Epidermidis when found with other co-pathogens are consistent with rates seen in pure isolates. Clinical long-term success (24 to 45 days after completion of therapy) rates were 66.7% for the levofloxacin-treated patients and 76.9% for the ciprofloxacin-treated patients (95% CI -23.40, 2.89 for levofloxacin minus ciprofloxacin). Adverse reactions reported in pediatric patients in clinical trials, adverse reactions reported in adults during clinical trials or post-marketing experience see Adverse Reactions (6)may also be expected to occur in pediatric patients. Clinical success rates (cure plus improvement) in the clinically evaluable population were 90.9% in the LEVAQUIN® 750 mg group and 91.1% in the LEVAQUIN® 500 mg group.
- In children older than 1 year, this medicine is not expected to cause different side effects or problems than it does in adults.
- Tell your health care provider if you have ever had swelling or a tear in the large artery that carries blood from the heart, called the aorta.
- Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria see Patient Counseling Information (17.1).
- Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study.
- Tell your health care provider if you are taking levofloxacin before you get a urine drug screen.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levofloxacin in children. However, because of this medicine’s toxicity, it should be used with caution, after other alternatives have been considered or found ineffective. Levofloxacin may be used in children 6 months of age and older to prevent anthrax infection after possible exposure, and to treat plague infection.
2 Dosage of Levofloxacin Tablets in Pediatric Patients with Inhalational Anthrax or Plague
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including LEVAQUIN®. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Levofloxacin will begin working within a matter of hours, but it can be two to three days before symptoms begin to improve. Take the full course of antibiotics as prescribed by a healthcare provider, even if you feel better after a few days.
Usual Pediatric Dose for Anthrax Prophylaxis
Drink extra fluids to keep your kidneys working properly while taking levofloxacin. Follow all directions on your prescription label and read all medication guides or instruction sheets about levofloxacin. Do not take other medicines unless they have been discussed with your doctor.
CLINICAL PHARMACOLOGY
- Based on the IDSA guidelines for the management of prosthetic joint infection, levofloxacin, in combination with rifampin, is an effective and recommended agent for oral phase treatment of prosthetic joint infection with staphylococci after completion of parenteral therapy.
- This medicine may cause your eyes to become more sensitive to light than they are normally.
- Injury can happen many weeks after taking this drug, and your risk is higher if you’re older.
Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. For uncomplicated urinary tract infections, you might only need 3 days of treatment. However, more serious infections like pneumonia levofloxacin oral route proper use or complicated skin infections may require 7 to 14 days of therapy. Additionally, researchers are investigating the potential for Levofloxacin to be used in combination with other antibiotics to treat multi-drug resistant infections.
Blood vessel injury warning
Levofloxacin is not efficiently removed by dialysis (peritoneal or hemodialysis) and is therefore of little benefit in cases of overdose. Your healthcare provider will choose the best alternative based on culture results when possible, which identify the specific bacteria causing your infection and which antibiotics will work best against it. Levofloxacin can pass into breast milk and may pose a risk to a nursing infant, potentially leading to cartilage damage. For this reason, it is generally not recommended for use while breastfeeding. If you need to take Levofloxacin, your healthcare provider may suggest an alternative antibiotic or advise temporarily stopping breastfeeding.
The mean (± SD) steady state peak plasma concentration in human adults receiving 500 mg orally or intravenously once daily is 5.7 ± 1.4 and 6.4 ± 0.8 mcg/mL, respectively; and the corresponding total plasma exposure (AUC0–24) is 47.5 ± 6.7 and 54.6 ± 11.1 mcg.h/mL, respectively. A total of 136 and 125 microbiologically evaluable patients were enrolled in the LEVAQUIN® and ciprofloxacin groups, respectively. The microbiologic eradication rate by patient infection at 5–18 days after completion of therapy was 75.0% in the LEVAQUIN® group and 76.8% in the ciprofloxacin group (95% CI -12.58, 8.98 for LEVAQUIN® minus ciprofloxacin). In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day) was 1.4 times the highest recommended human dose (750 mg) based upon relative body surface area. Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study. Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study.
3 Antidiabetic Agents
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. Pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose see Clinical Pharmacology (12.3) and Clinical Studies (14.9).
The mean ±SD peak and trough plasma concentrations attained following multiple once-daily IV regimens were approximately 6.4 ±0.8 and 0.6 ±0.2 mcg/mL after the 500 mg doses, and 12.1 ±4.1 and 1.3 ±0.71 mcg/mL after the 750 mg doses, respectively. Oral administration of a 500 mg dose of LEVAQUIN® with food prolongs the time to peak concentration by approximately 1 hour and decreases the peak concentration by approximately 14% following tablet and approximately 25% following oral solution administration. Therefore, LEVAQUIN® Tablets can be administered without regard to food. It is recommended that LEVAQUIN® Oral Solution be taken 1 hour before, or 2 hours after eating.
Of the fluoroquinolone class, levofloxacin has the most enhanced activity against gram-positive penicillin-sensitive and resistant organisms, notably Streptococcus pneumoniae and reduced action against gram-negative bacilli, notably Pseudomonas aeruginosa, compared to ciprofloxacin. There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects when the subjects’ differences in creatinine clearance are taken into consideration. Following a 500 mg oral dose of LEVAQUIN® to healthy elderly subjects (66 – 80 years of age), the mean terminal plasma elimination half-life of levofloxacin was about 7.6 hours, as compared to approximately 6 hours in younger adults. LEVAQUIN® dose adjustment based on age alone is not necessary See Use in Specific Populations (8.5).
Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Therefore, approval of this indication was based on an efficacy study conducted in animals see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10). Levofloxacin injection should be administered for adult and pediatric patients by slow IV infusion over 60 minutes (250 to 500 mg) and over 90 minutes (for 750 mg). Due to an increased risk of hypotension, bolus or rapid IV administration should be avoided.
If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor. This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you or your child take this medicine. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
Similarly, no apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels see Warnings and Precautions (5.4).
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