Drug Information for Ciprofloxacin Injection, USP (In 5% Dextrose) For Intravenous InfusionPremix in INTRAVIA Plastic Container (Baxter Healthcare Corporation): DESCRIPTION

Ciprofloxacin Injection, USP is a synthetic broad-spectrum antimicrobial agent for intravenous (I.V.) administration. Ciprofloxacin, a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C₁₇H₁₈FN₃O₃ and its chemical structure is:

Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.34. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin Injection, USP is available as 0.2% ready-for-use infusion solutions in 5% Dextrose Injection and packaged in flexible INTRAVIA plastic containers. The formula contains lactic acid as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6. Ciprofloxacin Injection, USP is a clear, colorless to slightly yellowish, nonpyrogenic sterile solution that contains no preservatives.

The flexible plastic container is fabricated from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container can leach out certain of its chemical components from the plastic in very small amounts; however biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution.