ASMANEX HFA

General Administration Information
For storage information, see the specific product information within the How Supplied section.

Route-Specific Administration

Topical Administration
-For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use. Avoid contact with the eyes. Avoid use on face, groin, or axillae.
-Patients who fail to respond to topical mometasone treatment after 2 weeks should be re-evaluated.
-Mometasone preparations should generally not be used with occlusive dressings. Instruct patients and caregivers not to bandage, cover, or wrap area in any way that may be occlusive unless recommended by their physician. Do not use in the diaper area of patients who require diapers or plastic pants; these garments may act as an occlusive dressing.
Cream/Ointment/Lotion Formulations
-Wash hands before and after mometasone application. Use gloves if required by universal precautions.
-Restrict application to the active lesions or affected areas and try to avoid normal surrounding skin.
-Lotion: Apply a few drops to the affected areas and massage lightly until it disappears.
-Cream and ointment: Apply a thin film to affected areas.



Inhalation Administration
Oral Inhalation Administration
-Educate patients and caregivers that mometasone is not a bronchodilator and should not be used as a rescue medication.
-Instruct patient and/or caregiver on proper inhalation technique.

Powder for Oral Inhalation (Asmanex Twisthaler, mometasone furoate dry powder inhaler [DPI])
-Each device is supplied within a moisture-protective foil pouch.
-When the foil pouch is opened, write the date on the cap label. Discard the unit when the counter reads '00' or 45 days after the foil pouch has been opened, whichever comes first.
-Do not use the DPI with a spacer or valve holding chamber (VHC) device.
-Most children less than 4 years of age may not generate sufficient inspiratory flow to activate DPIs.
-After administration, patients should be instructed to rinse their mouth out with water. The water should be spit out and not swallowed.
-After using, gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash the inhaler. Replace the cap tightly to protect the dry powder from moisture.
-The digital dose counter on the inhaler displays the doses remaining. When the counter indicates '00', the cap will lock and the unit must be discarded. If the dose counter is not working correctly, the unit should not be used.
-To avoid the spread of infection, do not use the inhaler in more than one person.

Aerosol for Oral Inhalation (Asmanex HFA, mometasone furoate metered-dose inhaler [MDI])
-Prime the mometasone MDI prior to initial use by releasing 4 test sprays into the air, away from the face and other people. If not used for more than 5 days, re-prime the inhaler by releasing 4 test sprays.
-Shake well before each spray.
-After administration, instruct the patient to their rinse mouth thoroughly with water to remove mometasone deposited in the mouth and to minimize dry mouth or throat, throat irritation, hoarseness, and local infection. Water should be spit out and not swallowed.
-To avoid the spread of infection, do not use the inhaler in more than one person.



Other Administration Route(s)
Intranasal Administration
-Instruct patient or caregiver on the proper use of the nasal spray.
-Shake well before each use.
-Before using for the first time, the unit must be primed. Keep the sprayer pointed away from people and pets. Pump the activator 10 times or until a fine spray appears. If the unit has not been used for 1 week, re-prime by pumping the activator twice or until a fine spray appears.
-After administration, wipe the nasal applicator with a clean tissue. Replace the cap right after cleaning.
-To avoid the spread of infection, do not use the inhaler in more than one person.

Orally inhaled or intranasal corticosteroids may cause growth inhibition in pediatric patients; linear growth retardation has also been reported in pediatric patients after prolonged use of topical corticosteroids. Monitor the growth of patients receiving orally inhaled products routinely (e.g., via stadiometry). Although data suggest that the effects on growth are minimal, the lowest effective dose of any corticosteroid dosage form should be utilized. In general, the benefits of regular inhaled corticosteroid (ICS) use outweigh the potential risk of relatively small and non-cumulative growth suppression in children with asthma; however, growth should be monitored. Growth inhibition has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients. Controlled clinical studies have shown that ICS may cause a mean reduction in growth velocity of approximately 1 centimeter (cm) per year (range: 0.3 to 1.8 cm/year) and that this reduction appears to depend on dose and duration of exposure. While not specifically addressing mometasone, the Childhood Asthma Management Program (CAMP) trial suggested that ICS use to control asthma in children may affect final adult height (median follow-up 7 years) by approximately 1 cm. Meta-analysis suggests regular use of low or medium daily dose ICS is associated with a mean reduction of 0.48 cm per year in linear growth velocity (14 trials, n = 5,717; 95% CI -0.65 to -0.3, p less than 0.0001) and a 0.61 cm change from baseline in height (15 trials, n = 3,275; 95% CI -0.83 to -0.38, p less than 0.00001) in children with mild to moderate asthma during a 1-year treatment period. Specifically, mometasone dry powder inhaler 100 to 200 mcg/day caused a mean reduction in growth velocity of 0.47 cm per year (1 trial, n = 184; 95% CI -0.97 to 0.03). This effect appears to be less pronounced after the first year of therapy and is not cumulative. In addition, a mean difference of -0.2 cm (n = 728; 95% CI 0.02 to 0.39) in growth velocity within the first year has been observed between low (50 to 100 mcg/day beclomethasone equivalent; 5.94 cm/year) and medium (200 mcg/day beclomethasone equivalent; 5.74 cm/year) dose ICS, indicating lower growth velocity in the those treated with higher dose ICS. Intranasal corticosteroids may also affect growth; however, no significant differences in growth velocity were noted for children (age range: 3 to 9 years) receiving 100 mcg/day of mometasone nasal spray compared with placebo during clinical trials.

