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Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 29.03.2022
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zenotas OZ tablets and other antibacterial drugs, Zenotas OZ tablets 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.
Zenotas OZ tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae.
Because fluoroquinolones, including Zenotas OZ, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Zenotas OZ for treatment of ABECB in patients who have no alternative treatment options.
Community-Acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.
Uncomplicated Skin and Skin Structure Infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.
Acute, Uncomplicated Urethral and Cervical Gonorrhea due to Neisseria gonorrhoeae.
Nongonococcal Urethritis and Cervicitis due to Chlamydia trachomatis.
Mixed Infections of the Urethra and Cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae.
Acute Pelvic Inflammatory Disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae.
NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.
Uncomplicated Cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
Because fluoroquinolones, including Zenotas OZ, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Zenotas OZ for treatment of uncomplicated cystitis in patients who have no alternative treatment options.
Complicated Urinary Tract Infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus,* or Pseudomonas aeruginosa.*
Prostatitis due to Escherichia coli.
* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
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 Zenotas OZ, USP. Therapy with Zenotas OZ, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Zenotas OZ, USP. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
Zenotas OZ is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Zenotas OZ may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Zenotas OZ belongs to the class of drugs known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, Zenotas OZ will not work for colds, flu, or other virus infections.
Zenotas OZ is available only with your doctor's prescription.
Adults: Given orally in a usual daily dose of 300-600 mg of Zenotas OZ (3-6 tabs) divided into 2-3 doses. If used for leprosy, it is recommended to give a total of 400-600 of Zenotas OZ per day divided into 2-3 doses. In general, the dosage should be adjusted according to the causative organism and the severity of the symptoms. For leprosy, Zenotas OZ should as a rule be co-administered with other antileprosy drugs.
Urinary Tract Infections: 1 x 100 mg up to 2 x 100 mg (or 1 x 200 mg).
Kidney and Reproductive Organ Infections: 2 x 100 mg up to 2 x 200 mg.
Respiratory Tract and Ear, Nose and Throat: 2 x 200 mg.
Skin and Soft Tissue Infections: 2 x 200 mg.
Bones and Joint Infections: 2 x 200 mg.
Abdominal Infections: 2 x 200 mg.
Septicaemia: 2 x 200 mg.
It is important that the individual doses be given at approximately equal intervals.
Depending on the severity of the infection and on the presence of complicating factors or pathogens of moderate susceptibility, it may be necessary to increase the dose to up 2 x 400 mg daily.
Patients with Impaired Renal Function: The initial dose is the same as for patients with normal renal function, whereas the maintenance dose should be reduced as follows: Creatinine clearance: 50-20 mL/min: 100-200 mg every 24 hrs; <20 mL/min: 100 mg every 24 hrs; haemodialysis or
Peritoneal dialysis:
100 mg every 24 hrs. In individual instances, it may be necessary to increase the dosage.Patients with Impaired Liver Function: The excretion of Zenotas OZ may be reduced in patients with severe impairment of liver function (eg, cirrhosis with ascites). A maximum daily dose of 400 mg of Zenotas OZ should therefore not be exceeded.
Duration of Treatment: The duration of treatment depends on the response of the causative organism and on the clinical picture. In most cases of acute infection, a course of treatment lasting 7-10 days is sufficient. In salmonelloses, the duration of treatment is usually 7-8 days, in shigelloses 3-5 days and in intestinal infections caused by E. coli 3 days.
For uncomplicated infections of the lower urinary tract, 3-day treatment is usually sufficient.
In case of infections with β-haemolytic streptococci (eg, purulent tonsillitis or erysipelas), treatment must be continued for at least 10 days in order to prevent late complications eg, rheumatic fever or inflammation of the renal glomeruli (glomerulonephritis). However, since β-haemolytic streptococci are of varying susceptibility to Zenotas OZ, treatment of such infections requires individual proof of susceptibility.
Until further experience is available, the duration of treatment should not exceed 2 months.
See also:
What is the most important information I should know about Zenotas OZ?
Hypersensitivity to 4-quinolone antibacterials, Zenotas OZ or to any of the excipients of Zenotas OZ.
Patients with past history of tendonitis and epilepsy or with a lowered seizure threshold; since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.
Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Use in pregnancy & lactation: The safety of Zenotas OZ for use in human pregnancy has not been established. Reproduction studies performed in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and postnatal development. However, as with other quinolones, Zenotas OZ has been shown to cause arthropathy in immature animals and therefore, its use during pregnancy is not recommended. Studies in rats have indicated that Zenotas OZ is secreted in milk. It should therefore not be used during lactation.
Use in children: Zenotas OZ is not indicated for use in children or growing adolescents.
Use Zenotas OZ solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zenotas OZ solution is only for the ear. Do not get it in your eyes, nose, or mouth.
- Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for 5 minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
- To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
- If you are using Zenotas OZ solution for a middle ear infection, pump the flap over the ear 4 times after instilling the medicine in order to help it reach the middle ear.
