Flovent Warnings & Precautions

Drug Library
Flovent - Warnings & Precautions [Fluticasone Propionate]

Pregnancy

Teratogenic Effects:

Pregnancy Category C.

Subcutaneous studies in the mouse and rat at 45 and 100 mcg/ kg, respectively (approximately 1/ 10 and 1/ 2 the maximum human daily inhalation dose based on mcg/ m 2 , respectively), revealed fetal toxicity characteristic of potent glucocorticoid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification.

In the rabbit, fetal weight reduction and cleft palate were observed following subcutaneous doses of 4 mcg/ kg (approximately 1/ 25 the maximum human daily inhalation dose based on mcg/ m 2 ). However, following oral administration of up to 300 mcg/ kg (approximately 3 times the maximum human daily inhalation dose based on mcg/ m 2 ) of fluticasone propionate to the rabbit, there were no maternal effects nor increased incidence of external, visceral, or skeletal fetal defects. No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration (see CLINICAL PHARMACOLOGY).

Less than 0.008% of the administered dose crossed the placenta following oral administration of 100 mcg/ kg to rats or 300 mcg/ kg to rabbits (approximately 1/ 2 and 3 times the maximum human daily inhalation dose based on mcg/ m 2 , respectively). There are no adequate and well-controlled studies in pregnant women. FLOVENT Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Experience with oral glucocorticoids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from glucocorticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous glucocorticoid dose and many will not need glucocorticoid treatment during pregnancy.

Nursing Mothers

It is not known whether fluticasone propionate is excreted in human breast milk. Subcutaneous administration of 10 mcg/ kg tritiated drug to lactating rats (approximately 1/ 20 the maximum human daily inhalation dose based on mcg/ m 2 ) resulted in measurable radioactivity in both plasma and milk. Because glucocorticoids are excreted in human milk, caution should be exercised when fluticasone propionate inhalation aerosol is administered to a nursing woman.

Pediatric Use

One hundred thirty-seven (137) patients between the ages of 12 and 16 years were treated with FLOVENT Inhalation Aerosol in the US pivotal clinical trials. The safety and effectiveness of FLOVENT Inhalation Aerosol in children below 12 years of age have not been established. Oral corticosteroids have been shown to cause a reduction in growth velocity in children and teenagers with extended use. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of corticosteroids should be considered (see PRECAUTIONS).

Geriatric Use:

Five hundred seventy-four (574) patients 65 years of age or older have been treated with FLOVENT Inhalation Aerosol in US and non-US clinical trials. There were no differences in adverse reactions compared to those reported by younger patients.