Prolevox injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after a person has been exposed to anthrax. Prolevox is also used to treat and prevent plague (including pneumonic and septicemic plague).
Prolevox belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Prolevox will not work for colds, flu, or other virus infections.
Prolevox is to be given only by or under the direct supervision of your doctor.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Prolevox Tablets, USP and other antibacterial drugs, Prolevox Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Prolevox Tablets, USP is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.
Culture and susceptibility testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Prolevox Tablets, USP. Therapy with Prolevox Tablets, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Prolevox Tablets, USP. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.
Prolevox Tablets, USP is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended.
Community-Acquired Pneumonia: 7–14 day Treatment Regimen
Prolevox Tablets, USP is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
Prolevox Tablets, USP is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae
Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens
Prolevox Tablets, USP is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute Bacterial Exacerbation of Chronic Bronchitis
Prolevox Tablets, USP is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Complicated Skin and Skin Structure Infections
Prolevox Tablets, USP is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis.
Uncomplicated Skin and Skin Structure Infections
Prolevox Tablets, USP is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.
Chronic Bacterial Prostatitis
Prolevox Tablets, USP is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis.
Prolevox Tablets, USP is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
Acute Pyelonephritis: 5 or 10-day Treatment Regimen
Prolevox Tablets, USP is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia.
Uncomplicated Urinary Tract Infections
Prolevox Tablets, USP is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Inhalational Anthrax (Post-Exposure)
Prolevox Tablets, USP is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of Prolevox Tablets, USP is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Prolevox has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Prolevox in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged Prolevox therapy should only be used when the benefit outweighs the risk.
Prolevox Tablets, USP is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of Prolevox could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an
efficacy study conducted in animals.
How should I use Prolevox?
Use Prolevox solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Prolevox solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Prolevox solution refilled.
Take Prolevox solution by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Drinking extra fluids while you are taking Prolevox solution is recommended. Check with your doctor for instructions.
Do not take a product that has magnesium, aluminum, calcium, zinc, or iron in it within 2 hours before or 2 hours after you take Prolevox solution. Examples of these products include certain antacids, multivitamins, quinapril, and calcium-fortified orange juice. Check with your doctor or pharmacist if you have a question about whether you should separate Prolevox solution from a certain food or product.
If you also take sucralfate or didanosine, do not take them within 2 hours before or 2 hours after taking Prolevox solution. Check with your doctor if you have questions.
Prolevox solution works best if it is taken at the same time each day.
To clear up your infection completely, take Prolevox solution for the full course of treatment. Keep taking it even if you feel better in a few days.
Do not miss any doses of Prolevox solution. If you miss a dose of Prolevox solution, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once or more than 1 dose in 1 day.
Ask your health care provider any questions you may have about how to use Prolevox solution.
Uses of Prolevox in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Treatment of community-acquired pneumonia, including multidrug-resistant strains of Streptococcus pneumoniae (MDRSP); nosocomial pneumonia; chronic obstructive pulmonary disease, acute exacerbation; rhinosinusitis, acute bacterial (ABRS); prostatitis (chronic bacterial); urinary tract infection (uncomplicated or complicated); acute pyelonephritis; skin or skin structure infections (uncomplicated or complicated); inhalational anthrax (postexposure) to reduce incidence or disease progression; prophylaxis and treatment of plague (pneumonic and septicemic) due to Yersinia pestis
Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve Prolevox for use in patients who have no alternative treatment options for acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and uncomplicated urinary tract infections.
Off Label Uses
Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax in adults, Prolevox is an effective and recommended agent for treatment of cutaneous anthrax and a recommended alternative agent for systemic anthrax.
Bite wound infection, prophylaxis or treatment (animal or human bite)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Prolevox, in combination with metronidazole or clindamycin, is an effective and recommended alternative option for treatment of bite wounds, particularly in patients with a human bite wound who are hypersensitive to beta-lactams.
Cervicitis or urethritis due to Chlamydia trachomatis infection
Based on the CDC sexually transmitted diseases treatment guidelines, Prolevox is an effective and recommended alternative agent in the treatment of cervicitis or urethritis due to C. trachomatis infection.
Diabetic foot infection
Based on the IDSA guideline for diagnosis and treatment of diabetic foot infections, Prolevox, in combination with clindamycin, is an effective and recommended treatment option for diabetic foot infections.
Based on the CDC sexually transmitted diseases treatment guidelines, Prolevox is an effective and recommended agent in the treatment acute epididymitis most likely caused by sexually transmitted chlamydia, gonorrhea, and enteric organisms in men who practice insertive anal sex (in combination with ceftriaxone) or for acute epididymitis most likely caused by enteric organisms (as monotherapy).
Helicobacter pylori eradication
Based on the American College of Gastroenterology clinical guideline for the treatment of Helicobacter pylori infection, Prolevox is an effective and recommended component of a multiple-drug regimen for the treatment of H. pylori infection.
Based on the Surgical Infection Society (SIS) and IDSA guidelines for the diagnosis and management of complicated intra-abdominal infections, Prolevox, in combination with metronidazole, is an effective and recommended treatment option for empiric therapy of complicated community-acquired intra-abdominal infections when resistance rates are less than 10% to 20%.
Data from 2 randomized, double-blind, placebo-controlled trials support the use of oral Prolevox for prophylaxis of bacterial infections in patients receiving myelosuppressive chemotherapy ).
