Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia
Diabetic foot infections of skin and soft tissue: treatment
Gynaecological infections
Infections intra-abdominal
Prophylaxis of infection in colorectal surgery

Administration

For intravenous infusion over a period of 30 minutes.

Contraindications

Children under 3 months
Breastfeeding
Haemodialysis
Renal impairment in children under 18 years
Severe renal impairment

Precautions and Warnings

Children 3 months to 2 years
Elderly
Restricted sodium intake
Central nervous system disorder
History of seizures
Mild renal impairment
Pregnancy

Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if hypersensitivity reactions occur

The efficacy of ertapenem in the treatment of community acquired pneumonia due to penicillin-resistant Streptococcus pneumoniae has not been established.

Experience of ertapenem to treat severe infections is limited.

The efficacy of ertapenem in the treatment of diabetic foot infections in patients with osteomyelitis has not been established.

For surgical procedures exceeding 4 hours, patients could be exposed to below optimum levels of ertapenem and treatment failure is a possibility.

Pregnancy and Lactation

Pregnancy

Use ertapenem with caution in pregnancy.

Adequate and well controlled studies have not been performed in pregnant women.

Ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus. However Briggs states that if the maternal condition requires the use of ertapenem,the antibiotic probably is safe at any time during gestation.

Animal studies have not indicated any direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development.

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

Ertapenem is contraindicated in breastfeeding.

Mothers should not breastfeed their infants while receiving ertapenem.

There is potential for adverse effects on the infant since ertapenem is excreted in human milk. However, Briggs states that the effects on a nursing infant from exposure to ertapenem via milk, although unknown, are of doubtful clinical significance, as most antibiotics are excreted into milk in low concentrations.

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
Abortion
Acid regurgitation
Acute generalised exanthematous pustulosis
Agitation
Allergic reaction
Altered serum creatinine values
Anaphylactoid reaction
Anaphylaxis
Anorexia
Antibiotic-associated colitis
Anxiety
Arrhythmias
Asthenia
Blood disorders
Blood pressure changes
Bradycardia
Candidiasis
Chest pain
Cholecystitis
Confusion
Constipation
Cough
Depression
Dermatitis
Dermatomycosis
Desquamation
Diarrhoea
Discolouration of stools
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dyspepsia
Dysphagia
Dyspnoea
Electrolyte disturbances
Epistaxis
Erythema
Extravasation
Faecal incontinence
Fatigue
Fever
Fungal infection
Genital bleeding
Haemorrhage
Hallucinations
Headache
Hepatic impairment
Hot flushes
Hypoglycaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum ALT/AST
Increase in serum glucose
Increased partial thromboplastin time
Injection site reactions
Insomnia
Jaundice
Malaise
Melaena
Mental status changes
Muscle cramps
Myoclonus
Nasal congestion
Nausea
Neutropenia
Oedema
Pelvic peritonitis
Petechiae
Pharyngeal discomfort
Phlebitis
Pneumonia
Positive Clostridium difficile toxin
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rales
Rash
Reduced lymphocyte count
Renal impairment
Rhonchi
Scleral disorders
Seizures
Serum bilirubin increased
Serum urea increased
Shoulder pain
Somnolence
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Thrombophlebitis
Tremor
Urinary tract infections
Urine abnormality
Urticaria
Vaginitis
Vomiting
Wheezing

Presentation

Powder for concentrate for solution for infusion containing ertapenem.

Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia
Diabetic foot infections of skin and soft tissue: treatment
Gynaecological infections
Infections intra-abdominal
Prophylaxis of infection in colorectal surgery

Dosage

Treatment of infection is usually 3 to 14 days, but this may vary depending on the type and severity of infection and the causative pathogens.

Adults

Children

Patients with Renal Impairment

Administration

For intravenous infusion over a period of 30 minutes.

Contraindications

Children under 3 months
Breastfeeding
Haemodialysis
Renal impairment in children under 18 years
Severe renal impairment

Precautions and Warnings

Children 3 months to 2 years
Elderly
Restricted sodium intake
Central nervous system disorder
History of seizures
Mild renal impairment
Pregnancy

Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if hypersensitivity reactions occur

The efficacy of ertapenem in the treatment of community acquired pneumonia due to penicillin-resistant Streptococcus pneumoniae has not been established.

Experience of ertapenem to treat severe infections is limited.

The efficacy of ertapenem in the treatment of diabetic foot infections in patients with osteomyelitis has not been established.

For surgical procedures exceeding 4 hours, patients could be exposed to below optimum levels of ertapenem and treatment failure is a possibility.

Pregnancy and Lactation

Pregnancy

Use ertapenem with caution in pregnancy.

Adequate and well controlled studies have not been performed in pregnant women.

Ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus. However Briggs states that if the maternal condition requires the use of ertapenem,the antibiotic probably is safe at any time during gestation.

Animal studies have not indicated any direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development.

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

Ertapenem is contraindicated in breastfeeding.

Mothers should not breastfeed their infants while receiving ertapenem.

There is potential for adverse effects on the infant since ertapenem is excreted in human milk. However, Briggs states that the effects on a nursing infant from exposure to ertapenem via milk, although unknown, are of doubtful clinical significance, as most antibiotics are excreted into milk in low concentrations.

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
Abortion
Acid regurgitation
Acute generalised exanthematous pustulosis
Agitation
Allergic reaction
Altered serum creatinine values
Anaphylactoid reaction
Anaphylaxis
Anorexia
Antibiotic-associated colitis
Anxiety
Arrhythmias
Asthenia
Blood disorders
Blood pressure changes
Bradycardia
Candidiasis
Chest pain
Cholecystitis
Confusion
Constipation
Cough
Depression
Dermatitis
Dermatomycosis
Desquamation
Diarrhoea
Discolouration of stools
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dyspepsia
Dysphagia
Dyspnoea
Electrolyte disturbances
Epistaxis
Erythema
Extravasation
Faecal incontinence
Fatigue
Fever
Fungal infection
Genital bleeding
Haemorrhage
Hallucinations
Headache
Hepatic impairment
Hot flushes
Hypoglycaemia
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in serum ALT/AST
Increase in serum glucose
Increased partial thromboplastin time
Injection site reactions
Insomnia
Jaundice
Malaise
Melaena
Mental status changes
Muscle cramps
Myoclonus
Nasal congestion
Nausea
Neutropenia
Oedema
Pelvic peritonitis
Petechiae
Pharyngeal discomfort
Phlebitis
Pneumonia
Positive Clostridium difficile toxin
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rales
Rash
Reduced lymphocyte count
Renal impairment
Rhonchi
Scleral disorders
Seizures
Serum bilirubin increased
Serum urea increased
Shoulder pain
Somnolence
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Thrombophlebitis
Tremor
Urinary tract infections
Urine abnormality
Urticaria
Vaginitis
Vomiting
Wheezing

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: March 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Invanz 1g powder for solution for infusion. Merck Sharp & Dohme Limited. Revised October 2019.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 June 2017