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Biomedical subjects

A Heyd

Publications and source records attributed to A Heyd.

18 recordsLinked to original sources

Short-course ciprofloxacin treatment of acute uncomplicated urinary tract infection in women. The minimum effective dose. The Urinary Tract Infection Study Group [corrected].

BACKGROUND: Three studies were undertaken to determine the minimum effective dosing regimen of ciprofloxacin for the treatment of acute, symptomatic, uncomplicated lower urinary tract infection. METHODS: All studies were multicenter, prospective, randomized, double-blind trials. A total of 970 evaluable patients with a diagnosis of urinary tract infection received oral ciprofloxacin (200 mg to 500 mg daily in one or two divided doses for 1, 3, 5, or 7 days) or norfloxacin (400 mg twice daily [BID] for 7 days). The primary measure of efficacy was bacteriologic eradication at the end of therapy. RESULTS: In study 1, bacteriologic eradication was reported in 95 (89%) and 101 (98%) of patients in the groups who received ciprofloxacin, 500-mg single dose and 250 mg BID for 7 days, respectively. Clinical success occurred in 101 patients (94%) who received a 500-mg single dose and in 103 patients (100%) who were administered 250 mg BID for 7 days. In study 2, eradication rates in the groups who received ciprofloxacin, 100 mg BID for 3 days, 250 mg BID for 3 days, and 250 mg BID for 7 days, were 98 (93%), 95 (90%), and 98 (93%), respectively. Clinical success was reported in 102 (97%), 105 (100%), and 104 (98%) of the patients, respectively. In study 3, the eradication rates in the groups who received ciprofloxacin in dosages of 500 mg once daily for 3 days and 500 mg once daily for 5 days and norfloxacin in a dosage of 400 mg BID for 7 days were 137 (92%), 134 (90%), and 133 (94%) of the women, respectively. Clinical success was the same (97%) in all three groups. Overall, short-course (either 3- or 5-day) therapy with ciprofloxacin was statistically equivalent to conventional (7-day) therapy with either ciprofloxacin or norfloxacin. Single-dose ciprofloxacin therapy was statistically less effective than conventional treatment. CONCLUSIONS: Ciprofloxacin at a dosage of 100 mg BID for 3 days was the minimum effective dose for the treatment of uncomplicated urinary tract infection in women.

Acute Disease

Compatibility of ciprofloxacin injection with selected drugs and solutions.

The compatibility of ciprofloxacin injection with selected antimicrobials and aminophylline was studied. Ciprofloxacin, amikacin sulfate, aminophylline, clindamycin phosphate, gentamicin sulfate, and tobramycin sulfate were mixed separately in minibags containing 0.9% sodium chloride injection or 5% dextrose injection; admixtures were stored for up to 48 hours at either 4 degrees C or 25 degrees C. Ciprofloxacin was also combined separately with each of the other drugs and solutions and stored under the same conditions. In addition, ciprofloxacin was combined with metronidazole in ready-to-use mini-bags of the latter drug and stored at 25 degrees C. Drug concentrations were measured by fluorescence polarization immunoassay or high-performance liquid chromatography. All admixtures were also examined visually. Stability was defined as retention of at least 90% of the original drug concentration with no visual evidence of incompatibility. With one exception, drugs in all single-drug admixtures were stable for 48 hours. The drug concentration eight hours after amikacin was mixed in 0.9% sodium chloride and refrigerated was 89% of the original concentration. When ciprofloxacin was combined with gentamicin, metronidazole, or tobramycin, all of the involved drugs were stable for 48 hours. Compatibility of ciprofloxacin-amikacin admixtures depended on the fluid and storage temperature; all such admixtures were stable for at least eight hours. A precipitate formed immediately whenever ciprofloxacin was mixed with clindamycin and within four hours after ciprofloxacin was mixed with aminophylline. Ciprofloxacin injection was compatible with gentamicin, metronidazole, and tobramycin and incompatible with aminophylline and clindamycin. The compatibility of ciprofloxacin-amikacin admixtures depended on the i.v. solution and storage temperature.

Amikacin

Safety of intravenous ciprofloxacin. A review.

Data from 1,878 courses of intravenous ciprofloxacin therapy, administered to 1,869 patients in 59 clinical trials, were analyzed for drug safety. The 985 men and 884 women had a mean age of 50 years, and more than one third were over 60 years of age. An overwhelming majority had at least one accompanying systemic illness, and the condition of more than half the patients was only fair or poor at the onset of therapy. Ciprofloxacin was administered in a unit dose of either 200 mg (68 percent of the patients) or 300 mg (28 percent) by intravenous infusion, generally over 30 minutes every 12 hours, at a mean daily dosage of 456 mg. The duration of intravenous therapy ranged from one to 57 days, with a mean of seven days; over 1,000 patients were treated for more than five days. Adverse events considered probably or possibly related to intravenous ciprofloxacin were reported in 15.8 percent of the courses; therapy was discontinued prematurely in 3 percent. Local reactions at the site of infusion were the most common, occurring in 4.4 percent of the courses. Changes in blood chemistry values (4.1 percent) included increases in alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. Reports of adverse effects referable to the gastrointestinal tract (3.0 percent) were primarily nausea and diarrhea. Central nervous system reactions (1.8 percent) included convulsive seizures, headache, and dizziness. In comparative trials, events considered probably or possibly drug related were reported for 17.3 and 13.6 percent of the ciprofloxacin- and ceftazidime-treated patients, respectively. The incidence of adverse events other than local reactions at the infusion site was not significantly different between the ciprofloxacin- and ceftazidime-treated patients (12.7 percent versus 11.0 percent, p greater than 0.2).