Based on the CDC Yellow Book, the IDSA practice guidelines for the diagnosis and management of infectious diarrhea, and the American College of Gastroenterology guideline for the diagnosis, treatment, and prevention of acute diarrheal infections in adults, Prolevox is an effective and recommended treatment option for the management of travelers' diarrhea.
Based on the American Thoracic Society, CDC, and IDSA guidelines for the treatment of tuberculosis, Prolevox is an effective and recommended alternative agent for treatment of drug-resistant tuberculosis caused by sensitive organisms or when first-line agents are intolerable.
Each tablet contains Levofloxacin 250 mg as active ingredient corresponding to Prolevox hemihydrate 256.23 mg.
Prolevox also contains the following inactive ingredients: Sodium chloride; sodium hydroxide; hydrochloric acid (qs: pH 4.8) and water for injection for a volume of 100 mL (Na+ concentration: 154 mmol/L).
Prolevox is a synthetic broad-spectrum antibacterial agent for oral and IV administration. Chemically, Prolevox, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. Prolevox is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate.
Its empirical formula is C18H20FN3O4·½H2O and its molecular weight is 370.38.
Prolevox is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6-5.8, the solubility of Prolevox is essentially constant (approximately 100 mg/mL). Prolevox is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Prolevox has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: A1+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2.
Dosage in Adult Patients with Normal Renal Function
The usual dose of Prolevox Tablets, USP is 250 mg, 500 mg, or 750 mg administered orally 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.
Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Dosage Adjustment in Adults with Renal Impairment
Administer Prolevox Tablets, USP 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 Prolevox 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 Prolevox 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
Prolevox Tablets, USP should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution.
Food and Prolevox Tablets, USP
Prolevox Tablets, USP can be administered without regard to food.
Hydration for Patients Receiving Prolevox Tablets, USP
Adequate hydration of patients receiving oral Prolevox Tablets, USP should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.
Chelation Agents : Antacids, Sucralfate, Metal Cations, Multivitamins Prolevox
While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of Prolevox
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 Prolevox, 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 Prolevox, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral Prolevox administration.
No significant effect of Prolevox 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 Prolevox absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that Prolevox enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Prolevox use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Prolevox 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 Prolevox, may increase the risk of CNS stimulation and convulsive seizures.
No significant effect of Prolevox 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 Prolevox 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 Prolevox is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.
No significant effect of Prolevox 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. Prolevox 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 Prolevox or cyclosporine when administered concomitantly.
No significant effect of Prolevox on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Prolevox absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Prolevox or digoxin is required when administered concomitantly.
Probenecid And Cimetidine
No significant effect of probenecid or cimetidine on the C of Prolevox was observed in a clinical study involving healthy volunteers. The AUC and t½ of Prolevox were higher while CL/F and CLR were lower during concomitant treatment of Prolevox with probenecid or cimetidine compared to Prolevox alone. However, these changes do not warrant dosage adjustment for Prolevox when probenecid or cimetidine is co-administered.
Interactions With Laboratory Or Diagnostic Testing
Some fluoroquinolones, including Prolevox, 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.
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
Exacerbation of Myasthenia Gravis
Other Serious and Sometimes Fatal Reactions
Central Nervous System Effects
Clostridium difficile-Associated Diarrhea
Peripheral Neuropathy that may be irreversible
Prolongation of the QT Interval
Musculoskeletal Disorders in Pediatric Patients
Blood Glucose Disturbances
Development of Drug Resistant Bacteria
Hypotension has been associated with rapid or bolus intravenous infusion of Prolevox. Prolevox should be infused slowly over 60 to 90 minutes, depending on dosage.
Crystalluria and cylindruria have been reported with quinolones, including Prolevox. Therefore, adequate hydration of patients receiving Prolevox should be maintained to prevent the formation of a highly concentrated urine.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Prolevox in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Prolevox for a wide variety of infectious diseases. Patients received Prolevox doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.
The overall incidence, type and distribution of adverse reactions was similar in patients receiving Prolevox doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Prolevox due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).
Adverse reactions occurring in ≥1% of Prolevox-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Prolevox-treated patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including Prolevox. The relationship of the drugs to these events is not presently established.
Table 8 lists adverse reactions that have been identified during post-approval use of Prolevox. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Patients hypersensitive to Prolevox or any other quinolones or any excipients of Prolevox. Patients with epilepsy and those with history of tendon disorder related to fluoroquinolone administration.
Use in pregnancy: Prolevox caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day. It was not teratogenic in rats at oral doses as high as 810 mg/kg/day or at IV dose up to 160 mg/kg/day. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day.
In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Prolevox must not be used in pregnant women or women suspected of being pregnant.
Use in lactation: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, Prolevox must not be used in breastfeeding women.
Use in children: Safety and effectiveness in pediatric patients and adolescents <16 years have not been established. Quinolones, including Prolevox, cause arthropathy and osteochondrosis in juvenile animals of several species.
Elderly: The pharmacokinetic properties of Prolevox in younger adults and elderly do not differ significantly when creatinine clearance is taken into consideration. However, since Prolevox is known to be substantially excreted by the kidney, the risk of toxic reactions to Prolevox may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
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).
The results of a survey conducted on ndrugs.com for Prolevox 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 Prolevox. 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