Drugs Similar to CEFEPIME

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 gram and 2 grams of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural Formula

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. structure

Cefepime for Injection, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than a 500 mg dose of cefepime. Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -( Z) -( O -methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES CONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied in a SmartPak ® pharmacy bulk package containing the equivalent of 100 grams of cefepime. Cefepime for Injection is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection will range in color from pale yellow to amber. Each SmartPak ® Pharmacy Bulk Package contains sterile Cefepime Hydrochloride, USP, equivalent to 100 grams of cefepime and is intended for intravenous infusion only. Its L-arginine content is approximately 70.7 grams. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. CONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2 -(Z)-O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O. Cefepime Injection in Galaxy Container is a frozen, iso-osmotic, sterile, non-pyrogenic premixed solution supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime [see Dosage and Administration (2) ]. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C 19 H 24 N 6 O 5 S 2 ). The solution is intended for intravenous use after thawing to room temperature. The components and dosage formulations are given in the table below: Table 5: Cefepime Injection in Galaxy Containers Premixed Frozen Solution Component Cefepime is present in the formulation as Cefepime Hydrochloride, USP. The amounts of Dextrose Hydrous, USP and L-Arginine, USP are approximate. Function Dosage Formulations 1 g in 50 mL 2 g in 100 mL Cefepime active ingredient 1 g 2 g Dextrose Hydrous, USP osmolality adjuster 1.03 g 2.06 g L-Arginine, USP The pH may have been adjusted with hydrochloric acid and/or additional L-Arginine, USP. The pH is 4.0 – 6.0. pH adjuster 725 mg 1.45 g Hydrochloric Acid pH adjuster As needed As needed Water for Injection, USP vehicle q.s. This is an abbreviation for sufficient quantity. 50 mL q.s. 100 mL Cefepime Injection will range in color from colorless to amber. The plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Structural Formula

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 gram and 2 grams of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural Formula

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Structural formula Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6 R ,7 R )-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -( Z )-( O -methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container. The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (C 19 H 24 N 6 O 5 S 2 ). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 – 6.0. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Its empirical formula is C 6 H 12 O 6 •H 2 O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula: The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures. Chemical Structure Dextrose Formula Illustration

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 gram and 2 grams of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural Formula

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2 -(Z)-O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than a 500 mg dose of cefepime. Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -( Z) -( O -methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES CONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied in a SmartPak ® pharmacy bulk package containing the equivalent of 100 grams of cefepime. Cefepime for Injection is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection will range in color from pale yellow to amber. Each SmartPak ® Pharmacy Bulk Package contains sterile Cefepime Hydrochloride, USP, equivalent to 100 grams of cefepime and is intended for intravenous infusion only. Its L-arginine content is approximately 70.7 grams. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. CONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinum chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. structure

Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O. Cefepime Injection in Galaxy Container is a frozen, iso-osmotic, sterile, non-pyrogenic premixed solution supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime [see Dosage and Administration (2) ]. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C 19 H 24 N 6 O 5 S 2 ). The solution is intended for intravenous use after thawing to room temperature. The components and dosage formulations are given in the table below: Table 5: Cefepime Injection in Galaxy Containers Premixed Frozen Solution Component Cefepime is present in the formulation as Cefepime Hydrochloride, USP. The amounts of Dextrose Hydrous, USP and L-Arginine, USP are approximate. Function Dosage Formulations 1 g in 50 mL 2 g in 100 mL Cefepime active ingredient 1 g 2 g Dextrose Hydrous, USP osmolality adjuster 1.03 g 2.06 g L-Arginine, USP The pH may have been adjusted with hydrochloric acid and/or additional L-Arginine, USP. The pH is 4.0 – 6.0. pH adjuster 725 mg 1.45 g Hydrochloric Acid pH adjuster As needed As needed Water for Injection, USP vehicle q.s. This is an abbreviation for sufficient quantity. 50 mL q.s. 100 mL Cefepime Injection will range in color from colorless to amber. The plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Structural Formula

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. cefepime-structure

Cefepime for Injection, USP (cefepime hydrochloride, USP) is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Structural formula Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural formula

Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6 R ,7 R )-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7 2 -( Z )-( O -methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C 19 H 25 ClN 6 O 5 S 2 •HCl•H 2 O. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container. The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (C 19 H 24 N 6 O 5 S 2 ). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 – 6.0. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Its empirical formula is C 6 H 12 O 6 •H 2 O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula: The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures. Chemical Structure Dextrose Formula Illustration