Prolonged use (e.g., more than 1 year) of high doses of inhaled corticosteroids, such as budesonide, especially when used in combination with frequent courses of systemic corticosteroids, may be associated with skeletal changes and reduced bone mineral density (BMD), which may increase the risk of osteopenia and osteoporosis. The clinical significance of small changes in BMD with regard to long-term outcomes, such as fracture, is unknown. Because bone development is crucial during the pediatric period, bone health should be a primary concern for all patients receiving high-dose inhaled corticosteroids and/or frequent courses of systemic corticosteroids. Major risk factors for decreased bone mineral density include family history of osteoporosis, prolonged immobilization, tobacco use, malnutrition, and use of other chronic drugs that may reduce bone mass (e.g., anticonvulsants, oral corticosteroids). Caregivers of patients with risk factors should be counseled on age appropriate calcium and vitamin D intake. Due to a minimal systemic absorption of less than 0.1% after appropriate use, adverse effects on bone are not expected with intranasal mometasone therapy.

As with other corticosteroids, all formulations of mometasone have the potential to cause hypothalamic-pituitary-adrenal (HPA) suppression, and pediatric patients may be at higher risk for HPA suppression compared to adults. Manifestations of Cushing's syndrome and HPA suppression with possible adrenocortical insufficiency and withdrawal symptoms after treatment discontinuation can occur if topical mometasone is applied over a large surface area, under occlusive dressings, or for prolonged periods of time. In such circumstances, periodic evaluation for HPA suppression is warranted. HPA axis suppression occurred in 16% of pediatric patients ages 6 to 23 months who were treated for approximately 3 weeks with mometasone cream, covering a mean body surface area of 41% (range, 15% to 94%). Symptoms of hypercorticism can occur with mometasone nasal spray or oral inhalation if recommended doses are exceeded or if patients are particularly sensitive to the effects of mometasone. Cushingoid features have been observed during clinical practice with the use of inhaled corticosteroids. In addition, data from a prospective study of asthmatic children and adolescents (n = 143) on orally inhaled corticosteroids reported HPA suppression in 65.1% of patients. Concomitant intranasal corticosteroid use and a forced expiratory volume (FEV1)/forced vital capacity (FVC) less than 80% were linked to an increased incidence of adrenal suppression. If HPA suppression is noted, attempts to carefully withdraw the drug or transition to a less potent steroid should be made. Signs and symptoms of glucocorticoid insufficiency may require systemic corticosteroids; patients with HPA suppression will require increased doses of corticosteroid therapy during periods of excessive stress.

Gastrointestinal adverse reactions, including abdominal pain (2% to 6%), nausea (1% to less than 5%), vomiting (1% to 5%), diarrhea (2% to less than 5%), gastroenteritis (1% to less than 3%), dyspepsia (2% to 5%), and anorexia (1% to less than 3%) have been reported in pediatric patients treated with inhaled or intranasal mometasone in clinical trials. Disturbances in taste (dysgeusia) have been reported with intranasal mometasone in postmarketing surveillance. Ulcerative colitis, colonic polyp, and gastroenteritis were reported in less than 1% of patients receiving mometasone aerosol inhaler during clinical trials; it is unclear whether investigators considered these events drug-related.

Use of mometasone topically, intranasally, or by inhalation has been associated with cases of visual impairment such as blurred vision, cataracts, glaucoma, increased intraocular pressure ( ocular hypertension ), and retinopathy (central serous chorioretinopathy) postmarketing. The risk of cataracts increases with long-term and high-dose corticosteroid use. The mechanism of corticosteroid-induced cataract formation is uncertain but may involve disruption of sodium-potassium pumps in the lens epithelium leading to accumulation of water in lens fibers and agglutination of lens proteins. Consider referring patients who develop ocular symptoms, such as visual impairment, after receipt of corticosteroids to an ophthalmologist for evaluation. Large doses or therapy duration greater than 6 months appear to increase risks. Low potency corticosteroids (e.g., hydrocortisone) have been reported to be safer for short-term use around the eye area. The mometasone sinus implant has not been shown to cause serious ocular effects; there were no serious adverse events or clinically significant increases in intraocular pressure or cataract formation during clinical trials leading to device approval; however, the possibility for these effects is present with use of any intranasal corticosteroid. Conjunctivitis is another ocular adverse reaction that has been reported by 2% to less than 5% of patients who received mometasone nasal spray in clinical trials.

Hypersensitivity reactions have been noted after the use of mometasone products, particularly the nasal and oral inhalation formulations. In postmarketing experience, rash (unspecified), pruritus, angioedema, and anaphylactic reaction have been reported with mometasone oral inhalation use, while anaphylaxis (symptoms unstated) and angioedema have been reported with use of nasal inhalation formulations; pruritus (less than 2%) has also been noted with topical use. It is important to note that the mometasone oral inhalation powder may contain small amounts of lactose and trace amounts of milk proteins; anaphylactoid reactions have been reported in milk allergic patients.

Children are more prone to systemic adverse reactions of topical mometasone because of larger skin surface to body weight ratio and thinner skin. Increased intracranial pressure has been reported in children receiving topical corticosteroids; manifestations of increased intracranial pressure include bulging fontanelles, headaches, and bilateral papilledema. Patients should avoid excessive administration of topical mometasone. Additionally, there have been case reports of intracranial hypertension with other intranasal and inhaled corticosteroids. Although this adverse reaction is rare, caution is advised for all dosage forms, particularly in at risk populations.

Immunosuppression and secondary bacterial, viral, and fungal infections are not uncommon with inhaled or intranasal corticosteroids; prolonged use and higher doses may increase the risk. Upper respiratory tract infections are among the most common adverse reactions associated with inhaled and intranasal mometasone occurring in 5% to 15% of patients. Oropharyngeal candidiasis (6% or less), otitis media (2% to less than 5%), sinusitis (3% to 6%), pharyngitis (8% to 13%), nasopharyngitis (5% to 8%), bronchitis (3%), and influenza (4%) were reported during clinical trials of pediatric and adult patients. Unspecified viral infection (14%) and urinary tract infection (2%) have been also observed in pediatric patients treated with inhaled or intranasal mometasone in clinical trials. Localized infections associated with inhaled mometasone use may be manifested as an overgrowth of fungus in the nose, mouth, and throat; oral candidiasis (thrush) is a well-known adverse reaction of oral inhalation steroid therapy. The incidence may be correlated with daily dose and appears to occur less frequently in pediatric patients. Rinsing the mouth after use may minimize the incidence of oropharyngeal thrush. Localized Candida albicans infections were also reported during clinical trials with intranasal mometasone; the manufacturer recommends performing periodic evaluations for the presence of Candida infections. Secondary bacterial skin infections have been reported in 4% to 5% of pediatric patients during clinical trials of mometasone cream and ointment. If concomitant skin infections develop during topical therapy, an appropriate antifungal or antibacterial agent should be used. If a favorable clinical response does not promptly occur, then discontinue mometasone cream/ointment/lotion until the infection is controlled. Additionally, health care providers are advised to be aware that use of corticosteroids may mask the manifestations of an infection.

