Oroflox L Dosage

• Dosage of Oroflox L in details
• Oroflox L interactions
• Oroflox L reviews

Dosage of Oroflox L in details

Dosage in Adult Patients with Normal Renal Function

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

§ The safety of Oroflox L 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 Oroflox L 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 Oroflox L 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 Oroflox L 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 Oroflox L 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

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

Hydration for Patients Receiving Oroflox L Injection

Adequate hydration of patients receiving intravenous Oroflox L 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 Oroflox L injection with other intravenous substances, additives or other medications should not be added to Oroflox L 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 Oroflox L injection with an infusion solution compatible with Oroflox L injection and with any other drug(s) administered via this common line.

Oroflox L Injection in Single-Use Vials

Single-use vials require dilution prior to administration.

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

Table 5: Preparation of Oroflox L

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 Oroflox L Injection Following Dilution: Oroflox L 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 Oroflox L?

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

Oroflox L 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 Oroflox L 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 Oroflox L 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 Oroflox L is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.

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

Cyclosporine: No significant effect of Oroflox L 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. Oroflox L 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 Oroflox L or cyclosporine when administered concomitantly.

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

Probenecid and Cimetidine: No significant effect of probenecid or cimetidine on the rate and extent of Oroflox L absorption were observed in a clinical study involving healthy volunteers. The AUC and t_1/2 of Oroflox L 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 Oroflox L alone. Although these differences were statistically significant, the changes were not high enough to warrant dosage adjustment for Oroflox L when probenecid or cimetidine is co-administered.

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

Reviews

The results of a survey conducted on ndrugs.com for Oroflox L 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 Oroflox L. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology