Meropenem

Use in Adult Patients with Renal Impairment Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.) When only serum creatinine is available, the following formula (Cockcroft and Gault equation) 1 may be used to estimate creatinine clearance. Males: Creatinine Clearance (mL/min) = Weight (kg) x (140 - age) __ 72 x serum creatinine (mg/dL) Females: 0.85 x above value [See table below.] There is inadequate information regarding the use of Meropenem for injection in patients on hemodialysis or peritoneal dialysis.

Preparation and Administration of Meropenem for injection Important Administration Instructions: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Intravenous Bolus Administration Re-constitute injection vials (500 mg and 1 gram) with sterile Water for Injection (see table 4 below).

Shake to dissolve and let stand until clear. Discard unused portion. Table 4: Volume of Sterile Water for Injection for Reconstitution of Injection Vials [See table below.] 0 mg 10 10 50 1 gram 20 20 50 For Infusion

Injection vials (500 mg and 1 gram) may be directly re-constituted with a compatible infusion fluid.

Alternatively, an injection vial may be re-constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid [ see Dosage and Administration and ].

Do not use flexible container in series connections.

Compatibility Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs.

Stability and Storage Freshly prepared solutions of Meropenem should be used. However, re-constituted solutions of Meropenem maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem should not be frozen. Intravenous Bolus Administration Meropenem injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F).

Intravenous Infusion Administration Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F). Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Dextrose Injection 5% should be used immediately.