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A high-performance liquid chromatographic analysis of erythromycin and its esters in plasma, urine and saliva is presented. A diethyl ether extract of sample was chromatographed on a reversed-phase column and components of the column effluent were monitored by electrochemical detection at +0.9 V (vs. Ag/AgCl). The method sensitivity limit was 10 ng with inter-day coefficients of variation from 3.2 to 10.3%. In order to assess precisely the relative concentrations of erythromycin esters (ethylsuccinate or estolate) and their active by-product erythromycin base, it is necessary to adopt measures preventing their continuous hydrolysis in biological fluids and during sample preparation.
Erythromycin taurate, a new derivative of erythromycin, was prepared by reacting erythromycin base with tauric acid and its physico-chemical and biological properties were evaluated. The derivative has reasonably good solubility in organic solvents. The partition coefficient values in chloroform/water 1.17 and octanol/water 1.16 systems indicate its good distribution in various tissues in vivo. The in vitro antimicrobial potency of the derivative (833.33 microg mg(-1)) is higher than that of the existing derivatives such as erythromycin estolate, erythromycin stearate, erythromycin ethyl succinate, erythromycin gluceptate, erythromycin lactobionate. The antimicrobial spectrum is comparable to that of the parent compound. Our results indicate that erythromycin taurate has a high potential for possible clinical application and is more efficient against Escherichia coli and Klebsiella pneumoniae than the parent base.
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A noncompliance rate of >30% is unsatisfactory. Whereas some variables significantly associated with compliance cannot be influenced (patient age; place of residence in town or city), others are amenable to modifications. These include the physician-patient interaction and the choice of antibiotic. Agents should be preferred that are well-accepted by patients, that enable short-term therapy with few daily doses and with a package that contains a dose-taking reminder.
We included one trial, involving 1071 women. Of these, 644 women between 22 weeks and 32 weeks' gestation were randomly assigned to one of three groups of antibiotic treatment (n = 174 erythromycin estolate, n = 224 erythromycin stearate, and n = 246 clindamycin hydrochloride) or a placebo (n = 427). Preterm birth data was not reported in this trial. Incidence of low birthweight less than 2500 grams was only evaluated for erythromycin (combined, n = 398) compared to placebo (n = 427) and there was no statistically significant difference between the two groups (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.46 to 1.07). There were no statistically significant differences in side effects sufficient to stop treatment between either group (RR 1.25, 95% CI 0.85 to 1.85).
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Food was withheld from foals overnight before intragastric administration of erythromycin estolate (25 mg/kg of body weight; n = 8) and erythromycin phosphate (25 mg/kg; 7). Four foals received both drugs with 2 weeks between treatments. Plasma erythromycin concentrations were determined at various times after drug administration by use of high-performance liquid chromatography. Maximum plasma peak concentrations, time to maximum concentrations, area under plasma concentration versus time curves, half-life of elimination, and mean residence times were determined from concentration versus time curves.
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Sectrophotometric analysis was used to determine the dissolution percentage of the tablets in vitro. High performance liquid chromatography and IBM/XT microcomputer was used to determine the bioavailability and pharmacokinetic parameters in vivo.
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Twelve trials with 1,720 participants met the inclusion criteria. Ten trials investigated treatment regimens and two investigated prophylaxis regimens. The quality of the trials was variable. Results showed that short-term antibiotics (azithromycin for three days, clarithromycin for seven days, or erythromycin estolate for seven days) were equally effective with long-term antibiotic treatment (erythromycin estolate or erythromycin for 14 days) in the microbiological eradication of Bordetella pertussis (B. pertussis) from the nasopharynx. The relative risk (RR) was 1.02 (95% confidence interval (CI) 0.98 to 1.05). Side effects were fewer with short-term treatment (RR 0.66; 95% CI 0.52 to 0.83). There were no differences in clinical improvement or microbiological relapse between short and long-term treatment regimens. Contact prophylaxis (of contacts older than six months of age) with antibiotics did not significantly improve clinical symptoms or the number of cases that developed culture positive B. pertussis.
Cefadroxil monohydrate, an oral cephalosporin with a long half-life, was compared to erythromycin estolate for efficacy in treating upper respiratory tract infections in children. The study was carried out on forty patients, twenty receiving cefadroxil and twenty receiving erythromycin. Each drug was dosed at 50 mg/kg/day and was given every 12 hours in two equally divided doses. The complete cure rate was 95% for the cefadroxil group and 80% for the erythromycin group. Two patients originally in the erythromycin test group showed no improvement either bacteriologically or clinically after 3 days of treatment. It was found that these patients harboured S. aureus which had become resistant to erythromycin during the course of therapy. Both patients were shifted to cefadroxil treatment and achieved complete cures. Two patients in the erythromycin group and one in the cefadroxil group were diagnosed as having scarlet fever. All three responded clinically, yet cultures from the two treated with erythromycin showed persistence of bacteria while the one treated with cefadroxil proved to be cured both clinically and bacteriologically.