- Zenotas OZ solution works best if used at the same time each day.
- To clear up your infection completely, use Zenotas OZ solution for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Zenotas OZ solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Zenotas OZ solution.
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 acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections (uncomplicated), urethral and cervical gonorrhea (acute, uncomplicated), urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection, mixed infections of the urethra and cervix, pelvic inflammatory disease (acute), cystitis (uncomplicated), urinary tract infections (complicated), prostatitis
Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.
Off Label Uses
Epididymitis
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, Zenotas OZ is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Zenotas OZ in combination with ceftriaxone for acute epididymitis likely caused by sexually transmitted chlamydia and gonorrhea and enteric organisms in men who practice insertive anal sex.
Leprosy (multibacillary)
Data from a limited number of patients in an open-label, parallel assessment study suggest that Zenotas OZ, in combination with rifampin and minocycline (ROM), may be beneficial for the treatment of multibacillary leprosy. Additional trials may be necessary to further define the role of multiple and single dose Zenotas OZ regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Zenotas OZ for the treatment of paucibacillary leprosy.
Spontaneous bacterial peritonitis (treatment)
According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Zenotas OZ may be considered as an alternative therapy to IV third-generation cephalosporins in patients with uncomplicated SBP who are not infected with a suspected quinolone-resistant organism. If fluoroquinolone-resistant, gram-negative bacteria are suspected as the causative organisms, when fluoroquinolones have been used for prophylaxis, or when patients are located in areas where incidence of quinolone-resistant bacterial infections are high, cefotaxime is the treatment of choice.
Traveler's diarrhea
Based on the Infectious Diseases Society of America Guidelines for the Practice of Travel Medicine and the American College of Gastroenterology (ACG) Guideline for the Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults, Zenotas OZ is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.
See also:
What other drugs will affect Zenotas OZ?
Drugs Known to Prolong QT Interval: Zenotas OZ, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (eg, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Prolongation of bleeding time has been reported during concomitant administration of Zenotas OZ and anticoagulants.
There may be a further lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs which lower the seizure threshold eg, theophylline. However, Zenotas OZ is not thought to cause a pharmacokinetic interaction with theophylline, unlike some other fluoroquinolones.
Further lowering of the cerebral seizure threshold may also occur with certain nonsteroidal anti-inflammatory drugs.
In case of convulsive seizures, treatment with Zenotas OZ should be discontinued.
Zenotas OZ may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.
Vitamin K Antagonists: Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.
Cimetidine: Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in t½ and AUC of some quinolones. The potential for interaction between Zenotas OZ and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Zenotas OZ, may increasethe risk of CNS stimulation and convulsive seizures.
Probenecid: The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion. The effect of probenecid on the elimination of Zenotas OZ has not been reported.
Theophylline: Steady-state theophylline levels may increase when Zenotas OZ and theophylline are administered concurrently. As with other quinolones, concomitant administration of Zenotas OZ may prolong the t½ of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.
Theophylline levels should be closely monitored and theophylline dosage adjustments made, if appropriate, when Zenotas OZ is co-administered. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.
Warfarin: Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Therefore, if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives, the prothrombin time or other suitable coagulation test should be closely monitored.
Antidiabetic Agents (eg, Insulin, Glyburide/Glibenclamide): Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.
Cyclosporine: Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones. The potential for interaction between Zenotas OZ and cyclosporine has not been reported.
Drugs Metabolized by Cytochrome P450 (CYP450) Enzymes: Most quinolone antimicrobial drugs inhibit CYP450 enzyme activity. This may result in a prolonged t½ for some drugs that are also metabolized by this system (eg, cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones. The extent of this inhibition varies among different quinolones.
Interactions with Laboratory Tests: Some quinolones, including Zenotas OZ, 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.
See also:
What are the possible side effects of Zenotas OZ?
Subjects with Otitis Externa
In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Zenotas OZ otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.
An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both Zenotas OZ and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.
In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.
In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.
Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes
In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with Zenotas OZ otic solution:
Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.
Post-marketing Adverse Events
Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Zenotas OZ otic solution 0.3% is unknown.
Zenotas OZ Solution also contains benzalkonium chloride as inactive ingredient.
Zenotas OZ is (±)-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.
Zenotas OZ has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Zenotas OZ occurs as pale yellowish-white to light yellowish-white crystals or crystalline powder, is odorless and has a bitter taste. It is freely soluble in glacial acetic acid, sparingly soluble in chloroform, slightly soluble in water, methanol, ethanol and acetone and very slightly soluble in ethyl acetate. It is slowly colorized by light and has no specific rotation.
Partition Coefficient: Chloroform: 0.1 mol/L phosphate buffer (pH 7.4):4.95. N-Octanol: 0.1 mol/L phosphate buffer (pH 7):0.33.
pH: 6-7. Osmotic pressure ratio (to physiological saline) 1-1.2.
However, we will provide data for each active ingredient