Meropenem Kabi Special Precautions

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.
Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. resistance: Prescribers are advised to take into account the local prevalence of resistance in these bacteria to penems.
Hypersensitivity reactions: As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported.
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis(TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalised exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.
Antibiotic-associated colitis: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including meropenem, and may range in severity from mild to life threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem. Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures: Seizures have infrequently been reported during treatment with carbapenems, including meropenem.
Hepatic function monitoring: Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis).
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary.
Direct antiglobulin test (Coombs test) seroconversion: A positive direct or indirect Coombs test may develop during treatment with meropenem.
Concomitant use with valproic acid/sodium valproate/valpromide: The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended.
Meropenem Kabi contains sodium.
Meropenem Kabi 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Meropenem Kabi 1 g: This medicinal product contains approximately 4.0 mEq of sodium per 1 g dose which should be taken into consideration by patients on a controlled sodium diet.
Effects on ability to drive and use machines: No studies on the effect on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem.