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DRUGS & SUPPLEMENTS
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Qumax
How old is patient? |
Qumax uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Clinical studies—uncomplicated cystitis
- Animal pharmacology
- References
INDICATIONS AND USAGE
Treatment
Qumax film-coated tablets are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: (See Dosage and Administration for specific dosing recommendations.)
LOWER RESPIRATORY TRACT
Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae or Moraxella catarrhalis.
NOTE: Qumax IS NOT INDICATED FOR THE EMPIRIC TREATMENT OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS WHEN IT IS PROBABLE THAT S PNEUMONIAE IS A CAUSATIVE PATHOGEN. S PNEUMONIAE EXHIBITS IN VITRO RESISTANCE TO Qumax, AND THE SAFETY AND EFFICACY OF Qumax IN THE TREATMENT OF PATIENTS WITH ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS CAUSED BY S PNEUMONIAE HAVE NOT BEEN DEMONSTRATED. IF Qumax IS TO BE PRESCRIBED FOR GRAM–STAIN–GUIDED EMPIRIC THERAPY OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS, IT SHOULD BE USED ONLY IF SPUTUM GRAM STAIN DEMONSTRATES AN ADEQUATE QUALITY OF SPECIMEN (> 25 PMNs/LPF) AND THERE IS BOTH A PREDOMINANCE OF GRAM-NEGATIVE MICROORGANISMS AND NOT A PREDOMINANCE OF GRAM-POSITIVE MICROORGANISMS.
URINARY TRACT
Uncomplicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES—UNCOMPLICATED CYSTITIS.)
Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter diversus,
NOTE: In clinical trials with patients experiencing complicated urinary tract infections (UTIs) due to P aeruginosa, 12 of 16 patients had the microorganism eradicated from the urine after therapy with Qumax. None of the patients had concomitant bacteremia. Serum levels of Qumax do not reliably exceed the MIC of Pseudomonas isolates. THE SAFETY AND EFFICACY OF Qumax IN TREATING PATIENTS WITH PSEUDOMONAS BACTEREMIA HAVE NOT BEEN ESTABLISHED.Appropriate culture and susceptibility tests should be performed before antimicrobial treatment in order to isolate and identify microorganisms causing infection and to determine their susceptibility to Qumax. In patients with UTIs, therapy with Qumax film-coated tablets may be initiated before results of these tests are known; once these results become available, appropriate therapy should be continued. In patients with an acute bacterial exacerbation of chronic bronchitis, therapy should not be started empirically with Qumax when there is a probability the causative pathogen is S pneumoniae.Beta-lactamase production should have no effect on Qumax activity.
Prevention / prophylaxis
Qumax is indicated preoperatively for the prevention of infection in the following situations:
- Transrectal prostate biopsy: to reduce the incidence of urinary tract infection, in the early and late postoperative periods (3–5 days and 3–4 weeks postsurgery).
- Transurethral surgical procedures: to reduce the incidence of urinary tract infection in the early postoperative period (3–5 days postsurgery).
CONTRAINDICATIONS
Qumax (lomefloxacin HCl) is contraindicated in persons with a history of hypersensitivity to Qumax or any member of the quinolone group of antimicrobial agents.
WARNINGS
MODERATE TO SEVERE PHOTOTOXIC REACTIONS HAVE OCCURRED IN PATIENTS EXPOSED TO DIRECT OR INDIRECT SUNLIGHT OR TO ARTIFICIAL ULTRAVIOLET LIGHT DURING OR FOLLOWING TREATMENT WITH Qumax. THESE REACTIONS HAVE ALSO OCCURRED IN PATIENTS EXPOSED TO SHADED OR DIFFUSE LIGHT, INCLUDING EXPOSURE THROUGH GLASS. PATIENTS SHOULD BE ADVISED TO DISCONTINUE Qumax THERAPY AT THE FIRST SIGNS OR SYMPTOMS OF A PHOTOTOXICITY REACTION SUCH AS A SENSATION OF SKIN BURNING, REDNESS, SWELLING, BLISTERS, RASH, ITCHING, OR DERMATITIS.
These phototoxic reactions have occurred with and without the use of sunscreens or sunblocks. Single doses of Qumax have been associated with these types of reactions. In a few cases, recovery was prolonged for several weeks. As with some other types of phototoxicity, there is the potential for exacerbation of the reaction on re-exposure to sunlight or artificial ultraviolet light prior to complete recovery from the reaction. In rare cases, reactions have recurred up to several weeks after stopping Qumax therapy.EXPOSURE TO DIRECT OR INDIRECT SUNLIGHT (EVEN WHEN USING SUNSCREENS OR SUNBLOCKS) SHOULD BE AVOIDED WHILE TAKING Qumax AND FOR SEVERAL DAYS FOLLOWING THERAPY. Qumax THERAPY SHOULD BE DISCONTINUED IMMEDIATELY AT THE FIRST SIGNS OR SYMPTOMS OF PHOTOTOXICITY. RISK OF PHOTOTOXICITY MAY BE REDUCED BY TAKING Qumax IN THE EVENING THE SAFETY AND EFFICACY OF Qumax IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS—Pediatric Use, Pregnancy and
QT interval prolongation/torsades de pointes
Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones, including Qumax. These rare cases were associated with one or more of the following factors: age over 60, female gender, underlying cardiac disease, and/or use of multiple medications. Qumax should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.
Peripheral neuropathy
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including Qumax. Qumax should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.
Tendon effects
Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including Qumax. Postmarketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Qumax should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including Qumax.
PRECAUTIONS
General
Alteration of the dosage regimen is recommended for patients with impairment of renal function. (See Dosage and Administration.)
Prescribing Qumax in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Information for patients
Patients should be advised
- to avoid to the maximum extent possible direct or indirect sunlight (including exposure through glass and exposure through sunscreens and sunblocks) and artificial ultraviolet light (eg sunlamps) during treatment with Qumax and for several days after therapy;
- that they may reduce the risk of developing phototoxicity from sunlight by taking the daily dose of Qumax at least 12 hours before exposure to the sun (eg in the evening);
- to discontinue Qumax therapy at the first signs or symptoms of phototoxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching, or dermatitis;
- that a patient who has experienced a phototoxic reaction should avoid re-exposure to sunlight and artificial ultraviolet light until he has completely recovered from the reaction. In rare cases, reactions have recurred up to several weeks after stopping Qumax therapy.
- to drink fluids liberally;
- that Qumax can be taken without regard to meals;
- that mineral supplements or vitamins with iron or minerals should not be taken within the 2-hour period before or after taking Qumax (see Drug Interactions);
- that sucralfate and antacids containing magnesium or aluminum, or Videx® (didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 4 hours before or 2 hours after taking Qumax. (See PRECAUTIONS — Drug Interactions.)
- that Qumax can cause dizziness and lightheadedness and, therefore, patients should know how they react to Qumax before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination;
- to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded;
- that Qumax may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction;
- that convulsions have been reported in patients taking quinolones, including Qumax, and to notify their physician before taking this drug if there is a history of this condition.
- that antibacterial drugs including Qumax should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Qumax is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Qumax or other antibacterial drugs in the future.
Drug interactions
Theophylline
In three pharmacokinetic studies including 46 normal, healthy subjects, theophylline clearance and concentration were not significantly altered by the addition of Qumax. In clinical studies where patients were on chronic theophylline therapy, Qumax had no measurable effect on the mean distribution of theophylline concentrations or the mean estimates of theophylline clearance. Though individual theophylline levels fluctuated, there were no clinically significant symptoms of drug interaction.
Antacids and sucralfate
Sucralfate and antacids containing magnesium or aluminum, as well as formulations containing divalent and trivalent cations such as Videx®, chewable/buffered tablets or the pediatric powder for oral solution can form chelation complexes with Qumax and interfere with its bioavailability. Sucralfate administered 2 hours before Qumax resulted in a slower absorption (mean Cmax decreased by 30% and mean Tmax increased by 1 hour) and a lesser extent of absorption (mean AUC decreased by approximately 25%). Magnesium- and aluminum-containing antacids, administered concomitantly with Qumax, significantly decreased the bioavailability (48%) of Qumax. Separating the doses of antacid and Qumax minimizes this decrease in bioavailability; therefore, administration of these agents should precede Qumax dosing by 4 hours or follow Qumax dosing by at least 2 hours.
Caffeine
Two hundred mg of caffeine (equivalent to 1 to 3 cups of American coffee) was administered to 16 normal, healthy volunteers who had achieved steady-state blood concentrations of Qumax after being dosed at 400 mg qd. This did not result in any statistically or clinically relevant changes in the pharmacokinetic parameters of either caffeine or its major metabolite, paraxanthine. No data are available on potential interactions in individuals who consume greater than 200 mg of caffeine per day or in those, such as the geriatric population, who are generally believed to be more susceptible to the development of drug-induced CNS-related adverse effects. Other quinolones have demonstrated moderate to marked interference with the metabolism of caffeine, resulting in a reduced clearance, a prolongation of plasma half-life, and an increase in symptoms that accompany high levels of caffeine.
Cimetidine
Cimetidine has been demonstrated to interfere with the elimination of other quinolones. This interference has resulted in significant increases in half-life and AUC. The interaction between Qumax and cimetidine has not been studied.
Cyclosporine
Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with other members of the quinolone class. Interaction between Qumax and cyclosporine has not been studied.
Omeprazole
No clinically significant changes in Qumax pharmacokinetics were observed when a single dose of Qumax 400 mg was given after multiple doses of omeprazole (20 mg qd) in 13 healthy volunteers. Changes in omeprazole pharmacokinetics were not studied.
Phenytoin
No significant differences were observed in mean phenytoin AUC, Cmax, Cmin or Tmax (although Cmax increased by 11%) when extended phenytoin sodium capsules (100 mg tid) were coadministered with Qumax (400 mg qd) for five days in 15 healthy males. Qumax is unlikely to have a significant effect on phenytoin metabolism.
Probenecid
Probenecid slows the renal elimination of Qumax. An increase of 63% in the mean AUC and increases of 50% and 4%, respectively, in the mean Tmax and mean Cmax were noted in 1 study of 6 individuals.
Terfenadine
No clinically significant changes occurred in heart rate or corrected QT intervals, or in terfenadine metabolite or Qumax pharmacokinetics, during concurrent administration of Qumax and terfenadine at steady-state in 28 healthy males.
Warfarin
Quinolones may enhance the effects of the oral anticoagulant, warfarin, or its derivatives. When these products are administered concomitantly, prothrombin or other suitable coagulation tests should be monitored closely. However, no clinically or statistically significant differences in prothrombin time ratio or warfarin enantiomer pharmacokinetics were observed in a small study of 7 healthy males who received both warfarin and Qumax under steady-state conditions.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenesis
Hairless mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 52 weeks while concurrently being administered Qumax. The Qumax doses used in this study caused a phototoxic response. In mice treated with both UVA and Qumax concomitantly, the time to development of skin tumors was 16 weeks. In mice treated concomitantly in this model with both UVA and other quinolones, the times to development of skin tumors ranged from 28 to 52 weeks.
Ninety-two percent (92%) of the mice treated concomitantly with both UVA and Qumax developed well-differentiated squamous cell carcinomas of the skin. These squamous cell carcinomas were nonmetastatic and were endophytic in character. Two-thirds of these squamous cell carcinomas contained large central keratinous inclusion masses and were thought to arise from the vestigial hair follicles in these hairless animals. In this model, mice treated with Qumax alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired miceThe clinical significance of these findings to humans is unknown.
Mutagenesis
One in vitro mutagenicity test (CHO/HGPRT assay) was weakly positive at Qumax concentrations ≥ 226 µg/mL and negative at concentrations < 226 µg/mL. Two other in vitro mutagenicity tests (chromosomal aberrations in Chinese hamster ovary cells, chromosomal aberrations in human lymphocytes) and two in vivo mouse micronucleus mutagenicity tests were all negative.
Impairment of fertility
Qumax did not affect the fertility of male and female rats at oral doses up to 8 times the recommended human dose based on mg/m2.
Pregnancy
Teratogenic effects. Pregnancy Category C
Reproductive function studies have been performed in rats at doses up to 8 times the recommended human dose based on mg/m2, and no impaired fertility or harm to the fetus was reported due to Qumax. Increased incidence of fetal loss in monkeys has been observed at approximately 3 to 6 times the recommended human dose based on mg/m2 (6 to 12 times the recommended human dose based on mg/kg). No teratogenicity has been observed in rats and monkeys at up to 16 times the recommended human dose exposure. In the rabbit, maternal toxicity and associated fetotoxicity, decreased placental weight, and variations of the coccygeal vertebrae occurred at doses 2 times the recommended human exposure based on mg/m2. There are, however, no adequate and well-controlled studies in pregnant women. Qumax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers
It is not known whether Qumax is excreted in human milk. However, it is known that other drugs of this class are excreted in human milk and that Qumax is excreted in the milk of lactating rats. Because of the potential for serious adverse reactions from Qumax in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric use
The safety and effectiveness of Qumax in pediatric patients and adolescents less than 18 years of age have not been established. Qumax causes arthropathy in juvenile animals of several species.
Geriatric use
Of the total number of subjects in clinical studies of Qumax, 25% were ≥ 65 years and 9% were ≥ 75 years. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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. (See Clinical Pharmacology — Pharmacokinetics in the geriatric population.)
ADVERSE REACTIONS
In clinical trials, most of the adverse events reported were mild to moderate in severity and transient in nature. During these clinical investigations, 5,623 patients received Qumax. In 2.2% of the patients, Qumax was discontinued because of adverse events, primarily involving the gastrointestinal system, skin (0.7%), or CNS (0.5%).
Adverse clinical events
The events with the highest incidence (≥ 1%) in patients, regardless of relationship to drug, were headache (3.6%), nausea (3.5%), photosensitivity (2.3%) [see Warnings], dizziness (2.1%), diarrhea (1.4%), and abdominal pain (1.2%).
Additional clinical events reported in < 1% of patients treated with Qumax, regardless of relationship to drug, are listed below:Autonomic: increased sweating, dry mouth, flushing, syncope.Body as a whole: fatigue, back pain, malaise, asthenia, chest pain, face edema, hot flashes, influenza-like symptoms, edema, chills, allergic reaction, anaphylactoid reaction, decreased heat tolerance.Cardiovascular: tachycardia, hypertension, hypotension, myocardial infarction, angina pectoris, cardiac failure, bradycardia, arrhythmia, phlebitis, pulmonary embolism, extrasystoles, cerebrovascular disorder, cyanosis, cardiomyopathy.Central and peripheral nervous system: tremor, vertigo, paresthesias, twitching, hypertonia, convulsions, hyperkinesia, coma.Gastrointestinal: dyspepsia, vomiting, flatulence, constipation, gastrointestinal bleeding, dysphagia, stomatitis, tongue discoloration, gastrointestinal inflammation.Hearing: earache, tinnitus.Hematologic: purpura, lymphadenopathy, thrombocythemia, anemia, thrombocytopenia, increased fibrinolysis. Hepatic: abnormal liver function.Metabolic: thirst, hyperglycemia, hypoglycemia, gout. Musculoskeletal: arthralgia, myalgia, leg cramps. Ophthalmologic: abnormal vision, conjunctivitis, photophobia, eye pain, abnormal lacrimation.Psychiatric: insomnia, nervousness, somnolence, anorexia, depression, confusion, agitation, increased appetite, depersonalization, paranoid reaction, anxiety, paroniria, abnormal thinking, concentration impairment. Reproductive system: Female: vaginal moniliasis, vaginitis, leukorrhea, menstrual disorder, perineal pain, intermenstrual bleeding. Male: epididymitis, orchitis. Resistance mechanism: viral infection, moniliasis, fungal infection.Respiratory: respiratory infection, rhinitis, pharyngitis, dyspnea, cough, epistaxis, bronchospasm, respiratory disorder, increased sputum, stridor, respiratory depression. Skin/Allergic: pruritus, rash, urticaria, skin exfoliation, bullous eruption, eczema, skin disorder, acne, skin discoloration, skin ulceration, angioedema. (See also Body as a whole.) Special senses: taste perversion.Urinary: hematuria, micturition disorder, dysuria, strangury, anuria.
Adverse laboratory events
Changes in laboratory parameters, listed as adverse events, without regard to drug relationship include:
Hematologic: monocytosis, eosinophilia (0.1%), leukopenia (0.1%), leukocytosis (0.1%). Renal: elevated BUN (0.1%), decreased potassium (0.1%), increased creatinine (0.1%).Hepatic: elevations of ALT (SGPT) (0.4%), AST (SGOT) (0.3%), bilirubin (0.1%), alkaline phosphatase (0.1%).Additional laboratory changes occurring in < 0.1% in the clinical studies included: elevation of serum gamma glutamyl transferase, decrease in total protein or albumin, prolongation of prothrombin time, anemia, decrease in hemoglobin, thrombocythemia, thrombocytopenia, abnormalities of urine specific gravity or serum electrolytes, increased albumin, elevated ESR, albuminuria, macrocytosis.
Post-Marketing Adverse Events
Post-marketing adverse events
Adverse events reported from worldwide marketing experience with Qumax are: anaphylaxis, cardiopulmonary arrest, laryngeal or pulmonary edema, ataxia, cerebral thrombosis, hallucinations, painful oral mucosa, pseudomembranous colitis, hemolytic anemia, hepatitis, tendinitis, diplopia, photophobia, phobia, exfoliative dermatitis, hyperpigmentation, Stevens-Johnson syndrome, toxic epidermal necrolysis, dysgeusia, interstitial nephritis, polyuria, renal failure, urinary retention, and vasculitis.
Quinolone-class adverse events
Additional quinolone-class adverse events include: peripheral neuropathy, torsades de pointes, erythema nodosum, hepatic necrosis, possible exacerbation of myasthenia gravis, dysphasia, nystagmus, intestinal perforation, manic reaction, renal calculi, acidosis and hiccough.
Laboratory adverse events include: agranulocytosis, elevation of serum triglycerides, elevation of serum cholesterol, elevation of blood glucose, elevation of serum potassium, albuminuria, candiduria, and crystalluria.
OVERDOSAGE
Information on overdosage in humans is limited. In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. Hemodialysis or peritoneal dialysis is unlikely to aid in the removal of Qumax as < 3% is removed by these modalities.
Clinical signs of acute toxicity in rodents progressed from salivation to tremors, decreased activity, dyspnea, and clonic convulsions prior to death. These signs were noted in rats and mice as Qumax doses were increased.
DOSAGE AND ADMINISTRATION
Qumax may be taken without regard to meals. Sucralfate and antacids containing magnesium or aluminum, or Videx® (didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 4 hours before or 2 hours after taking Qumax. Risk of reaction to solar UVA light may be reduced by taking Qumax at least 12 hours before exposure to the sun (eg, in the evening). (See Clinical Pharmacology.)
See Indications and Usage for information on appropriate pathogens and patient populations.
Treatment
Patients with normal renal function
The recommended daily dose of Qumax is described in the following chart:
| Infection | Unit Dose | Frequency | Duration | Daily Dose |
|---|---|---|---|---|
| Acute bacterial exacerbation of chronic bronchitis | 400 mg | qd | 10 days | 400 mg |
| Uncomplicated cystitis in females caused by E coli | 400 mg | qd | 3 days | 400 mg |
| Uncomplicated cystitis caused by K pneumoniae, P mirabilis, or S Saprophyticus | 400 mg | qd | 10 days | 400 mg |
| Complicated UTI | 400 mg | qd | 14 days | 400 mg |
Elderly patients
No dosage adjustment is needed for elderly patients with normal renal function (ClCr≥ 40 mL/min/1.73 m2).
Patients with impaired renal function
Qumax is primarily eliminated by renal excretion. Modification of dosage is recommended in patients with renal dysfunction. In patients with a creatinine clearance > 10 mL/min/1.73 m2 but < 40 mL/min/1.73 m2, the recommended dosage is an initial loading dose of 400 mg followed by daily maintenance doses of 200 mg (1/2 tablet) once daily for the duration of treatment. It is suggested that serial determinations of Qumax levels be performed to determine any necessary alteration in the appropriate next dosing interval.
If only the serum creatinine is known, the following formula may be used to estimate creatinine clearance. Men: (weight in kg) × (140 – age)
(72) × serum creatinine (mg/dL)Women: (0.85) × (calculated value for men)
Dialysis patients
Hemodialysis removes only a negligible amount of Qumax (3% in 4 hours). Hemodialysis patients should receive an initial loading dose of 400 mg followed by daily maintenance doses of 200 mg (1/2 tablet) once daily for the duration of treatment.
Patients with cirrhosis
Cirrhosis does not reduce the nonrenal clearance of Qumax. The need for a dosage reduction in this population should be based on the degree of renal function of the patient and on the plasma concentrations.
Prevention / prophylaxis
The recommended dose of Qumax is described in the following chart:
| Procedure | Dose | Oral Administration |
|---|---|---|
| Transrectal prostate biopsy | 400 mg single dose | 1–6 hours prior to procedure |
| Transurethral surgical procedures | 400 mg single dose | 2–6 hours prior to procedure |
HOW SUPPLIED
Qumax (lomefloxacin HCl) is supplied as a scored, film-coated tablet containing the equivalent of 400 mg of Qumax base present as the hydrochloride. The tablet is oval, white, and film-coated with "MAXAQUIN 400" debossed on one side and scored on the other side and is supplied in:
| NDC Number | Size |
|---|---|
| 0025-5501-01 | bottle of 20 |
Store at 59° to 77°F (15° to 25°C).
