Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.
Generic name: IMIPENEM ANHYDROUS 500mg in 100mL, CILASTATIN 500mg in 100mL, RELEBACTAM ANHYDROUS 250mg in 100mL
Dosage form: injection, powder, for solution
Recommended Dosage in Adults
The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older with creatinine clearance (CLcr) of 90 mL/min or greater. A dose reduction is recommended for patients with CLcr less than 90 mL/min (Table 1) [see Dosage and Administration (2.2)]. The severity and location of infection, as well as clinical response should guide the duration of therapy. The recommended duration of treatment with RECARBRIO is 4 days to 14 days.
Dosage Adjustments in Patients with Renal Impairment
Dosage adjustment is recommended in patients with renal impairment. Patients who have a CLcr less than 90 mL/min require dosage reduction of RECARBRIO (Table 1). For patients with fluctuating renal function, CLcr should be monitored.
|Estimated CLcr (mL/min)*||Recommended Dosage of RECARBRIO (imipenem/cilastatin and relebactam) (mg)†||Dosing Interval|
|RECARBRIO is provided as a single vial in a fixed-dose combination; the dose for each component will be adjusted equally during preparation [see Dosage and Administration (2.4)].|
|60 to 89||1 gram (imipenem 400 mg, cilastatin 400 mg, and relebactam 200 mg)||Every 6 hours|
|30 to 59||0.75 grams (imipenem 300 mg, cilastatin 300 mg, and relebactam 150 mg)||Every 6 hours|
|15 to 29||0.5 grams (imipenem 200 mg, cilastatin 200 mg, and relebactam 100 mg)||Every 6 hours|
|End Stage Renal Disease (ESRD) on Hemodialysis‡||0.5 grams (imipenem 200 mg, cilastatin 200 mg, and relebactam 100 mg)||Every 6 hours|
Patients with CLcr less than 15 mL/min should not receive RECARBRIO unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of RECARBRIO for patients undergoing peritoneal dialysis.
Imipenem, cilastatin, and relebactam are cleared from the circulation during hemodialysis. For patients maintained on hemodialysis, administer RECARBRIO after hemodialysis and at intervals timed from the end of that hemodialysis session.
Preparation of RECARBRIO Solution for Intravenous Administration
RECARBRIO is supplied as a dry powder in a single-dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion. To prepare the infusion solution, contents of the vial must be constituted with the appropriate diluent as instructed below. A list of appropriate diluents is as follows:
- 0.9% Sodium Chloride Injection, USP
- 5% Dextrose Injection, USP
- 5% Dextrose Injection, USP + 0.9% Sodium Chloride Injection, USP
- 5% Dextrose Injection, USP + 0.45% Sodium Chloride Injection, USP
- 5% Dextrose Injection, USP + 0.225% Sodium Chloride Injection, USP
RECARBRIO has low aqueous solubility. To ensure complete dissolution of RECARBRIO it is important to adhere to the following instructions:
- Step 1) For diluents available in 100 mL prefilled infusion bags, proceed to step 2. For diluents not available in 100 mL prefilled infusion bags, aseptically withdraw 100 mL of the desired diluent and transfer it to an empty infusion bag, then proceed to step 2.
- Step 2) Withdraw 20 mL (as two 10 mL aliquots) of diluent from the appropriate infusion bag and constitute the vial with one 10 mL aliquot of the diluent. The constituted suspension is for intravenous infusion only after dilution in an appropriate infusion solution.
- Step 3) After constitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag.
- Step 4) Add the second 10 mL aliquot of infusion diluent to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution before administering. Agitate the resulting mixture until clear.
Constituted solutions of RECARBRIO range from colorless to yellow. Variations of color within this range do not affect the potency of the product.
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.
The above instructions for preparation of RECARBRIO solution for intravenous administration must be followed for all patients, irrespective of the intended patient's renal function. The volume of this prepared RECARBRIO solution to be administered to patients is determined based on renal function [see Dosage and Administration (2.4)].
Preparation of RECARBRIO Solution for Intravenous Administration in Patients with Renal Impairment
For patients with renal impairment, prepare a reduced dose of RECARBRIO (1 gram, 0.75 grams, or 0.5 grams) [see Dosage and Administration (2.2)] by preparing a 100 mL solution containing 1.25 grams (as described above in Section 2.3) then withdrawing and discarding the excess according to Table 2.
|Creatinine Clearance (mL/min)||Dosage of RECARBRIO (imipenem/cilastatin/relebactam)||After preparation as instructed above, remove from the 100 mL prepared bag the volume indicated below and discard||Resulting volume that provides the indicated reduced dose|
|60 to 89||1 gram (imipenem 400 mg, cilastatin 400 mg, and relebactam 200 mg)||20 mL||80 mL|
|30 to 59||0.75 grams (imipenem 300 mg, cilastatin 300 mg, and relebactam 150 mg)||40 mL||60 mL|
|15 to 29 or ESRD on hemodialysis||0.5 grams (imipenem 200 mg, cilastatin 200 mg, and relebactam 100 mg)||60 mL||40 mL|
Storage of Constituted Solution
RECARBRIO, as supplied in single-dose glass vials upon constitution with the appropriate diluent and following further dilution in the infusion bag, maintains satisfactory potency for at least 2 hours at room temperature (up to 30°C) or for at least 24 hours under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze solutions of RECARBRIO.
Compatible Injectable Drug Products
Compatible Drug Products
The physical compatibility of RECARBRIO with selected injectable drug products was evaluated in two commonly available diluents. Compatible drugs with the corresponding compatible diluent (i.e., 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP) are listed below. RECARBRIO should not be co-administered through the same intravenous line (or cannula), with other drug products not listed below, as no compatibility data are available. Refer to the respective prescribing information of the co-administered drug(s) to confirm compatibility of simultaneous co-administration.
List of Compatible Injectable Drugs for use with 5% Dextrose USP or 0.9% Sodium Chloride USP Injection as Diluents
More about Recarbrio (cilastatin / imipenem / relebactam)
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- During pregnancy
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- Drug class: carbapenems/beta-lactamase inhibitors
- FDA approval history
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