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warnings and cautions
5. WARNINGS AND PRECAUTIONS Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. ( 5.1 ) Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. ( 5.2 ) 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. ( 5.4 ) Hypercorticism and adrenal suppression with higher than recommended dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue mometasone furoate nasal spray slowly. ( 5.5 ) Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving mometasone furoate nasal spray. ( 5.6 , 8.4 ) 5.1 Local Nasal Effects Epistaxis In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with mometasone furoate nasal spray than those who received placebo [ see Adverse Reactions (6) ] . Candida Infection In clinical studies with mometasone furoate nasal spray 50 mcg, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of mometasone furoate nasal spray 50 mcg should be discontinued and appropriate local or systemic therapy instituted, if needed. Nasal Septum Perforation Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids. As with any long-term topical treatment of the nasal cavity, patients using mometasone furoate nasal spray 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa. Impaired Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred. 5.2 Glaucoma and Cataracts Nasal and inhaled corticosteroids may 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. Glaucoma and cataract formation was evaluated in one controlled study of 12 weeks' duration and one uncontrolled study of 12 months' duration in patients treated with mometasone furoate nasal spray, 50 mcg at 200 mcg/day, using intraocular pressure measurements and slit lamp examination. No significant change from baseline was noted in the mean intraocular pressure measurements for the 141 mometasone furoate nasal spray-treated patients in the 12-week study, as compared with 141 placebo-treated patients. No individual mometasone furoate nasal spray-treated patient was noted to have developed a significant elevation in intraocular pressure or cataracts in this 12-week study. Likewise, no significant change from baseline was noted in the mean intraocular pressure measurements for the 139 mometasone furoate nasal spray-treated patients in the 12-month study and again, no cataracts were detected in these patients. Nonetheless, nasal and inhaled corticosteroids have been associated with the development of glaucoma and/or cataracts. 5.3 Hypersensitivity Reactions Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue mometasone furoate nasal spray if such reactions occur [ see Contraindications (4) ] . 5.4 Immunosuppression Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, 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 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 globin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) 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 infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections. 5.5 Hypothalamic-Pituitary-Adrenal Axis Effect Hypercorticism and Adrenal Suppression 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. If such changes occur, the dosage of mometasone furoate nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. 5.6 Effect on Growth Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving mometasone furoate nasal spray. To minimize the systemic effects of intranasal corticosteroids, including mometasone furoate nasal spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [ see Use in Specific Populations (8.4) ].
6. ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [ see Warnings and Precautions (5.1) ] Cataracts and glaucoma [ see Warnings and Precautions (5.2) ] Immunosuppression [ see Warnings and Precautions (5.4) ] Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [ see Warnings and Precautions (5.5 , 5.6) , Use in Specific Populations (8.4) ] The most common adverse reactions (≥5%) included headache, viral infection, pharyngitis, epistaxis and cough. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1- 800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Allergic Rhinitis Adults and adolescents 12 years of age and older In controlled US and international clinical studies, a total of 3210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with mometasone furoate nasal spray 50 mcg at doses of 50 to 800 mcg/day. The majority of patients (n = 2103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer. Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators. All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received mometasone furoate nasal spray 50 mcg, 200 mcg/day vs. placebo and that were more common with mometasone furoate nasal spray 50 mcg than placebo, are displayed in TABLE 1 below. TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER – ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING) Mometasone Furoate Nasal Spray 200 mcg (n = 2103) Vehicle Placebo (n = 1671) Headache 26 22 Viral Infection 14 11 Pharyngitis 12 10 Epistaxis/Blood-Tinged Mucus 11 6 Coughing 7 6 Upper Respiratory Tract Infection 6 2 Dysmenorrhea 5 3 Musculoskeletal Pain 5 3 Sinusitis 5 3 Other adverse events which occurred in less than 5% but greater than or equal to 2% of adult and adolescent patients (ages 12 years and older) treated with mometasone furoate nasal spray 50 mcg, 200-mcg/day (regardless of relationship to treatment), and more frequently than in the placebo group included: arthralgia, asthma, bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea, and rhinitis. Pediatric patients <12 years of age In controlled US and international studies, a total of 990 pediatric patients (ages 3 to 11 years) with allergic rhinitis received treatment with mometasone furoate nasal spray 50 mcg, at doses of 25 to 200 mcg/day. The majority of pediatric patients (n = 720) were treated with 100 mcg/day. A total of 163 pediatric patients have been treated for one year or longer. Two percent or less of patients in clinical trials who received mometasone furoate nasal spray 50 mcg discontinued treatment because of adverse events and the discontinuation rate was similar for the placebo and active comparators. Adverse events which occurred in ≥5% of pediatric patients (ages 3 to 11 years) treated with mometasone furoate nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included upper respiratory tract infection (5% in mometasone furoate nasal spray 50 mcg group vs. 4% in placebo) and vomiting (5% in mometasone furoate nasal spray 50 mcg group vs. 4% in placebo). Other adverse events which occurred in less than 5% but greater than or equal to 2% of pediatric patients (ages 3 to 11 years) treated with mometasone furoate nasal spray 50 mcg, 100 mcg/day vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: diarrhea, nasal irritation, otitis media, and wheezing. The adverse event (regardless of relationship to treatment) reported by 5% of pediatric patients ages 2 to 5 years who received mometasone furoate nasal spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each mometasone furoate nasal spray, 50 mcg and placebo) and that was more common with mometasone furoate nasal spray, 50 mcg than placebo, included: upper respiratory tract infection (7% vs. 0%, respectively). The other adverse event which occurred in less than 5% but greater than or equal to 2% of mometasone furoate pediatric patients ages 2 to 5 years treated with 100 mcg doses vs. placebo (regardless of relationship to treatment) and more frequently than in the placebo group included: skin trauma. Nasal Polyps Adults 18 years of age and older In controlled clinical studies, the types of adverse events observed in patients with nasal polyps were similar to those observed for patients with allergic rhinitis. A total of 594 adult patients (ages 18 to 86 years) received mometasone furoate nasal spray 50 mcg at doses of 200 mcg once or twice daily for up to 4 months for treatment of nasal polyps. The overall incidence of adverse events for patients treated with mometasone furoate nasal spray 50 mcg was comparable to patients with the placebo except for epistaxis, which was 9% for 200 mcg once daily, 13% for 200 mcg twice daily, and 5% for the placebo. Nasal ulcers and nasal and oral candidiasis were also reported in patients treated with mometasone furoate nasal spray 50 mcg primarily in patients treated for longer than 4 weeks. Nasal Congestion Associated with Seasonal Allergic Rhinitis A total of 1008 patients aged 12 years and older received mometasone furoate nasal spray 50 mcg 200 mcg/day (n = 506) or placebo (n = 502) for 15 days. Adverse events that occurred more frequently in patients treated with mometasone furoate nasal spray 50 mcg than in patients with the placebo included sinus headache (1.2% in mometasone furoate nasal spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1% in mometasone furoate nasal spray 50 mcg group vs. 0.2% in placebo) and the overall adverse event profile was similar to that observed in the other allergic rhinitis trials. 6.2 Post-Marketing Experience The following adverse reactions have been identified during the post-marketing period for mometasone furoate nasal spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.