Composition:
Utilisé dans le traitement:
Examiné médicalement par Oliinyk Elizabeth Ivanovna, Pharmacie Dernière mise à jour le 24.03.2022
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Uritrat est indiqué pour le traitement des adultes atteints des infections suivantes causées par des souches sensibles des micro-organismes désignés:
Infections des tracts urinaires
Infections non compliquées des voies urinaires (y compris la cystite) dues à Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Citrobacter freundii1, Enterobacter aerogenes1, Enterobacter cloacae1, Proteus vulgaris1, Staphylococcus aureus1, ou Streptococcus agalactiae1.
Étant donné que les fluoroquinolones, y compris Uritrat, ont été associées à des effets indésirables graves (voir AVERTISSEMENTS), et pour certains patients, l'infection non compliquée des voies urinaires est auto-limitante, réservez Uritrat pour le traitement des infections non compliquées des voies urinaires (y compris la cystite) chez les patients qui n'ont pas d'autre option de traitement.
Infections compliquées des voies urinaires dues à Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa , ou Serratia marcescens1. Maladies sexuellement transmissibles (voir AVERTISSEMENTS)
Gonorrhée urétrale et cervicale non compliquée due à Neisseria gonorrhoeae.
Prostatite
Prostatite due à Escherichia coli.
(Voir DOSAGE ET ADMINISTRATION pour des instructions de dosage appropriées.)
La production de pénicillinase ne doit avoir aucun effet sur l'activité de la norfloxacine.
Des tests de culture et de sensibilité appropriés doivent être effectués avant le traitement afin d'isoler et d'identifier les organismes à l'origine de l'infection et de déterminer leur sensibilité à la norfloxacine. Un traitement par la norfloxacine peut être instauré avant que les résultats de ces tests ne soient connus; une fois que les résultats sont disponibles, un traitement approprié doit être administré. Les tests de culture et de sensibilité répétés effectués périodiquement pendant le traitement fourniront des informations non seulement sur l'effet thérapeutique des agents antimicrobiens mais également sur l'émergence possible d'une résistance bactérienne.
Pour réduire le développement de bactéries résistantes aux médicaments et maintenir l'efficacité d'Uritrat et d'autres médicaments antibactériens, Uritrat ne doit être utilisé que pour traiter ou prévenir les infections qui sont prouvées ou fortement suspectées d'être causées par des bactéries sensibles. Lorsque des informations sur la culture et la sensibilité sont disponibles, elles doivent être prises en compte lors de la sélection ou de la modification du traitement antibactérien. En l'absence de telles données, l'épidémiologie locale et les schémas de sensibilité peuvent contribuer à la sélection empirique de la thérapie.
La solution ophtalmique d'Uritrat (norfloxacine) est indiquée pour le traitement de la conjonctivite lorsqu'elle est causée par des souches sensibles des bactéries suivantes:
Acinetobacter calcoaceticus **
Aeromonas hydrophila **
Haemophilus influenzae
Proteus mirabilis **
Pseudomonas aeruginosa **
Serratia marcescens **
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus warnerii **
Streptococcus pneumoniae
Une surveillance appropriée de la réponse bactérienne à l'antibiothérapie topique doit accompagner l'utilisation de la solution ophtalmique d'Uritrat (norfloxacine).
** L'efficacité de cet organisme a été étudiée dans moins de 10 infections.
Les comprimés Uritrat doivent être pris au moins une heure avant ou au moins deux heures après un repas ou une ingestion de lait et / ou d'autres produits laitiers. Les multivitamines, autres produits contenant du fer ou du zinc, des antiacides contenant du magnésium et de l'aluminium, du sucralfate ou du Videx® (Didanosine), des comprimés à croquer / tamponner ou la poudre pédiatrique pour solution buvable, ne doivent pas être pris dans les 2 heures suivant l'administration de norfloxacine. Les comprimés Uritrat doivent être pris avec un verre d'eau. Les patients recevant Uritrat doivent être bien hydratés (voir PRÉCAUTIONS).
