Active substance: Norfloxacin
Abstract Background Although uncomplicated urinary tract infections UTIs are often self-limiting, most patients will be prescribed antibiotic treatment.
Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with cephalosporins or macrolides, but less frequently than those treated with penicillins, clindamycin, sulfonamides, or vancomycin.
Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States.
Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients.
Simultaneous use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture. Fluoroquinoline treatment is associated with risk that is similar to or less than that associated with broad spectrum cephalosporins.
Therefore, cyclosporine serum levels should be monitored and appropriate cyclosporine dosage adjustments made when these drugs are used concomitantly.
Medications Some quinolones exert an inhibitory effect on the cytochrome P-450 system, thereby reducing theophylline clearance and increasing theophylline blood levels. For these reasons, before you start taking norfloxacin it is important that your doctor knows: If you are pregnant, trying for a baby, or breast-feeding.
If you are under 18 years of age. If you have ever experienced a problem with your tendons after taking another quinolone antibiotic these are called ofloxacin, levofloxacin, ciprofloxacin, moxifloxacin, and nalidixic acid. If you have any problems with the way your kidneys work.
If you have epilepsy or any other condition that causes fits. If you have a heart condition, or if you have been told you have an unusual heartbeat. If you have a condition causing tired and weak muscles, called myasthenia gravis.
This is a genetic disorder which causes problems after eating foods such as fava beans. If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
If you have ever had an allergic reaction to a medicine.
Methods Trial design and participants The study was a double-blind, randomized, parallel group, multicenter non-inferiority trial. Patients were randomized in a 1:1 ratio to treatment with either ibuprofen or pivmecillinam.
All patients received oral and written information about the trial and signed an informed consent form.
The trial was conducted in compliance with the International Conference on Harmonisation guidelines for good clinical practice GCP and the Declaration of Helsinki.
Safety data were monitored throughout the trial by a certified monitor in each country. There was no independent data monitoring committee for the trial. All study personnel were trained in GCP. We recruited non-pregnant women aged 18—60 years with symptoms of an uncomplicated UTI.
Inclusion criteria were dysuria combined with either increased urinary frequency or urinary urgency or both, with or without visible hematuria. Ability to give written consent was assessed by the study nurse or study doctor.
Potential participants were excluded if they were assessed as having severe psychiatric illness, dementia, severe drug addiction, or inability to communicate in the official language of the country.