Administration, Oral

A survey of clinical experience with ciprofloxacin, a new quinolone antimicrobial.

Ciprofloxacin is a new quinolone antimicrobial agent with activity against a broad spectrum of gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and methicillin-resistant strains of staphylococci. The efficacy and safety results of 80 clinical studies of the oral form of ciprofloxacin are reported. Drug safety was assessed in 2236 courses in 2203 adult patients treated primarily in the United States. Data from 1676 courses were suitable for analysis of drug efficacy. The unit dose for most patients ranged from 250 mg to 750 mg (median, 500 mg), usually given every 12 hours. The duration of treatment ranged from 3 to 231 days (median, 10 days). Predominant among 1722 infections were those of the urinary tract (43%), skin structures (29%), and respiratory tract (19%); the remainder were bone and joint infections (5%), bacteremias (2%), and intra-abdominal (1%), gastrointestinal (1%), and pelvic infections (less than 1%). Signs and symptoms of infection resolved in 79% of all cases; a further 15% improved, and 5% failed to improve. Pathogens were eradicated in 89% of urinary tract infections and persisted in 5%; 80% of patients still had sterile urine at the 3-to 6-week follow-up. In 81% of nonurinary tract infections, pathogens were eradicated; they persisted in 11%, and superinfection occurred in less than 5%. After treatment, 89% of the 2253 causative organisms were eradicated and 2% were reduced to clinically insignificant counts; 8% persisted. Of 411 isolates of P. aeruginosa, 77% were eradicated, as were 97% of 421 Escherichia coli and 80% of 248 Staphylococcus aureus isolates. Also eradicated were 95% of 166 Klebsiella, 96% of 139 Proteus mirabilis, 100% of 20 other Proteus, 94% of 123 Enterobacter, 100% of 68 Haemophilus influenzae, 96% of 49 Citrobacter, 89% of 45 Serratia, 95% of 41 Streptococcus pneumoniae, 91% of 43 Salmonella, 100% of 38 Morganella morganii, and 100% of 35 Providencia isolates. Adverse reactions were judged probably or possibly drug-related in 14.8% of courses; drug treatment had to be stopped prematurely in 3.5%. The most frequent reactions were gastrointestinal complaints (chiefly nausea, diarrhea, and vomiting), metabolic disorders (elevated SGOT, SGPT, serum creatinine, or blood urea nitrogen), and nervous system effects (dizziness, light-headedness, restlessness, tremor, and headache). Crystalluria, judged to be related to ciprofloxacin, occurred in two patients.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent

Ciprofloxacin: an update on clinical experience.

This report presents the results of 146 clinical trials of the oral form of ciprofloxacin, a new quinolone antimicrobial agent active against a broad spectrum of gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and methicillin-resistant strains of staphylococci. The safety of ciprofloxacin was assessed in 2,829 patients, most of whom were treated in the United States, and the analysis of efficacy was based on data from 3,981 patients evaluated through June 1986. In general, the patients received ciprofloxacin at a dosage of 250 to 750 mg every 12 hours; the median dose was 500 mg twice daily. Dose-ranging studies in male patients with urinary tract infections indicated that a regimen of 500 or 750 mg twice daily was not substantially more effective than a regimen of 250 mg twice daily. Forty-four double-blind, controlled trials were conducted to compare the efficacy and safety of oral ciprofloxacin with those of standard therapeutic agents in the treatment of infections of the urinary tract, skin and skin structure, respiratory tract, and bone. Ciprofloxacin at 250 mg twice daily was as effective as trimethoprim/sulfamethoxazole at 160/800 mg twice daily in the treatment of urinary tract infections. Orally administered ciprofloxacin in a regimen of 750 mg twice daily was shown to be as effective as cefotaxime administered intravenously at 2 g three times daily in the treatment of infections of the skin and skin structure. When compared with ampicillin for the treatment of respiratory tract infections, ciprofloxacin was as effective in resolving or improving markedly the signs and symptoms of infection and eradicated a higher percentage of causative organisms. Adverse reactions considered probably or possibly related to the drug were reported for 16.2 percent of the patients treated; most were of only mild or moderate intensity and resolved after therapy was completed. Emergence of resistant organisms associated with ciprofloxacin therapy has been reported infrequently.

Bacterial Infections

Clinical experience with ciprofloxacin in the USA.

