|
Overdosage & Contraindications
CONTRAINDICATIONS
Hypersensitivity to any component of this product. In the event of overdose, it is reasonable to employ the usual supportive measures; e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. There have been reports of acute overdosage in pediatric patients in post-marketing experience and clinical studies of up to at least 150 mg/ day with SINGULAIR. The clinical and laboratory findings observed were consistent with the safety profile in adults and older pediatric patients. There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed were thirst, somnolence, mydriasis, hyperkinesia, and abdominal pain. It is not known whether montelukast is removed by peritoneal dialysis or hemodialysis. OVERDOSAGE Text Continues Below
No mortality occurred following single oral doses of montelukast up to 5000 mg/ kg in mice (estimated exposure was approximately 250 times the AUC for adults and children at the maximum recommended daily oral dose) and rats (estimated exposure was approximately 170 times the AUC for adults and children at the maximum recommended daily oral dose). No specific information is available on the treatment of overdosage with SINGULAIR. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/ day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/ day to patients for approximately a week without clinically important adverse experiences. In the event of overdose, it is reasonable to employ the usual supportive measures; e. g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. Page: 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
