How do you administer this medicine?
Dosage of Floxabact in details
The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
Dosage in Adult Patients with Normal Renal Function
The usual dose of Floxabact 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. Floxabact plasma concentrations achieved in humans are reasonably likely to predict clinical benefit
§ The safety of Floxabact 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 Floxabact 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 Floxabact 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 Floxabact 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 Floxabact 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
Floxabact 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 Floxabact injection has been associated with hypotension and must be avoided. Floxabact injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Floxabact injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Floxabact Injection
Adequate hydration of patients receiving intravenous Floxabact 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 Floxabact injection with other intravenous substances, additives or other medications should not be added to Floxabact 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 Floxabact injection with an infusion solution compatible with Floxabact injection and with any other drug(s) administered via this common line.
Floxabact Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Floxabact injection is supplied in single-use vials containing a concentrated Floxabact solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Floxabact in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of Floxabact/mL. These Floxabact 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 Floxabact 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 Floxabact, 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 Floxabact according to Table 5:
Table 5: Preparation of Floxabact
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 Floxabact Injection Following Dilution: Floxabact 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 Floxabact?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Floxabact, especially:
This list is not complete. Other drugs may interact with Floxabact, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Floxabact, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
Chelation Agents : Antacids, Sucralfate, Metal Cations, Multivitamins Floxabact
While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of Floxabact
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 Floxabact, 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 Floxabact, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral Floxabact administration.
No significant effect of Floxabact 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 Floxabact absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that Floxabact enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Floxabact use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Floxabact 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 Floxabact, may increase the risk of CNS stimulation and convulsive seizures.
No significant effect of Floxabact 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 Floxabact 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 Floxabact is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.
No significant effect of Floxabact 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. Floxabact 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 Floxabact or cyclosporine when administered concomitantly.
No significant effect of Floxabact on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Floxabact absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Floxabact or digoxin is required when administered concomitantly.
Probenecid And Cimetidine
No significant effect of probenecid or cimetidine on the C of Floxabact was observed in a clinical study involving healthy volunteers. The AUC and t½ of Floxabact were higher while CL/F and CLR were lower during concomitant treatment of Floxabact with probenecid or cimetidine compared to Floxabact alone. However, these changes do not warrant dosage adjustment for Floxabact when probenecid or cimetidine is co-administered.
Interactions With Laboratory Or Diagnostic Testing
Some fluoroquinolones, including Floxabact, 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.
ReviewsThe results of a survey conducted on ndrugs.com for Floxabact are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Floxabact. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
2 consumers reported frequency of useHow frequently do I need to take Floxabact?
It was reported by ndrugs.com website users that Floxabact should ideally be taken Once in a day as the most common frequency of the Floxabact. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Floxabact should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
2 consumers reported dosesWhat doses of Floxabact drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Floxabact drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Information checked by Dr. Sachin Kumar, MD Pharmacology