See also:
What is the most important information I should know about Qmax?
Hypersensitivity to 4-quinolone antibacterials, Qmax or to any of the excipients of Qmax.
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 Qmax 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, Qmax has been shown to cause arthropathy in immature animals and therefore, its use during pregnancy is not recommended. Studies in rats have indicated that Qmax is secreted in milk. It should therefore not be used during lactation.
Use in children: Qmax is not indicated for use in children or growing adolescents.
See also:
What are the possible side effects of Qmax?
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 Qmax 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 Qmax 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 Qmax 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 Qmax otic solution 0.3% is unknown.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Qmax tablets and other antibacterial drugs, Qmax 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.
Qmax 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 Qmax, have been associated with serious adverse reactions, and for some patients ABECB is self-limiting, reserve Qmax 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 Qmax, have been associated with serious adverse reactions, and for some patients uncomplicated cystitis is self-limiting, reserve Qmax 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 Qmax, USP. Therapy with Qmax, 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 Qmax, 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.
Qmax 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. Qmax may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Qmax belongs to the class of drugs known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, Qmax will not work for colds, flu, or other virus infections.
Qmax is available only with your doctor's prescription.
Qmax Solution also contains benzalkonium chloride as inactive ingredient.
Qmax 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.
Qmax has a molecular formula of C18H20FN3O4, molecular weight of 361.37 and melting point of 260°-270°C (decomposition). Qmax 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.
Use Qmax solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Qmax 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 IndicationsTreatment 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 UsesEpididymitis
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines and the Canadian Guidelines on Sexually Transmitted Infections, Qmax is an effective and recommended treatment option for acute epididymitis likely caused by enteric organisms (as monotherapy). The CDC guidelines also recommend Qmax 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 Qmax, 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 Qmax regimens in paucibacillary leprosy. The World Health Organization Expert Committee on Leprosy and the National Hansen's Disease Program currently do not recommend Qmax for the treatment of paucibacillary leprosy.
Spontaneous bacterial peritonitis (treatment)According to national and international guidelines regarding treatment of spontaneous bacterial peritonitis (SBP), Qmax 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 diarrheaBased 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, Qmax is an effective and recommended fluoroquinolone for antibiotic treatment of traveler's diarrhea.
Adults: Given orally in a usual daily dose of 300-600 mg of Qmax (3-6 tabs) divided into 2-3 doses. If used for leprosy, it is recommended to give a total of 400-600 of Qmax 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, Qmax 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 Qmax may be reduced in patients with severe impairment of liver function (eg, cirrhosis with ascites). A maximum daily dose of 400 mg of Qmax 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 Qmax, 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 other drugs will affect Qmax?
Drugs Known to Prolong QT Interval: Qmax, 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 Qmax 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, Qmax 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 Qmax should be discontinued.
Qmax 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 Qmax and cimetidine has not been reported.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): The concomitant administration of a NSAID with a quinolone, including Qmax, 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 Qmax has not been reported.
Theophylline: Steady-state theophylline levels may increase when Qmax and theophylline are administered concurrently. As with other quinolones, concomitant administration of Qmax 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 Qmax 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 Qmax 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 Qmax, 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.
