Olopatadine and mometasone furoate
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Dosing in kidney impairment
Hypercorticism and adrenal suppression with misuse or use of higher-than-recommended dosages or at the regular dosage in susceptible patients at risk for such effects If chickenpox develops, treatment with antiviral agents may be considered. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections. 5.6 Hypercorticism and Adrenal Suppression Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including RYALTRIS, are misused by taking higher-than-recommended dosages [see Dosage and Administration] or in patients at risk for such effects. 5.7 Effect on Growth Nasal corticosteroids, including RYALTRIS, may cause a reduction in growth velocity when administered to pediatric patients.
Dosing in liver impairment
Hepatic Impairment No studies have been conducted with RYALTRIS in patients with hepatic impairment. However, there have been reports of concentrations of mometasone furoate appearing to increase with severity of hepatic impairment [see Clinical Pharmacology].
Preparation and administration
Administration Information
Administer RYALTRIS by intranasal route only.
Shake the bottle well before each use.
Prime RYALTRIS before initial use by releasing 6 sprays or until a fine mist appears. When RYALTRIS has not been used for 14 or more days, re-prime by releasing 2 sprays or until a fine mist appears.
Avoid spraying RYALTRIS into the eyes or mouth.
Drug interactions
Check olopatadine and mometasone furoate against a medication listLabel text (3 paragraphs)
No formal drug-drug interaction studies have been performed with RYALTRIS. The drug interactions of the combination are expected to reflect those of the individual components [see Clinical Pharmacology ( 12.3 )] .
7.1 Central Nervous System Depressants Concurrent use of RYALTRIS with alcohol or other central nervous system depressants should be avoided because somnolence and impairment of central nervous system performance may occur [see Warnings and Precautions ( 5.2 )] .
7.2 Inhibitors of Cytochrome P450 3A4 Studies have shown that mometasone furoate, a component of RYALTRIS, is primarily and extensively metabolized to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome P450 (CYP) 3A4 in the metabolism of this compound. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the mometasone furoate plasma concentration and potentially increase the risk for adverse reactions. Caution should be exercised when considering the coadministration of RYALTRIS with strong CYP3A4 inhibitors [see Clinical Pharmacology ( 12.3 )] .
Contraindications
4 CONTRAINDICATIONS RYALTRIS is contraindicated in patients with known hypersensitivity to any ingredients of RYALTRIS. Hypersensitivity reactions, including wheezing, has occurred after nasal administration of mometasone furoate [see Warnings and Precautions ( 5.4 )]. Patients with known hypersensitivity to any ingredients of RYALTRIS, including mometasone furoate. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for olopatadine and mometasone furoate. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on RYALTRIS or mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Postmarketing experience with antihistamines, with similar mechanism of action to olopatadine, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are no published human data specific to olopatadine. Animal reproduction studies have not been conducted with RYALTRIS. However, animal reproduction studies are available for olopatadine hydrochloride and mometasone furoate.
Oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 120 and 1600 times the maximum recommended human daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) . In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1 to 16 times the MRHDID on a mcg/m 2 or AUC basis (see Data) .
However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data No reproductive toxicology studies were conducted with RYALTRIS; however, studies are available for olopatadine hydrochloride and mometasone furoate, as described below. Olopatadine hydrochloride In an oral embryo-fetal development study, pregnant rats were dosed throughout the period of organogenesis at doses up to 600 mg/kg/day. Maternal toxicity, producing death and reduced maternal body weight gain was observed at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis).
Olopatadine produced cleft palate at 60 mg/kg/day (approximately 120 times the MRHDID on a mg/m 2 basis) and decreased embryo-fetal viability and reduced fetal weight in rats at 600 mg/kg/day (approximately 1200 times the MRHDID on a mg/m 2 basis). In an oral embryo-fetal development study,…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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