Indications
Neopenem® is indicated for treatment, in adults and children, of the following infections caused by single or multiple susceptible bacteria and
as empiric therapy prior to the identification of the causative organisms: ● Lower Respiratory Tract Infections
● Urinary Tract Infections, including complicated infections
● Intra-abdominal Infections
● Gynaecological Infections, including postpartum infections
● Skin and Skin Structure Infections
● Meningitis
● Septicaemia
● Empiric treatment, including initital monotherapy, for presumed bacterial infections in host-compromised, neutropenic patient
Because of its broad spectrum of bactericidal activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria, Neopenem®
is effective for the treatment of polymicrobial infections.

Dosage and Administration
ADULTS:
Usual dose
500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or expected susceptibility of
the pathogen(s) and the condition of the patient.
Exceptions
1. Febrile episodes in neutropenic patients – the dose should be 1 g every 8 hours.
2. Meningitis – the dose should be 2 g every 8 hours.
As with other antibiotics, caution may be required in using Meropenem as monotherapy in critically ill patients with known or suspected
Pseudomonas aeruginosa lower respiratory tract infections.
Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infections.
Neopenem® should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15
to 30 minutes (see Method of Administration).
ELDERLY
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
CHILDREN
For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10 to 40 mg/kg every 8 hours
depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. In
children over 50 kg weight, adult dosage should be used.
Exceptions
1. Febrile episodes in neutropenic patients – the dose should be 20 mg/kg every 8 hours.
2. Meningitis – the dose should be 40 mg/kg every 8 hours.
Neopenem® should be given as an IV bolus over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes.
There is no experience in children with renal impairment.

Contraindications
Neopenem® is contraindicated in patients who have demonstrated hypersensitivity to this product.
Warnings and Precautions
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to
Neopenem®. As with all beta-lactam antibiotics rare hypersensitivity reactions have been reported.
Rarely, pseudomembranous colitis has been reported with Neopenem® as with virtually all antibiotics; therefore, its diagnosis should be
considered in patients who develop diarrhoea in association with the use of Neopenem®.
Neopenem® may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.
Use in Children
Efficacy and tolerability in infants under 3 months old have not been established; therefore, Neopenem® is not recommended for use below
this age.
Use in Patients with Liver Disease
Patients with pre-existing liver disorders should have liver function monitored during treatment with Neopenem®.

Use in Pregnancy & Lactation
Pregnancy category B. The safety of Neopenem® in human pregnancy has not been established, although animal studies have not shown an
adverse effect on the developing foetus. Neopenem® should not be used in pregnancy unless the potential benefit justifies the potential risk to
the foetus.
Meropenem is detectable at very low concentrations in animal breast milk. Neopenem® should not be used in breast-feeding women unless
the potential benefit justifies the potential risk to the baby