Ryaltris Special Precautions

General: During transfer from systemic corticosteroid to OLOPATADINE AND MOMETASONE (RYALTRIS), some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue OLOPATADINE AND MOMETASONE (RYALTRIS) therapy. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Ear/Nose/Throat: In clinical trials of 2 to 52 weeks' duration, epistaxis was observed more frequently in patients treated with OLOPATADINE AND MOMETASONE (RYALTRIS) than those who received placebo (see Adverse Reactions).
OLOPATADINE AND MOMETASONE (RYALTRIS) should not be used in the presence of untreated localized infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Instances of nasal ulceration and nasal septal perforation have been reported in patients following the intranasal application of antihistamines. Following the use of intranasal aerosolized corticosteroids, instances of nasal septum perforation have been reported very rarely.
As with any long-term treatment, patients using OLOPATADINE AND MOMETASONE (RYALTRIS) over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops, discontinuance of OLOPATADINE AND MOMETASONE (RYALTRIS) therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing OLOPATADINE AND MOMETASONE (RYALTRIS).
Endocrine and Metabolism: Patients who are transferred from long-term administration of systemically active corticosteroids to OLOPATADINE AND MOMETASONE (RYALTRIS) require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of hypothalamic-pituitary-adrenal (HPA) axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
Immune: Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Ophthalmologic: Following the use of intranasal aerosolized corticosteroids, instances of increased intraocular pressure have been reported very rarely.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances; this may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Sexual Health: Fertility: Studies have not been performed to evaluate the effect of intranasal administration of OLOPATADINE AND MOMETASONE (RYALTRIS) or the respective monotherapies olopatadine hydrochloride and mometasone furoate on human fertility.
Olopatadine administered to male and female rats at oral doses of approximately 810-fold the maximum recommended human daily intranasal dose (MRHDID) (on mg/m² basis, assuming a human body weight of 60 kg) resulted in a decrease in the fertility index and reduced implantation rate. No effects on fertility were observed at doses of approximately 100-fold the MRHDID on mg/m² basis.
Mometasone furoate administered subcutaneously to rats at doses of approximately 5- and 1-fold the MRHDID on body weight and mg/m² basis, respectively did not result in impairment of fertility.
Driving and Operating Machinery: Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Use in Children: Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving OLOPATADINE AND MOMETASONE (RYALTRIS). The safety and efficacy of OLOPATADINE AND MOMETASONE (RYALTRIS) in children under 6 years of age have not been established. No data are available.