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
2.5 Storage of Constituted Solution
RECARBRIO, as supplied in single-dose glass vials upon constitution with the appropriate diluent andfollowing further dilution in the infusion bag, maintains satisfactory potency for at least 2 hours at roomtemperature (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.
2.6 Incompatible Injectable Drug Products
RECARBRIO for injection for intravenous infusion is physically incompatible with propofol in 5 % DextroseUSP or 0.9 % Sodium Chloride USP.
3 DOSAGE FORMS AND STRENGTHS
RECARBRIO (imipenem, cilastatin, and relebactam) for injection, 1.25 grams is supplied as a white tolight yellow sterile powder for constitution in a single-dose glass vial containing imipenem 500 mg(equivalent to 530 mg imipenem monohydrate), cilastatin 500 mg (equivalent to 531 mg cilastatinsodium), and relebactam 250 mg (equivalent to 263 mg relebactam monohydrate).
4 CONTRAINDICATIONS
RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severesystemic allergic reaction such as anaphylaxis) to any component of RECARBRIO.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patientsreceiving therapy with beta lactams. Before initiating therapy with RECARBRIO, careful inquiry should bemade concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, otherbeta lactams, and other allergens. If a hypersensitivity reaction to RECARBRIO occurs, discontinue thetherapy immediately.
RECARBRIO is contraindicated in patients with a history of severe hypersensitivity to any component ofRECARBRIO [see Contraindications (4)].
5.2 Seizures and Other Central Nervous System (CNS) Adverse Reactions
CNS adverse reactions, such as seizures, confusional states, and myoclonic activity, have been reportedduring treatment with imipenem/cilastatin, a component of RECARBRIO, especially when recommendeddosages of imipenem were exceeded. These have been reported most commonly in patients with CNSdisorders (e.g., brain lesions or history of seizures) and/or compromised renal function.
Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adversereactions including seizures occur, patients should undergo a neurological eva luation to determinewhether RECARBRIO should be discontinued.
5.3 Increased Seizure Potential Due to Interaction with Valproic Acid
Concomitant use of RECARBRIO, with valproic acid or divalproex sodium may increase the risk ofbreakthrough seizures. Avoid concomitant use of RECARBRIO with valproic acid or divalproex sodium orconsider alternative antibacterial drugs other than carbapenems [See Drug Interactions ( |
