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INDICATIONS AND DOSAGE

Levofloxacin is indicated for the treatment of adults (>18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlarnydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae. (See CLINICAL STUDIES.)

Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, or Streptococcus pyoganes.

Complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Acute pysionsphritis (mild to moderate) caused by Escherichia coli.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identity organisms causing the infection and to determine their susceptibility to levofloxacin. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.

As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

DOSAGE AND ADMINISTRATION
The usual dose levofloxacin is 500 mg orally every 24 hours as described in TABLE 11. These recommendations apply to patients with normal renal function (i.e., CLCR>80 ml/min), for patients with altered renal function (i.e., CLCR?80 ml/min) see TABLE 12 and Renal Insuffiency (below). Oral doses should be administered at least two hours before or two hours after antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multi-vitamin preparations with zinc.

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
Men: Creatinine Clearance ml/min) = [Weight (kg) x (140 - age)] / [ 72 x serum creatinine (mg/dl)]
Women: 0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function. There are no significant differences in levofloxacin pharmacokinetics between male and female subjects when subjects' differences in creatinine clearance are taken into consideration. Following a 500 mg oral dose of levofloxacin to healthy male subjects, the mean terminal plasma elimination half-life of levofloxacin was about 7.5 hours, as compared to approximately 6.1 hours in female subjects. This difference was attributable to the variation in renal function status of the male and female subjects and was not believed to be clinically significant. Drug absorption appears to be unaffected by the gender of the subjects. Dose adjustment base on gender alone is not necessary.

Race
The effect of race on levofloxacin pharmacokinetics was examined through a covariate analysis performed on data from 72 subjects: 48 white and 24 nonwhite. The apparent total body clearance and apparent volume of distribution were not affected by the race of the subjects.

Renal Insufficiency
Clearance of levofloxacin is reduced and plasma elimination half-life is prolonged in patients with impaired renal function (creatinine clearance <80 ml/min), requiring dosage adjustment in such patients to avoid accumulation. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or CAPD. (See PRECAUTIONS, General.)

Hepatic Insufficiency
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.

Bacterial Infection
The pharmacokinetics of levofloxacin in patients with serious community-acquired bacterial infections are comparable to those observed in healthy subjects.

Drug-Drug Iinteractions
The potential for pharmacokinetic drug interactions between levofloxacin and theophylline, warfarin, cyclosporine, digoxin, probenecid, cimetidine, sucralfate, and antacids has been evaluated. (See DRUG INTERACTIONS.)

HOW SUPPLIED
Tablets
Levaquin Tablets are supplied as 250 and 500 mg modified rectangular, film-coated tablets.
250 mg tablets: color, terra cotta pink debossing: "McNeil 1520" on side 1 and "250" on side 2
500 mg tablets: color, peach debossing: "McNeil 1525" on side 1 and "500" on side 2
Storage: Levofloxacin should be stored at 15 ° to 30 °C (59 ° to 85 °F) in well-closed containers.

Injection
Levaquin Injection is available for intravenous administration.
Levaquin Injection in single-use vials (20 ml) containing a concentrated solution with the equivalent of 500 mg of levofloxacin.
Levaquin Injection premix in flexible containers containing a dilute solution with the equivalent of 250 or 500 mg of levofloxacin in 5% Dextrose (D5W).