Meronem

Meronem Special Precautions

meropenem

Manufacturer:

Sumitomo Dainippon Pharma

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Full Prescribing Info
Special Precautions
There is some clinical and laboratory evidence of partial cross-allergenicity between other carbapenems and beta-lactam antibiotics, penicillins and cephalosporins. Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions (SCAR)) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Meronem IV, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapanems or other beta-lactam agents. If an allergic reaction occurs, Meronem IV must be discontinued immediately and appropriate alternative therapy instituted.
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 Meronem IV (See "Adverse Reactions"). If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.
Use of Meronem IV in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels.
As with other antibiotics, overgrowth of non-susceptible organisms may occur and, therefore, continuous monitoring of each patient is necessary.
Use in infections caused by methicillin resistant staphylococci is not recommended.
Rarely, pseudomembranous colitis has been reported on Meronem IV as with practically all antibiotics and may vary in severity from slight to life-threatening. Therefore, antibiotics should be prescribed with care for individuals with a history of gastro-intestinal complaints, particularly colitis.
It is important to consider the diagnosis of pseudomembranous colitis in the case of patients who develop diarrhoea in association with the use of Meronem IV. Although studies indicate that a toxin produced by Clostridium difficile is one of the main causes of antibiotic-associated colitis, other causes should be considered.
The co-administration of Meronem IV with potentially nephrotoxic drugs should be considered with caution. (For dosage see "Dosage & Administration").
The concomitant use of valproic acid/sodium valproate and Meronem IV is not recommended. Meronem IV may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients (see "Interactions").
Effect on Ability to Drive or Operate Machinery: No studies 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, paraesthesia, and convulsions have been reported for Meronem IV.
Use in Children: Efficacy and tolerability in infants under 3 months old have not been established; therefore, Meronem IV is not recommended for use below this age. There is no experience in children with altered hepatic or renal function.
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