Cilastatin and Imipenem

PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. Urinary tract infections. Intra-abdominal infections. Gynecologic infections. Bacterial septicemia. Bone and joint infections. Skin and skin structure infections. Endocarditis. Limitations of Use: PRIMAXIN is not indicated in patients with meningitis because safety and efficacy have not been established. PRIMAXIN is not recommended in pediatric patients with CNS infections because of the risk of seizures. PRIMAXIN is not recommended in pediatric patients weighing less than 30 kg with impaired renal function.

PRIMAXIN is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug. Cilastatin is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.

The dosage of PRIMAXIN in adult patients should be based on suspected or confirmed pathogen susceptibility. For adult patients with normal renal function (creatinine clearance of greater than or equal to 90 mL/min), the recommended dosage regimens are: 500 mg every 6 hours OR 1000 mg every 8 hours OR 1000 mg every 6 hours. See full prescribing information for dosage recommendations in pediatric patients. A reduction in dose must be made for a patient with a creatinine clearance of less than 90 mL/min. Patients with creatinine clearances of less than 15 mL/min should not receive PRIMAXIN unless hemodialysis is instituted within 48 hours. Reconstitute PRIMAXIN vial with appropriate diluent and dilute the reconstituted suspension with an appropriate infusion solution before administering by intravenous infusion.

PRIMAXIN is contraindicated in patients who have shown hypersensitivity to any component of this product. Known hypersensitivity to any component of PRIMAXIN

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. If an allergic reaction to PRIMAXIN occurs, discontinue the drug immediately. Seizure Potential: Seizures and other CNS adverse reactions, such as confusional states and myoclonic activity, have been reported during treatment with PRIMAXIN. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anticonvulsant therapy if not already instituted, and the dosage of PRIMAXIN re-examined to determine whether it should be decreased, or the antibacterial drug discontinued. Increased Seizure Potential Due to Interaction with Valproic Acid: Co-administration of PRIMAXIN, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations.

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions Seizure Potential Increased Seizure Potential Due to Interaction with Valproic Acid Clostridioides difficile -Associated Diarrhea (CDAD) Development of Drug-Resistant Bacteria The most frequently occurring adverse reactions (≥0.2%) in adults were phlebitis, nausea, diarrhea, vomiting, rash, pain injection site, fever, hypotension, seizures, erythema at injection site, dizziness, pruritus, vein induration, urticaria, somnolence. The most frequently occurring adverse reactions (>1%) in pediatric patients greater than or equal to 3 months of age were diarrhea, rash, phlebitis, gastroenteritis, vomiting, IV site irritation, urine discoloration.

Ganciclovir: Generalized seizures have been reported in patients who received ganciclovir. Do not co-administer unless benefit outweighs risk. Probenecid: Concomitant administration of PRIMAXIN and probenecid results in increases in the plasma level and half-life of imipenem. Concomitant administration is not recommended. Valproic acid/divalproex sodium: Concomitant use with PRIMAXIN is generally not recommended. Consider other antibacterial drugs to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium.

Before Reconstitution: PRIMAXIN dry powder should be stored at a temperature below 25°C (77°F).