Sianem Special Precautions

Prior to initiation of therapy with Imipenem and Cilastatin sodium, careful inquiry should be made concerning previous hypersensitivity reactions to β-lactam antibiotics, including penicillins and cephalosporins, or other β-lactam antibiotics. Because there is clinical and laboratory evidence of partial cross-allergenicity among penicillins and other β-lactam antibiotics.
Nausea and/or vomiting or diarrhea generally occur during administration of Imipenem, ameliorated by decreasing the IV infusion rate.
Seizure has been reported in neonates and children 3 months of age or younger receiving the drug. In addition, there was a study shown that high incidence of seizures was observed in children 3 months to 12 years of age who received Imipenem and Cilastatin sodium for empiric treatment of bacterial meningitis.
Renal, hepatic, and hematologic systems should be evaluated periodically during prolonged therapy with Imipenem and Cilastatin sodium.
Should not be used in children who weigh less than 30 kg with renal impairment because no safety data.
Use with caution in patients with CNS disorders (e.g. a history of seizures, recent head trauma) or patients with renal impairment. This may cause central nervous system disorders such as confusion or seizures. Those with a history of epilepsy may be necessary co-administration between anticonvulsants, Imipenem and Cilastatin sodium and doctors should monitor closely.
Prolonged use of Imipenem and Cilastatin sodium may result in overgrowth of nonsusceptible organisms, especially Candida spp., Enterococci, and Pseudomonas spp. If superinfection occurs, appropriate therapy should be instituted.
Because Clostridium difficile-associated diarrhea and colitis has been reported with Imipenem and Cilastatin sodium, it should be considered in the differential diagnosis of patients who develop diarrhea during or following therapy with the drug. Mild cases respond to the discontinuation of the drug alone. In the moderate to severe cases, treatment with an antibacterial drug effective against C. difficile colitis may be considered.
If hypersensitivity reactions occur during Imipenem and Cilastatin sodium therapy, the drug should be discontinued. Severe hypersensitivity or anaphylactic reactions should be treated with appropriate therapy (e.g. epinephrine, oxygen, IV corticosteroids, airway management including intubation) as indicated.
For patients with restricted sodium, Imipenem and Cilastatin sodium should be used with caution.
Use in Children: Should not be used in children who weigh less than 30 kg with renal impairment because no safety data.