EXBLIFEP Solution for injection Ref.[108537] Active ingredients: Cefepime

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

EXBLIFEP (cefepime and enmetazobactam) for injection is a combination product that contains cefepime, a cephalosporin antibacterial drug, and enmetazobactam, a beta-lactamase inhibitor, for intravenous administration.

Cefepime, present as cefepime hydrochloride monohydrate, is a white to pale yellow powder. The chemical name for cefepime is (6R,7R,Z)7(2-(2-aminothiazol-4-yl)2(methoxyimino)acetamido)3((1-methylpyrrolidinium-1-yl)methyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylate. The empirical formula of cefepime hydrochloride monohydrate is C19H24N6O5S2ยท2HClยทH2O, the molecular weight is 571.50, and its chemical structure is:

Figure 1. Structure of Cefepime:

Enmetazobactam is a white to off-white powder, with a molecular weight of 314.38. The chemical name for enmetazobactam is (2S,3S,5R)-3-methyl-3-((3-methyl-1H-1,2,3-triazol-3-ium-1-yl)methyl)-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its empirical formula is C11H14N4O5S and its chemical structure is:

Figure 2. Structure of Enmetazobactam:

EXBLIFEP 2.5 grams (cefepime and enmetazobactam) for injection is supplied as a white to off-white sterile powder for reconstitution. Each vial contains 2 grams of cefepime (equivalent to 2.3 g of cefepime hydrochloride), 0.5 grams of enmetazobactam, and 1.414 grams of L-arginine.

Dosage Forms and Strengths

EXBLIFEP 2.5 grams (cefepime and enmetazobactam) for injection, is supplied as a white to off-white sterile powder for reconstitution in single-dose vials, containing 2 grams cefepime and 0.5 grams enmetazobactam.

How Supplied

EXBLIFEP 2.5 grams (cefepime and enmetazobactam) for injection is supplied as a white to off-white sterile powder for reconstitution in single-dose, clear glass vials sealed with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial is supplied in cartons of 10 vials (NDC 83289-101-02).

Each vial contains 2 grams of cefepime and 0.5 grams of enmetazobactam.

Manufactured for: Allecra Therapeutics SAS, 68300 Saint Louis, France

Drugs

Drug Countries
EXBLIFEP Lithuania, United States

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