Adverse reactions occurred in approximately 1.5% to 5% of patients overall during clinical trials of topical mometasone; however, the incidence is higher in pediatric patients (5% to 14%) because they are more susceptible than adults to skin atrophy, including striae, and HPA suppression. In all populations, skin atrophy (e.g., easy bruising, loss of elasticity or normal skin markings, shininess, telangiectasia (1% to 2%), thinness) and skin irritation (burning, stinging, itching, tingling) are the most common adverse reactions of topical corticosteroid therapy. Other adverse reactions to topical mometasone formulations (cream, lotion, ointment) include acneiform rash, bacterial infection, candidiasis, decreased glucocorticoid levels, erythema, folliculitis (1% to 3%), furunculosis, hypertrichosis, maceration of the skin, miliaria, paresthesias (2%), perioral dermatitis, pruritus (less than 2%), rosacea, skin hypopigmentation (1%), striae, vesiculation, and xerosis. The incidence of adverse reactions may be increased if occlusive dressings are used. Contact dermatitis has also been reported with topical mometasone. If irritation develops, discontinue mometasone and begin appropriate therapy. Allergic contact dermatitis with corticosteroids is most commonly diagnosed by observing a failure to heal rather than a noting a clinical exacerbation. Such a reaction should be confirmed with appropriate diagnostic patch testing.

In general, excessive use of corticosteroids can lead to impaired wound healing. Mometasone should not be applied directly or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.

Headache (3% to 26%), which occurred predominantly in adolescent and adult patients, was the most frequently reported nervous system adverse reaction associated with the use of inhaled or nasal mometasone therapy in clinical trials. Fatigue has been noted in 1% to less than 3% of patients in clinical trials. Depression (11%) has been reported in adult patients treated with inhaled mometasone therapy. Behavioral changes, including hyperactivity and irritability, have been reported in pediatric patients with other inhaled corticosteroids, and these also may occur with mometasone therapy.

Musculoskeletal adverse reactions, including arthralgia (2% to less than 5%), musculoskeletal pain (4% to 8%), back pain (3% to 6%), and myalgia (2% to less than 5%), which occurred predominantly in adolescent and adult patients, have been reported with inhaled or intranasal mometasone during clinical trials. When transitioning from systemic corticosteroids to inhaled corticosteroids, some patients experience joint and/or muscle pain as a symptom of withdrawal from the systemic corticosteroid; carefully evaluate any patient with musculoskeletal symptoms who is transitioning off of systemic therapy. In addition, dysmenorrhea was reported by 4% to 9% of female adolescent and adult patients during clinical trials of inhaled or intranasal mometasone. Endometriosis was reported in less than 1% of patients receiving inhaled mometasone aerosol during clinical trials; it is unclear whether investigators considered this event drug-related or not.

Adverse reactions affecting the respiratory tract are common in patients receiving intranasal or inhaled mometasone. The most common include upper respiratory tract infection (5% to 15%), pharyngitis (8% to 13%), rhinitis (4% to 15%), sinusitis (5% to 6%), cough (7%), epistaxis or blood tinged mucous (1% to 11%), bronchitis (2% to less than 5%), chest pain (unspecified) (less than 5%), dysphonia (1% to less than 3%), nasal irritation (1% to less than 5%), throat irritation, and xerostomia (dry mouth and throat; 1% to less than 3%). Asthma exacerbation, which may include cough, dyspnea, wheezing (2% to less than 5%), and/or bronchospasm has been reported with inhaled and intranasal formulations. Use of a fast-acting inhaled bronchodilator and mometasone discontinuation is recommended if such symptoms occur. Although not reported in children, nasal congestion was reported commonly in adult patients using the inhalational dry powder formulation. Nasal septum perforation is a rare, but severe complication of intranasal steroids. Disturbances in smell (parosmia) and nasal dryness have also been reported with intranasal mometasone in postmarketing surveillance. Hemoptysis was reported in less than 1% of patients receiving mometasone aerosol inhaler during clinical trials; it is unclear whether investigators considered this event drug-related.

Miscellaneous adverse reactions reported with mometasone therapy include fever (7% in children 4 to 11 years) and otalgia (1% to less than 5%). Hyperglycemia, hypertension, and edema have also been reported rarely with topical and inhaled corticosteroid therapy.

The mometasone sinus implant, used postoperatively in adult patients undergoing ethmoid sinus surgery, is not FDA-approved for use in pediatric patients. Potential adverse reactions associated with the implant are expected to be similar to those associated with other sinus stents, gels, or packing. These adverse reactions include foreign body sensation, foreign body response (including formation of granulation tissue), premature displacement of the implant or small implant fragments out the nares, swallowing of the implant or implant fragments, and adherence of crusting to implant resulting in or contributing to pain, pressure, and/or headache. Although not observed in clinical trials, aspiration of small implant fragments could theoretically occur. In rare instances, the physiochemical condition associated with sinus surgery, with or without sinus implants, may present a risk of infection and toxic-shock syndrome.

Use of mometasone does not contraindicate administration of live-virus vaccines. According to the Advisory Committee on Immunization Practices (ACIP), administration of live-virus vaccines is safe and effective when steroid therapy is administered topically or by inhalation.

Mometasone is contraindicated in any patient with a known hypersensitivity to the medication or any component of the formulation. Although true corticosteroid hypersensitivity is rare, it can occur and cross-hypersensitivity to other corticosteroids is possible. Hypersensitivity reactions including rash, pruritis, angioedema, and anaphylactic reactions have been reported with mometasone use. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which may help to determine whether hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and after the administration of any corticosteroid. Mometasone inhalation powder is contraindicated in patients with severe milk protein hypersensitivity; this formulation contains lactose and has been associated, rarely, with anaphylactoid reactions. The implantable sinus stent, used postoperatively in adults with chronic sinusitis, is specifically contraindicated in patients with a known hypersensitivity to lactide, glycolide, or caprolactone copolymers.

Inhaled formulations of mometasone are contraindicated in the primary treatment of patients with status asthmaticus or other types of acute bronchospasm for which intensive therapy is warranted. Advise patients that mometasone is not a bronchodilator and is not indicated for relief of acute bronchospasm.

As with other inhaled asthma medications, paradoxical bronchospasm can occur with an immediate increase in wheezing after administration of inhaled mometasone. A short-acting beta-2-receptor agonist (SABA), such as albuterol, should be available at all times to treat acute asthma symptoms. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment. During such episodes, patients may require therapy with oral corticosteroids.

Systemic absorption of topical or inhaled mometasone can result in varying complications depending on the clinical situation and type of administration. In some cases, mometasone may not produce systemic concentrations high enough to avoid adrenocortical insufficiency in patients transitioning from systemic corticosteroids. Use mometasone with caution when substituting it for oral corticosteroid administration and avoid abrupt discontinuation; deaths due to adrenal insufficiency have been reported in asthma patients during and after such a change. Patients receiving mometasone may require initiation or resumption of systemic corticosteroids during periods of stress or during severe asthma attacks. Systemic absorption of topical or inhaled corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, increased intracranial pressure, hyperglycemia, and glycosuria in some patients. Use mometasone with caution in patients with underlying Cushing's syndrome. Concomitant intranasal corticosteroid use and a forced expiratory volume (FEV1)/forced vital capacity (FVC) less than 80% has been linked to an increased incidence of HPA suppression in pediatric asthma patients on inhaled corticosteroid therapy. Patients with poor adherence to corticosteroid therapy have a negative risk. With topical corticosteroid use, infants and children may absorb proportionally larger amounts of drug due to a larger skin surface area to body weight ratio, increasing systemic absorption. Other factors that may increase the systemic absorption of topical corticosteroids include: prolonged use, use over larger surface areas or where the epidermal barrier is disrupted (i.e., skin abrasion), or with the use of an occlusive dressing (including diapers and plastic pants) over the application site. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. If signs of HPA suppression occur with the use of intranasal corticosteroids, the drug should be slowly discontinued. Asthmatic children on inhaled corticosteroids should be appropriately monitored. There may be an increased risk of HPA suppression in patients with low body mass index (BMI); some experts recommend adrenal screening in this population. If HPA suppression occurs with any mometasone formulation, patients will require systemic corticosteroids during periods of physiologic stress. If surgery is required, patients should notify all health care providers that they have received corticosteroids within the last 12 months. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Use topical and inhaled corticosteroids, like mometasone, with caution in patients with diabetes mellitus. Hyperglycemia and exacerbation of diabetes can occur with systemic absorption of corticosteroids. In addition, use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.

As with any long-term topical treatment of the nasal cavity, patients using mometasone intranasally over several months or longer should be examined periodically for possible changes in the nasal mucosa. Instances of nasal septum perforation have been reported after use of intranasal corticosteroids. Furthermore, because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal perforation or ulcer, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Corticosteroid therapy may result in immunosuppression and an increased susceptibility to infection. The use of mometasone in the presence of infection, including tuberculosis of the skin, active or latent tuberculosis of the respiratory tract, fungal infections, systemic parasitic infection, untreated bacterial infections, ocular herpes simplex, and cutaneous or systemic viral infection (e.g., herpes infection, measles, or varicella), should be initiated or continued cautiously and only if clearly needed. Because of the potential for worsening infection, mometasone therapy may need to be interrupted during some active infections. Chickenpox and measles can have a more serious or even fatal course in susceptible children using corticosteroids; the exact risk associated with inhaled or topical mometasone is unclear. If an unimmunized patient is exposed to chickenpox or measles, proper prophylaxis may be indicated. Corticosteroid therapy can reactivate tuberculosis and should not be used except when chemoprophylaxis is instituted concomitantly. Although patients receiving systemic corticosteroid therapy are more susceptible to secondary infection than patients not receiving corticosteroids, administration via the inhaled route minimizes this risk. The incidence or course of acute bacterial or viral infection is probably minimally affected by inhaled corticosteroids in immunocompetent individuals. The use of nasal or inhaled mometasone may also result in localized fungal infection of the nose, mouth, and pharynx with Candida albicans. Instruct patients to rinse mouth after each use of inhaled mometasone to minimize risk. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic therapy; in most cases, treatment with mometasone can continue during antifungal therapy. Also, patients using mometasone nasal spray for extended periods (i.e., months) should be examined periodically for evidence of infection or other adverse effects on the nasal mucosa. If concomitant skin infections are present or develop during topical mometasone therapy, an appropriate antifungal or antibacterial agent should be used. If clinical improvement does not occur promptly, discontinue topical mometasone until the infection has been properly treated.