Fonction rénale normale
La dose quotidienne recommandée d'Uritrat est décrite dans le tableau suivant:
Infection | La description | Dose unitaire | Fréquence | Durée | Dose quotidienne |
Tract urinaire | UTI (cystite) non compliquée en raison de E. coli, K. pneumoniae, ou P. mirabilis | 400 mg | q12h | 3 jours | 800 mg |
UTI non compliquée en raison d'autres organismes indiqués | 400 mg | q12h | 7-10 jours | 800 mg | |
UTI compliquées | 400 mg | q12h | 10-21 jours | 800 mg | |
Maladies sexuellement transmissibles | Gonorrhée simple | 800 mg | dose unique | 1 jour | 800 mg |
Prostatite | Aigu ou chronique | 400 mg | q12h | 28 jours | 800 mg |
Insuffisance rénale
Uritrat peut être utilisé pour le traitement des infections des voies urinaires chez les patients atteints d'insuffisance rénale. Chez les patients dont le taux de clairance de la créatinine est de 30 ml / min / 1,73 m² ou moins, la posologie recommandée est d'un comprimé de 400 mg une fois par jour pendant la durée indiquée ci-dessus. À cette posologie, la concentration urinaire dépasse les CMI de la plupart des agents pathogènes urinaires sensibles à la norfloxacine, même lorsque la clairance de la créatinine est inférieure à 10 ml / min / 1,73 m².
Lorsque seul le taux de créatinine sérique est disponible, la formule suivante (en fonction du sexe, du poids et de l'âge du patient) peut être utilisée pour convertir cette valeur en clairance de la créatinine. La créatinine sérique doit représenter un état constant de fonction rénale.
Hommes: | (poids en kg) x (140 - âge) |
(72) x créatinine sérique (mg / 100 ml) | |
Femmes: | (0,85) x (valeur supérieure) |
Personnes âgées
Les patients âgés traités pour des infections des voies urinaires dont la clairance de la créatinine est supérieure à 30 ml / min / 1,73 m² doivent recevoir les doses recommandées dans la fonction rénale normale.
Les patients âgés traités pour des infections des voies urinaires qui ont une clairance de la créatinine de 30 ml / min / 1,73 m² ou moins devraient recevoir 400 mg une fois par jour, comme recommandé sous Insuffisance rénale.
La dose recommandée chez l'adulte et le patient pédiatrique (un an et plus) est d'une ou deux gouttes de solution ophtalmique d'Uritrat (norfloxacine) appliquées par voie topique aux yeux affectés quatre fois par jour pendant sept jours maximum. Selon la gravité de l'infection, la posologie du premier jour de traitement peut être d'une ou deux gouttes toutes les deux heures pendant les heures de veille.
Uritrat (norfloxacin) is contraindicated in persons with a history of hypersensitivity, tendinitis, or tendon rupture associated with the use of norfloxacin or any member of the quinolone group of antimicrobial agents.
Uritrat (norfloxacin) Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to norfloxacin, or the other members of the quinolone group of antibacterial agents or any other component of this medication.
WARNINGS
Disabling And Potentially Irreversible Serious Adverse Reactions Including Tendinitis And Tendon Rupture, Peripheral Neuropathy, And Central Nervous System Effects
Fluoroquinolones, including Uritrat, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly s een adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting Uritrat. Patients of any age or without pre-existing risk factors have experienced these adverse reactions (see WARNINGS, Tendinitis and Tendon Rupture, Peripheral Neuropathy and Central Nervous System Effects).
Discontinue Uritrat immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including Uritrat, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis And Tendon Rupture
Fluoroquinolones, including Uritrat, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting Uritrat, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Discontinue Uritrat immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including Uritrat, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture (see ADVERSE REACTIONS). Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
Peripheral Neuropathy
Fluoroquinolones, including Uritrat, have been associated with an increased risk of peripheral neuropathy. 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 fluoroquinolones, including Uritrat. Symptoms may occur soon after initiation of norfloxacin and may be irreversible in some patients (see WARNINGS). Discontinue Uritrat immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including Uritrat, in patients who have previously experienced peripheral neuropathy (see ADVERSE REACTIONS).
Central Nervous System Effects
Fluoroquinolones, including Uritrat, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses. Quinolones may also cause CNS stimulation which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If these reactions occur in patients receiving norfloxacin, the drug should be discontinued and appropriate measures instituted.
