AHFS Class:

8:12.18 Quinolones

Generic Name

• LevoFLOXacin

Levofloxacin is available as a 25-mg/mL concentrate for injection in 20-mL (500-mg) and 30-mL (750-mg) single-use, preservative-free vials.²⁸⁹⁵ Each mL of the concentrate contains levofloxacin 25 mg in water for injection with sodium hydroxide and hydrochloric acid for pH adjustment.²⁸⁹⁵ The concentrate must be diluted to a 5-mg/mL solution before administration.²⁸⁹⁵ Adding 250 mg (10 mL) to 40 mL of diluent, 500 mg (20 mL) to 80 mL of diluent, or 750 mg (30 mL) to 120 mL of diluent will result in a concentration of 5 mg/mL.²⁸⁹⁵

Levofloxacin also is available as a 5 mg/mL premixed, ready-to-use solution in 50-, 100-, or 150-mL single-use flexible plastic containers containing levofloxacin 250, 500, or 750 mg, respectively, in dextrose 5%.³⁸³⁴ Sodium hydroxide and hydrochloric acid may have been added to adjust the pH.³⁸³⁴

pH

The concentrate and premixed solutions have a pH from 3.8 to 5.8.²⁸⁹⁵; ³⁸³⁴

Levofloxacin concentrate, when diluted to a concentration of 5 mg/mL, has a pH of about 4.6 to 4.7 in dextrose 5%, sodium chloride 0.9%, dextrose 5% in sodium chloride 0.9%, or dextrose 5% in sodium chloride 0.45% with potassium chloride 0.15%; a pH of 4.9 in dextrose 5% in Ringer’s injection, lactated; a pH of 5 in Plasma-Lyte 56/dextrose 5%; and a pH of 5.5 in sodium lactate M.²⁸⁹⁵

Tonicity

The premixed infusion solutions are nearly isotonic.³⁸³⁴

Trade Name(s)

Levaquin

Levofloxacin concentrate for injection must be diluted in a compatible infusion solution to a concentration of 5 mg/mL prior to administration.²⁸⁹⁵ Levofloxacin injection is administered only at a concentration of 5 mg/mL by slow intravenous infusion over at least 60 minutes.²⁸⁹⁵; ³⁸³⁴ Doses of 750 mg should be administered over 90 minutes.²⁸⁹⁵; ³⁸³⁴ No other route is recommended.²⁸⁹⁵; ³⁸³⁴ Rapid infusion or bolus administration must not be used because of the potential for hypotension.²⁸⁹⁵; ³⁸³⁴

Intact vials should be stored at controlled room temperature and protected from light.²⁸⁹⁵ The premixed infusion solutions should be stored at or below 25°C and protected from light, freezing, and excessive heat.³⁸³⁴ A brief exposure to temperatures up to 40°C does not adversely affect the premixed product.³⁸³⁴ The injection and infusion admixtures are clear and yellow to greenish yellow in appearance.²⁸⁹⁵; ³⁸³⁴ This color also does not adversely affect the product.¹⁹⁸⁶; ²⁸⁹⁵; ³⁸³⁴ Unused portions in single-use vials or flexible plastic containers should be discarded after use.²⁸⁹⁵; ³⁸³⁴

Levofloxacin concentrate diluted to a concentration of 5 mg/mL in a compatible diluent is stated to be stable for 72 hours stored at or below 25°C and for 14 days stored at 5°C.²⁸⁹⁵

Levofloxacin may form stable coordination compounds with metal ions.²⁸⁹⁵ The chelation potential is greatest with Al³⁺ and declines from Cu²⁺ to Zn²⁺ to Mg²⁺ to Ca²⁺.²⁸⁹⁵

pH Effects

Levofloxacin has a solubility of 100 mg/mL at pH values ranging from 0.6 to 5.8.²⁸⁹⁵ The solubility increases as pH increases up to 6.7, with a maximum solubility of 272 mg/mL.²⁸⁹⁵ Above pH 6.7, solubility decreases to a minimum of 50 mg/mL at pH 6.9.²⁸⁹⁵

Freezing Solutions

Levofloxacin concentrate diluted to a concentration of 5 mg/mL in a compatible diluent in glass bottles or plastic infusion containers is stable for 6 months frozen at -20°C.²⁸⁹⁵ Frozen solutions should be thawed at room temperature or in the refrigerator.²⁸⁹⁵ Accelerated thawing using microwaves or hot water immersion is not recommended.²⁸⁹⁵ Thawed solutions should not be refrozen.²⁸⁹⁵

Light Effects

Levofloxacin undergoes slow degradation when exposed to ultraviolet light.²³⁹⁹ Losses have been reported upon long-term light exposure.²⁶³⁶

Central Venous Catheter

Levofloxacin (McNeil) 1 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.²³³⁵

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Additional Compatibility Information

Levofloxacin must not be administered through the same intravenous line with any solution containing multivalent cations (e.g., magnesium).²⁸⁹⁵; ³⁸³⁴

Infusion Solutions

In a simulated Y-site administration study, levofloxacin (Sagent) 5 mg/mL in dextrose 5% was physically compatible with Normosol R for up to 4 hours at 21°C protected from light.³⁷¹⁹

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions March 31, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.