Regulatory Information
LOTUS INTERNATIONAL PTE. LTD.
LOTUS INTERNATIONAL PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
SPRAY, SUSPENSION
**DOSAGE AND ADMINISTRATION** **Dosing Considerations** A relief of nasal allergic symptoms is observed within 10 minutes after administration of RYALTRIS®. However, since the full effect of RYALTRIS® depends on its regular use, patients must be instructed to take the nasal inhalation at regular intervals. **Recommended Dose and Dosage Adjustment** Adults and Adolescents (12 Years of Age and Older): The recommended dose of RYALTRIS® is two sprays in each nostril twice daily (morning and evening). **Administration** Administer RYALTRIS® by the intranasal route only. Avoid spraying RYALTRIS® into the eyes or mouth. Shake the bottle well before each use. Priming: Prime RYALTRIS® before initial use by releasing 6 sprays. When RYALTRIS® has not been used for 14 days or more, re-prime by releasing 2 sprays or until a fine mist appears. **Missed Dose** If a single dose is missed, the next dose should be taken when it is due. A double dose should not be taken at the same time.
NASAL
Medical Information
**INDICATIONS** RYALTRIS® is indicated for the treatment of moderate to severe symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 12 years of age and older.
**CONTRAINDICATIONS** RYALTRIS® is contraindicated for patients who: - Are hypersensitive to this medicine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Qualitative and Quantitative Composition – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - Have untreated fungal, bacterial, or tuberculosis infections of the respiratory tract.
R01AD59
mometasone, combinations
Manufacturer Information
LOTUS INTERNATIONAL PTE. LTD.
Glenmark Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
RYALTRIS Nasal Spray_PI.pdf
Approved: April 11, 2023