Ryaltris 600, 25 Mcg 240 Nasal Spray

Product Description:

• RYALTRIS is Novel fixed-dose combination nasal spray of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate developed as a single nasal spray for the treatment of allergic rhinitis patient in adult and pediatric patients 6 years of age and older.


• RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed-dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate).


• RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium chloride, sodium hydroxide, and water for injection. It has a pH of approximately 3.7

How to use:

For adults : 2 sprays per each nostril twice daily

For Pediatrics : 1 spray per each nostril twice daily

• Patients should prime RYALTRIS®before initial use.


• Prime by pushing down on the pump quickly and firmly 6 times, releasing the spray into the air, away from the eyes and face until a fine mist appears.


• If you do not use RYALTRIS®for 14 or more days, you will need to shake the bottle well, and prime the pump with 2 sprays or until a fine mist appears.


• Avoid spraying RYALTRIS®into the eyes or mouth

Caution & Warnings:

• Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, andCandida albicansinfection: Monitor patients periodically for signs of adverse reactions on the nasal mucosa. (5.1)


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


• Avoid concurrent use of alcohol or other central nervous system (CNS) depressants with RYALTRIS 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 RYALTRIS. Hypersensitivity reactions including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue RYALTRIS 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.

Ingredients:

• Mometasone+Olopatadine