This interim analysis of the efficacy and safety of ciprofloxacin is based on case reports of 1241 adult patients treated primarily in the USA; 1026 were suitable for analysis of drug efficacy. The daily dose ranged from 500 to 1500 mg, the unit dose being given every 12 h. Duration of treatment ranged from 5 to 211 days (mean 12.6 days). In 1046 cases of infection the site was the urinary tract (514), skin structures (218), respiratory tract (215), blood (43), bone (27), abdomen (13), gastrointestinal tract (13) and pelvis (3). Organisms responsible for infection were Escherichia coli (282), Pseudomonas aeruginosa (238), Staphylococcus spp. (149), Streptococcus spp. (107), Klebsiella spp. (105), Proteus spp. (97), Haemophilus spp. (71), Enterobacter spp. (58), Salmonella spp. (44), Citrobacter spp. (27), and Serratia spp. (22). Signs and symptoms of infection resolved in 84% of all cases; 12.6% improved and 3.4% failed to improve. Pathogens were eradicated in 91% of urinary tract infections and in 87% of all other cases of infection combined; superinfections occurred in 5.3% of all patients. At the four-week follow-up 83% of patients with urinary tract infection still had sterile urine. Adverse reactions during therapy were considered probably or possibly drug-related in 166 patients. Nausea (37), diarrhea (25), vomiting (15), nervousness (28), and rash (9) were the most frequent; in only 2% of cases was it necessary to discontinue the drug. Results of ophthalmologic studies were generally unremarkable. Occasional elevations of SGOT and SGPT, and rare elevations of NPN related to ciprofloxacin therapy were seen.

Administration, Oral

Physical-chemical aspects of denture retention and stability: a review of the literature.

The physical-chemical mechanism of retention of dentures is a highly complex one. A review of the literature suggests in addition that retention also is a personal phenomenon under the control of numerous factors. Chief among the factors involved in the retention of a well-adapted denture are the forces related to the wetting of the denture and of the mucosal surfaces and the cohesive or intermolecular characteristics of the saliva. The ill-fitting denture most often results from an increase of variation in the denture-mucosa interspace, probably due to bone resorption rather than to any major changes in the physical-chemical factors.

Atmospheric Pressure

Recording pH method of characterizing composition and monitoring dissolution profile of an anhydride-acid copolymer and its salt derivatives.

A sensitive potentiometric monitoring method was developed that permits the continuous measurement of the disolution profiles of methyl vinyl ether-maleic anhydride-acid copolymers and salt derivatives. Three distinct rate periods were observed in the dissolution rate of the anhydride copolymer, expressed as percent anhydride dissolved, was independent of sample weight over the weight range studied. The acid form of the copolymer showed only one dissolution rate period, with dissolution being very rapid. The rapid initial pH decrease observed during the first stage of dissolution for a series of anhydride-acid copolymer powder samples correlated closely with the anhydride-acid ratio, permitting chemical characterization of the copolymer functionality simultaneously with the analysis of dissolution profiles. Similarly, the extent of copolymer alkaline salt conversion was inversely proportional to the initial maximum pH increase observed during the first stage of dissolution of these salts. Mechanisms of dissolution of copolymer powder materials are discussed and compared to the dissolution of compressed disks and films reported previously.

Hydrogen-Ion Concentration

Enhancing fluidity of concentrated antacid suspensions.

Highly concentrated antacid suspension can by fluidized by adding a colloidal polyelectrolyte to alter the charge on antacid particles from positive to negative. A deflocculated state is assumed to exist in such preparations, as supported by electrophoretic and viscometric analyses. When viscosity is directly correlated with the zota-potential, viscometry becomes particularly useful in confirming that the suspension has been maximally fluidized.

Aluminum Hydroxide

Single-dose ciprofloxacin for the treatment of uncomplicated gonorrhea: a worldwide summary.

BACKGROUND AND OBJECTIVES: Antibiotic therapy for Neisseria gonorrhoeae infections has evolved owing to the development of resistance to penicillin and tetracycline therapy. A variety of antimicrobials, including the fluoroquinolones, have been proposed as useful alternatives. GOAL OF THE STUDY: To evaluate the efficacy and safety of oral ciprofloxacin as single-dose treatment for urogenital and extragenital gonococcal infections. STUDY DESIGN: 1180 patients with uncomplicated gonococcal infection received single-dose ciprofloxacin regimens ranging from 100 mg to 2000 mg to demonstrate microbiologic efficacy and to determine the minimum effective dose. Eight of 18 studies were randomized, controlled trials with ampicillin/probenecid, amoxicillin/probenecid, ceftriaxone, or spectinomycin as control drugs. RESULTS: Although a ciprofloxacin dose-response was not detected, 250 mg was used in most of the studies. Among 815 patients with 910 infected sites receiving 250 mg of ciprofloxacin, bacteriologic eradication was achieved in 563 (100%) male urethral, 199 (100%) female cervical, 101 (99%) male and female rectal, and 47 (96%) male and female pharyngeal sites. CONCLUSION: Although the World Health Organization and the Centers for Disease Control and Prevention have identified 500 mg of ciprofloxacin as a single-dose treatment regimen for uncomplicated gonorrhea, the clinical data from the multinational studies indicate that a 250-mg single-dose of ciprofloxacin is equally effective in the management of uncomplicated gonorrhea, including extragenital sites of infection.

Adult