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Dosage of Levofloxacin-Winthrope in details
Dosage in Adult Patients with Normal Renal Function
The usual dose of Levofloxacin-Winthrope 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.
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
* Due to Bacillus anthracis and Yersinia pestis
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ 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-Winthrope plasma concentrations achieved in humans are reasonably likely to predict clinical benefit
§ The safety of Levofloxacin-Winthrope in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients. Prolonged Levofloxacin-Winthrope therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Dosage Adjustment in Adults with Renal Impairment
Administer Levofloxacin-Winthrope 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-Winthrope 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-Winthrope due to decreased clearance.
Table 3 shows how to adjust dose based on creatinine clearance.
Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin-Winthrope injection should not be coadministered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line.
Caution: Rapid or bolus intravenous infusion of Levofloxacin-Winthrope injection has been associated with hypotension and must be avoided. Levofloxacin-Winthrope injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin-Winthrope injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacin-Winthrope Injection
Adequate hydration of patients receiving intravenous Levofloxacin-Winthrope injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.
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-Winthrope injection with other intravenous substances, additives or other medications should not be added to Levofloxacin-Winthrope injection in single-use vials, 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-Winthrope injection with an infusion solution compatible with Levofloxacin-Winthrope injection and with any other drug(s) administered via this common line.
Levofloxacin-Winthrope Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacin-Winthrope injection is supplied in single-use vials containing a concentrated Levofloxacin-Winthrope solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Levofloxacin-Winthrope in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of Levofloxacin-Winthrope/mL. These Levofloxacin-Winthrope injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL Levofloxacin-Winthrope solution with the approximate pH values:
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of Levofloxacin-Winthrope, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use.
Prepare the desired dosage of Levofloxacin-Winthrope according to Table 5:
Table 5: Preparation of Levofloxacin-Winthrope
For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Stability of Levofloxacin-Winthrope Injection Following Dilution: Levofloxacin-Winthrope injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.
What other drugs will affect Levofloxacin-Winthrope?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Levofloxacin-Winthrope, especially:
a diuretic or "water pill";
heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;
medicine to treat depression or mental illness--amitriptylline, clomipramine, desipramine, iloperidone, imipramine, nortriptyline, and others; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may interact with Levofloxacin-Winthrope, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Chelation Agents : Antacids, Sucralfate, Metal Cations, Multivitamins Levofloxacin-Winthrope
While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of Levofloxacin-Winthrope
Oral Solution with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of Levofloxacin-Winthrope, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of Levofloxacin-Winthrope, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral Levofloxacin-Winthrope administration.
No significant effect of Levofloxacin-Winthrope on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on Levofloxacin-Winthrope absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that Levofloxacin-Winthrope enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Levofloxacin-Winthrope use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Levofloxacin-Winthrope is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.
Non-Steroidal Anti-Inflammatory Drugs
The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including Levofloxacin-Winthrope, may increase the risk of CNS stimulation and convulsive seizures.
No significant effect of Levofloxacin-Winthrope on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on Levofloxacin-Winthrope 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-Winthrope is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.
No significant effect of Levofloxacin-Winthrope on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have been reported in the patient population when coadministered with some other fluoroquinolones. Levofloxacin-Winthrope Cmax and ke were slightly lower while Tmax and t½ were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication. The differences, however, are not considered to be clinically significant. Therefore, no dosage adjustment is required for Levofloxacin-Winthrope or cyclosporine when administered concomitantly.
No significant effect of Levofloxacin-Winthrope on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Levofloxacin-Winthrope absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Levofloxacin-Winthrope or digoxin is required when administered concomitantly.
Probenecid And Cimetidine
No significant effect of probenecid or cimetidine on the C of Levofloxacin-Winthrope was observed in a clinical study involving healthy volunteers. The AUC and t½ of Levofloxacin-Winthrope were higher while CL/F and CLR were lower during concomitant treatment of Levofloxacin-Winthrope with probenecid or cimetidine compared to Levofloxacin-Winthrope alone. However, these changes do not warrant dosage adjustment for Levofloxacin-Winthrope when probenecid or cimetidine is co-administered.
Interactions With Laboratory Or Diagnostic Testing
Some fluoroquinolones, including Levofloxacin-Winthrope, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.
- DailyMed. "LEVOFLOXACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "RIX4E89Y14: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Cytochrome P-450 CYP1A2 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology