Original Market Approval: January 14, 2000. Pediatric Exclusivity Granted: March 2, 2005 ... of 8 10 mg/kg generally not to exceed 600 mg/day in a BID regimen ...
... to 8 mcg/kg/hr) developed abdominal distension and atrial thrombus after 1 week. ... Abdominal distension. Safety (long-term) Poor growth. Poor weight gain ...
1 year old child (gender unspecified) with respiratory depression and ... 9 year old boy with neuroblastoma experienced increased alanine aminotransferase, ...
Office of New Drugs. Food and Drug Administration. 2. Background Drug Information ... to diet to reduce total cholesterol, LDL-C and Apo B levels in adolescent girls ...
Marilyn Pitts. Sonny Saini. Rosemary Johann-Liang. DAIOP. Wiley Chambers. OPT. Dianne Murphy. Ann Myers. DNP. Lisa Jones. Thomas Laughren. PMHS. Lisa Mathis ...
Most common were in patients treated for nocturnal enuresis (unapproved indication) ... Abnormal dreams; hallucination; panic reaction; aggression; hallucination, ...