Detrimental effects on bone metabolism are expected to be much lower with inhaled corticosteroids compared to systemically-administered corticosteroids. However, some data suggest that high-dose inhaled steroids may also decrease bone formation and increase resorption, and decreases in bone mineral density have been reported in patients receiving long-term therapy of inhaled corticosteroids. Because bone development is critical in pediatric patients, monitoring is warranted in patients receiving high-doses or chronic corticosteroid treatment. Patients receiving inhaled steroids, such as mometasone, may be at increased risk of bone loss compared to healthy individuals; compounding risk factors include preexisting osteopenia, prolonged immobilization, family history of osteoporosis, tobacco smoking, malnutrition, and use of other medications that may reduce bone mass. Due to a systemic absorption of < 0.1% after appropriate use, adverse effects on bone are not expected with intranasal mometasone therapy; however, there may be potential in susceptible individuals or when used in high doses.

Use mometasone cautiously in patients with severe hepatic disease. Liver failure may predispose patients to HPA axis suppression; clearance of the drug is reduced in this population.

Do not use topical corticosteroids to treat acne vulgaris, acne rosacea, or perioral dermatitis as they may exacerbate these conditions. Mometasone topical preparations are not recommended to be applied to the face. Topical corticosteroids should not be used in patients with evidence of pre-existing skin atrophy or infection. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use topical mometasone preparations with caution in patients with markedly impaired circulation or peripheral vascular disease; skin ulceration has been reported in these patients after topical corticosteroid use. Use of lower potency topical corticosteroids may be necessary in some patients.

Take care to avoid ocular exposure and use of mometasone around the eyes; cases of visual impairment, cataracts, glaucoma, increased intraocular pressure, central serous chorioretinopathy, and ocular hypertension have been reported with topical corticosteroids. These ophthalmic side effects have also occurred during use of nasal and inhaled corticosteroids. Patients receiving corticosteroids chronically should be periodically assessed for increased intraocular pressure, cataract formation, glaucoma, or any other visual disturbance. Consider referring patients who develop ocular symptoms to an ophthalmologist for evaluation.

Marked decrease in skin thickness and delayed skin recovery have been noted in cutaneous areas exposed to sun after the topical application of corticosteroids. Patients that apply mometasone topical formulations to exposed portions of the body should avoid excessive sunlight (UV) exposure, both natural and artificial.

In utero exposure to corticosteroids may result in hypoadrenalism. Monitor neonates of mothers who received corticosteroids during pregnancy carefully.

Orally inhaled or intranasal corticosteroids may cause growth inhibition in pediatric patients; linear growth retardation has also been reported in pediatric patients after prolonged use of topical corticosteroids. Although data suggest that the effects on growth are minimal, the lowest effective dose of any corticosteroid dosage form should be utilized and growth should be routinely monitored during use. In general, the benefits of regular inhaled corticosteroid (ICS) use outweigh the potential risk of relatively small and non-cumulative growth suppression in children with asthma. The National Asthma Education and Prevention Program Expert Panel warns that prolonged use (e.g., > 1 year) of high doses of ICS, especially when used in combination with frequent courses of systemic corticosteroids, may increase the risk of adverse growth effects. Growth inhibition has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients. Controlled clinical studies have shown that ICS may cause a mean reduction in growth velocity of approximately 1 centimeter (cm) per year (range: 0.3-1.8 cm/year) and that this reduction appears to depend on dose and duration of exposure. While not specifically addressing mometasone, the Childhood Asthma Management Program (CAMP) trial suggested that ICS use to control asthma in children may affect final adult height (median follow-up 7 years) by approximately 1 cm. Meta-analysis suggests regular use of low or medium daily dose ICS is associated with a mean reduction of 0.48 cm per year in linear growth velocity (14 trials, n = 5717; 95% CI -0.65 to -0.3, p < 0.0001) and a 0.61 cm change from baseline in height (15 trials, n = 3275; 95% CI -0.83 to -0.38, p < 0.00001) in children with mild to moderate asthma during a 1 year treatment period. Specifically, mometasone dry powder inhaler 100-200 mcg/day caused a mean reduction in growth velocity of 0.47 cm per year (1 trial, n = 184; 95% CI -0.97 to 0.03). This effect appears to be less pronounced subsequent to the first year of therapy and is not cumulative. In addition, a mean difference of -0.2 cm (n = 728; 95% CI 0.02-0.39) in growth velocity within the first year has been observed between low (50-100 mcg/day beclomethasone equivalent; 5.94 cm/year) and medium (200 mcg/day beclomethasone equivalent; 5.74 cm/year) dose ICS, indicating lower growth velocity in the those treated with higher dose ICS. Intranasal corticosteroids may also affect growth ; however, no significant differences in growth velocity were noted for children (age range: 3-9 years) receiving 100 mcg/day of mometasone nasal spray compared with placebo during clinical trials.

Description: Mometasone is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties; products are available in topical, nasal, and inhaled dosage forms. Mometasone is used topically to relieve the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and psoriasis. Most mometasone products are of medium-potency; however, the mometasone ointment is considered more potent. Topical mometasone is resistant to metabolism in the skin, and repeated applications may lead to a depot effect and prolonged actions and an increased risk of systemic absorption. Mometasone nasal spray treats symptoms of perennial or seasonal allergic rhinitis. Rhinitis guidelines strongly recommend intranasal corticosteroids as the preferred medication when choosing monotherapy for persistent allergic rhinitis; they may also be offered as first-line therapy for nonallergic rhinitis (NAR) although intranasal antihistamines are strongly recommended as a first-line monotherapy option for NAR. Respiratory inhalations are used for the maintenance treatment of asthma. For the treatment of asthma, the dry powder formulation has the advantage in that it can be given once daily, as opposed to the other ICSs that must be given twice daily. Inhaled corticosteroids (ICSs) are the preferred pharmacologic treatment in the long-term management of persistent asthma for most patients. Maintenance ICS therapy may also decrease the frequency and severity of exercise-induced bronchoconstriction (EIB); short-acting beta-2 agonists (SABAs) also help prevent EIB but tolerance can develop with regular SABA use. The rhinitis guidelines strongly recommend intranasal corticosteroids be the preferred medication when choosing monotherapy for persistent allergic rhinitis; they may also be offered as first-line therapy for nonallergic rhinitis although intranasal antihistamines are strongly recommended as a first-line monotherapy option for this. The mometasone inhalation powder is FDA-approved for use in pediatric patients 4 years of age and older, while the aerosol inhaler is approved in children 5 years and older. Nasal mometasone sprays and most topical formulations are FDA-approved for use in pediatric patients 2 years of age and older.

