CLINICAL TOLERABILITY AND SAFETY OF AZITHROMYCIN IN CHILDREN

被引:11
作者
HOPKINS, SJ
WILLIAMS, D
机构
[1] Central Research Division, Pfizer, Inc., Groton, CT 06340, Eastern Point Road
关键词
AZITHROMYCIN; PEDIATRIC; OTITIS MEDIA; PHARYNGITIS; SAFETY;
D O I
10.1097/00006454-199504002-00009
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Azithromycin oral suspension was administered to 1928 children aged 6 months to 15 years in Phase II/III United States clinical trials. Infections treated included acute otitis media (n = 1150) and streptococcal pharyngitis (n = 754), Predominant dosage regimens were 30 mg/kg over 5 days for otitis media and 60 mg/kg over 5 days for pharyngitis. Treatment-related side effects occurred in 9.9% of azithromycin patients, compared with 18.4% of comparator patients, The only azithromycin side effects with an incidence greater than or equal to 1% were diarrhea (3.1%), vomiting (2.5%), loose stools (1.0%) and abdominal pain (1.9%), Both azithromycin regimens were well tolerated. Only 0.9% of multidose azithromycin recipients discontinued therapy because of side effects, compared with 2.2% of comparators. Marked laboratory test abnormalities were rare and of equal incidence to comparators, and no patient discontinued treatment because of abnormal laboratory values, Azithromycin was well tolerated in the presence of a variety of concurrent conditions and concomitant medications.
引用
收藏
页码:S67 / S71
页数:5
相关论文
共 16 条
[1]   DETERMINANTS OF NONCOMPLIANCE WITH SHORT-TERM ANTIBIOTIC REGIMENS [J].
COCKBURN, J ;
GIBBERD, RW ;
REID, AL ;
SANSONFISHER, RW .
BRITISH MEDICAL JOURNAL, 1987, 295 (6602) :814-818
[2]   THE PHARMACOKINETICS OF AZITHROMYCIN IN HUMAN SERUM AND TISSUES [J].
FOULDS, G ;
SHEPARD, RM ;
JOHNSON, RB .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 1990, 25 :73-82
[3]  
GROB PR, 1992, SCAND J INFECT DIS S, V83, P7
[4]  
HONIG P, 1993, CLIN PHARMACOL THER, V53, P161
[5]   CLINICAL SAFETY AND TOLERANCE OF AZITHROMYCIN IN CHILDREN [J].
HOPKINS, S .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 1993, 31 :111-117
[6]   CLINICAL TOLERATION AND SAFETY OF AZITHROMYCIN [J].
HOPKINS, S .
AMERICAN JOURNAL OF MEDICINE, 1991, 91 :S40-S45
[7]  
HOPKINS SJ, 1994, REV CONTEMP PHARMACO, V5, P383
[8]  
LISBYSUTCH SM, 1990, CLIN PHARMACY, V9, P15
[9]   PHARMACOKINETICS OF AZITHROMYCIN IN PEDIATRIC-PATIENTS AFTER ORAL-ADMINISTRATION OF MULTIPLE DOSES OF SUSPENSION [J].
NAHATA, MC ;
KORANYI, KI ;
GADGIL, SD ;
HILLIGOSS, DM ;
FOUDA, HG ;
GARDNER, MJ .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1993, 37 (02) :314-316
[10]  
NAHATA MC, 1995, CLIN PHARMACOL THER, V57, P178