Dymista Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C.
Azelastine hydrochloride: Although the adequate and well-controlled studies in human have not been done but studies in animals have shown teratogenic effects and classified as pregnancy category C. In mice received oral azelastine hydrochloride 68.6 mg/kg/day (280 times of the maximum recommended human daily nasal dose which based on mg/m²) shown external and skeletal abnormalities, embryotoxic, fetotoxic and teratogenic. It is similar to abortion and fetotoxic effects in rats receiving oral azelastine hydrochloride 68.6 mg/kg/day (550 times of the maximum recommended human daily nasal dose which based on mg/m²). In rats given oral azelastine hydrochloride 30 mg/kg/day (240 times of the maximum recommended human daily nasal dose which based on mg/m²) caused delayed ossification (undeveloped metacarpus) and increased incidence of 14^th rib.
Fluticasone propionate: Fluticasone propionate classifies as pregnancy category C and corticosteroids have been shown the teratogenicity in animals. Subcutaneous fluticasone propionate was given in the mouse and rats at the dosing equivalent to 4 times of the MRD in adult humans based on a mcg/m² (45 and 100 mcg/kg, respectively), revealed fetal toxicity including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. The fetal weight reduction and cleft palate also observed in rabbits receiving subcutaneous fluticasone propionate at 4 mcg/kg dosing (less than the MRD in adult humans on a mcg/m² basis) but there was no teratogenic reports in rabbits given the oral dose 300 mcg/kg which is 25 times the MRD in adult humans on a mcg/m² basis. Fluticasone propionate crossed the placenta following the 1,000 mcg/kg oral administration in rats and the 300 mcg/kg oral dosing in rabbits (approximately 4 and 25 times the MRD intranasal dose for adult humans on a mcg/m² basis, respectively).
Lactation: It is not known whether Dymista Nasal Spray is excreted in human breast milk.
Azelastine hydrochloride: It is not known if azelastine hydrochloride is excreted in human milk.
Fluticasone propionate: Thought, it is not known whether fluticasone propionate is excreted in human milk but it should be considered because the systemic corticosteroids distribute into breast milk.