Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0040425 (tonsillitis)
 1,594 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Amoxicillin granule (100 mg AMPC potency per 1.0 g granule) was administered to pediatric patients with the following results. 1) AAMPC serum concentration and the urinary recovery of two preparations (Clamoxyl 'Beecham' and Sawacillin 'Fujisawa') granule were compared in a cross over trial in 5 healthy adult volunteers. No significant difference in the results was observed between the two granules. 2) The peak serum concentration after oral administration of 10 mg/kg AMPC to 5 children gave an average of 5.06 mug/ml 1 hour after administration. The 6-hour urinary excretion was distributed 51.4 approximatley 78.9%. 3) AMPC was administered at a dose of about 20 mg/kg/day to 35 children with acute pediatric infections that is scarlet fever, acute tonsillitis, tonsillitis lacunalis, acute bronchitis, bronchial asthma +bronchitis and infectious impetigo. An effective therapeutic result was obtained in all cases. 4) The granule was well accepted by young children, and at a dose level of about 20 mg/kg/day for a week no disorder on hepatorenal function was observed in any og the patients.
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PMID:[Clinical investigation of amoxicillin (clamoxyl 'Beecham') granules in pediatrics (author's transl)]. 104 99

Authors compared the efficacy and safety of 10-day regimen of Cefaclor (CEC), oral suspension, at the dose of 25 mg/kg BID, and Amoxicillin/clavulanic acid (AMC), and Erythromycin (E) both given TID at the dose of 15 mg/kg in the treatment of proven group A beta hemolytic streptococcal pharyngo-tonsillitis. Of the 673 enrolled pediatric patients, 245 were selected and assigned to three groups of treatment (85 received CEC, 78 received AMC and 82 received E) and 217 were evaluated for efficacy. Clinical evaluations were performed on days 5 and 10 of treatment and 20 days after its completion (follow up). Before treatment, on treatment day 10 and at follow up throat swab cultures were performed. In evaluable patients the post-therapy clinical success and bacteriological eradication rate for CEC was 91.8% (68 of 74 evaluable patients); the rate for AMC and E were 90.5% (67/74) and 76.8% (53/69) respectively. At follow up bacteriological eradication was observed in 63 of 68 clinically cured patients (92.6%) in the CEC treatment group; in 64 of 67 (95.5%) in the AMC treatment group and in 49 of 53 (92.4%) in the E treatment group. Adverse events occurred in 24 of 217 (11.05%) treated patients and the incidence of side effects was lower in CEC group. In vitro sensitivity tests showed 37.9% of isolated SBEGA strains resistant to macrolides and 32% of SBEGA strains resistant to tetracycline. In our experience Cefaclor administered BID is as effective and more safe than Amoxicillin/clavulanic acid and more effective than Erythromycin both given TID.
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PMID:[Beta-haemolytic group A streptococcal acute pharyngo-tonsillitis in pediatric patients: a clinical and epidemiological study]. 1497 38

