The pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. Pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose see Indications and Usage (1.13), Dosage and Administration (2.2), Clinical Pharmacology (12.3) and Clinical Studies (14.9). Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including levofloxacin. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any o ther sign of hypersensitivity. Convulsions, toxic psychoses, increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including levofloxacin.

6 Hydration for Patients Receiving Levofloxacin Tablets

In immature dogs (4–5 months old), oral doses of 10 mg/kg/day for 7 days and intravenous doses of 4 mg/kg/day for 14 days of levofloxacin resulted in arthropathic lesions. Administration at oral doses of 300 mg/kg/day for 7 days and intravenous doses of 60 mg/kg/day for 4 weeks produced arthropathy in juvenile rats. Three-month old beagle dogs dosed orally with levofloxacin at 40 mg/kg/day exhibited clinically severe arthrotoxicity resulting in the termination of dosing at Day 8 of a 14-day dosing routine. Slight musculoskeletal clinical effects, in the absence of gross pathological or histopathological effects, resulted from the lowest dose level of 2.5 mg/kg/day (approximately 0.2-fold the pediatric dose based upon AUC comparisons).

5 Uncomplicated Skin and Skin Structure Infections

• There is limited information regarding IV Compatibility of Levofloxacin (oral) in the drug label.
• Caution should be used when prescribing LEVAQUIN® to elderly patients especially those on corticosteroids.
• Children treated with LEVAQUIN® had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in Table 9.
• Levofloxacin tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa see Clinical Studies (14.8).
• Drinking alcohol while taking levofloxacin might increase your risk of dizziness, drowsiness, or stomach upset.
• LEVAQUIN® is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN®. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of LEVAQUIN Injection with an infusion solution compatible with LEVAQUIN Injection and with any other drug(s) administered via this common line. LEVAQUIN is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis see Clinical Studies (14.7). LEVAQUIN is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis see Clinical Studies (14.5). As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN .

If you are taking more than one dose a day, try to space out your doses so ideally, take a tablet every 12 hours. Levofloxacin works by stopping the growth of bacteria.Levofloxacin treats only bacterial infections. Levofloxacin generally safe.It can cause serious side effects, including tendon problems, side effects on your nerves , serious mood or behavior changes, or low blood sugar (which can lead to coma).

Drug Images

Check with your doctor right away if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness. Using this medicine with any of the following medicines is usually not recommended, but levofloxacin oral route proper use may be required in some cases. Using this medicine with any of the following medicines is not recommended.

The CDC recommends use as an alternative therapy only if standard parenteral cephalosporin therapy is not feasible, community prevalence and individual risk of quinolone-resistant gonococcal organisms is low, and if follow-up is likely. Based on the American College of Gastroenterology clinical guideline for the treatment of Helicobacter pylori infection, levofloxacin is an effective and recommended component of a multiple-drug regimen for the treatment of H. Adequate hydration of patients receiving LEVAQUIN® should be maintained to prevent the formation of highly concentrated urine. If levofloxacin isn’t right for you, several alternative antibiotics can treat similar infections.

The plasma concentration profile of levofloxacin after IV administration is similar and comparable in extent of exposure (AUC) to that observed for levofloxacin tablets when equal doses (mg/mg) are administered. Therefore, the oral and IV routes of administration can be considered interchangeable see Figure 2 and Figure 3. The pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration. However, since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function see Clinical Pharmacology (12.3). In clinical trials, 1534 children (6 months to 16 years of age) were treated with oral and intravenous levofloxacin.

Adverse Effects

Synovitis and articular cartilage lesions were observed at the 10 and 40 mg/kg dose levels (approximately 0.7-fold and 2.4-fold the pediatric dose, respectively, based on AUC comparisons). Articular cartilage gross pathology and histopathology persisted to the end of the 18-week recovery period for those dogs from the 10 and 40 mg/kg/day dose levels. The mean ±SD peak and trough plasma concentrations attained following multiple once-daily oral dosage regimens were approximately 5.7 ±1.4 and 0.5 ±0.2 mcg/mL after the 500 mg doses, and 8.6 ±1.9 and 1.1 ±0.4 mcg/mL after the 750 mg doses, respectively.

• Based on the IDSA guidelines for the diagnosis and treatment of native vertebral osteomyelitis, oral levofloxacin is effective and recommended for the treatment of native vertebral osteomyelitis caused by susceptible gram-negative organisms.
• This will reduce the risk that future infections are resistant to levofloxacin or other similar medicines.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
• However, more serious infections like pneumonia or complicated skin infections may require 7 to 14 days of therapy.
• Oral administration with food prolongs the Tmax by approximately 1 hour and slightly decreases the Cmax, but these changes are not likely to be clinically significant.

7 Complicated Urinary Tract Infections and Acute Pyelonephritis: 5-day Treatment Regimen

The 95% CI for the difference of response rates (LEVAQUIN® minus comparator) was -6, 19. In the second study, 264 patients were enrolled in a prospective, multi-center, non-comparative trial of 500 mg LEVAQUIN® administered orally or intravenously once daily for 7 to 14 days. Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported.

This medication is typically used to treat a variety of bacterial infections. However, it’s essential to understand its potential side effects and interactions with other medications. For more detailed information about Levofloxacin, including its uses, side effects, and precautions, you can refer to this comprehensive resource. 7.3 Antidiabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent.

LEVAQUIN® is a fluoroquinolone antibiotic medicine used in adults, 18 years or older, to treat certain infections caused by certain germs called bacteria. Read the Medication Guide that comes with LEVAQUIN® before you start taking it and each time you get a refill. In adults, the safety of LEVAQUIN® for treatment durations of up to 28 days is well characterized.

The medication can affect blood sugar levels, sometimes causing them to go too high or too low, especially in people taking diabetes medications. Ciprofloxacin is frequently chosen for urinary tract infections and certain types of gastrointestinal infections. It’s been around longer and has more research behind it for certain conditions. Generic levofloxacin works just as effectively as the brand-name versions and often costs less.