Ryaltris Use In Pregnancy & Lactation

Pregnant Women: No adequate and well-controlled studies in pregnant women have been conducted with OLOPATADINE AND MOMETASONE (RYALTRIS) or the respective monotherapies for olopatadine hydrochloride and mometasone furoate.
Olopatadine was not teratogenic in rabbits and rats at oral doses of approximately 1600- and 1200-fold the MRHDID on mg/m² basis, respectively. However, rats treated at approximately 120-fold or more and rabbits treated at approximately 100-fold or more the MRHDID on mg/m² basis during the organogenesis showed a decrease in live fetuses (see Pharmacology: Toxicology under Actions)
Like other glucocorticoids, mometasone furoate is a teratogen in rodents and rabbits. Teratology studies were conducted in rats, mice and rabbits by the oral, topical (dermal), and/or subcutaneous routes (see Pharmacology: Toxicology under Actions). As with other nasal corticosteroid preparations, mometasone furoate should be used in pregnant women, nursing mothers or women of childbearing age only if the potential benefit justifies the potential risk to the mother, fetus, or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Because animal studies are not always predictive of human responses, OLOPATADINE AND MOMETASONE (RYALTRIS) should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Breast-feeding: Olopatadine has been identified in the milk of nursing rats following oral administration.
Glucocorticosteroids are excreted in human milk.
It is unknown whether nasally administered olopatadine hydrochloride/metabolites or mometasone furoate monohydrate/metabolites are excreted in human breast milk. OLOPATADINE AND MOMETASONE (RYALTRIS) should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.