Mometasone Furoate + Olopatadine Hydrochloride

This preparation nasal spray is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

This is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed-dose combination of a olopatadine hydrochloride and mometasone furoate monohydrate.

Olopatadine is a histamine-1 (H1) receptor inhibitor. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

The recommended dosage is 2 sprays in each nostril twice daily. Shake the bottle well before each use. Prime this nasal spray before initial use by releasing 6 sprays or until a fine mist appears. When this nasal spray has not been used for 14 or more days, re-prime by releasing 2 sprays or until a fine mist appears. Avoid spraying into the eyes or mouth.

Pediatric Use: The safety and effectiveness of this nasal spray in pediatric patients below the age of 12 years have not been established.

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.

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.

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.

This nasal spray is contraindicated in patients with known hypersensitivity to any ingredients of RYALTRIS. Hypersensitivity reactions, including wheezing, has occurred after nasal administration of mometasone furoate.

The following clinically significant adverse reactions are described:

• Local Nasal Adverse Reactions
• Somnolence and Impaired Mental Alertness
• Glaucoma and Cataracts
• Hypersensitivity Reactions
• Immunosuppression and Risk of Infections
• Hypercorticism and Adrenal Suppression

There are no available data of mometasone furoate use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcome. There are no available data on the presence of olopatadine or mometasone furoate or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids similar to mometasone furoate, are excreted in human milk. However, mometasone furoate concentrations in plasma after nasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low.

Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa.

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery when taking this nasal spray.

Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with this nasal spray because additional reductions in alertness and additional impairment of CNS performance may occur.

Glaucoma and cataracts: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

Hypersensitivity Reactions: Hypersensitivity reactions can occur with this nasal spray. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue this nasal spray if such reactions occur.

Immunosuppression and Risk of Infections: Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients: Use caution in patients with the above because of the potential for worsening of these infections.

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.

Potential reduction in growth velocity in children: Routinely monitor the growth in pediatric patients receiving this nasal spray.

Store this upright with the purple dust cap on at room temperature (between 20°C and 25°C). Do not store in a freezer or refrigerator.