Mometasone: uses, appearance and warnings

Mometasone Furoate Monohydrate Nasal Spray is a corticosteroid indicated for: Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older ( 1.1 ) Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older ( 1.2 ) 1.1 Prophylaxis of Seasonal Allergic Rhinitis Mometasone furoate monohydrate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. 1.2 Treatment of Chronic Rhinosinusitis with Nasal Polyps Mometasone furoate monohydrate nasal spray is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.

Nasal spray: 50 mcg of mometasone furoate in each spray. Nasal spray: 50 mcg of mometasone furoate in each spray ( 3 )

Mometasone Furoate Monohydrate Nasal Spray: 50 mcg mometasone furoate monohydrate per spray is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and translucent dust cap contains 17 g of product formulation (NDC 59651-402-17). 120 sprays, each delivering 50 mcg of mometasone furoate per actuation Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. When mometasone furoate monohydrate nasal spray is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable. SHAKE WELL BEFORE EACH USE.

Mometasone furoate monohydrate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients [see Warnings and Precautions (5.3) , Description (11) ]. Patients with known hypersensitivity to mometasone furoate or any of the ingredients of mometasone furoate monohydrate nasal spray. ( 4 )

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 ) Glaucoma and cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use mometasone furoate monohydrate nasal spray long term. ( 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 monohydrate nasal spray slowly. ( 5.5 ) Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving mometasone furoate monohydrate nasal spray. ( 5.6 , 8.4 ) 5.1 Local Nasal Adverse Reactions Epistaxis Epistaxis was observed more frequently in patients with allergic rhinitis and patients with chronic rhinosinusitis with nasal polyps who received mometasone furoate monohydrate nasal spray than those who received placebo [see Adverse Reactions (6.1) ]. Candida Infection Localized infections of the nose and pharynx with Candida albicans has occurred from nasal administration of mometasone furoate. When such an infection develops, use of mometasone furoate monohydrate nasal spray should be discontinued and appropriate local or systemic therapy instituted, if needed. Nasal Septum Perforation Instances of nasal septum perforation occurred in patients following the nasal application of corticosteroids, including mometasone furoate monohydrate nasal spray. As with any long-term topical treatment of the nasal cavity, patients using mometasone furoate monohydrate nasal spray 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 Glaucoma and cataracts may be reported with systemic and topical (including nasal, inhaled and ophthalmic) corticosteroid use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use mometasone furoate monohydrate nasal spray long term [see Adverse Reactions (6) ] . 5.3 Hypersensitivity Reactions Hypersensitivity reactions including instances of wheezing may occur after the nasal administration of mometasone furoate monohydrate. Discontinue mometasone furoate monohydrate nasal spray if such reactions occur [see Contraindications (4) ] . 5.4 Immunosuppression and Risk of Infections 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 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 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 Hypercorticism and Adrenal Suppression Hypercorticism and adrenal suppression may occur when nasal corticosteroids, including mometasone furoate monohydrate nasal spray, are used at higher-than-recommended dosages [see Dosage and Administration (2) ] or in patients at risk for such effects. If such changes occur, the dosage of mometasone furoate monohydrate nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. 5.6 Effect on Growth Corticosteroids, including mometasone furoate monohydrate nasal spray, may cause a reduction in growth velocity when administered to pediatric patients. Routinely, monitor the growth of pediatric patients receiving mometasone furoate monohydrate nasal spray. To minimize the systemic effects of nasal corticosteroids, including mometasone furoate monohydrate nasal spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4) ] .

The following clinically significant adverse reactions are described elsewhere in labeling: Epistaxis, Ulcerations, Candida albicans Infection, Impaired Wound Healing [see Warnings and Precautions (5.1) ] Glaucoma and Cataracts [see Warnings and Precautions (5.2) ] Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression, including Growth Reduction [see Warnings and Precautions (5.5 , 5.6) , Use in Specific Populations (8.4) ] The most common adverse reactions (incidence ≥5%) included headache, viral infection, pharyngitis, epistaxis and cough. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

No formal drug-drug interaction studies have been conducted with mometasone furoate monohydrate nasal spray. Inhibitors of Cytochrome P450 3A4: Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome CYP3A4 in the metabolism of this compound. Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. …