The effects of norfloxacin on brain function or on the electrical activity of the brain have not been tested. Therefore, until more information becomes available, norfloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors which predispose to seizures (see ADVERSE REACTIONS).
Exacerbation Of Myasthenia Gravis
Fluoroquinolones, including Uritrat, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Post-marketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid Uritrat in patients with known history of myasthenia gravis. (See PATIENT INFORMATION and ADVERSE REACTIONS, Post-Marketing, Musculoskeletal.)
Safety in Children, Adolescents, Nursing mothers, and during Pregnancy: THE SAFETY AND EFFICACY OF ORAL NORFLOXACIN IN PEDIATRIC PATIENTS, ADOLESCENTS (UNDER THE AGE OF 18), PREGNANT WOMEN, AND NURSING MOTHERS HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS, Pediatric Use, Pregnancy, and Nursing Mothers subsections.) The oral administration of single doses of norfloxacin, 6 times2 the recommended human clinical dose (on a mg/kg basis), caused lameness in immature dogs. Histologic examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Other quinolones also produced erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species (see Animal Pharmacology).
Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including
Uritrat. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
- fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome);
- vasculitis; arthralgia; myalgia; serum sickness;
- allergic pneumonitis;
- interstitial nephritis; acute renal insufficiency or failure;
- hepatitis; jaundice; acute hepatic necrosis or failure;
- anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity, and supportive measures should be instituted (see PATIENT INFORMATION and ADVERSE REACTIONS).
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including Uritrat. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria and itching. Only a few patients had a history of hypersensitivity reactions. If an allergic reaction to norfloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, including intubation, should be administered as indicated.
Clostridium Difficile Associated Diarrhea
Clostridium Difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Uritrat and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Syphilis Treatment
Norfloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with norfloxacin should have a follow-up serologic test for syphilis after three months.
PRECAUTIONS
General
Needle-shaped crystals were found in the urine of some volunteers who received either placebo, 800 mg norfloxacin, or 1600 mg norfloxacin (at or twice the recommended daily dose, respectively) while participating in a double-blind, crossover study comparing single doses of norfloxacin with placebo. While crystalluria is not expected to occur under usual conditions with a dosage regimen of 400 mg b.i.d., as a precaution, the daily recommended dosage should not be exceeded and the patient should drink sufficient fluids to ensure a proper state of hydration and adequate urinary output.
Alteration in dosage regimen is necessary for patients with impaired renal function (see DOSAGE AND ADMINISTRATION).
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolone antibiotics after sun or UV light exposure.
Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (see ADVERSE REACTIONS, Post-Marketing).
Rarely, hemolytic reactions have been reported in patients with latent or actual defects in glucose-6phosphate dehydrogenase activity who take quinolone antibacterial agents, including norfloxacin (see ADVERSE REACTIONS).
Prescribing Uritrat 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
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Serious Adverse Reactions
Advise patients to stop taking Uritrat if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
Inform patients of the following serious adverse reactions that have been associated with Uritrat or other fluoroquinolone use:
- Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of Uritrat and may occur together in the same patient. Inform patients to stop taking Uritrat immediately if they experience an adverse reaction and to call their healthcare provider.
- Tendinitis and Tendon Rupture: instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Uritrat treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with the use of Uritrat, that symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, patients should immediately discontinue Uritrat and contact their physicians.
- Central Nervous System Effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including Uritrat. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to norfloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
- Exacerbation of Myasthenia Gravis: inform patients that fluoroquinolones like Uritrat may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
- Hypersensitivity Reactions: Inform patients that Uritrat can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
- Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking Uritrat. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
- Diarrhea: Inform patients that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
- Prolongation of the QT interval: inform patients of the following:
- that norfloxacin may cause changes in the electrocardiogram (QTc interval prolongation).
- that norfloxacin should be avoided in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.
- that norfloxacin should be used with caution in subjects receiving drugs that affect the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants.
- to inform their physicians of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia or recent myocardial ischemia.
- Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
Other Information
Patients should be advised:
- to drink fluids liberally.
- that Uritrat should be taken at least one hour before or at least two hours after a meal or ingestion of milk and/or other dairy products.
