Ryaltris Special Precautions

Local Nasal Effects: Instances of nasal ulceration and nasal septal perforation have been reported in patients following the intranasal application of antihistamines.
Instances of nasal septal perforation have been reported following the intranasal application of corticosteroids.
Instances of epistaxis have been reported in patients following the intranasal application of antihistamines and corticosteroids (see Adverse Reactions).
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 RYALTRIS until healing has occurred.
Mometasone furoate should not be used in the presence of untreated localised infection involving the nasal mucosa. Following 12 months of treatment with mometasone furoate nasal spray, there was no evidence of atrophy of the nasal mucosa. Mometasone furoate tended to reverse the nasal mucosa closer to a normal histological phenotype.
As with any long-term treatment, patients using 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 RYALTRIS therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing RYALTRIS.
Visual disturbances, including Glaucoma, Cataract and Chorioretinal disorders: 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 which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Hypersensitivity Reactions: Hypersensitivity reactions, including instances of wheezing, may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue RYALTRIS if such reactions occur (see Contraindications).
Immunosuppression: 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.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Effects: Intranasal steroid products are designed to deliver drug directly to the nasal mucosa in order to minimise overall systemic glucocorticoid exposure and side effects. When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. Physicians should be alert for evidence of systemic effects, especially in chronically treated patients. However, there is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with mometasone furoate nasal spray. Care must be taken while transferring patients from systemic steroid treatment to RYALTRIS if there is any reason to suppose that their adrenal function is impaired.
During transfer from systemic corticosteroids to intranasal corticosteroids 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. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
Somnolence: Somnolence has been reported as uncommon following administration of RYALTRIS in the clinical studies (see Effects on Ability to Drive and Use Machines as follows).
Effect on growth: Intranasal corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. Routinely monitor the growth of paediatric patients receiving RYALTRIS (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Hepatic Impairment: No studies have been conducted with RYALTRIS in patients with hepatic impairment. However, there have been reports of concentrations of mometasone furoate appearing to increase with severity of hepatic impairment. Based on data from the individual components, no adjustment of the dosing regimen of RYALTRIS is warranted in patients with hepatic impairment (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Effect on laboratory tests: No data available.
Effects on Ability to Drive and Use Machines: Due to the potential occurrence of somnolence, patients using RYALTRIS should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of RYALTRIS until they know how they react to the nasal spray.
Caution is required if RYALTRIS is used concomitantly with alcohol or other CNS depressants. Somnolence has been reported following administration of RYALTRIS in 2 out of 789 subjects taking RYALTRIS in the clinical studies.
Use in Children: Paediatric use: Safety in children 6 to 11 years of age has not been studied beyond 2 weeks of use or in perennial allergic rhinitis. The safety and effectiveness of RYALTRIS in patients below the age of 6 years has not been established.
Retardation of growth rate in children may occur with intranasal corticosteroids, particularly at high doses prescribed for prolonged periods of time. Long term glucocorticoid exposure carries particular risks in the 6 to 11 year age group. Routinely monitor the growth of paediatric patients receiving intranasal corticosteroids. A placebo-controlled clinical trial in which paediatric patients were administered 100 micrograms of mometasone furoate nasal spray daily for one year did not observe a reduction in growth velocity. Periods of treatment greater than one year have not been studied (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Periodic clinical review, pursuit of lowest effective dosing, and consideration of adjunctive treatment modalities are recommended in paediatric patients aged 6 to 11 years.
Use in the Elderly: Based on population pharmacokinetic analysis among patients 12 years of age and older, the pharmacokinetics of olopatadine and mometasone furoate with RYALTRIS was not influenced by age.
No overall differences in safety or efficacy were observed in data collected from 145 patients aged 65 years and older versus younger patients who were treated with RYALTRIS in placebo- and active-controlled studies.