Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients with otitis externa

ABSTRACT The pharmacokinetics of daptomycin (10 mg/kg once daily) was studied in 4 critically ill pediatric patients aged 8 to 14 yrs. The area under the concentration-time curve from time zero to infinity (AUC 0–∞ ) of plasma concentrations on day 1 ranged between 123.8 to 663.9 μg · h/ml, with lower values observed in septic and burn patients; clearance ranged from 15.1 to 80.7 ml/h/kg. Higher-than-recommended doses of daptomycin may be needed in septic children to ensure optimal drug exposure. Interpatient variability may suggest a role for therapeutic drug monitoring.

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A Comparative Study on Efficacy of Polymyxin B, Neomycin and Polymyxin B, Neomycin, Hydrocortisone in the Treatment of Otitis Externa at Nepal Medical College and Teaching Hospital, Kathmandu

Birat Journal of Health Sciences ◽

10.3126/bjhs.v2i2.18516 ◽

2017 ◽

Vol 2 (2) ◽

pp. 162-167

Author(s):

Mayuri Gupta ◽

S Aryal

Keyword(s):

Teaching Hospital ◽

Otitis Externa ◽

Clinical Signs ◽

Polymyxin B ◽

Medical College ◽

Significant Difference ◽

Group A ◽

Group B ◽

Cure Rates

IntroductionAcute otitis externa (AOE) is a common but preventable ear condition. Tenderness with movement of the tragus or pinna is a classic feature of otitis Externa. Polymyxin B, neomycin, hydrocortisone preparations are the choice for first-line therapy when the tympanic membrane is intact. This study atiempted to compare the efficacy of polymyxin B, neomycin and polymyxin B, neomycin, hydrocortisone in the treatment of otitis Externa.ObjectiveTo compare the efficacy of polymyxin B, neomycin and polymyxin B, neomycin, hydrocortisone in the treatment of otitis Externa.MethodologyTo evaluate the efficacy of polymyxin B, neomycin and polymyxin B, neomycin, hydrocortisone in the treatment of otitis Externa, a hospital based, randomized, prospective study was conducted in Nepal Medical College and Teaching Hospital (NMCTH), Atiarkhel, Kathmandu from August 2012 to May 2014. 70 outpatients suffering from otitis Externa who met the inclusion and exclusion criteria were included. Patients were randomized into group A and group B with lotiery system. Odd number patients were included in group A and even number patients in group B. Group A patients received pack soaked with ribbon gauge in polymyxin B, neomycin ointment and Group B patients received pack soaked with ribbon gauge in polymyxin B, neomycin, hydrocortisone ointment. The patients were called for follow up after 48 hours and 96 hours to assess the improvement on the basis of tragal and circumduction tenderness either present or absent (present 1 or absent 2). A decrease in the clinical signs and symptoms (i.e. tragal and circumduc_on tenderness) was noted. Absence of pain was considered as clinically cured.ResultsIn comparison to polymyxin B, neomycin group, hydrocortisone group exhibited statistically significant effectiveness after 48 hours of treatment (p<0.05), but in cure rates after 96 hours, no statistical significant difference was observed between two groups (p>0.05).ConclusionPolymyxin B, neomycin, hydrocortisone group showed higher and faster cure rates than polymyxin B, neomycin group in the treatment of otitis Externa at 48 hours follow up. Birat Journal of Health SciencesVol.2/No.1/Issue 2/ Jan - April 2017, Page: 162-167

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Phase I and pharmacokinetic (PK) study of lenalidomide (LEN) in pediatric patients with relapsed/refractory solid tumors or myelodysplastic syndrome (MDS): A Children's Oncology Group Phase I Consortium study

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.10023 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 10023-10023

Author(s):

S. L. Berg ◽

H. Russell ◽

M. Cairo ◽

A. M. Ingle ◽

P. C. Adamson ◽

...

Keyword(s):

Phase I ◽

Solid Tumors ◽

Pediatric Patients ◽

Phase 1 ◽

Fixed Dose ◽

Ischemic Event ◽

Thromboembolic Risk ◽

Once Daily ◽

Antiproliferative Effects ◽

Dose Levels

10023 Background: LEN, which has immunomodulatory, antiangiogenic, and antiproliferative effects, is indicated for the treatment of adults with MDS and multiple myeloma. We report the final results of a phase 1 and PK study of LEN in children with recurrent or refractory solid tumors (ST) or MDS. Methods: LEN was administered by mouth once daily for 21 of 28 days. Cohorts of 3 to 12 children with ST were enrolled at 15, 25, 40, 55 and 70 mg/m2/d dose levels. Children with MDS received a fixed dose of 5 mg/m2/d. PK and correlative biology studies were performed in cycle 1. Results: 49 patients (23 female), median age 16 years (range, 1–21) were enrolled and received a median of 1 cycle (range 1–11). 39/46 ST patients and 3/3 MDS patients were fully evaluable for toxicity. 0/3 patients with MDS had DLT. At 15 mg/m2/d, 1/6 ST patients developed DLT (Gr 3 hypercalcemia). At 25 mg/m2/d 1 patient had a cerebrovascular ischemic event of uncertain relationship to LEN; future subjects were screened for thromboembolic risk factors prior to enrollment. At 40 mg/m2/d 3/12 patients developed DLTs (Gr 3 hypophosphatemia/hypokalemia; Gr 4 neutropenia delaying the start of the next cycle for > 7 days; Gr 3 somnolence); at 55 mg/m2/d 1/6 patients developed DLT (Gr 3 urticaria). At 70 mg/m2/d 0/6 patients had DLT. No further dose escalation was attempted. No objective responses were observed. LEN enhanced IL-2 and IL-15 concentrations; NK expansion and activation; and NK and LAK cytotoxicity (Ayello, ASH, 2008). The median apparent LEN clearance and half-life were 135 ± 45 ml/min/m2 and 2.3 ± 1.1 hr. Conclusions: LEN is well tolerated at doses up to 70 mg/m2/d x 21d of 28 days in children with recurrent or refractory ST. Enhancement of immune function is significant. PK parameters in children are similar to those in adults. No significant financial relationships to disclose.

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