INHALED DOSAGE RANGES BY PRODUCT
The ranges presented help define low, medium, and high ICS daily dosing according to asthma treatment recommendations. The NAEPP 2020 focused updates state that ICS ranges from the NAEPP 2007 guidelines need to be updated in future NAEPP guidance.

Mometasone furoate dry powder inhaler (DPI)
Children 4 years and younger: Not available

Children 5 years: Not available

Children 6 to 11 years: Not available

Children and Adolescents 12 years and older:
-GINA-Low Dose: 200 mcg
-Medium Dose: 200 mcg
-High Dose: 400 mcg

-NAEPP-Low Dose: 200 mcg
-Medium Dose: 400 mcg
-High Dose: more than 400 mcg


Mometasone furoate oral inhalation aerosol (standard particle size HFA)
Children 4 years and younger: Not available

Children 5 years:
-GINA-Low Dose: 100 mcg
-Medium Dose: Not available
-High Dose: Not available

-NAEPP: Not available

Children 6 to 11 years:
-GINA-Low Dose: 100 mcg
-Medium Dose: 100 mcg
-High Dose: 200 mcg

-NAEPP: Not available

Children and Adolescents 12 years and older:
-GINA-Low Dose: 200 mcg to 400 mcg
-Medium Dose: 200 mcg to 400 mcg
-High Dose: more than 400 mcg

-NAEPP: Not available

For asthma maintenance treatment:
-in patients previously receiving bronchodilators alone:
Oral Inhalation dosage (inhalation powder; i.e. Asmanex Twisthaler):
Children 4 to 11 years: 110 mcg (1 oral inhalation of 110 mcg/actuation) once daily in the evening is the initial and maximum dose.
Children and Adolescents 12 to 17 years: 220 mcg (1 oral inhalation of 220 mcg/actuation) once daily in the evening initially. Titrate after 2 weeks if needed for control. Max: 1 oral inhalation of 220 mcg/actuation twice daily or 2 oral inhalations of 220 mcg/actuation once daily in the evening (440 mcg/day). Titrate to the lowest effective dose once asthma stability is achieved.
Oral Inhalation dosage (inhalation aerosol; e.g., Asmanex HFA):
Children 5 to 11 years: 100 mcg (2 oral inhalations of 50 mcg/actuation) twice daily is the initial and maximum dose.
Children and Adolescents 12 to 17 years: 200 mcg (2 oral inhalations of 100 mcg/actuation) twice daily initially. If asthma is not controlled after 2 weeks, the higher strength may provide additional control. Max: 2 oral inhalations of 200 mcg/actuation twice daily (400 mcg inhaled twice daily). Titrate to the lowest effective dose once asthma stability is achieved.
-in patients previously receiving inhaled corticosteroids:
Oral Inhalation dosage (inhalation powder; i.e. Asmanex Twisthaler):
Children 4 to 11 years: 110 mcg (1 oral inhalation of 110 mcg/actuation) once daily in the evening is the initial and maximum dose.
Children and Adolescents 12 to 17 years: Initially, 220 mcg (1 oral inhalation of 220 mcg/actuation) once daily in the evening. Titrate after 2 weeks if needed for control. Max: 1 oral inhalation of 220 mcg/actuation twice daily or 2 oral inhalations of 220 mcg/actuation once daily in the evening (440 mcg/day). Titrate to the lowest effective dose once asthma stability is achieved.
Oral Inhalation dosage (inhalation aerosol; e.g., Asmanex HFA):
Children 5 to 11 years: 100 mcg (2 oral inhalations of 50 mcg/actuation) twice daily is the initial and maximum dose.
Children and Adolescents 12 to 17 years: 200 mcg (2 oral inhalations of 100 mcg/actuation) twice daily or 400 mcg (2 oral inhalations of 200 mcg/actuation) twice daily. Choose dose based on previous asthma therapy including the previous inhaled corticosteroid dosage and the patient's current control of asthma symptoms and risk of future exacerbation. If asthma fails to be controlled after 2 weeks of therapy with 2 oral inhalations of 100 mcg/actuation twice daily, the higher strength may provide additional control. Max: 2 oral inhalations of 200 mcg/actuation twice daily (400 mcg twice daily). Titrate to the lowest effective dose once asthma stability is achieved.
-in patients previously receiving oral corticosteroids:
Oral Inhalation dosage (inhalation powder; i.e. Asmanex Twisthaler):
Children 4 to 11 years: 110 mcg (1 oral inhalation of 110 mcg/actuation) once daily in the evening is the initial and maximum dose.
Children and Adolescents 12 to 17 years: 440 mcg (2 oral inhalations of 220 mcg/actuation) twice daily. Max: 2 oral inhalations of 220 mcg/actuation twice daily (440 mcg inhaled twice daily). Reduce oral corticosteroid no faster than 2.5 mg/day of prednisone or equivalent on a weekly basis, beginning after at least 1 week of inhaled therapy. Carefully monitor for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency. Once oral corticosteroid reduction is complete, titrate to the lowest effective inhaled mometasone dose.
Oral Inhalation dosage (inhalation aerosol; e.g., Asmanex HFA):
Children 5 to 11 years: 100 mcg (2 oral inhalations of 50 mcg/actuation) twice daily is the initial and maximum dose.
Children and Adolescents 12 to 17 years: 400 mcg (2 oral inhalations of 200 mcg/actuation) twice daily. Max: 2 oral inhalations of 200 mcg/actuation twice daily (400 mcg twice daily). Reduce the oral corticosteroid no faster than 2.5 mg/day of prednisone or equivalent on a weekly basis, beginning after at least 1 week of inhaled therapy. Carefully monitor for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency. Once oral corticosteroid reduction is complete, titrate to the lowest effective inhaled mometasone dose.

