PRIMAXIN (imipenem/cilastatin sodium)

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction

Drug Names

Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)

VIVOTIF

Drug contraindication overview.

*Hypersensitivity to any ingredient in the formulation.

Adverse reaction overview.

The most common adverse effects reported in >=0.2% of adults include phlebitis, nausea, diarrhea, vomiting, rash, pain and erythema at the injection site, fever, hypotension, seizures, dizziness, pruritus, vein induration, urticaria, and somnolence. The most common adverse effects reported in >1% of pediatric patients >=3 months of age include diarrhea, rash, phlebitis, gastroenteritis, vomiting, IV site irritation, and urine discoloration. The most common adverse effects reported in >1% of neonates and infants <3 months of age include convulsions, diarrhea, oliguria/anuria, oral candidiasis, rash, and tachycardia.

Safety and efficacy of imipenem/cilastatin in pediatric patients is supported by evidence from adequate and well-controlled studies in adults and clinical studies in pediatric patients. Adverse effects reported with the drug in neonates and children are similar to those reported in adults and include GI effects (e.g., diarrhea, vomiting, gastroenteritis), rash, urogenital effects (e.g., urine discoloration, oliguria, anuria), and reactions at the site of IV infusion (e.g., phlebitis, IV site irritation). Such adverse effects generally have been reported in 1-4% of pediatric patients receiving imipenem and cilastatin.

However, seizures have been reported in neonates and children <=3 months of age receiving the drug. Therefore, because of the risk of seizures, the manufacturer recommends that IV imipenem/cilastatin should not be used in pediatric patients with CNS infections. The manufacturer also recommends that because there are insufficient data to date evaluating IV imipenem/cilastatin in pediatric patients with impaired renal function who weigh <30 kg, the drug should not be used in these patients.

Diluents containing benzyl alcohol should not be used to prepare imipenem/cilastatin for IV administration to neonates. Administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates. Toxicity has not been demonstrated in pediatric patients older than 3 months of age, although small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None