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Enteral suspension of nifedipine for neonates. Part 1. Formulation of nifedipine suspension for hospital use.

OBJECTIVE: To formulate an oral suspension of nifedipine for paediatric use and to assess its content uniformity as well as the microbiological and physical stabilities of the hypromellose solution that was used in the formulation. METHOD: Six concentrations (0.5-3.0%) of hypromellose colloids and water as a blank were compounded with nifedipine, both as a powder and as crushed tablets, to a concentration of 1 mg/mL. Four different screening tests were used to find the most homogenous and dose-accurate combination. First, nifedipine suspensions were stored in vials for one month and visual homogenity of the redispersed suspensions was observed. Second, the homogenity of the suspensions was studied by measuring the nifedipine concentration from upper, middle and lower parts of the redispersed suspension. Next, the nifedipine concentration was measured from the suspensions immediately, 1 min and 2 min after shaking to ensure dose accuracy during the administration period. Finally, suspensions were packaged into oral disposable syringes and nifedipine concentrations were determined after one month of storage. Content uniformity of the packaged single-dose syringe suspensions was studied according to a method established by the European Pharmacopoeia. Microbiological stability, density, pH, osmolality, viscosity and surface tension of the hypromellose solution were studied over a 12-month storage period. RESULTS: From the results of the screening tests of hypromellose solution, 1.0% hypromellose was chosen as the vehicle for nifedipine enteral suspensions, made from both crushed tablets and nifedipine powder. Nifedipine suspensions made from hypromellose 1.0% were easiest to redisperse as a homogenous solution, and it also appeared best on visual inspection. The content uniformity of the suspension complied with the test recommended by the European Pharmacopoeia. The 1.0% hypromellose solution was found to be microbiologically stable for 6 months and physically stable for 12 months.

Calcium Channel Blockers↗

Experience with suprapubic vesicourethral suspension and endoscopic suspension of the vesical neck for stress urinary incontinence in females.

The morbidity and efficacy of suprapubic vesicourethral suspension and endoscopic suspension of the vesical neck for correction of stress urinary incontinence in females were analyzed. Between 1974 and 1981, 41 women were treated with the former procedure and between 1981 and 1984, 50 were treated with the latter. The two treatment groups were well matched with respect to age, duration of incontinence, grade of incontinence, previous unsuccessful anti-incontinence surgical procedures and experience of the operating surgeon. The incidences of excessive intraoperative blood loss, postoperative abdominal complications and late complications in the suprapubic suspension group were 7, 14 and 2 per cent, respectively, and in the endoscopic suspension group, zero, zero and 2 per cent, respectively. The mean duration of postoperative hospitalization in the suprapubic suspension and the endosocpic suspension groups were 9.4 and 6.9 days, respectively. Seventy-three per cent of the patients treated by suprapubic suspension (mean duration of follow-up 71 months) and 86 per cent of the patients treated by endoscopic suspension (mean duration of follow-up 19 months) were cured. We conclude that the morbidity of endoscopic suspension is less than that of suprapubic suspension and that the early results of endoscopic suspension are equivalent.

Adult↗

Enteral suspension of nifedipine for neonates. Part 2. Stability of an extemporaneously compounded nifedipine suspension.

OBJECTIVE: To investigate the chemical, microbiological and physical stability of an extemporaneously prepared nifedipine oral suspension, packaged in disposable syringes and prepared in a hospital pharmacy for paediatric use. METHODS: Two different suspensions were prepared, from nifedipine tablets and drug powder, by using an autoclaved 1.0% solution of hypromellose as the vehicle. The final theoretical drug concentration was 1 mg/mL. Doses of 1.0 ml were packaged into a 2 ml syringe with a cap. Nifedipine suspensions were stored under three conditions: at room temperature (22 degrees C), in a refrigerator (6 degrees C) protected from light, and at room temperature (22 degrees C) exposed to artificial daylight (400 lux) under controlled circumstances. The nifedipine concentration was measured in suspensions protected from light on days 0, 1, 3, 5, 7, 14, 21 and 28, and in suspensions exposed to light at 0, 3, 6, 18 and 24 h, and on days 2, 3, 5 and 7 after preparation. Nifedipine was analysed by a reproducible and validated stability-indicating HPLC-method. Microbiological and physical stability of the nifedipine suspension samples protected from light were examined for 28 days. RESULTS: Mean nifedipine concentration remained over 90% of the initial concentration throughout the 4-week study period in light-protected unit-dose suspensions, prepared from either crushed tablets or drug powder with hypromellose 1.0%. When exposed to light, however, nifedipine decomposed rapidly. Photodegradation of nifedipine exceeded 25% within 3 h and was essentially complete within 7 days. CONCLUSION: In the University Hospital of Kuopio, newborns have been treated with nifedipine suspension prepared from tablets, and preliminary experiences with administration of suspension have been encouraging. It may also be possible to apply this methodology to other medicines used in paediatrics.