- that multivitamins or other products containing iron or zinc, antacids or Videx®3 (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within the two-hour period before or within the two-hour period after taking norfloxacin (see PRECAUTIONS: DRUG INTERACTIONS).
- that some quinolones may increase the effects of theophylline and/or caffeine (see PRECAUTIONS: DRUG INTERACTIONS).
- that convulsions have been reported in patients taking quinolones, including Uritrat, and to notify their physician before taking this drug if there is a history of this condition.
Patients should be counseled that antibacterial drugs including Uritrat should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Uritrat 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 Uritrat or other antibacterial drugs in the future.
Laboratory Tests
As with any potent antibacterial agent, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No increase in neoplastic changes was observed with norfloxacin as compared to controls in a study in rats, lasting up to 96 weeks at doses 8-9 times2 the usual human dose (on a mg/kg basis).
Norfloxacin was tested for mutagenic activity in a number of in vivo and in vitro tests. Norfloxacin had no mutagenic effect in the dominant lethal test in mice and did not cause chromosomal aberrations in hamsters or rats at doses 30-60 times2 the usual human dose (on a mg/kg basis). Norfloxacin had no mutagenic activity in vitro in the Ames microbial mutagen test, Chinese hamster fibroblasts and V-79 mammalian cell assay. Although norfloxacin was weakly positive in the Rec-assay for DNA repair, all other mutagenic assays were negative including a more sensitive test (V-79).
Norfloxacin did not adversely affect the fertility of male and female mice at oral doses up to 30 times2 the usual human dose (on a mg/kg basis).
Pregnancy
Teratogenic Effects
Pregnancy Category C. Norfloxacin has been shown to produce embryonic loss in monkeys when given in doses 10 times2 the maximum daily total human dose (on a mg/kg basis). At this dose, peak plasma levels obtained in monkeys were approximately 2 times those obtained in humans. There has been no evidence of a teratogenic effect in any of the animal species tested (rat, rabbit, mouse, monkey) at 6-50 times2 the maximum daily human dose (on a mg/kg basis). There are, however, no adequate and well-controlled studies in pregnant women. Norfloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether norfloxacin is excreted in human milk.
Pediatric Use
The safety and effectiveness of oral norfloxacin in pediatric patients and adolescents below the age of 18 years have not been established. Norfloxacin causes arthropathy in juvenile animals of several animal species. (See WARNINGS and Animal Pharmacology.)
Geriatric Use
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Uritrat. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Uritrat to elderly patients, especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Uritrat and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur (see BOXED WARNING; WARNINGS; and ADVERSE REACTIONS, Post-Marketing).
Of the 340 subjects in one large clinical study of Uritrat for treatment of urinary tract infections, 103 patients were 65 and older, 77 of whom were 70 and older; no overall differences in safety and effectiveness were evident between these subjects and younger subjects. In clinical practice, no difference in the type of reported adverse experiences have been observed between the elderly and younger patients except for a possible increased risk of tendon rupture in elderly patients receiving concomitant corticosteroids (see WARNINGS). In addition, increased risk for other adverse experiences in some older individuals cannot be ruled out (see ADVERSE REACTIONS).
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 DOSAGE AND ADMINISTRATION).
A pharmacokinetic study of Uritrat in elderly volunteers (65 to 75 years of age with normal renal function for their age) was carried out (see CLINICAL PHARMACOLOGY).
In general, elderly patients may be more susceptible to drug-associated effects of the QTc interval. Therefore, precaution should be taken when using Uritrat concomitantly with drugs that can result in prolongation of the QTc interval (e.g., class IA or class III antiarrhythmics) or in patients with risk factors for torsades de pointes (e.g., known QTc prolongation, uncorrected hypokalemia).
REFERENCES
1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.
2 Based on a patient weight of 50 kg.
WARNINGS
NOT FOR INJECTION INTO THE EYE.
Serious and occasionally fatal hypersensitivity (anaphylactoid or anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactoid or anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids and airway management, including intubation, should be administered as indicated.
PRECAUTIONS
General
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate measures should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers have been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See Information for Patients.)
Carcinogenesis, Mutagenesis, Impairment of Fertility
No increase in neoplastic changes was observed with norfloxacin as compared to controls in a study in rats, lasting up to 96 weeks at doses eight to nine times the usual human oral dose***.
