Nevotek Uses

• Nevotek indications
• Uses of Nevotek in details
• Nevotek description
• Nevotek dosage
• Nevotek interactions
• Nevotek side effects
• Nevotek contraindications

What is Nevotek?

Nevotek 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. Nevotek is also used to treat and prevent plague (including pneumonic and septicemic plague).

Nevotek belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Nevotek will not work for colds, flu, or other virus infections.

Nevotek is to be given only by or under the direct supervision of your doctor.

Nevotek indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nevotek Tablets, USP and other antibacterial drugs, Nevotek 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.

Nevotek 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 Nevotek Tablets, USP. Therapy with Nevotek 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 Nevotek 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.

Nosocomial Pneumonia

Nevotek 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

Nevotek 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.

Community-Acquired Pneumonia: 5-day Treatment Regimen

Nevotek 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

Nevotek 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

Nevotek 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

Nevotek 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

Nevotek 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

Nevotek Tablets, USP is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis.

Complicated Urinary Tract Infections: 5-day Treatment Regimen

Nevotek Tablets, USP is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Complicated Urinary Tract Infections: 10-day Treatment Regimen

Nevotek 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

Nevotek Tablets, USP is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia.

Uncomplicated Urinary Tract Infections

Nevotek 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)

Nevotek 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 Nevotek Tablets, USP is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Nevotek has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Nevotek 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 Nevotek therapy should only be used when the benefit outweighs the risk.

Plague

Nevotek 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 Nevotek 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 Nevotek?

Use Nevotek tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nevotek tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Nevotek tablets refilled.
• Take Nevotek tablets by mouth with or without food.
• Drinking extra fluids while you are taking Nevotek tablets 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 Nevotek tablets. 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 Nevotek tablets 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 Nevotek tablets. Check with your doctor if you have questions.
• Nevotek tablets works best if it is taken at the same time each day.
• To clear up your infection completely, take Nevotek tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
• Do not miss any doses of Nevotek tablets. If you miss a dose of Nevotek tablets, 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 Nevotek tablets.

Uses of Nevotek in details

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 Nevotek 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

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax in adults, Nevotek 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), Nevotek, 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, Nevotek 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, Nevotek, in combination with clindamycin, is an effective and recommended treatment option for diabetic foot infections.

Epididymitis, acute

Based on the CDC sexually transmitted diseases treatment guidelines, Nevotek 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, Nevotek is an effective and recommended component of a multiple-drug regimen for the treatment of H. pylori infection.

Intra-abdominal infection, complicated, community-acquired

Based on the Surgical Infection Society (SIS) and IDSA guidelines for the diagnosis and management of complicated intra-abdominal infections, Nevotek, 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%.

Neutropenia (chemotherapy-induced), antibacterial prophylaxis

Data from 2 randomized, double-blind, placebo-controlled trials support the use of oral Nevotek for prophylaxis of bacterial infections in patients receiving myelosuppressive chemotherapy ).

Travelers' diarrhea

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, Nevotek is an effective and recommended treatment option for the management of travelers' diarrhea.

Tuberculosis

Based on the American Thoracic Society, CDC, and IDSA guidelines for the treatment of tuberculosis, Nevotek is an effective and recommended alternative agent for treatment of drug-resistant tuberculosis caused by sensitive organisms or when first-line agents are intolerable.

Nevotek description

Each tablet contains Levofloxacin 250 mg as active ingredient corresponding to Nevotek hemihydrate 256.23 mg.

Nevotek 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).

Nevotek is a synthetic broad-spectrum antibacterial agent for oral and IV administration. Chemically, Nevotek, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. Nevotek 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.

Nevotek 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 Nevotek is essentially constant (approximately 100 mg/mL). Nevotek 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. Nevotek 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.

Nevotek dosage

Dosage in Adult Patients with Normal Renal Function

The usual dose of Nevotek

Oral Solution 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 Nevotek 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 Nevotek 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 Nevotek 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

Nevotek

Oral Solution

Nevotek

Oral Solution 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.

Administration Instructions

Food and Nevotek

Oral Solution

It is recommended that Nevotek

Oral Solution be taken 1 hour before or 2 hours after eating.

Hydration for Patients Receiving Nevotek

Oral Solution

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

Nevotek interactions

See also:
What other drugs will affect Nevotek?

To avoid incomplete absorption of oral Nevotek, antacids containing magnesium hydroxide and/or aluminium hydroxide should not be used concomitantly. The administration of these drugs are recommended at least 2 hrs before or 2 hrs after Nevotek administration.

The studies showed that there are no significant interactions between Nevotek with theophylline, warfarin, cyclosporin, digoxin, probenecid and cimetidine. However, concomitant administration of other quinolones with the drugs previously mentioned may change the pharmacokinetic and pharmacodynamic properties significantly. Therefore, the drugs listed as follows must be considered if Nevotek is co-administered:

Theophylline: Theophylline levels should be closely monitored and appropriate dosage adjustments made.

Warfarin: Prothrombin time or other suitable anticoagulation test should be monitored.

Cyclosporin: No significant clinical changes, hence no dosage adjustment of cyclosporin or Nevotek is required.

Digoxin: No significant clinical changes, hence no dosage adjustment of digoxin or Nevotek is required.

The concomitant administration of NSAID with a quinolone, including Nevotek, may increase the risk of CNS stimulation and convulsive seizures.

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients receiving quinolones concomitantly with oral antidiabetic drugs. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered.

Nevotek side effects

See also:
What are the possible side effects of Nevotek?

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

• Tendon Effects
• Exacerbation of Myasthenia Gravis
• Hypersensitivity Reactions
• Other Serious and Sometimes Fatal Reactions
• Hepatotoxicity
• 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
• Photosensitivity/Phototoxicity [see
• Development of Drug Resistant Bacteria

Hypotension has been associated with rapid or bolus intravenous infusion of Nevotek. Nevotek should be infused slowly over 60 to 90 minutes, depending on dosage.

Crystalluria and cylindruria have been reported with quinolones, including Nevotek. Therefore, adequate hydration of patients receiving Nevotek 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 Nevotek 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 Nevotek for a wide variety of infectious diseases. Patients received Nevotek 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 Nevotek doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Nevotek 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 Nevotek-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Nevotek-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 Nevotek. The relationship of the drugs to these events is not presently established.

Postmarketing Experience

Table 8 lists adverse reactions that have been identified during post-approval use of Nevotek. 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.

Nevotek contraindications

See also:
What is the most important information I should know about Nevotek?

Patients hypersensitive to Nevotek or any other quinolones or any excipients of Nevotek. Patients with epilepsy and those with history of tendon disorder related to fluoroquinolone administration.

Use in pregnancy: Nevotek 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, Nevotek 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, Nevotek 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 Nevotek, cause arthropathy and osteochondrosis in juvenile animals of several species.

Use in

Elderly: The pharmacokinetic properties of Nevotek in younger adults and elderly do not differ significantly when creatinine clearance is taken into consideration. However, since Nevotek is known to be substantially excreted by the kidney, the risk of toxic reactions to Nevotek 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.

Active ingredient matches for Nevotek:

Levofloxacin in Turkey.

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. PubChem. "LEVOFLOXACIN". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "LEVOFLOXACIN". http://www.drugbank.ca/drugs/DB01137 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology