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Levofloxacina Eurogenerici Dosage |
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The usual dose of Levofloxacina Eurogenerici 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)
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. Levofloxacina Eurogenerici plasma concentrations achieved in humans are reasonably likely to predict clinical benefit
§ The safety of Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici 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.
Administer Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici due to decreased clearance.
Table 3 shows how to adjust dose based on creatinine clearance.
Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici injection has been associated with hypotension and must be avoided. Levofloxacina Eurogenerici injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacina Eurogenerici injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacina Eurogenerici Injection
Adequate hydration of patients receiving intravenous Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici injection with other intravenous substances, additives or other medications should not be added to Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici injection with an infusion solution compatible with Levofloxacina Eurogenerici injection and with any other drug(s) administered via this common line.
Levofloxacina Eurogenerici Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacina Eurogenerici injection is supplied in single-use vials containing a concentrated Levofloxacina Eurogenerici solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Levofloxacina Eurogenerici in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of Levofloxacina Eurogenerici/mL. These Levofloxacina Eurogenerici 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.
Compatible
Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici, 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 Levofloxacina Eurogenerici according to Table 5:
Table 5: Preparation of Levofloxacina Eurogenerici
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 Levofloxacina Eurogenerici Injection Following Dilution: Levofloxacina Eurogenerici 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.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Levofloxacina Eurogenerici, especially:
a diuretic or "water pill";
theophylline;
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 Levofloxacina Eurogenerici, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Antacids, Sucralfate, Metal Cations and Multivitamins: Tablet: While the chelation by divalent cations is less marked than with other quinolones, concurrent administration of Levofloxacina Eurogenerici tablets with antacids containing magnesium or aluminum, as well as sucralfate, metal cations eg, iron and multivitamin preparations with zinc, may interfere with the gastrointestinal absorption of Levofloxacina Eurogenerici, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations eg, iron and multivitamins preparations with zinc or didanosine (Videx) chewable/buffered tablets or the pediatric powder for oral solution may substantially interfere with the gastrointestinal absorption of Levofloxacina Eurogenerici, resulting in systemic levels considerably lower than desired. These agents should be taken at least 2 hrs before or 2 hrs after Levofloxacina Eurogenerici administration.
Injection: There are no data concerning an interaction of IV quinolones with oral antacids, sucralfate, multivitamins, didanosine (Videx) or metal cations. However, no quinolone should be co-administered with any solution containing multivalent cations, eg magnesium, through the same IV line.
Theophylline: No significant effect of Levofloxacina Eurogenerici on the plasma concentrations, AUC and other disposition parameters for theophylline was detected in a clinical study involving 14 healthy volunteers. Similarly, no apparent effect of theophylline on Levofloxacina Eurogenerici absorption and disposition was observed. However, concomitant administration of other quinolones 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 Levofloxacina Eurogenerici is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.
Warfarin: No significant effect of Levofloxacina Eurogenerici 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 Levofloxacina Eurogenerici absorption and disposition was observed. There have been reports during the post-marketing experience in patients that Levofloxacina Eurogenerici enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Levofloxacina Eurogenerici use have been associated with episodes of bleeding. Prothrombin time, international normalized ratio (INR) or other suitable anticoagulation tests should be closely monitored if Levofloxacina Eurogenerici is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
Cyclosporine: No significant effect of Levofloxacina Eurogenerici 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 co-administered with some other quinolones. Levofloxacina Eurogenerici Cmax and ka 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 Levofloxacina Eurogenerici or cyclosporine when administered concomitantly.
Digoxin: No significant effect of Levofloxacina Eurogenerici on the peak plasma concentrations, AUC and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Levofloxacina Eurogenerici absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Levofloxacina Eurogenerici or digoxin is required when administered concomitantly.
Probenecid and Cimetidine: No significant effect of probenecid or cimetidine on the rate and extent of Levofloxacina Eurogenerici absorption was observed in a clinical study involving healthy volunteers. The AUC and t½ of Levofloxacina Eurogenerici were 27-38% and 30% higher, respectively, while CL/F and CLR were 21-35% lower during concomitant treatment with probenecid or cimetidine compared to Levofloxacina Eurogenerici alone. Although these differences were statistically significant, the changes were not high enough to warrant dosage adjustment for Levofloxacina Eurogenerici when probenecid or cimetidine is co-administered.
Nonsteroidal Anti-Inflammatory Drugs: The concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone, including Levofloxacina Eurogenerici, may increase the risk of CNS stimulation and convulsive seizures.
Antidiabetic Agents: Disturbances of blood glucose, including hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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