WARNINGS AND PRECAUTIONS
Epistaxis was observed in 1% of patients with SAR treated with RYALTRISTM and 0.6% of patients with SAR who received placebo in 2-week studies.
Instances of nasal ulceration and nasal septal perforation have occurred in patients following the nasal application of antihistamines such as RYALTRISTM.
Monitor patients periodically for signs of adverse effects on the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should avoid use of RYALTRISTM until healing has occurred.
Localized infections of the nose and pharynx with Candida albicans have occurred from nasal administration of mometasone furoate.
When such an infection occurs, discontinue RYALTRISTM and institute appropriate local or systemic therapy. Patients using RYALTRISTM over several months or longer should be examined periodically for evidence of Candida infection.
Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle, after administration of RYALTRISTM. Concurrent use of RYALTRISTM 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.
Somnolence was reported in 0.3% of patients with SAR treated with RYALTRISTM and none of the patients with SAR who received placebo in 2-week studies.
Nasal and inhaled corticosteroids, including RYALTRISTM, can result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Hypersensitivity reactions can occur with RYALTRISTM. Hypersensitivity reactions, including wheezing, have occurred after the nasal administration of mometasone furoate. Discontinue RYALTRISTM if such reactions occur.
Persons who are using drugs that suppress the immune system, such as corticosteroids, including RYALTRISTM, are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of RYALTRISTM have not been established in pediatric patients younger than 12 years of age and RYALTRISTM is not indicated for use in this population. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective Prescribing Information for VZIG and IG). 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.
Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including RYALTRISTM, are misused by taking higher-than-recommended dosages or in patients at risk for such effects.
Nasal corticosteroids, including RYALTRISTM, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of RYALTRISTM have not been established in pediatric patients younger than 12 years of age and RYALTRISTM is not indicated for use in this population. Routinely monitor the growth of pediatric patients receiving RYALTRISTM.
|Olopatadine HCl nasal spray†
|Mometasone furoate nasal spray†
|Dysgeusia||24 (3.0)||16 (2.1)||0 (0)||2 (0.3)|
|Epistaxis||8 (1.0)||11 (1.5)||6 (0.8)||5 (0.6)|
|Nasal discomfort||8 (1.0)||4 (0.5)||4 (0.5)||6 (0.8)|
*Adapted from RYALTRISTM Nasal Spray approved prescribing information, Glenmark Specialty SA, Switzerland.