Levofloxacin intravenous

Dosage in Adult Patients with Normal Renal Function The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance ≥ 50 mL/min.

For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration ]. Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) [See table below.] 10 to 14 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7 Acute Bacterial Sinusitis (ABS) 750 mg 5 500 mg 10 to 14 * Due to the designated pathogens [see Indications and Usage ]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage ]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage ]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis.

This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies ]. ß The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied.

An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions , Use in Specific Populations , and Clinical Studies ] . Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Higher doses of Levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

Dosage Adjustment in Adults with Renal Impairment Administer levofloxacin injection with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced. No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations ]. Table 3 shows how to adjust dose based on creatinine clearance. Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) [See table below.]

Hepatic Impairment Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.

Administration Instructions Levofloxacin Injection Caution: Rapid or bolus intravenous infusion of levofloxacin injection has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion.

It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. Hydration for Patients Receiving Levofloxacin Injection Adequate hydration of patients receiving intravenous levofloxacin injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions and Patient Counseling Information ].

Preparation of Intravenous Product Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection Premix in single-dose flexible containers, or infused simultaneously through the same intravenous line.

If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line. Levofloxacin Injection Premix in Single-dose Flexible Containers (5 mg/mL) Levofloxacin Injection is supplied in flexible containers within a foil overwrap.

These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-dose. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 150 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL.

No further dilution of these preparations is necessary. Because the premix flexible containers are for single-dose only, any unused portion should be discarded. Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers: 1. Tear outer wrap at the notch and remove solution container. 2. Check the container for minute leaks by squeezing the inner bag firmly.

If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. 3. Do not use if the solution is cloudy or a precipitate is present. 4. Use sterile equipment. 5. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration: 1. Close flow control clamp of administration set. 2. Remove cover from port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5.

Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. 6. Open flow control clamp to expel air from set. Close clamp. 7. Regulate rate of administration with flow control clamp.