Norfloxacin was tested for mutagenic activity in a number of in vivo and in vitro tests. Norfloxacin had no mutagenic effect in the dominant lethal test in mice and did not cause chromosomal aberrations in hamsters or rats at doses 30 to 60 times the usual oral dose***. Norfloxacin had no mutagenic activity in vitro in the Ames microbial mutagen test, Chinese hamster fibroblasts and V-79 mammalian cell assay. Although norfloxacin was weakly positive in the Rec-assay for DNA repair, all other mutagenic assays were negative including a more sensitive test (V-79).
Norfloxacin did not adversely affect the fertility of male and female mice at oral doses up to 33 times the usual human oral dose***.
Pregnancy
Teratogenic Effects Pregnancy Category C. Norfloxacin has been shown to produce embryonic loss in monkeys when given in doses 10 times the maximum human oral dose*** (400 mg b.i.d.), with peak plasma levels that are two to three times those obtained in humans. There has been no evidence of a teratogenic effect in any of the animal species tested (rat, rabbit, mouse, monkey) at 6 to 50 times the human oral dose. There are no adequate and well-controlled studies in pregnant women. Uritrat (norfloxacin) Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether norfloxacin is excreted in human milk following ocular administration. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from norfloxacin, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see ANIMAL PHARMACOLOGY).
Pediatric Use
Safety and effectiveness in infants below the age of one year have not been established.
Although quinolones including norfloxacin have been shown to cause arthropathy in immature animals after oral administration, topical ocular administration of other quinolones to immature animals has not shown any arthropathy and there is no evidence that the ophthalmic dosage form of those quinolones has any effects on the weight-bearing joints.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and young patients.
***All factors are based on a standard patient weight of 50 kg. The usual oral dose of norfloxacin is 800 mg daily. One drop of Uritrat (norfloxacin) Ophthalmic Solution 0.3% contains about 1/6,666 of this dose (0.12 mg).
Études à dose unique
Dans les essais cliniques impliquant 82 sujets sains et 228 patients atteints de gonorrhée, traités avec une dose unique de norfloxacine, 6,5% ont signalé des expériences indésirables liées au médicament. Cependant, les chiffres d'incidence suivants ont été calculés sans référence à la relation médicamenteuse.
Les expériences indésirables les plus courantes (> 1,0%) ont été: étourdissements (2,6%), nausées (2,6%), maux de tête (2,0%) et crampes abdominales (1,6%).
Les réactions supplémentaires (0,3% -1,0%) ont été: anorexie, diarrhée, hyperhidrose, asthénie, douleur anale / rectale, constipation, dyspepsie, flatulence, picotements des doigts et vomissements.
Des changements indésirables en laboratoire considérés comme liés au médicament ont été signalés chez 4,5% des patients / sujets. Ces changements de laboratoire étaient les suivants: augmentation de l'AST (SGOT) (1,6%), diminution du WBC (1,3%), diminution du nombre de plaquettes (1,0%), augmentation des protéines urinaires (1,0%), diminution de l'hématocrite et de l'hémoglobine (0,6%) et augmentation des éosinophiles (0,6%).
Études à doses multiples
Dans les essais cliniques impliquant 52 sujets sains et 1980 patients atteints d'infections des voies urinaires ou de prostatite traités par plusieurs doses de norfloxacine, 3,6% ont signalé des expériences indésirables liées au médicament. Cependant, les chiffres d'incidence ci-dessous ont été calculés sans référence à la relation médicamenteuse.
Les expériences indésirables les plus courantes (> 1,0%) étaient: nausées (4,2%), maux de tête (2,8%), étourdissements (1,7%) et asthénie (1,3%).
Des réactions supplémentaires (0,3% -1,0%) ont été: douleurs abdominales, maux de dos, constipation, diarrhée, sécheresse de la bouche, dyspepsie / brûlures d'estomac, fièvre, flatulences, hyperhidrose, selles molles, prurit, éruption cutanée, somnolence et vomissements.
Les réactions moins fréquentes (0,1% -0,2%) comprenaient: gonflement abdominal, allergies, anorexie, anxiété, goût amer, vision trouble, bursite, douleurs thoraciques, frissons, dépression, dysménorrhée, œdème, érythème, gonflement du pied ou de la main, insomnie, ulcère buccal, infarctus du myocarde, palpitations, prurit ani, urique rénal,.
