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The efficacy and safety of 7-10-day courses of lomefloxacin (single daily dose of 400 mg) or norfloxacin (twice-daily doses of 400 mg) for the treatment of uncomplicated urinary tract infections were compared in two large, multicenter, randomized trials. This article presents the combined results of these trials, which were conducted in a total of 27 centers throughout the United States. A total of 727 adults, mostly women, with symptoms of acute urinary tract infection were enrolled; 370 patients were randomized to lomefloxacin treatment, and 357 received norfloxacin. The bacteriologic cure rate at 5-9 days post-therapy was 98.2% in the lomefloxacin group and 96.3% in the norfloxacin group (p = nonsignificant). The clinical success rate of 99.1% in the lomefloxacin group was significantly higher than the success rate of 93.5% in the norfloxacin group (p = 0.002). Adverse events were reported by 157 lomefloxacin-treated patients and 129 patients receiving norfloxacin. Adverse events attributable to drug treatment occurred in 41 patients (11.1%) in the lomefloxacin group and 27 (7.6%) in the norfloxacin group. Eight lomefloxacin (2.2%) and three norfloxacin patients (0.8%) were withdrawn from treatment because of adverse events probably attributable to the drug. The incidence of dizziness, tremor, and photosensitivity rash was higher in the lomefloxacin group than in the norfloxacin group, while the incidence of nausea was higher in the norfloxacin group. The results of these trials demonstrate that once-daily administration of 400 mg lomefloxacin is as safe and effective clinically as, and superior bacteriologically to, twice-daily administration of 400 mg norfloxacin in the treatment of acute uncomplicated urinary tract infections in adult patients.
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PMID:Efficacy of lomefloxacin as compared to norfloxacin in the treatment of uncomplicated urinary tract infections in adults. 131 75

Symptoms of infection in the elderly may be absent, vague or atypical. Infection should be suspected when an elderly patient presents with a decline in well-being or with non-specific symptoms such as falls, dizziness, confusion, anorexia or weakness. Common infections include bacterial pneumonia, urinary tract infection, intra-abdominal infections, gram-negative bacteremia and infection of decubitus ulcers. Antibiotic therapy is not recommended for asymptomatic bacteriuria or locally infected decubitus ulcers. Drug dosages should be adjusted for the age-associated decline in renal function and for hepatic or renal insufficiency. The trend in antibiotic therapy is evolving toward the use of third-generation cephalosporins instead of aminoglycosides to avoid the side effects of nephrotoxicity and ototoxicity. Pneumococcal, influenza and tetanus/diphtheria immunizations help prevent morbidity and mortality.
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PMID:Common infections in the elderly. 848 May 62

In a double-blind, randomized, multicenter study, 400 women with symptoms of acute urinary tract infections were treated with either a 7-day course of temafloxacin hydrochloride (400 mg once a day; n = 204) or a 10-day course of trimethoprim (160 mg) and sulfamethoxazole (800 mg) (TMP-SMZ) twice daily (n = 196). The bacteriologic cure rates at 5 to 9 days posttherapy were 100% in the temafloxacin group and 97% in the TMP-SMZ group (P = 0.035). The clinical cure rates were 93% in the temafloxacin group and 95% in the TMP-SMZ group (P greater than 0.1). Adverse events, including nausea, vomiting, rash, headache, and dizziness, were experienced by 19.6% of the temafloxacin group and 23.5% of the TMP-SMZ group. Transient leukopenia occurred in 0.5 and 4.1% of the temafloxacin and TMP-SMZ groups, respectively. Temafloxacin, 400 mg once a day for 7 days, appears to be at least as safe and effective as a 10-day course of TMP-SMZ in the management of acute urinary tract infection in women.
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PMID:Comparative, double-blind, prospective, multicenter trial of temafloxacin versus trimethoprim-sulfamethoxazole in uncomplicated urinary tract infections in women. 195 47

Norfloxacin, a broad-spectrum antimicrobial analog of nalidixic acid, was evaluated by comparing it to trimethoprim-sulfamethoxazole in 93 office patients with recurrent urinary tract infections. In this prospective randomized study, norfloxacin and trimethoprim-sulfamethoxazole were given on the same dosage schedule with the former drug given as a 400-mg tablet twice daily and the latter drug given as a double strength tablet twice daily. Overall, 50 patients received norfloxacin and 43 patients received trimethoprim-sulfamethoxazole with a cure rate of 96 percent and 79 percent, respectively. Whether a patient had one infection or multiple previous infections, norfloxacin appeared to be superior to trimethoprim-sulfamethoxazole. Only minor side effects were noted in either group, and no patient withdrew from this study as a direct result of these side effects. Minor complaints of nausea, dizziness, and headache were found in the norfloxacin group (24%) and in the trimethoprim-sulfamethoxazole group (16%). Both agents are effective in treating urinary tract infections but norfloxacin is superior to trimethoprim-sulfamethoxazole in patients with either recurrent complicated infections or one previous uncomplicated urinary tract infection.
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PMID:Treatment of recurrent urinary tract infection with norfloxacin versus trimethoprim-sulfamethoxazole. 240 23

The efficacy and safety of ciprofloxacin in the treatment of 68 episodes of bacteremia were studied. Patients were treated intravenously (30 cases), orally (13 cases), or with sequential intravenous/oral therapy (25 cases). Intravenous doses ranged from 200 to 400 mg per day and oral doses ranged from 1,000 to 1,500 mg per day. According to the criteria of McCabe and Jackson, 39 cases had nonfatal and 29 had ultimately fatal underlying diseases. The clinical condition of patients at the start of therapy was critical or poor in 40 cases and fair or good in 28. Sixty-four of the 68 episodes of bacteremia were monomicrobial and the remaining four were polymicrobial. The causative micro-organisms were: Escherichia coli (18 episodes), Pseudomonas aeruginosa (13 episodes), Acinetobacter sp. (10 episodes), Salmonella sp. (seven episodes), Enterobacter sp. (six episodes), Proteus sp. (four episodes), Serratia sp. (four episodes), Haemophilus influenzae (three episodes), Klebsiella sp. (three episodes), Staphylococcus aureus (2 episodes), and Morganella morganii (two episodes). Overall clinical efficacy of ciprofloxacin was 94 percent (64 of 68 patients). Bacteremia persisted in four patients (failure rate of 6 percent). Five organisms persisted: Acinetobacter sp. (two patients), P. aeruginosa (one patient), Enterobacter sp. (one patient), and Serratia sp. (one patient). Side effects were phlebitis associated with intravenous administration (four cases), dizziness (four cases), and superinfection (six cases). Superinfecting organisms and sites were as follows: Enterococcus faecalis, wound (2 cases); Candida sp., urinary tract infection (one case); Acinetobacter anitratus (ciprofloxacin resistant), urinary tract infection (one case); Staphylococcus epidermidis, blood (one case); and Clostridium perfringens, blood (one case). Ciprofloxacin administered either intravenously, orally, or intravenously followed by the oral route is effective therapy in the treatment of severe bacteremic infections.
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PMID:Ciprofloxacin in patients with bacteremic infections. The Spanish Group for the Study of Ciprofloxacin. 258 66

