RiteMED Meropenem Trihydrate Special Precautions

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on beta-lactam therapy. These reactions are more likely to occur in those with a history of sensitivity to multiple allergens. A thorough inquiry about the patient's previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams, and other allergens should be made before initiating therapy with meropenem.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine, oxygen, intravenous steroids, and airway management, including intubation. Other therapy may also be administered as indicated.
Seizure Potential: Seizures and other adverse CNS experiences have been reported during meropenem therapy, particularly in patients with CNS disorders (e.g., brain lesions or history of seizures), bacteria meningitis and/or compromised renal function.
Do not exceed recommended dosage especially in those with known factors that predispose to seizures. Continue anticonvulsant therapy in those with known seizure disorders. If focal tremors, myoclonus, or seizures occur, evaluate the patient neurologically, initiate anticonvulsant therapy if necessary, and determine whether meropenem dosage should be decreased or the drug discontinued.
Interaction with Valproic Acid: The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended.
Meropenem may reduce serum levels of valproic acid to subtherapeutic levels which can increase patient's predisposition to seizure (see INTERACTIONS).
Clostridium difficile-associated diarrhea (CDAD): This has been reported with the use of nearly all antibacterial agents, including meropenem, and may range in severity from mild to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Sodium Content: Meropenem contains sodium (see DESCRIPTION) which should be taken into consideration when treating patients requiring restricted sodium intake.
Other Precautions: There is partial cross-allergenicity among beta-lactam antibiotics, including penicillins, cephalosporins, or other beta-lactams.
Although meropenem has a low toxicity profile, the renal, hepatic, and hematopoietic status of patients undergoing prolonged treatment with the drug should be evaluated periodically.
Prescribing meropenem in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Effects on Ability to Drive and Use Machines: Patients on meropenem on an outpatient basis may develop adverse events such as seizures, headaches, and or paresthesias. Until it is reasonably established that meropenem is well tolerated, patients should be advised to avoid performing tasks which require complete mental alertness such as driving and operating machinery.
Hepatic Impairment: Patients with pre-existing liver disorders should have their liver function monitored during treatment with meropenem.
Renal Impairment: Dose adjustment is recommended in patients with creatinine clearance less than 51 mL/min. In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding has been reported.
Use in Pregnancy: (Pregnancy Category B) There are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, meropenem should be used during pregnancy only when clearly needed.
Use in Lactation: It is not known whether meropenem is excreted in human milk; thus it should be used with caution in breastfeeding women.
Use in Children: The safety and efficacy of meropenem have not been established in children less than 3 months old.
Use in Elderly: There are no substantial differences in safety and efficacy compared with younger adults. However, since elderly patients are more likely to have decreased renal function, care should be taken in dose selection and renal function should be monitored.