Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

We determined the efficacy and safety of orally administered ofloxacin, 400 mg twice daily, in the treatment of infections due to multiply-resistant bacteria. Patients (n = 99) were treated for 84 infections in 82 patients evaluable for efficacy with a bacteriologic response of 71%. Organisms treated included Pseudomonas aeruginosa (39), Staphylococcus aureus (11), Serratia marcescens (9), Enterobacter species (7), five each of Escherichia coli, Citrobacter, Salmonella, Klebsiella, and other organisms. The overall clinical responses was 89%: 28 (90%) of 16 osteomyelitis, 10 (83%) of 12 urinary tract infections, and three of three bacteremias. Insomnia occurred in 27% and responded to dose reduction. Resistance of P. aeruginosa to ofloxacin developed in 15% of isolates. No hepatic, renal, or hematologic toxicity developed in spite of long therapy, 283 days. Ofloxacin was an effective therapy for lower respiratory, urinary, bone, and soft tissue infections due to multiply-resistant Gram-negative bacteria and is effective for selected Staphylococcus aureus infections.
 ...
PMID:Oral ofloxacin therapy of infections due to multiply-resistant bacteria. 179 58

The safety profile of ofloxacin was evaluated on the basis of adverse reactions and abnormal laboratory values seen in United States clinical trials and phase I studies addressing specific issues. The most frequently reported adverse reactions occurring in 2,197 patients who received three to 10 days of ofloxacin in United States clinical trials were nausea (3.5 percent), insomnia (1.8 percent), headache (1.4 percent), and dizziness (1.2 percent). Adverse reactions were not serious and usually rapidly reversible. The incidence of adverse reactions did not increase with increasing age. There is no clinically significant interaction with methylxanthines (caffeine or theophylline). Crystalluria was not observed. Ofloxacin is a well-tolerated fluoroquinolone antimicrobial agent.
 ...
PMID:The safety profile of ofloxacin. 269 Jun 23

In clinical trials performed in Italy, 2,003 patients, suffering from various infectious diseases, have so far been treated with ofloxacin. In most cases dosages of 200 mg, 300 mg or 400 mg b. i. d. have been used. In all, 130 adverse reactions have been recorded in 116 patients (5.8%): gastrointestinal events (mostly nausea, vomiting and gastric pain) in 4.8% of the patients, neurological events (mostly headache and insomnia) in 0.7%, cutaneous reactions in 0.4% and others in 0.5% cases. The drug-event causal relationship was assessed by the investigators as unlikely in 5.0% of the events, as possible in 47.1%, as probable in 31.4% and as almost certain in 16.5%. The severity of adverse reactions was judged as mild in 55% of the cases, as moderate in 38% and as severe in 7%. In 30 patients (1.5%), treatment was discontinued because of occurrence of side effects. Abnormal laboratory values probably related to treatment were reported in 25 patients (2.1%). Ofloxacin is well tolerated and shows a safety profile comparable with that of the best tolerated oral antibacterials.
 ...
PMID:Safety profile of ofloxacin: the Italian data base. 295 62

Pharmacokinetic studies using a new oral quinolone ofloxacin were carried out in 12 healthy volunteers. The mean Cmax was 2.7 mg/l after the first dose of 200 mg ofloxacin rising to 3.4 mg/l after the seventh dose. The Tmax was between 1-2 h and the serum half life 5 h. Saliva concentrations matched serum levels but the absolute values were lower. Urinary concentrations ranged from 141 to 330 mg/l and the 12 h excretion was 62% after the seventh dose. Faecal concentrations were high and persisted for up to five days after the last dose. The major effect of ofloxacin on the faecal flora was the rapid and complete elimination of aerobic Gram-negative bacilli. Streptococci were generally increased but there was no change in the total anaerobic bacterial count. Pre-treatment composition of the faecal flora was re-established between 3 and 26 days after the last dose. Ofloxacin was well tolerated by the volunteers and only two complained of significant side effects, gastrointestinal disturbance and insomnia. Ofloxacin is a valuable addition to the range of antimicrobial agents available for the oral treatment of bacterial infection.
 ...
PMID:Pharmacokinetics of ofloxacin and the effect on the faecal flora of healthy volunteers. 318 53

The side-effect profile of levofloxacin was compared with that of other fluoroquinolones based on European and international data from approximately 130 million prescriptions. Levofloxacin was found to be very safe with a low rate of hepatic abnormalities (1/650,000). In contrast, 140 trovafloxacin-treated patients developed hepatic problems, 14 of which were severe, and 8 required transplantation. The main CNS problems associated with fluoroquinolones include dizziness, convulsions, psychosis, and insomnia. Levofloxacin, ofloxacin, and moxifloxacin reportedly have the lowest potential of inducing central nervous system (CNS) adverse events among the fluoroquinolones currently available. Cardiovascular problems were seen in 1/15 million levofloxacin prescriptions compared to 1-3% of sparfloxacin patients having QTc prolongation of greater than 500 msec. Moxifloxacin was also associated with QTc prolongation when compared to non-fluoroquinolone comparators. Nausea, vomiting, and diarrhoea remain the main adverse drug reactions (ADRs) associated with levofloxacin. However, the ADR rate for levofloxacin is still one of the lowest of any fluoroquinolone at 2% (compared to 2-10% for other fluoroquinolones). Ofloxacin and levofloxacin have a very low phototoxic potential, whereas this is a problem for sparfloxacin, enoxacin, and pefloxacin. The tolerance profile of levofloxacin can be considered to be very good, and better than most, if not all of the fluoroquinolones available.
 ...
PMID:Comparison of side effects of levofloxacin versus other fluoroquinolones. 1154 84