Augmentin, a formulation of amoxycillin trihydrate 250 mg and sodium clavulanate 125 mg per tablet (A-CS) (Augmentin; Beecham), was used in treating 29 episodes of urinary tract infection occurring in 26 patients admitted to the Spinal Unit of the H. F. Verwoerd Hospital, Pretoria. Patients who had a urinary bacterial cell count of more than 105 of the same amoxycillin-resistant organism before and after the oral administration of amoxycillin 500 mg 3 times a day for 48 hours, received 2 A-CS 375 mg tablets orally, 3 times a day at the start if a meal for 5 days. The 29 strains of amoxycillin-resistant organisms treated in this study were: Escherichia coli (11), Klebsiella pneumoniae (11), Proteus mirabilis (4), Enterobacter cloacae (2), and Staphylococcus epidermidis (1). The bacteriological success rate 24 hours after therapy was 100% and 8 days after therapy 69%, dependent on patient management. In patients on free drainage and managed with condoms a bacteriological success rate of 55,5% was recorded and in patients managed by intermittent catheterization a bacteriological success rate of 75% was recorded. Side-effects were minimal; 1 patient complained of dizziness and no instances of nausea or vomiting were reported. Haematological, renal and hepatic monitoring before and after A-CS-therapy revealed no drug-related toxicity.
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PMID:[Treatment with amoxicillin and clavulanic acid of urinary tract infections in patients with spinal injuries]. 697 6

In this report, we assess the safety of terazosin in the treatment of patients with symptomatic benign prostatic hyperplasia. We analyzed seven prospectively designed placebo-controlled trials involving 3,080 patients, 1,689 of whom received the study drug in doses ranging from 1 mg to 20 mg daily for a total of 1,282 patient-years of exposure. The most common side effects seen in treated patients were dizziness (10.7%), asthenia (7.5%), and peripheral edema (4.0%). These side effects were generally reported as mild and improved after cessation of therapy. The incidence of withdrawal from the study due to side effects was 14.5% in the treatment arm versus 11.4% in the placebo control arm. Also noted was a statistically significant decreased risk of urinary tract infection and myocardial infarction in the terazosin-treated group. This updated report confirms that terazosin can be administered safely to a population of men with symptomatic benign prostatic hyperplasia with minimal clinically significant side effects.
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PMID:Side effects of terazosin in the treatment of symptomatic benign prostatic hyperplasia. 916 69

Sildenafil citrate, an oral therapy for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), the predominant isozyme metabolizing cGMP in the corpus cavernosum. Chemically, it is a compound of the pyrazolo-pyrimidinyl-methylpiperazine class. Sildenafil has no direct relaxant effect on human corpus cavernosum but enhances the relaxant effect of nitric oxide (NO) on the corpus cavernosum by inhibiting PDE5, which is responsible for degradation of cGMP in this tissue. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil increases concentrations of cGMP in the corpus cavernosum, causing smooth muscle relaxation and blood flow into the penis, resulting in an erection. Sildenafil at recommended doses has no effect in the absence of sexual stimulation. The drug is rapidly absorbed after oral administration, with absolute bioavailability of 40%. Its pharmacokinetics are dose proportional over the recommended dosage range. Maximum plasma concentrations are reached within 30 to 120 minutes after oral dosing in the fasting state. Sildenafil is cleared predominantly by the hepatic microsomal isoenzymes CYP3A4 (major route) and CYP2C9 (minor route). Clinical studies assessed the effect of sildenafil on the ability of men with erectile dysfunction to engage in sexual activity and, specifically, to achieve and maintain an erection sufficient for satisfactory sexual intercourse. Sildenafil was evaluated at doses of 25, 50, and 100 mg in randomized, double-masked, placebo-controlled clinical trials of up to 6 months' duration. The drug was administered to hundreds of patients aged 19 to 87 years having erectile dysfunction of various etiologies for a mean duration of 5 years. Sildenafil was associated with statistically significant improvement in erectile function compared with placebo. Adverse effects reported at a rate of >2% were headache, flushing, dyspepsia, nasal congestion, urinary tract infection, abnormal vision, diarrhea, dizziness, and rash. No cases of priapism were reported. The use of sildenafil is contraindicated in men who are taking organic nitrates, because of the potential for a precipitous decrease in blood pressure. Postmarketing reports and surveillance have revealed at least 39 deaths with sildenafil use in men having a history of heart disease, men taking nitrate medications, and men in poor physical health due to lack of exercise. Many of the men who experienced serious adverse effects or death had a variety of concomitant diseases and were taking multiple medications.
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PMID:Safety and efficacy of sildenafil citrate in the treatment of male erectile dysfunction. 991 1