Calcium Channel Blockers↗

Novel face-lift suspension suture and inserting instrument: use of large anchors knotted into a suture with attached needle and inserting device allowing for single entry point placement of suspension suture. Preliminary report of 20 cases with 6-to 12-month follow-up.

BACKGROUND: Various suspension suture techniques exist to elevate the mid-face, jowls, and neck. OBJECTIVE: To assess safety and efficacy of a new suspension suture and inserting instrument with both standard and minimal incision (no-skin-excision) face-lifts. METHODS: A new type of multianchor suspension suture assembled from commercially available 2-0 absorbable monofilament material, with 5 to 9 equally spaced knots through which are secured 7 to 9 mm bits of 0 thickness similar suture material, and an attached straightened needle, was used to elevate and suspend facial tissues to temporal or mastoid fascia. The suspension sutures are placed in the deep subcutaneous tissues, just above the superficial musculo aponeurotic system (SMAS), by use of a novel, blunt instrument, which does not require a second, distal exit point. The suspension suture distal end floats free. The proximal needle end is sutured to fascia. The suture was used on 20 patients. Fourteen of them underwent pure, "no-skin-excision," suspension lifts. Six had suspension suture elevation of the mid-face in conjunction with relatively conservative open lifts. Nine- to 12-month results were evaluated. RESULTS: With open face-lifts, 9- to 12-month results are excellent with significant persistence of the correction initially achieved. Resulting scars remained fine line. There were no complications. With pure suspension lifts, initial results were impressive. By 6 months, correction started to fade. By 12 months 100% of initial correction for jowls, and 80 to 100% for mid-face, appeared lost. Recovery time was 2 to 4 days. There were no significant complications. CONCLUSION: Large multianchor, absorbable monofilament sutures can safely and effectively enhance results of conservative lifts, with remarkable elevation of the mid-face not achievable with simple SMAS flaps. These suspension sutures can easily and safely achieve impressive, though relatively short-term results, with a minimal incision, "no-skin-excision" technique.

Female↗

Oral bioequivalence of three ciprofloxacin formulations following single-dose administration: 500 mg tablet compared with 500 mg/10 mL or 500 mg/5 mL suspension and the effect of food on the absorption of ciprofloxacin oral suspension.

The oral bioequivalence and tolerability of two ciprofloxacin formulations (tablet and suspension) and the effect of food on the absorption of ciprofloxacin oral suspension were investigated. Sixty-eight young, healthy male subjects participated in two separate, randomized, crossover studies. In study 1, ciprofloxacin as a single 500 mg tablet or as 500 mg/10 mL oral suspension was administered in a fasted state on day 1. In study 2, subjects participated in a three-way crossover study in which ciprofloxacin suspension was administered as 500 mg/10 mL in a fasted state, or 500 mg/10 mL with food, or 500 mg/5 mL in a fasted state. Plasma ciprofloxacin concentrations were measured by high-performance liquid chromatography. Standard pharmacokinetic parameters were estimated using non-compartmental methods. In study 1, geometric mean Cmax values of ciprofloxacin following the single 500 mg tablet and 500 mg/10 mL suspension doses were 2.36 and 2.18 mg/L, respectively; corresponding geometric mean t(max) values were 1.1 and 1.6 h, respectively. Geometric mean AUC(0-infinity) values were 12.0 and 11.8 mg x h/L, respectively. In study 2, geometric least squares mean Cmax values following ciprofloxacin 500 mg/10 mL and 500 mg/5 mL suspension during fasted conditions were 1.54 and 1.59 mg/L, respectively. Corresponding geometric least squares mean AUC(0-infinity) values were 7.3 and 8.0 mg x h/L. Administration of ciprofloxacin 500 mg/10 mL suspension, in either a fasted or fed state, was not associated with significant changes in Cmax (1.54 mg/L for fasted vs 1.37 mg/L for fed) or AUC(0-infinity) values (7.28 mg x h/L for fasted vs 8.19 mg x h/L for fed). Each ciprofloxacin formulation was well tolerated for the duration of each study. These studies demonstrated bioequivalence between ciprofloxacin 500 mg tablet and two strengths of ciprofloxacin suspension (500 mg/10 mL and 500 mg/5 mL). Bioavailability was unaltered by food.