Streptococcal eradication rates of 86% were demonstrated in 97 patients seen on day 14 and in 73 patients seen on both days 14 and 28 after a ten-day course of erythromycin estolate therapy given at a dosage of 20 mg/kg/day, administered in two equal doses. The efficacy of this regimen compares favorably with other results in which this and other erythromycin preparations have been employed at higher doses, usually in the range of 30 to 50 mg/kg/day. Our reported effectiveness at a lower than usual dose of erythromycin is probably explained by the following factors: the known susceptibility of group A streptococci to low concentrations of erythromycin, the uniform absorption of the estolate formulation of erythromycin, and adequate compliance in adhering to the treatment regimen by the majority of our patients. This dosage schedule of erythromycin is simple to administer; and a reduction by half of the total dose usually recommended provides an economical advantage for patients.
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The analyzed data were collected retrospectively and biopsies were not performed in all patients.
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The simultaneous determination of erythromycin propionate and erythromycin base in serum and urine by high-performance liquid chromatography using oleandomycin as internal standard is described. The separation was achieved on a reversed-phase C18 column employing acetonitrile-0.05 M phosphate buffer (65:35), adjusted to pH 7.0, as the mobile phase with coulometric detection. Hydrolysis of the ester during blood sample collection was minimised by immediate high-speed centrifugation of collected blood samples, followed by separation and immediate freezing of the serum fraction. A solid-phase extraction procedure, combined with a simple phase-separation step was used prior to chromatographic analysis. The method has the necessary precision, sensitivity and accuracy to allow the simultaneous determination of both components in serum and urine following a single 500-mg oral dose of erythromycin estolate.
ilosone drug study
The effects of a new semisynthetic macrolide, roxithromycin, on drug metabolizing enzymes of rat liver were compared with two erythromycins, the base (EB) and the estolate (EE), after 7 days' treatment with high oral doses (400 and 800 mg/kg daily). Dose-related higher concentrations of roxithromycin were reached in serum and liver than after EB or EE. The two reference erythromycins induced the synthesis of microsomal enzymes and formed inactive cytochrome P-450-metabolite complexes. N-Demethylation of erythromycin itself and aminopyrine was increased by the treatment. Liver microsomal enzyme activities were not induced and the inactive cytochrome P-450-metabolite complex was not formed after 400 mg/kg of roxithromycin and only to a very limited extent after 800 mg/kg (10% vs. 50% after EE). At the higher dose microsomal activities were not changed by roxithromycin and only aminopyrine N-demethylation was reduced.
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To study the benefits and risks of antibiotic treatment of and contact prophylaxis against whooping cough.
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In a randomized, prospective, multicenter trial, 227 children ranging in age from 3 to 17 years who had tonsillopharyngitis and a throat culture positive for group A beta-hemolytic streptococci (GABHS) were treated with erythromycin estolate (40 mg/kg/d in two divided doses for five days) or penicillin V (30 mg/kg/d in three divided doses for ten days). Clinical signs and symptoms of tonsillopharyngitis were recorded, and throat cultures were obtained before treatment as well as one to three days and six weeks after treatment. Clinical success (cure and improvement) was observed on days 6 to 8 in 100 of 102 (98%) assessable children treated with erythromycin estolate and on days 11 to 13 in 97 of 99 (98%) assessable children treated with penicillin V. Of all patients showing clinical success, 11 were rated as improved, all of whom were treated with erythromycin estolate. There was a trend towards increased use of analgesic treatment in the erythromycin estolate group (41% vs 33%). On completion of treatment, the rate of eradication of GABHS was 83.3% in the erythromycin estolate group compared with 87.9% in the penicillin V group. The difference is not significant but does not take into account patients excluded because of erythromycin resistance (3.7%). Clinical recurrence was observed in 11 (10.8%) patients treated with erythromycin estolate and in 6 (6.1%) patients treated with penicillin V (non-significant difference). Compliance in the erythromycin estolate group was statistically superior to that in the penicillin V group. The incidence and nature of adverse events were similar in both treatment groups.
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Multicenter, parallel group, double blind trial in which patients 6 months to 16 years of age with community-acquired pneumonia were randomized 2:1 to receive either azithromycin for 5 days or conventional therapy for 10 days (amoxicillin/clavulanate if < or =5 years of age or erythromycin estolate if >5 years of age). Patients from 23 geographically diverse sites were evaluated for clinical outcomes and/or adverse events at Days 3 to 5, Days 15 to 19 and 4 to 6 weeks posttherapy. Microbiology (culture or polymerase chain reaction) was done at baseline and Days 15 to 19 for bacteria, Chlamydia pneumoniae and Mycoplasma pneumoniae. Serology for C. pneumoniae and M. pneumoniae was done at baseline and 4 to 6 weeks posttherapy.
