Nimedine Dosage/Direction for Use

Nimedine is available as intravenous infusion only.
The dosage recommendations for Nimedine represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present.
The total daily dosage of Nimedine should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s) and renal function.
Dosage in Adults: For Intravenous Injection Only: The dosage of Nimedine in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 2 as follows. The dosage recommendations for Nimedine represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.
These doses should be used for patients with creatinine clearance of ≥90 mL/min. A reduction in dose must be made for patients with creatinine clearance <90 mL/min as shown in Table 3 (see Dosage in Adult Patients with Renal Impairment as follows).
Recommend that the maximum total daily dosage not exceed 4 g/day.
Administer 500 mg by intravenous infusion over 20 to 30 minutes.
Administer 1000 mg by intravenous infusion over 40 to 60 minutes.
In patients who develop nausea during the infusion, the rate of infusion may be slowed. (See Table 2.)

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Dosage in Adult Patients with Renal Impairment: Patients with creatinine clearance less than 90 mL/min require dosage reduction of Nimedine as indicated in Table 3. The serum creatinine should represent a steady state of renal function. Use the Cockroft-Gault method described as follows to calculate the creatinine clearance: (See equation and Table 3.)

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In patients with creatinine clearances of 15-30 mL/min, there may be an increased risk of seizures (see Precautions). Patients with creatinine clearance less than 15 mL/min should not receive Nimedine unless haemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of Nimedine for patients undergoing peritoneal dialysis.
Dosage in Hemodialysis Patients: When treating patients with creatinine clearances of less than 15 mL/min who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 15-30 mL/min as previously mentioned in Table 3. Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive Nimedine after hemodialysis and at intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, Nimedine is recommended only when the benefit outweighs the potential risk of seizures (see Dosage in Adult Patients with Renal Impairment as previously mentioned).
Dosage in Paediatric Patients (3 months or older): Nimedine is not recommended in paediatric patients with CNS infections because of the risk of seizures (see Precautions).
Nimedine is not recommended in paediatric patients <30 kg with renal impairment, as no data are available (see Precautions).
Based on studies in adults, the maximum total daily dose in pediatric patients should not exceed 4 g/day (see Dosage in Adults as previously mentioned).
The recommended dosage for pediatric patients with non-CNS infections is shown in Table 4 as follows: (See Table 4.)

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Preparation of Nimedine for IV Administration: Nimedine is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted using aseptic technique prior to IV infusion as outlined as follows.
To prepare the infusion solution, contents of the vial must be reconstituted by adding approximately 10 mL of the appropriate diluent to the vial. List of appropriate diluents are as follows: 0.9% Sodium Chloride Injection, 5% Glucose Injection.
The content of the vial is transferred to 100 ml of appropriate infusion solution.
Add approximately 10 ml of the appropriate infusion solution to the vial. Shake well and transfer the resulting mixture to the infusion solution container.
Repeat the previously mentioned procedure with additional 10 ml of infusion solution to ensure complete transfer of vial contents to the infusion solution. Agitate the resulting mixture until clear.
The concentration of the reconstituted solution following the previously mentioned procedure is approximately 5 mg/ml for both Imipenem and Cilastatin.
Reconstituted solutions of Nimedine range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
For patients with renal insufficiency, a reduced dose of Nimedine will be administered according to the patient's CrCl, as determined from Table 5. Prepare 100 mL of infusion solution as directed previously. Select the volume (mL) of the final infusion solution needed for the appropriate dose of Nimedine as shown in Table 5.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if discoloration or visible particles are observed. (See Table 5.)

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Route of Administration: Intravenous infusion.