MiddleBrook Pharmaceuticals (formerly Advancis Pharmaceutical) is developing an improved version of amoxicillin using its pulsatile oral drug delivery technology, called PULSYS. Amoxicillin PULSYS is intended to provide a lower treatment dose, once-daily alternative to currently approved amoxicillin and penicillin regimens for the treatment of adolescents/adults with pharyngitis and/or tonsillitis. If amoxicillin PULSYS is approved, it will be the first and only once-daily amoxicillin therapy approved for use in the US. Regulatory submissions for the treatment of pharyngitis/tonsillitis have been made in the US. Amoxicillin PULSYS is in clinical development for the treatment of pharyngitis and/or tonsillitis due to group A streptococcal infections in adolescents/adults as a tablet formulation. MiddleBrook was conducting clinical development of a sprinkle formulation for children. However, this has been put on hold for financial reasons. MiddleBrook is seeking regulatory approval for this product as a 505(b)(2) product, which is one that is not considered to be a completely new product, but is also not a generic product. It is a product with some differences from a previously approved product and clinical data to support such differences are required; however, the basic safety and efficacy studies may have been conducted by other organisations. In June 2007, Advancis Pharmaceutical was renamed as MiddleBrook Pharmaceuticals, Inc. MiddleBrook and Par Pharmaceuticals entered a co-promotion agreement for this product in June 2004. Par was to fund future development in exchange for co-exclusive marketing rights and exclusive rights to sell amoxicillin PULSYS. MiddleBrook retained responsibility for the manufacturing programme and also retained all patents and brand names and was responsible for their enforcement. However, this collaboration was subsequently terminated in August 2005 by Par Pharmaceutical. MiddleBrook received the US $4.75 million R&D reimbursement payment due in the third quarter of 2005 and expects no further payments under the collaboration. Under certain circumstances, the termination clauses of the agreement may entitle Par to receive a share of net profits up to 50% of its total US $23 million investment in the development of certain amoxicillin PULSYS products, should a product covered by the agreement be successfully commercialised. Following the end of the first quarter of 2005, MiddleBrook entered into agreements with Clonmel Healthcare Ltd (STADA Group), which will provide MiddleBrook with commercial supply of its amoxicillin PULSYS products being evaluated in phase III trials. MiddleBrook has closed US $24 million in private placement of common equity; funds will be used to support the regulatory approval process for the once-daily amoxicillin pulsatile product. The company conducted phase III trials of this once-daily pulsatile amoxicillin product for the treatment of pharyngitis/tonsillitis due to group A streptococcal infections (commonly referred to as strep throat). Two trials of a 775 mg tablet formulation were conducted in adolescent/adult populations. In December 2006, the company entered into a definitive private placement agreement, raising US $18 million in gross proceeds. It intends to use the proceeds to prepare for the potential commercial launch of amoxicillin PULSYS and to continue the development of other products. The first of the adolescent/adult phase III trials was initiated in October 2004 in the US. This double-blind, non-inferiority, pivotal trial enrolled 510 such patients who received amoxicillin PULSYS 775 mg administered in tablet form once daily for 7 days or the US FDA standard comparator regimen, penicillin 250 mg administered four times daily for 10 days. However, in June 2005, the company reported that amoxicillin PULSYS failed to achieve the primary endpoint of this trial (i.e. bacterial eradication). The company initiated the second adolescent/adult phase III trial in November 2005. This two-arm, double-blind, double-dummy, non-inferiority trial enrolled a total of 620 patients from the US and Canada. Patients received amoxicillin PULSYS (775 mg tablet once daily for 10 days) or the standard penicillin regimen previously mentioned. Top-line results presented in August 2006 showed that the desired microbiological and clinical endpoints were achieved in this trial. In addition, the trial showed that amoxicillin PULSYS achieved 85% bacterial eradication in the per-protocol population, in accordance with the FDA's guidance for approval as a first-line therapy for pharyngitis. MiddleBrook has completed a phase I dose finding trial of its paediatric 'sprinkle' formulation of amoxicillin PULSYS in healthy volunteers. The company commenced a two-arm, investigator-blinded, non-inferiority, US-based, phase III trial in Janary 2005 to evaluate a 'sprinkle' formulation of amoxicillin PULSYS among paediatric patients with acute pharyngitis/tonsillitis caused by group A streptococcal infections. The drug was administered in multiparticulate granules, designed to be sprinkled over food, in two dosages: 475 mg once daily in patients aged 6 months to 4 years, and 775 mg once daily for children aged 5-12 years. Patients were given either 7 days' treatment with amoxicillin PULSYS or penicillin VK four times daily for 10 days. The primary endpoint of the paediatric trial was the same as the adult one. However, in July 2005, the company reported that the product failed to achieve its desired microbiological and clinical endpoints (primary and secondary) in this trial. MiddleBrook was to review the full data and evaluate what steps, if any, could be taken to improve future outcomes.
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PMID:Amoxicillin pulsatile - MiddleBrook: APC 111, APC-111, PULSYS-enhanced amoxicillin. 1796 30

To evaluate clinical effects of amoxicillin and clavulanate potassium in the treatment of children with suppurative tonsillitis, 146 children with suppurative tonsillitis were randomly divided into a ceftezole sodium group and an amoxicillin and clavulanate potassium group. The two groups were given anti-infection treatment using different drugs. Symptomatic treatment was carried out once symptoms such as fever appeared. Five to seven days were taken as one treatment course. Blood routine examination and the detection of C-reactive protein (CRP) were performed three days after treatment. Indexes such as the time to the relief of symptoms, the count of white blood cells, the proportion of neutrophil and CRP levels and the incidence of adverse reactions were compared between groups to evaluate the curative effect. The overall response rate of the amoxicillin and clavulanate potassium group was 94.52%, while that of the ceftezole sodium group was 78.08%; the difference was statistically significant (P<0.05). The improvement of white blood cells and CRP levels of the amoxicillin and clavulanate potassium group was more obvious than that of the ceftezole sodium group (P<0.05). The difference of the time to the improvement of symptoms between the two groups had statistical significance; the amoxicillin and clavulanate potassium group was superior to the ceftezole sodium group (P<0.05). No severe drug-related adverse reactions were observed. Amoxicillin and clavulanate potassium dispersible tablet is effective in treating children with suppurative tonsillitis as it can rapidly relieve the clinical symptoms without increasing incidence of adverse reactions.
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PMID:Amoxicillin and clavulanate potassium in treating children with suppurative tonsillitis. 2895 95