Mometasone Furoate + Olopatadine Nasal prep

Seasonal Allergic Rhinitis, and allergy associated Rhino-conjunctivitis patients

Intranasal spray Seasonal Allergic Rhinitis 2 sprays in each nostril twice daily (morning and evening) Hepatic impairment Not studied; however, increasing concentrations of mometasone have been reported with severity of hepatic impairment

Intranasal spray Seasonal Allergic Rhinitis and allergy associated Rhino-conjunctivitis patients Children (6 to 11 Years of Age): The recommended dose is 1 spray per nostril twice daily (morning and evening). >12 years: 2 sprays per nostril BID

Renal impairment Mometasone: Not studied Olopatadine Mild, moderate, or severe (single dose): No change in peak plasma concentration for single dose Severe (CrCl <30 mL/min/1.73 m2) at steady-state: AUC 2-fold higher and peak plasma concentration ~10-fold higher

Hypersensitivity to any ingredients of nasal spray

Some patients may experience symptoms of withdrawal from systemically active corticosteroids. This may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema. Epistaxis was observed in 1% of patients treated with Mometasone Furoate + Olopatadine because of Impaired Nasal wound healing. Concurrent use of Mometasone Furoate + Olopatadine with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Not Classi Pregnancy Data are unavailable on use in pregnant females to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes Animal data Olopatadine: Oral administration of olopatadine to pregnant rats and rabbits caused a decrease in number of live fetuses at maternal doses 120x and 1600x the maximum recommended human daily intranasal dose (MRHDID) on a mg/m2 basis, respectively Mometasone: Administration of mometasone to pregnant rats and rabbits caused increased fetal malformations and decreased fetal survival and growth at doses that produced exposures 1-16x the MRHDID on a mcg/m2 or AUC basis Lactation Data are unavailable on presence of drug in human milk, effects on breastfed children, or on milk production Other corticosteroids are excreted in human milk Olopatadine has been identified in milk of nursing rats following oral administration; unknown whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk

1-10% Dysgeusia (3%) Epistaxis (1%) Nasal discomfort (1%)

Mometasone furoate is an intranasal corticosteroid that inhibits the release of inflammatory mediators from inflammatory cells. Olopatadine blocks the Histamine receptor-1 and stabilizes the mast cells to inhibit further release of histamine.