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Erythromycin is frequently prescribed in Germany for acute otitis media, but well-designed clinical trials under present epidemiological conditions are lacking. Therefore, a double-blind, randomized, multicenter trial was performed to compare the clinical efficacy and safety of erythromycin estolate versus amoxicillin in children with acute otitis media and to identify the risk factors associated with clinical failure. Investigators from 19 centers throughout Germany recruited 302 children with clinical, otoscopic, and tympanometric evidence of acute otitis media. In a double-blind fashion, patients were allocated randomly to a 10-day course of erythromycin estolate at 40 mg/kg/day in two divided doses or amoxicillin at 50 mg/kg/day in two divided doses. Clinical examinations, otoscopy, and tympanometry were performed at baseline, day 3-5, day 9-11, and at 5 weeks. Clinical outcome was assessed on day 9-11. Two-hundred eighty children were evaluable for efficacy (erythromycin group, 141; amoxicillin group, 139). Both groups were comparable with respect to demographic data and severity of disease at entry. Treatment was successful in 94% of the erythromycin-treated patients and in 96% of the amoxicillin-treated patients. Clinical outcome was statistically equivalent between groups within a range of 7 percentage points. Clinical recurrence was seen in eight erythromycin-treated children (5.7%) and in seven amoxicillin-treated children (5.0%) (P=0.81). Patients with bilateral disease at entry were at higher risk of unfavourable outcome, whereas age and presence/absence of otorrhea at entry were not associated with outcome. Treatment-related adverse events were recorded in eight (5.3%) of 151 erythromycin-treated patients and in 11 (7.3%) of 151 amoxicillin-treated patients. In this study in an outpatient setting in Germany, erythromycin estolate was as safe and effective as amoxicillin in the treatment of acute otitis media. Both drugs can be administered in a convenient twice-daily dosage schedule.
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All household contacts of 152 children with culture-positive pertussis who provided consent (n = 362). After withdrawals, there were 135 households with 310 contacts. Exclusions included pregnancy, age <6 months, already receiving an erythromycin-containing antibiotic, and erythromycin allergy. INTERVENTUINS: Erythromycin estolate (40 mg/kg/day in 3 divided doses; maximum dose 1 g) or placebo for 10 days. Nasopharyngeal cultures, pertussis antibodies, and clinical symptoms were assessed before and after treatment.
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Sesbania grandiflora, commonly known as 'sesbania', is widely used in Indian folk medicine for the treatment of liver disorders. Oral administration of an ethanolic extract of S. grandiflora leaves (200 mg/kg/day) for 15 days produced significant hepatoprotection against erythromycin estolate (800 mg/kg/day)-induced hepatotoxicity in rats. The increased level of serum enzymes (aspartate transaminase, alanine transaminase, alkaline phosphatase), bilirubin, cholesterol, triglycerides, phospholipids, free fatty acids, plasma thiobarbituric acid reactive substances and hydroperoxides observed in rats treated with erythromycin estolate were significantly decreased in rats treated concomitantly with sesbania extract and erythromycin estolate. The sesbania extract also restored the depressed levels of antioxidants to near normal. The results of the study reveal that sesbania could afford a significant protective effect against erythromycin estolate-induced hepatotoxicity. The effect of sesbania was compared with that of silymarin, a reference hepatoprotective drug.
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Two studies of 100 healthy volunteers requesting sterilization were planned, one in Julpia Andhermanik and the other in Kolkata (Calcutta). A readily available marketed tablet preparation containing 500 mg of the estolate salt of erythromycin was used for the trial. In one study (Bishnupur), the tablet was crushed before placing in a copper-T IUD inserter for placement at the fundus. In the other study (Kolkata), crushed tablets were processed into 50 mg pellets of the same diameter as standard quinacrine pellets and 10 pellets were inserted at the fundus using aseptic precautions. Procedures in each study were repeated at 30 days. Oral contraceptives were prescribed for three cycles following first insertion. No incentive was offered for participation in the trial. Follow-up treatment, including first-trimester abortion for pregnancy due to failure of the sterilization procedure, was assured without charge. Due to extraordinary patient demand, one study (Bishnupur) was expanded to 690 cases for reasons of compassion.