CLINICAL STUDIES—UNCOMPLICATED CYSTITIS
In three controlled clinical studies of uncomplicated cystitis in females, two performed in the United States and one in Canada, Qumax was compared to other oral antimicrobial agents. In these studies, using very strict evaluability criteria and microbiological criteria at 5–9 days posttherapy follow-up, the following bacterial eradication outcomes were obtained:
STUDIES 1, 2, AND 3
| U.S. AND CANADIAN STUDIES | ||||
|---|---|---|---|---|
| Qumax 3-Day Treatment | Norfloxacin 3-Day Treatment | Ofloxacin 3-Day Treatment | Trimethoprim/ sulfamethoxazole 10-Day Treatment | |
| E coli | 133/135 | 36/39 (92%) | 65/67 (97%) | 33/34 (97%) |
| K pneumoniae | 7/7 (100%) | 2/2 (100%) | 4/4 (100%) | 2/2 (100%) |
| P mirabilis | 8/8 (100%) | 1/1 (100%) | 2/2 (100%) | 1/1 (100%) |
| S saprophyticus | 11/11 (100%) | 3/3 (100%) | 1/1 (100%) | 0/0 |
STUDY 4
In a controlled clinical study of uncomplicated cystitis performed in Sweden, Qumax 3-day treatment was compared with Qumax 7-day treatment and norfloxacin 7-day treatment. In this study, using very strict evaluability criteria and microbiological criteria at 5–9 days post-therapy follow-up, the following bacterial eradication outcomes were obtained:
| SWEDISH STUDY | ||||
|---|---|---|---|---|
| Qumax 3-Day Treatment | Qumax 7-Day Treatment | Norfloxacin 7-Day Treatment | ||
| E coli | 101/109 (93%) | 102/104 (98%) | 108/110 (98%) | |
| K pneumoniae | 2/2 (100%) | 5/5 (100%) | 1/1 (100%) | |
| P mirabilis | 0/0 | 6/6 (100%) | 4/4 (100%) | |
| S saprophyticus | 11/17 (65%) | 23/23 (100%) | 16/16 (100%) | |
ANIMAL PHARMACOLOGY
Qumax and other quinolones have been shown to cause arthropathy in juvenile animals. Arthropathy, involving multiple diarthrodial joints, was observed in juvenile dogs administered Qumax at doses as low as 4.5 mg/kg for 7 to 8 days (0.3 times the recommended human dose based on mg/m2 or 0.6 times the recommended human dose based on mg/kg). In juvenile rats, no changes were observed in the joints with doses up to 91 mg/kg for 7 days (2 times the recommended human dose based on mg/m2 or 11 times the recommended human dose based on mg/kg). (See Warnings.)
In a 13-week oral rat study, gamma globulin decreased when Qumax was administered at less than the recommended human exposure. Beta globulin decreased when Qumax was administered at 0.6 to 2 times the recommended human dose based on mg/m2. The A/G ratio increased when Qumax was administered at 6 to 20 times the human dose. Following a 4-week recovery period, beta globulins in the females and A/G ratios in the females returned to control values. Gamma globulin values in the females and beta and gamma globulins and A/G ratios in the males were still statistically significantly different from control values. No effects on globulins were seen in oral studies in dogs or monkeys in the limited number of specimens collected. Twenty-seven NSAIDs, administered concomitantly with Qumax, were tested for seizure induction in mice at approximately 2 times the recommended human dose based on mg/m2. At a dose of Qumax equivalent to the recommended human exposure based on mg/m2 (10 times the human dose based on mg/kg), only fenbufen, when coadministered, produced an increase in seizures. Crystalluria and ocular toxicity, seen with some related quinolones, were not observed in any lomefloxacin-treated animals, either in studies designed to look for these effects specifically or in subchronic and chronic toxicity studies in rats, dogs, and monkeys. Long-term, high-dose systemic use of other quinolones in experimental animals has caused lenticular opacities; however, this finding was not observed with Qumax.
REFERENCES
- National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests—4th ed. Approved Standard NCCLS Document M2–A4, vol 10, No. 7, NCCLS, Villanova, Pa, 1990.
- National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically—2nd ed. Approved Standard NCCLS Document M7–A2, vol 10, No. 8, NCCLS, Villanova, Pa, 1990.
Rx only
LAB-0141-6.0
Qumax pharmaceutical active ingredients containing related brand and generic drugs:
Qumax available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.