Administration, Oral↗

Course of pH during the formation of amoxicillin by a suspension-to-suspension reaction.

Amoxicillin can be produced in an enzymatic suspension-to-suspension reaction in which the substrate(s) and product(s) are mainly present as solid particles, while the reaction takes place in the liquid phase. During these suspension-to-suspension reactions different subprocesses take place, such as dissolution/crystallization of substrates and products, enzymatic synthesis of the product(s), and undesired enzymatic hydrolysis of substrates and/or products. All these subprocesses are influenced by pH and also influence the pH because the reactants are weak electrolytes. This paper describes a quantitative model for predicting pH and concentrations of reactants during suspension-to-suspension reactions. The model is based on mass and charge balances, pH-dependent solubilities of the reactants, and enzyme kinetics. For the validation of this model, the kinetically controlled synthesis of amoxicillin from 6-aminopenicillanic acid and D-(p)hydroxyphenylglycine methyl ester was studied. The pH and the dissolved concentrations took a very different course at different initial substrate amounts. This was described quite reasonably by the model. Therefore, the model can be used as a tool to optimize suspension-to-suspension reactions of weak electrolytes.

Journal Article↗

Optical properties of myofibril and actomyosin suspensions. 1. Angular dependence of light scattering by myofibril suspensions and its changes under myofibril contraction.

The angular dependence of light scattering by myofibril suspensions has been measured within the angle range of 0.05 degrees and 160 degrees at different suspension concentrations and wavelengths. Angular diagrams appear to be highly asymmetry, and extended forward in the direction of the primary light propagation. A suspension with the concentration of 0.1 mg/ml at 550 nm scatters, for example, no less than 90% light at angles of less than 6 degrees. The scattering diagram becomes less asymmetric upon increasing the suspension concentration and decreasing the wavelength of the light. Upon addition of MgATP in the presence of Ca2+, a myofibril suspension undergoes two kinds of optical change, namely, fast ones corresponding to myofibril contraction, and slow ones correlating with the subsequent aggregation of the contracted myofibrils. Fast changes are believed to be due to the increase of the refractive index of the contracting myofibrils, and slow changes to the increase in the size of the suspension particles resulting from aggregation. Light scattering by myofibril and actomyosin suspensions seems to be due not only to the particle as a whole, but also to its internal structure.

Actomyosin↗

Physical properties of microbial suspensions. II. Properties of microbial suspensions and their supernatants during fermentation conditions.

Physical properties of suspensions of Saccharomyces cerevisiae, Candida utilis and Escherichia coli (density, viscosity and surface tension) were measured in synthetic suspensions formed of centrifuged biomass and supernatants from various stages of batch cultivation in the range from 0 to 10% w/v for yeasts and from 0 to 0.25% w/v for bacteria. Surface tension was also measured in native suspensions in the range of 0 less than or equal to Cm less than or equal to 2.0% w/v. All single cell suspensions were found to be Newtonian in behaviour. Densities strictly obey the mixing law, viscosities of Saccharomyces cerevisiae suspensions were correlated by an empirical relation in dependence of Cm and t, surface tensions were correlated graphically for suspensions of Saccharomyces cerevisiae and Escherichia coli, since experiments with both microorganisms have shown that the previously published approximate correlation can safely be used.

Candida↗

Assessment of drug salt release from solutions, suspensions and in situ suspensions using a rotating dialysis cell.

A rotating dialysis cell consisting of a small (10 ml) and a large compartment (1000 ml) was used to study the release of drug salt (bupivacaine 9-anthracene carboxylate) from (i). solutions, (ii). suspensions and (iii). in situ formed suspensions. Initial release experiments from suspensions indicated that the release of drug salt in deionized water was predominantly limited by the diffusion across the membrane whereas it is essentially dissolution rate controlled in 0.05 M phosphate buffer (pH 7.40). Thus, the in vitro model appears to have a potential in formulation screening when phosphate buffer is used as release media. Generally, the initial release of the drug salt from in situ suspensions occurred faster as compared to conventional suspensions, probably due to incomplete precipitation of the drug salt, and hence formation of supersaturated solutions where the rate of release is predominantly determined by the concentration gradient. However, when an adequately concentrated solution of the drug salt was used to prepare the in situ suspension, the initial fast release was followed by a substantial sustained release indicating that the release had become dissolution rate limited.

Anesthetics, Local↗

Clinical comparison of cefuroxime axetil suspension and amoxicillin/clavulanate suspension in the treatment of pediatric patients with acute otitis media with effusion.

Two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle-ear fluid obtained by use of tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime axetil suspension and amoxicillin/clavulanate suspension, in the treatment of children 3 months to 12 years old diagnosed with acute otitis media with effusion (AOME). Four hundred seventy-seven pediatric patients with signs and symptoms of AOME were enrolled at 20 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanate suspension 40 mg/kg per day in three divided doses (n = 242). Patients were assessed for their response to treatment once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 4 days and at 14 to 18 days). In the study that included tympanocentesis, bacteriologic assessments were based on middle-ear fluid cultures obtained pretreatment, and, when possible, posttreatment in patients with an unsatisfactory clinical outcome. Organisms were isolated from the pretreatment middle-ear fluid specimens of 120 (73%) of 164 patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae. Haemophilus influenzae, and Moraxella catarrhalis (27%, 24%, and 6% of isolates, respectively). Forty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was obtained in 70% of clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.40). With respect to the eradication of bacterial pathogens, in the study that included tympanocentesis a satisfactory outcome (cure or presumed cure) was obtained in 84% (32 of 38) and 95% (36 of 38) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.26). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (37% vs 16%; P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs 12%; P < 0.001), particularly diarrhea. Eight patients in the cefuroxime axetil group and 11 patients in the amoxicillin/clavulanate group withdrew from the studies because of drug-related adverse events. These results indicate that cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in the treatment of pediatric patients with AOME, but produces fewer gastrointestinal adverse events, particularly diarrhea.

Amoxicillin↗

Efficacy and safety of ciprofloxacin oral suspension versus trimethoprim-sulfamethoxazole oral suspension for treatment of older women with acute urinary tract infection.

OBJECTIVES: To compare the efficacy and safety of ciprofloxacin (CIP) oral suspension to trimethoprim/sulfamethoxazole (TMP/SMX) oral suspension among older women with acute urinary tract infections (UTIs). DESIGN: Prospective, randomized, open-label, multicenter study of older women (age 65 and older). SETTING: Community and nursing home. PARTICIPANTS: A total of 261 older women were evaluable for safety. Of these, 172 (86 community, 86 nursing home) were evaluable for clinical and bacteriological efficacy. INTERVENTION: Patients were randomized to a 10-day regimen of either CIP (250 mg/5 mL twice daily) or TMP/SMX (160/800 mg/20 mL twice daily). MEASUREMENTS: Clinical response 4 to 10 days posttherapy. RESULTS: For the efficacy-valid population, posttherapy clinical resolution was statistically superior following CIP (97%) versus TMP/SMX (85%) (95% CI=2.0-21.3; P= .009). Eradication of pretreatment bacterial isolates posttherapy was also higher following CIP (95%) versus TMP/SMX (84%) (95% CI=2.7-21.3; P= .019). For the intent-to-treat population, posttherapy clinical resolution was significantly higher in the CIP group (96%) than in the TMP/SMX group (87%) (95% CI=0.2-16.7; P= .025). Safety was assessed in the intent-to-treat population and the incidence of drug-related adverse events were significantly lower following CIP (17%) than following TMP/SMX (27%) (P= .047). Premature discontinuation due to these events was also less prevalent with CIP than with TMP/SMX (2% vs 11%, respectively) (P= .004). CONCLUSION: CIP suspension showed higher clinical success and bacteriological eradication rates than did TMP/SMX for both community-based and nursing home-residing older women with acute UTIs. Furthermore, CIP suspension was associated with significantly lower rates of adverse events and premature discontinuations compared with TMP/SMX suspension.

Acute Disease↗

Oesophageal bioadhesion of sodium alginate suspensions 2. Suspension behaviour on oesophageal mucosa.

Sodium alginate suspensions in a range of water miscible vehicles were investigated as novel bioadhesive liquids for targeting the oesophageal mucosa. Such a dosage form might be utilised to coat the oesophageal surface and provide a protective barrier against gastric reflux, or to deliver therapeutic agents site-specifically. Alginate suspensions swelled and formed an adherent viscous layer on contact with the mucosa. The swelling kinetics of alginate particles on the oesophageal surface was examined with respect to vehicle composition and related to the extent, duration and location of bioadhesion within the oesophagus. Mucosal retention was evaluated in two in vitro models utilising tissue immersion and a peristaltic tube. By varying the vehicle composition it was possible to modulate the rate of swelling of alginate particles on the mucosa and the mucosal retention of suspensions. Suspensions containing predominantly glycerol exhibited superior retention and were preferentially retained within the lower oesophagus. The propensity of these suspensions to rapidly swell on the mucosa and establish adhesive/cohesive bonds may explain their enhanced retention. The potential to control, through vehicle composition, the extent, duration and location of oesophageal retention could provide a useful tool for site targeting of viscous polymers to the oesophagus.

Adhesives↗

Selecting suspension points and excising the vagina during Michigan four-wall sacrospinous suspension.

OBJECTIVE: To describe the variations in the location of the vaginal apex and the length of vagina excised in women undergoing the Michigan four-wall sacrospinous suspension for posthysterectomy vaginal vault prolapse. METHODS: A prospective observational study of 76 women who had the Michigan modification sacrospinous suspension performed between 1998 and 2001 for posthysterectomy vaginal vault prolapse was carried out. Demographics and preoperative, operative, and postoperative findings were noted, including the pelvic organ prolapse quantification score. The locations of the suspension points relative to the hysterectomy scar were recorded. The amount of vagina excised at surgery and the pre- and postoperative vaginal lengths are reported. RESULTS: The mean length and standard deviation of vagina excised was 4.6 +/- 2.5 cm. The apex created at sacrospinous fixation was at the hysterectomy scar in only seven women (9%). It was most often situated behind the hysterectomy scar, in 58 cases (76%); it was situated in front of it in 11 (14%). In seven women no vagina was excised, and in the remaining 69 women a mean length of 5.1 +/- 2.2 cm was removed. The mean vaginal lengths were 9.7 +/- 1.7 cm preoperatively and 9.4 cm +/- 0.8 postoperatively, a 0.3-cm difference. CONCLUSION: When one performs the Michigan modification sacrospinous suspension, the chosen suspension points are often not at the hysterectomy scar, and in women with large prolapses excess vagina frequently is excised without compromising postoperative vaginal length.

Aged↗

METABOLISM OF TISSUE CELLS IN SUSPENSION. SYNTHESIS OF RIBONUCLEIC ACID BY LEIVER CELLS IN SUSPENSION.

1. Liver cells in suspension are shown to incorporate several RNA precursors into their RNA. 2. The incorporation of [(32)P]phosphate and [(14)C]adenine into the RNA of the cell suspension is usually of the same order as that in the perfused (or unperfused) liver slices. However, the initial lag in the incorporation of adenine into the RNA of the cell suspensions is much longer than that obtained for the tissue slices, and the optimum incorporation of adenine in the former, unlike that in the latter, needs exogenous glucose and probably a high concentration of phosphate. 3. The cell suspensions also differ from the tissue slices in being unable to incorporate [(14)C]orotic acid into their RNA, and resemble tumour tissues in incorporating uracil into their RNA at a rate significantly higher than that obtained with the tissue slices. 4. The above differences in the metabolic behaviour of liver-cell suspensions and tissue slices are considered to be due to the different levels of organization of the liver cells in the two tissue preparations.

Adenine↗

A comparison of fluconazole oral suspension and amphotericin B oral suspension in older patients with oropharyngeal candidosis. Multicentre Study Group.

BACKGROUND: the optimum treatment for oropharyngeal candidosis, particularly in older patients, has not been established. Local treatment with nystatin and amphotericin B can be problematic. The oral suspension formulation of fluconazole may offer a good alternative to these conventional agents. OBJECTIVE: to compare the safety and efficacy of fluconazole oral suspension with amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis. DESIGN: randomized open-label study. PATIENTS: three hundred and five patients, aged 62 or older, with at least one sign or symptom of oropharyngeal candidosis. METHODS: we evaluated patients for the signs and symptoms of candidosis before receiving the study drug and on days 4, 7 and 14. We assessed patients who were cured or improved after 7-14 days of treatment 2 weeks after the end of treatment (follow-up). We obtained specimens from buccal lesions for microscopic examination (baseline only) and culture at baseline and on days 7 and 14. Patients were evaluated for adverse events on days 4, 7 and 14. RESULTS: one hundred and fifty patients received fluconazole and 155 received amphotericin B. There were no statistically significant differences in clinical or mycological response between fluconazole and amphotericin B at the end of treatment or at follow-up. At the end of treatment, 122 (81%) of 150 fluconazole-treated and 135 (87%) of 155 amphotericin B-treated patients were clinically cured or improved. Mycological cure rates were 35% and 46% for fluconazole and amphotericin B, respectively. The symptoms of burning sensation and buccal pain resolved significantly sooner (P < 0.05) in fluconazole-treated patients. The presence of dentures did not affect the response to antifungal therapy. The incidence of adverse events was 46% in the fluconazole group and 50% in the amphotericin B group (not statistically significant). CONCLUSION: fluconazole oral suspension is a good therapeutic alternative to amphotericin B oral suspension in the treatment of older patients with oropharyngeal candidosis.