The causes of Datura intoxication include medication overdose, misuse of edible vegetables, deliberate abuse as a hallucinogen, homicidal or robbery and accidental intoxication from contaminated food. We report an incident of 14 people with Datura intoxication caused by ingesting wild Datura suaveolans for food. The incubation period was 15 to 30 min. The symptoms/signs were dizziness, dry mouth, flushed skin, palpitation, nausea, drowsiness, tachycardia, blurred vision, mydriasis, hyperthermia, disorientation, vomiting, agitation, delirium, urine retention, hypertension and coma. Three patients were hospitalized for 2-3 days. Thirteen persons received supportive fluid therapy. One patient did not receive medical therapy, he induced vomiting and drank a lot of water. Four patients presented with delirium/coma and 3 received physostigmine therapy with good response. One patient was intubated because of coma and respiratory depression. Three persons needed Foley catheterization for urine retention or coma status. One patient had a complication of urinary tract infection and antibiotic management. All patients recovered with no sequelae.
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PMID:Poisoning by Datura leaves used as edible wild vegetables. 1043 80

Urinary tract infection (UTI) is a common illness, with > or =30% of all women experiencing a UTI during their lifetime. Less than a decade ago, the standard therapy for acute uncomplicated UTIs involved treatment with > or =7 days of an antibacterial agent, but recent studies using a variety of newly introduced antibiotics, including the fluoroquinolones, have demonstrated that a 1- to 5-day treatment regimen can be equally effective. This randomized, double-masked, multicenter study was conducted to compare the efficacy and tolerability of a single dose of sparfloxacin with those of a 3-day regimen of sparfloxacin and a 7-day regimen of ciprofloxacin in the treatment of women with community-acquired acute uncomplicated urinary tract infection. A total of 1175 women were enrolled; 395 received sparfloxacin as a single 400-mg dose on day 1, 394 received sparfloxacin as a 400-mg loading dose on day 1 followed by 200 mg once daily for 2 additional days, and 386 received ciprofloxacin 250 mg twice daily for 7 days. Patients were comparable with respect to demographic characteristics and underlying conditions. A total of 954 patients were clinically assessable; 490 of these were also bacteriologically assessable. All patients treated were included in the tolerability analysis. Escherichia coli (75.4%), Klebsiella pneumoniae (4.9%), Enterococcus faecalis (4.6%), and Staphylococcus saprophyticus (4.1%) were the most commonly isolated organisms. In the all-treated population, clinical success was achieved 5 to 9 days after therapy in 91.8%, 92.2%, and 91.6% of patients in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; bacteriologic success was observed in 91.7%, 92.6%, and 96.6% of those in the 3 groups. Sustained clinical success rates 4 to 6 weeks after therapy were 76.6%, 80.2%, and 79.5% in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; sustained bacteriologic success rates were 80.7%, 90.1%, and 92.6%. The most common adverse events were nausea, headache, vaginal thrush, dizziness, and diarrhea; >92% of adverse events were mild or moderate in severity. The 2 drugs had comparable frequencies of adverse events, except for photosensitivity, which occurred in 3.3% of the 3-day sparfloxacin group, 1.3% of the single-dose sparfloxacin group, and 0.3% of the ciprofloxacin group (P = 0.005). The 3-day sparfloxacin regimen was effective and well tolerated. The initial response to single-dose sparfloxacin treatment was comparable to the response to the other 2 regimens, but the single-dose regimen proved less effective over time, with higher rates of clinical recurrence and bacteriologic relapse. Sparfloxacin provides an alternative to ciprofloxacin for patients with acute uncomplicated urinary tract infection who are not at risk for photosensitivity reactions or adverse events associated with a prolonged corrected QT interval.
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PMID:Comparison of sparfloxacin and ciprofloxacin in the treatment of community-acquired acute uncomplicated urinary tract infection in women. Sparfloxacin Multicenter Uncomplicated Urinary Tract Infection Study Group. 1044 Jun 21


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