Lavasa Dosage

• Dosage of Lavasa in details
• Lavasa interactions
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Dosage of Lavasa in details

Dosage in Adult Patients with Normal Renal Function

The usual dose of Lavasa 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. Lavasa plasma concentrations achieved in humans are reasonably likely to predict clinical benefit

§ The safety of Lavasa 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 Lavasa 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 Lavasa 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 Lavasa 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 Lavasa 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

Lavasa injection should not be coadministered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line.

Administration Instructions

Caution: Rapid or bolus intravenous infusion of Lavasa injection has been associated with hypotension and must be avoided. Lavasa injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Lavasa injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Hydration for Patients Receiving Lavasa Injection

Adequate hydration of patients receiving intravenous Lavasa injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.

Preparation of

Intravenous Product

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 Lavasa injection with other intravenous substances, additives or other medications should not be added to Lavasa 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 Lavasa injection with an infusion solution compatible with Lavasa injection and with any other drug(s) administered via this common line.

Lavasa Injection in Single-Use Vials

Single-use vials require dilution prior to administration.

Lavasa injection is supplied in single-use vials containing a concentrated Lavasa solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Lavasa in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of Lavasa/mL. These Lavasa 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 Lavasa 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 Lavasa, 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 Lavasa according to Table 5:

Table 5: Preparation of Lavasa

Intravenous Solution

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 Lavasa Injection Following Dilution: Lavasa 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 Lavasa?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Lavasa, 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 Lavasa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Lavasa interactions

There are no data concerning an interaction of quinolones IV with oral antacids, sucralfate, multivitamins, didanosine 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 Lavasa 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 Lavasa 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 Lavasa is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.

Warfarin: No significant effect of Lavasa on the C_max, 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 Lavasa absorption and disposition was observed. There have been reports during the postmarketing experience in patients that Lavasa enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Lavasa use have been associated with episodes of bleeding. Prothrombin time, INR or other suitable anticoagulation tests should be closely monitored if Lavasa is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.

Cyclosporine: No significant effect of Lavasa on the C_max, 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. Lavasa C_max and k_e were slightly lower while T_max and t_½ 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 Lavasa or cyclosporine when administered concomitantly.

Digoxin: No significant effect of Lavasa on the C_max, AUC and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Lavasa absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Lavasa or digoxin is required when administered concomitantly.

Probenecid and Cimetidine: No significant effect of probenecid or cimetidine on the rate and extent of Lavasa absorption were observed in a clinical study involving healthy volunteers. The AUC and t_1/2 of Lavasa were 27-38% and 30% higher, respectively, while CL/F and CL_R were 21-35% lower during concomitant treatment with probenecid or cimetidine compared to Lavasa alone. Although these differences were statistically significant, the changes were not high enough to warrant dosage adjustment for Lavasa when probenecid or cimetidine is co-administered.

Nonsteroidal Anti-Inflammatory Drugs: The concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone, including Lavasa, 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.

References

1. 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).
2. 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).
3. 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