV: 1g, dly; Treatment duration: ≤7 days
  (STG, Adult 2019)

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South African registered indications and dosages &
Indications and dosages registered in other jurisdictions

Complicated intra-abdominal infections

• IV/IM: 1g, dly; Treatment duration: 5-14 days (Manufacturer recommendation)

Complicated skin and soft tissue infections

• IV/IM: 1g, dly; Treatment duration: 7-14 days (Manufacturer recommendation)

Complicated urinary tract infections including pyelonephritis

• IV/IM: 1g, dly; Treatment duration: 10-14 days (Manufacturer recommendation)

Acute pelvic infections

• IV/IM: 1g, dly; Treatment duration: 3-10 days (Manufacturer recommendation)

Osteomyelitis

• IV/IM: 1g, dly; Treatment duration: 6 weeks

Intravenous catheter associated sepsis

• IV/IM: 1g, dly

Prosthetic joint infection

• IV/IM: 1g, dly; Treatment duration: 4-6 weeks

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IV route can be used for up to 14 days, IM for up to 7 days

IV: Infuse over a period of 30 minutes

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

Dosages below include:

• General dosage
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Gram-positive and Gram-negative aerobic cocci (excluding Entercocci spp., Acinetobacter spp. and methicillin-resistant Staphylococcus spp.); Gram-positive and Gram-negative aerobic bacilli (excluding C. jeikeium, Lactobacillus spp., P. aeruginosa, B. cepacia, and Legionella spp.); some anaerobes, including C. clostidioforme, Peptostreptococcus spp., Fusobacterium spp.

General dosage

• IV/IM: 15mg/kg, 12hrly; Max: 1g/24hrs

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Not recommended for use as empiric therapy (administration of antibiotics based on the assumption of a causative organism) in community acquired infections

---

See additional prescribing points for administration directions

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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 registered indications and dosages & Indications and dosages registered in other jurisdictions

Complicated intra-abdominal infections

• Younger than 3 months: Not established for use
• Between 3 months - 12 years: IV/IM: 15mg/kg, 12hrly; Treatment duration: 5-14 days ; Max: 1g/24hrs (Manufacturer recommendation)
• Older than 12 years: See adult dosage

Complicated skin and soft tissue infections

• Younger than 3 months: Not established for use
• Between 3 months - 12 years: IV/IM: 15mg/kg, 12hrly; Treatment duration: 7-14 days ; Max: 1g/24hrs (Manufacturer recommendation)
• Older than 12 years: See adult dosage

Community acquired pneumonia
Complicated urinary tract infections including pyelonephritis

• Younger than 3 months: Not established for use
• Between 3 months - 12 years: IV/IM: 15mg/kg, 12hrly; Treatment duration: 10-14 days ;Max: 1g/24hrs (Manufacturer recommendation)
• Older than 12 years: See adult dosage

Acute pelvic infections

• Younger than 3 months: Not established for use
• Between 3 months - 12 years: IV/IM: 15mg/kg, 12hrly; Treatment duration: 3-10 days.; Max: 1g/24hrs (Manufacturer recommendation)
• Older than 12 years: See adult dosage

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IV route can be used for up to 14 days, IM for up to 7 days

IV: Infuse over a period of 30 minutes

Pregnancy

• Caution; no evidence of risk in studies
• Adequate and well-controlled studies have not been performed in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development. However, ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus

Breastfeeding 

• Caution; not recommended
• Ertapenem is excreted in human milk. Because of the potential for adverse reactions on the infant, mothers should not breastfeed their infants while receiving ertapenem

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; dose adjustment recommended

CrCl (ml/min)	Dose
> 30	No adjustment necessary
< 30	IV/IM: Max: 500mg, dly
Haemodialysis	IV/IM: Max: 500mg, dly; If the daily dose is given within 6hours prior to haemodialysis, a supplementary dose of 150mg is required following hemodialysis. If ertapenem is given at least 6 hours prior to hemodialysis, no supplementary dose is needed