Les valeurs biologiques anormales observées chez ces patients / sujets étaient: éosinophilie (1,5%), élévation de l'ALAT (SGPT) (1,4%), diminution du nombre de globules blancs et / ou neutrophiles (1,4%), élévation de l'AST (SGOT) (1,4%) et augmentation de la phosphatase alcaline (1,1,1%). Ceux qui se produisent moins fréquemment comprenaient une augmentation du BUN, une augmentation de la LDH, une augmentation de la créatinine sérique, une diminution de l'hématocrite et une glycosurie.
Post-marketing
L'effet indésirable le plus fréquemment signalé dans l'expérience post-commercialisation est une éruption cutanée.
Des effets sur le SNC caractérisés par des crises généralisées, des myoclonies et des tremblements ont été rapportés avec Uritrat (voir AVERTISSEMENTS). Des troubles visuels ont été rapportés avec des médicaments de cette classe.
Les effets indésirables supplémentaires suivants ont été rapportés depuis la commercialisation du médicament:
Réactions d'hypersensibilité
Des réactions d'hypersensibilité ont été rapportées, notamment des réactions anaphylactoïdes, un œdème de Quincke, une dyspnée, une vascularite, une urticaire, une arthrite, une arthralgie et une myalgie (voir AVERTISSEMENTS).
Peau
Nécrolyse épidermique toxique, syndrome de Stevens-Johnson et érythème polymorphe, dermatite exfoliatrice, réactions de photosensibilité / phototoxicité (voir PRÉCAUTIONS), vascularite leucocytoclastique, éruption cutanée avec éosinophilie et symptômes systémiques (syndrome DRESS).
Gastro-intestinal
Colite pseudomembraneuse, hépatite, jaunisse, y compris jaunisse cholestatique et tests de la fonction hépatique élevés, pancréatite (rare), stomatite. L'apparition de symptômes de colite pseudomembraneuse peut survenir pendant ou après le traitement antibactérien (voir AVERTISSEMENTS).
Hépatique
Insuffisance hépatique, y compris les cas mortels.
Cardiovasculaire
En de rares occasions, intervalle QTc prolongé et arythmie ventriculaire, y compris les torsades de pointes.
Rénal
Néphrite interstitielle, insuffisance rénale.
Système nerveux / psychiatrique
Neuropathie périphérique irréversible, syndrome de Guillain-Barré, ataxie, paresthésie, hypoesthésie, troubles psychiques, y compris réactions psychotiques et confusion.
Musculo-squelettique
Tendinite, rupture du tendon; exacerbation de la myasthénie grave (voir AVERTISSEMENTS, Exacerbation de la myasthénie grave); créatine kinase élevée (CK), spasmes musculaires.
Hématologique
Neutropénie; leucopénie; agranulocytose; anémie hémolytique, parfois associée à une carence en glucose-6phosphate déshydrogénase; thrombocytopénie.
Sens spéciaux
Perte auditive, acouphènes, diplopie, dysgueusie.
Les autres événements indésirables rapportés avec les quinolones comprennent: agranulocytose, albuminurie, candidurie, cristallurie, cylindrurie, dysphagie, élévation de la glycémie, élévation du cholestérol sérique, élévation du potassium sérique, élévation des triglycérides sériques, hématurie, nécrose hépatique, hypoglycémie symptomatique, nystagmus, hypotension posturale,.
Dans les essais cliniques, l'effet indésirable lié au médicament le plus fréquemment signalé était une brûlure ou une gêne locale. Les autres effets indésirables liés à la drogue étaient l'hypéémie conjonctivale, la chimiose, la photophobie et un goût amer après l'instillation.
Aucune létalité significative n'a été observée chez les souris et les rats mâles et femelles à des doses orales uniques allant jusqu'à 4 g / kg.
En cas de surdosage aigu, l'estomac doit être vidé en provoquant des vomissements ou par un lavage gastrique, et le patient doit être soigneusement observé et recevoir un traitement symptomatique et de soutien. Une hydratation adéquate doit être maintenue.
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However, we will provide data for each active ingredient