Administration, Oral↗

Intracerebral grafting of neuronal cell suspensions. IV. Behavioural recovery in rats with unilateral 6-OHDA lesions following implantation of nigral cell suspensions in different forebrain sites.

Single and multiple implants of nigral cell suspensions were grafted to the forebrains of rats with unilateral 6-hydroxydopamine-induced dopamine denervations. Control lesions alone induced a marked behavioural asymmetry, as assessed by amphetamine- and apomorphine-induced rotation, sensorimotor tests and side bias in an unbaited T-maze, and the animals were hyperactive to a low dose of apomorphine. Single suspension placements into different denervated striatal regions were capable of reversing the behavioural asymmetries dependent upon the specific placement for each test. Multiple suspension grafts were capable of reversing all behavioural asymmetries, and additionally abolished the supersensitive hyperactivity to apomorphine. By contrast, single suspension grafts placed into the substantia nigra or lateral hypothalamus had no detectable effect on any functional measure. The results indicate that nigral suspension grafts can be at least as effective as solid grafts in reversing the functional deficits induced by dopamine denervation, provided that placements are selected within appropriate dopamine terminal regions of the forebrain (e.g. caudate-putamen or nucleus accumbens).

Animals↗

Efficacy of cefuroxime axetil suspension compared with that of penicillin V suspension in children with group A streptococcal pharyngitis.

The bacteriological and clinical efficacies of cefuroxime axetil suspension (20 mg/kg of body weight per day in two divided doses) were compared with those of penicillin V suspension (50 mg/kg/day in three divided doses) in a multicenter, randomized, evaluator-blinded study. Children aged 2 to 13 years with clinical signs and symptoms of acute pharyngitis and a positive throat culture for group A beta-hemolytic streptococci (GABHS) were eligible. Patients were assessed and samples from the throat for culture were obtained at the time of diagnosis, 3 to 7 days after the initiation of treatment, and 4 to 8 days and 19 to 25 days after the completion of 10 days of therapy. Of the 385 evaluable patients, GABHS were eradicated from 244 of 259 (94.2%) cefuroxime-treated patients and 106 of 126 (84.1%) penicillin-treated patients (P = 0.001). Complete resolution of the signs and symptoms present at the time of diagnosis was achieved in 238 of 259 (91.9%) cefuroxime-treated patients and 102 of 126 (81.0%) penicillin-treated patients (P = 0.001). Potential drug-related adverse events were reported in 7.0 and 3.2% of the cefuroxime- and penicillin-treated patients, respectively (P = 0.078). In the present study, cefuroxime axetil suspension given twice daily resulted in significantly greater bacteriological and clinical efficacies than those of penicillin V suspension given three times daily to pediatric patients with acute pharyngitis and a positive throat culture for GABHS.

Acute Disease↗

Astemizole suspension in the maintenance treatment of paediatric hay fever: a comparison with terfenadine suspension.

A study was carried out in general practice during the summer months of 1985 to compare the efficacy and tolerance of astemizole suspension with terfenadine suspension in the treatment of paediatric hay fever. The 65 patients who entered the study were all aged between 6 and 12 years and had suffered from hay fever in at least one previous season. Each child was randomly allocated to receive either 5 ml astemizole suspension (1 mg/ml) once daily or 5 ml terfenadine suspension (6 mg/ml) twice daily for a period of 8 weeks on a single-blind basis. Symptom scores assessed by the patient (or parent/guardian) on two visual analogue scales for ocular and nasal symptoms showed no significant difference between the treatment groups, neither did an analysis of visual analogue scores for runny nose, blocked nose, wheeze, sneezing or eye symptoms assessed by the investigator on entry or after 4 and 8 weeks. The global assessments made by the investigator at 4 weeks and the patient at 8 weeks, however, indicated significantly better overall symptom control in the astemizole group. Both treatments were well tolerated, side-effects being few and minor.

Astemizole↗