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During a 24-month period, throat-swab cultures were obtained on 1,362 well children who were 3 months to 14 years of age. The overall incidence of positive cultures for group-A beta-hemolytic Streptococcus was 3.3%; in those children older than 1 year, it was 4.4%. The largest incidence of positive cultures occurred in the 5- to 7-year-old (8.3%) and 8- to 10-year-old (4.5%) age groups. No positive cultures were obtained from 339 infants younger than 1 year of age. There was no relation between positive cultures and the month of the year. There were no significant differences between the age, sex, presence of tonsils, previous group-A streptococcal infections, or the presence in a daycare center or school of children with positive cultures compared with those children with negative cultures. Follow-ups were obtained on 29 of 45 children with positive throat cultures; all of the children were asymptomatic and had normal results of physical examinations. Group-A streptococci of the same serotype as the original isolate were isolated from 19 of these children. Three to four days after a ten-day course of erythromycin estolate, five of 19 children again had positive cultures. Twenty-six of the 29 children had a total of 43 siblings residing in the home. Serotypically identical group-A streptococci were isolated from five siblings (11%). Only one of 29 patients from whom paired serum samples were obtained showed a fourfold rise or fall in the Streptozyme titers.
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Preterm birth is a significant obstetric problem in high-income countries. Genital infection including ureaplasmas are suspected of playing a role in preterm birth and preterm rupture of the membranes. Antibiotics are used to treat women with preterm prelabour rupture of the membranes and results in prolongation of pregnancy and lowers the risks of maternal and neonatal infection. However, antibiotics may be beneficial earlier in pregnancy to eradicate potentially causative agents.
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Certain macrolide antibiotics, such as troleandomycin (TAO), oleandomycin, and erythromycin estolate (Ilosone), can lower the maintenance dose of glucocorticoids required by severely asthmatic patients. These effects were postulated to be caused by an as yet undefined steroid-sparing effect. In this study, TAO in combination with methylprednisolone, when compared with methylprednisolone alone, was demonstrated to significantly increase liver glycogen deposition in adrenalectomized mice, intact mice, and adrenalectomized rats; protect histamine-sensitized mice following beta adrenergic blockade or adrenalectomy; further decrease the steroid-lowered glucose tolerance of mice and significantly increase the plasma corticosteroid levels in rats. TAO alone did not have these effects. TAO plus betamethasone, and erythromycin estolate plus methylprednisolone also increased liver glycogen deposition. However, TAO did not appear to potentiate the effects of hydrocortisone. Erythromycin stearate and to a lesser degree erythromycin ethylsuccinate when combined with methylprednisolone also decreased histamine lethality in mice. Leucomycin and tetracycline did not enhance the effects of methylprednisolone. TAO, alone or with methylprednisolone, did not alter serum glutamic oxaloacetic transaminase (SGOT) levels in rats. Thus, TAO and some other macrolides did not exert their effects on corticosteroids as antimicrobial agents, adrenocorticotropic hormone (ACTH)--like compounds, or quasisteroids, but as steroid-sparing agents by some undefined mechanism.
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Chlamydia trachomatis is an obligate intracellular parasite responsible for many clinical syndromes, including neonatal conjunctivitis and pneumonia. The gold standard of diagnosis has been isolation in cell culture. However, this requires days of processing. Several rapid diagnostic tests are available. Giemsa staining of conjunctival smears, enzyme immunoassay, and the fluorescein-conjugated monoclonal antibody test. Both the EIA and the FA tests show promise as ideal rapid diagnostic tests. Treatment of chlamydial conjunctivitis must focus upon the eradication of nasopharyngeal carriage as well as cure of ophthalmic symptoms. The need for nasopharyngeal eradication is underscored by the fact that it is the source for chlamydial pneumonia as well as for conjunctival re-infection. Clinical studies have shown that oral erythromycin estolate or ethylsuccinate suspension 50 mg/kg/day twice-daily or four times a day for 14 to 21 days are the therapeutic regimens of choice. Neonatal ocular prophylaxis is currently under study. One per cent silver nitrate does not prevent chlamydial conjunctivitis but preliminary studies do show favorable results with topical erythromycin. Nevertheless, neither 1 per cent silver nitrate nor topical erythromycin eradicate nasopharyngeal carriage, elimination of which is necessary for the prevention of neonatal chlamydial pneumonia.
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Based on our results brand name oral antibiotic formulations do not necessarily taste better than their generic counterparts.
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The MIC(50/90) (mg/L) and MPC(50/90) (mg/L), respectively, were as follows: azithromycin 0.13/0.25 and 1/4; clarithromycin 0.031/0.063 and 0.13/0.5; erythromycin 0.063/0.13 and 0.25/2. We calculated from published pharmacokinetic values that the AUC(24)/MPC(90) for azithromycin was 0.85; for clarithromycin it was 96, and for erythromycin base and estolate it was 4 and 10, respectively. Thus the AUC(24)/MPC(90) was about 50 times higher for clarithromycin than for azithromycin.