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Insomnia 
• Confusion
• Agitation 
• Anxiety 
• Depression
• Altered mental status
• Headache
• Dizziness
• Somnolence
• Taste perversion 
• Seizure
• Tremor
• Syncope
• Hallucinations
• Depressed level of consciousness 
• Dyskinesia 
• Myoclonus
• Gait disturbance
• Headache
• Hallucinations

Cardiovascular Disorders

• Sinus bradycardia
• Arrhythmia 
• Tachycardia 
• Phlebitis
• Thrombophlebitis
• Hypotension
• Haemorrhage 
• Hot flush
• Hypertension

Respiratory Disorders

• Dyspnoea
• Pharyngeal discomfort
• Nasal congestion 
• Cough
• Epistaxis
• Rales/rhonchi 
• Wheezing

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Constipation
• Acid regurgitation 
• Dry mouth 
• Dyspepsia 
• Abdominal pain
• Dysphagia
• Faecal incontinence 
• Pelvic peritonitis
• Teeth staining
• Diarrhoea
• Melaena

Hepatobiliary Disorders

• Cholecystitis
• Jaundice
• Hepatic disorder

Genitourinary Disorders

• Genital bleeding
• Abortion

Endocrine and Metabolic Disorders

• Anorexia
• Hypoglycaemia

Musculoskeletal Disorders

• Muscle cramp 
• Shoulder pain
• Muscular weakness

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Erythema 
• Urticaria
• Dermatitis 
• Desquamation
• Drug rash with eosinophilia and systemic symptoms 
• Diaper dermatitis
• Erythema 
• Rash
• Petechiae
• Extravasation
• Injection site induration
• Infusion site pain
• Infusion site burning 
• Infusion site pruritus 
• Infusion site erythema 
• Infusion site warmth

Immune, Blood and Lymphatic System Disorders

• Oral candidiasis 
• Candidiasis
• Fungal infection 
• Pseudomembranous enterocolitis 
• Vaginitis
• Pneumonia 
• Dermatomycosis 
• Postoperative wound infection
• Urinary tract infection
• Neutropenia
• Thrombocytopenia
• Allergy
• Anaphylaxis

Sensory Disorders

• Scleral disorder

• CYP450 inhibitors
• P-glycoprotein inhibitors
• Valproic acid/sodium valprate

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Administration directions - adults and children older than 12 years

• IV infusion: Reconstitute 1g with 10ml water for injection (WFI) or normal saline. Shake well to dissolve and transfer contents to 50ml normal saline. Complete infusion within 6hrs
• IM: Reconstitute the contents of a 1g vial with 3.2ml of 1% or 2% lignocaine solution without adrenaline. Shake well. Withdraw the contents of the vial and administer by deep IM injection into a large muscle mass. Use within 1 hour after preparation

Administration directions - between 3 months to 12 years

• IV infusion: Reconstitute 1g vial with 10ml WFI or normal saline. Shake well. Dissolve and withdraw a volume equal to 15mg/kg and dilute in normal saline to concentration of 20mg/ml. Complete infusion within 6hrs
• IM: Reconstitute the contents of a 1g vial with 3.2ml of 1% or 2% lignocaine solution without adrenaline. Shake well. Withdraw a volume equal to 15mg/kg and administer by deep IM injection into a large muscle mass. Use within 1 hour after preparation

Ertapenem inhibits bacterial cell wall synthesis through its binding to penicillin binding proteins. Ertapenem is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, cephalosporinases and extended spectrum beta-lactamases.

Spectrum of activity: Gram-positive and Gram-negative aerobic cocci (excluding Entercocci spp., Acinetobacter spp. and methicillin-resistant Staphylococcus spp.); Gram-positive and Gram-negative aerobic bacilli (excluding C. jeikeium, Lactobacillus spp., P. aeruginosa, B. cepacia, and Legionella spp.);Some anaerobes, including C. clostidioforme, Peptostreptococcus spp., Fusobacterium spp.

Injection (per vial) 1g

• Abexem (Abex Pharmaceutica)
• Ertapenem Aspen (Pharmacare Limited)
• Invabex (Abex Pharmaceutica)
• Invanz (MSD) originator
• Iverzam (Aurogen South Africa)
• MSD-Ertapenem (MSD)