D. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C
Formoterol fumarate administered throughout organogenesis did not cause malformations in rats or rabbits following oral administration. However, formoterol fumarate was found to be teratogenic in rats and rabbits in other testing laboratories. When given to rats throughout organogenesis, oral doses of 0.2 mg/kg (approximately 40 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis) and above delayed ossification of the fetus, and doses of 6 mg/kg (approximately 1200 times the maximum recommended daily inhalation dose in humans on a mg/m2 basis) and above decreased fetal weight. Formoterol fumarate has been shown to cause stillbirth and neonatal mortality at oral doses of 6 mg/kg and above in rats receiving the drug during the late stage of pregnancy. These effects, however, were not produced at a dose of 0.2 mg/kg. Because there are no adequate and well-controlled studies in pregnant women, PERFOROMIST Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Women should be advised to contact their physician if they become pregnant while taking PERFOROMIST Inhalation Solution.
8.2 Labor and DeliveryThere are no adequate and well-controlled human studies that have investigated the effects of PERFOROMIST Inhalation Solution during labor and delivery.
Because beta-agonists may potentially interfere with uterine contractility, PERFOROMIST Inhalation Solution should be used during labor only if the potential benefit justifies the potential risk.
8.3 Nursing MothersIn reproductive studies in rats, formoterol was excreted in the milk. It is not known whether formoterol is excreted in human milk, but because many drugs are excreted in human milk, caution should be exercised if PERFOROMIST Inhalation Solution is administered to nursing women. There are no well-controlled human studies of the use of PERFOROMIST Inhalation Solution in nursing mothers.
Women should be advised to contact their physician if they are nursing while taking PERFOROMIST Inhalation Solution.
8.4 Pediatric UsePERFOROMIST Inhalation Solution is not indicated for use in children. The safety and effectiveness of PERFOROMIST Inhalation Solution in pediatric patients have not been established. The pharmacokinetics of formoterol fumarate has not been studied in pediatric patients.
8.5 Geriatric UseOf the 586 subjects who received PERFOROMIST Inhalation Solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. Of the 123 subjects who received PERFOROMIST Inhalation Solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.
The pharmacokinetics of PERFOROMIST Inhalation Solution has not been studied in elderly subjects.
10 OVERDOSAGE
The expected signs and symptoms with overdosage of PERFOROMIST Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occu |
