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).
- 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.
- See the list of the ingredients in LEVAQUIN® at end of this Medication Guide.
- Talk to your health care provider about how to maintain healthy blood sugar levels while you are taking this medicine.
- You may need to check your blood sugar more often if you have changes to your diet, exercise regimen, or medicines for diabetes.
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Levofloxacin is a fluoroquinolone antibiotic used to treat various bacterial infections, including pneumonia and urinary tract infections (UTIs). Levofloxacin can cause low blood sugar, which can be serious and may lead to death. You may need to check your blood sugar more often if you have changes to your diet, exercise regimen, or medicines for diabetes.
Clinical Pharmacology
Tell your health care provider if you have any of these side effects that bother you. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some medicines can make levofloxacin much less effective when taken at the same time.
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 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.
- The medication can also pass into breast milk, so nursing mothers need to discuss alternatives with their doctor.
- Levofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).
- The microbiological eradication rates at the posttherapy visit were 66.7% for levofloxacin and 60.6% for comparator.
- Interpretation involves correlation of the diameter obtained in the disk test with the MIC for levofloxacin.
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.
A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
In pediatric patients, the safety of levofloxacin for treatment durations of more than 14 days has not been studied. An increased incidence of musculoskeletal adverse events (arthralgia, arthritis, tendonopathy, gait abnormality) compared to controls has been observed in clinical studies with treatment duration of up to 14 days. Long-term safety data, including effects on cartilage, following the administration of levofloxacin to pediatric patients is limited see Warnings and Precautions (5.9), Use in Specific Populations (8.4). Convulsions and toxic psychoses have been reported in patients receiving fluoroquinolones, including LEVAQUIN®.
Adverse Effects
Pregnant women should generally avoid levofloxacin unless the benefits clearly outweigh the risks, as it may affect the developing baby’s bones and joints. The medication can also pass into breast milk, so nursing mothers need to discuss alternatives with their doctor. If you have concerns about the safety of Levofloxacin or would like to learn more about alternative treatments, our telemedicine providers are here to assist you. Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue levofloxacin and consult a physician.
Usual Adult Dose for Nongonococcal Urethritis
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.
Clinical monitoring
The median time to resolution was 7 days for levofloxacin-treated children and 9 for non-fluoroquinolone-treated children (approximately 80% resolved within 2 months in both groups). No child had a severe or serious disorder and all musculoskeletal disorders resolved without sequelae. Children treated with levofloxacin had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in Table 9. Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine see Dosage and Administration (2.5).
When should I seek medical advice while taking Levofloxacin?
In clinical trials using multiple-dose levofloxacin oral route proper use 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.
Dosage Forms
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.