For transient increase in bronchospasm* (e.g., episodic wheezing) as asthma reliever therapy:
Oral Inhalation dosage (inhalation powder; i.e., Asmanex Twisthaler):
Children 4 to 11 years: GINA recommends 110 mcg (1 oral inhalation of 110 mcg/actuation) as needed whenever short-acting beta-2 agonist (SABA) is given. FDA-approved Max: 110 mcg/day. NAEPP does not recommend intermittent as-needed ICS/SABA therapy in this age group because therapy has not been adequately studied.
Children and Adolescents 12 to 17 years: GINA recommends 110 to 220 mcg (1 to 2 oral inhalations of 110 mcg/actuation or 1 oral inhalation of 220 mcg/actuation) as needed whenever short-acting beta-2 agonist (SABA) is given. NAEPP only recommends as-needed ICS/SABA as an option for patients with mild persistent asthma. FDA-approved Max: 880 mcg/day.
Oral Inhalation dosage (inhalation aerosol; e.g., Asmanex HFA):
Children and Adolescents 12 to 17 years: GINA recommends 200 mcg (1 oral inhalation of 200 mcg/actuation) as needed whenever short-acting beta-2 agonist (SABA) is given. NAEPP only recommends as-needed ICS/SABA as an option for patients with mild persistent asthma. FDA-approved Max: 800 mcg/day.

For exercise-induced bronchospasm prophylaxis*:
Oral Inhalation dosage (inhalation powder; i.e., Asmanex Twisthaler):
Children and Adolescents 12 years and older: 220 mcg (1 oral inhalation of 220 mcg/actuation) once daily in the evening is the usual initial recommended dose. FDA-approved Max: 880 mcg/day. Titrate to the lowest effective dose. Regular ICS (controller) use reduces the incidence of EIB.

For the management of symptoms of seasonal allergies or perennial allergies, including allergic rhinitis and nasal congestion:
Nasal dosage (nasal suspension spray; e.g., Nasonex):
Children 2 to 11 years: 1 spray (50 mcg/spray) in each nostril once daily (total daily dose of 100 mcg).
Children and Adolescents 12 years and older: 2 sprays (50 mcg/spray) in each nostril once daily (total daily dose of 200 mcg).

For seasonal allergic rhinitis prophylaxis:
Nasal dosage (nasal suspension spray; e.g., Nasonex):
Children and Adolescents 12 years and older: 2 sprays (50 mcg/spray) in each nostril once daily (total daily dose of 200 mcg). In patients with a known seasonal allergen that precipitates nasal symptoms, initiation of mometasone nasal spray 2 to 4 weeks prior to the anticipated start of the pollen season is recommended.

For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, eczema, lichen planus, localized bullous pemphigoid, localized vitiligo, and phimosis:
-for the general treatment of corticosteroid-responsive dermatoses:
Topical dosage (cream or ointment):
Children and Adolescents 2 years to 17 years: Apply a thin layer topically to the affected skin area(s) once daily. If no improvement is seen within 2 weeks, reassess diagnosis. Safety and efficacy have not been established beyond 3 weeks of therapy.
Topical dosage (lotion):
Children and Adolescents 12 to 17 years: Apply a few drops to the affected skin area(s) once daily. If no improvement is seen within 2 weeks, reassess diagnosis.
-for the treatment of phimosis:
Topical dosage (cream or ointment):
Children and Adolescents 2 to 17 years: Apply a thin layer topically to the affected skin area(s) 2 times daily for 4 to 8 weeks. The FDA-approved dosage is a thin layer topically to the affected skin area(s) once daily.
Infants* and Children* 1 year: Apply a thin layer topically to the affected skin area(s) 2 times daily for 4 to 8 weeks.
Topical dosage (lotion):
Children and Adolescents 12 to 17 years: Apply a few drops topically to the affected skin area(s) 2 times daily for 4 to 8 weeks. The FDA approved dosage is a few drops to the affected skin area(s) once daily.

For the treatment of psoriasis:
Topical dosage (cream or ointment):
Children and Adolescents 2 to 17 years: Apply a thin layer topically to the affected skin area(s) once daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.
Topical dosage (lotion):
Children and Adolescents 12 to 17 years: Apply a few drops to the affected skin area(s) once daily. If no response is seen within 2 weeks, reassess treatment options. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Maximum Dosage Limits:
-Neonates
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Children
Younger than 2 years: Safety and efficacy have not been established.
2 to 3 years: Once daily application for cream or ointment; 100 mcg/day intranasally. Safety and efficacy have not been established for inhaler products or lotion.
4 years: Once daily application for cream or ointment; 100 mcg/day intranasally; 110 mcg/day oral inhalation via dry powder inhaler; safety and efficacy have not been established for aerosol inhaler.
5 to 11 years: Once daily application for cream or ointment; 100 mcg/day intranasally; 110 mcg/day oral inhalation via dry powder inhaler; 200 mcg/day oral inhalation via aerosol inhaler.
12 years: Once daily application for cream, ointment, or lotion; 200 mcg/day intranasally; 880 mcg/day oral inhalation via dry powder inhaler; 800 mcg/day oral inhalation via aerosol inhaler.
-Adolescents
Once daily application for cream, ointment, or lotion; 200 mcg/day intranasally; 880 mcg/day oral inhalation via dry powder inhaler; 800 mcg/day oral inhalation via aerosol inhaler.

Patients with Hepatic Impairment Dosing
Inhalational and intranasal mometasone undergo extensive first-pass metabolism in the liver. Specific guidelines for dosage adjustments in hepatic impairment are not available; however, caution is recommended in those with severe hepatic impairment.

Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

*non-FDA-approved indication

Monograph content under development

Mechanism of Action: Mometasone is a corticosteroid that exhibits anti-inflammatory, antipruritic, and vasoconstrictive effects as well as limiting allergic responses. The specific mechanisms of action depend on the route of administration and condition being treated.

Topical effects:
Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme that causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, and keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation, and scaling of the affected skin.

Treatment of asthma:
Clinical effects in asthma include a reduction in bronchial hyperresponsiveness to allergens, a decreased number of asthma exacerbations, and an improvement in FEV1, peak-flow rate, and respiratory symptoms. Because corticosteroid effects take several hours to days to become clinically noticeable, they are ineffective for primary treatment of severe acute bronchospastic attacks or for status asthmaticus. Inhaled corticosteroids have no bronchodilatory properties. In the treatment of asthma, orally inhaled corticosteroids block the late phase allergic response to allergens. Mediators involved in the pathogenesis of asthma include histamine, leukotrienes (slow releasing substance of anaphylaxis, SRS-A), eosinophil chemotactic factor of anaphylaxis (ECF-A), neutrophil chemotactic factor (NCF), cytokines, hydroxyeicosatetraenoic acids, prostaglandin-generating factor of anaphylaxis (PGF-A), prostaglandins, major basic protein, bradykinin, adenosine, peroxides, and superoxide anions. Different cell types are responsible for release of these mediators including airway epithelium, eosinophils, basophils, lung parenchyma, lymphocytes, macrophages, mast cells, neutrophils, and platelets. Corticosteroids inhibit the release of these mediators, attenuate mucous secretion and eicosanoid generation, up-regulate beta-receptors, promote vasoconstriction, and suppress inflammatory cell influx and inflammatory processes.

Treatment of allergies:
Intranasal mometasone reduces allergic responses of several cell types (e.g., mast cells and eosinophils) involved in the allergic response by the same cellular mechanism as the topical corticosteroids. Clinically, symptoms such as rhinorrhea and postnasal drip, nasal congestion, sneezing, and pharyngeal itching are reduced.

Pharmacokinetics: Mometasone is administered topically to the skin, intranasally, and by oral inhalation. In vitro, protein binding has been shown to be approximately 98 to 99%. Once in the systemic circulation, mometasone undergoes extensive hepatic metabolism to multiple metabolites. Excretion is primarily in the bile, and to a limited extent, in the urine. Radioactive labeling studies show that 74% of an inhaled dose of mometasone is excreted in the feces, with a mean percentage of 8% in the urine. The elimination half-life of mometasone in adults is approximately 5 to 6 hours.

Mometasone is highly lipophilic. This increased lipophilicity is correlated with a greater deposition into respiratory tract tissue, a greater binding affinity, and a slower release from respiratory tract tissue. Mometasone has the lowest systemic bioavailability of the inhaled or intranasal corticosteroids.

Affected cytochrome P450 isoenzymes and drug transporters: CYP3A4
In vitro data indicate that mometasone is a CYP3A4 substrate. Although systemic concentrations of mometasone are usually low or undetectable, strong inhibitors of CYP3A4 (e.g., ketoconazole) can increase plasma mometasone concentrations in some patients.


-Route-Specific Pharmacokinetics
Topical Route
Approximately 0.4% of an applied dose of mometasone cream and 0.7% of an applied dose of mometasone ointment reach the systemic circulation within 8 hours of application on normal skin without occlusion. However, systemic absorption after topical application of mometasone is highly dependent on the vehicle, the state of the skin at the application site, the use of occlusive dressings, and the age of the patient. Absorption is increased in areas that have skin damage, inflammation, or where the stratum corneum is thin, such as the eyelids, genitalia, and face. Factors that can increase systemic absorption of topical mometasone include occlusive dressings, large surface area, frequent application, longer duration of treatment, increased humidity or temperature, and younger age.

Inhalation Route
Systemic absorption following a dose by oral inhalation is generally minimal. A single 400 mcg dose of orally inhaled mometasone resulted in a 1% absolute systemic bioavailability compared to the same intravenous (IV) dose.
-Mometasone furoate inhalation powder (i.e., Asmanex Twisthaler): Lung delivery is approximately 11%. In an adult study, mean steady-state peak plasma concentrations (Cmax) were 94 to 114 pg/mL after receiving the highest recommended inhaled dosage (400 mcg twice daily) for 28 days; Cmax was reached 1 to 2.5 hours after administration.
-Mometasone furoate aerosol (i.e., Asmanex HFA): In healthy adult patients, the mean peak concentration (Cmax) and AUC values were 53 pg/mL and 992 pg x hour/mL, respectively, after a single 800 mcg dose of mometasone furoate aerosol; median time to maximal concentration (Tmax) values ranged from 0.5 to 2 hours. After both single and multiple doses of the mometasone furoate/formoterol fumarate combination product, asthmatic patients demonstrated a mean Tmax of 1 to 2 hours. Single-dose administration of mometasone furoate/formoterol fumarate 400 mcg/10 mcg resulted in a mean Cmax of 20 pg/mL and AUC of 170 pg x hour/mL; corresponding estimates for twice-daily dosing were 60 pg/mL and 577 pg x hour/mL, respectively.

Other Route(s)
Intranasal Route
The systemic bioavailability of mometasone administered as the nasal spray is very minimal (less than 0.1%). After administration, approximately 30% of a dose is deposited in the nose; the remainder is swallowed and undergoes extensive first-pass hepatic metabolism.


-Special Populations
Hepatic Impairment
The pharmacokinetics of mometasone have not been studied in pediatric patients with hepatic impairment. The pharmacokinetics of a single inhaled dose of 400 mcg via dry powder inhaler were studied in a small group of adults with mild (n = 4), moderate (n = 4), and severe (n = 4) hepatic impairment. One or 2 subjects in each group had detectable peak plasma concentrations (ranging from 50 to 105 pcg/mL). Although data are limited, peak plasma concentrations appeared to increase with increasing severity of hepatic impairment.