Mometasone (Nasonex) Contraindications and Precautions
- acne rosacea
- acne vulgaris
- nasal septal perforation
- nasal surgery
- nasal trauma
- ophthalmic administration
- perioral dermatitis
- status asthmaticus
- abrupt discontinuation
- asthma
- breast-feeding
- cataracts
- children
- corticosteroid hypersensitivity
- Cushing’s syndrome
- diabetes mellitus
- elderly
- fungal infection
- glaucoma
- herpes infection
- hypothalamic-pituitary-adrenal (HPA) suppression
- increased intracranial pressure
- infection
- measles
- occlusive dressing
- ocular exposure
- pregnancy
- skin abrasion
- skin atrophy
- surgery
- tuberculosis
- varicella
- viral infection
- visual disturbance
Mometasone (Nasonex) Contraindications and Precautions
Mometasone is contraindicated in any patient with a history of hypersensitivity to other corticosteroids or any ingredients in the preparation. Rare cases of immediate hypersensitivity reactions have been reported after the intranasal or respiratory administration of mometasone.
Mometasone inhalation therapy is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Topical corticosteroids should be used for brief periods or under close medical supervision in patients with evidence of pre-existing skin atrophy, especially the elderly. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Use of lower potency topical corticosteroids may be necessary in some patients. Clinical studies of mometasone cream and solution showed no overall differences in safety or effectiveness between elderly and younger adult subjects. Clinical studies of mometasone lotion did not include sufficient numbers of elderly patients to determine whether they respond differently from younger adult subjects. Other reported clinical experience with topical mometasone products has not identified differences in responses between elderly and younger adults. However, greater sensitivity of the elderly cannot be ruled out.
Systemic absorption of topical or inhaled corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Use mometasone with caution in patients with underlying Cushing’s syndrome. Conditions which increase systemic absorption of topical corticosteroids include use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Although the risk of developing HPA suppression is very low with inhaled mometasone, patients should, nevertheless, be monitored for this possibility. If HPA suppression occurs, 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 inhaled corticosteroids within the last 12 months. Infrequently, signs and symptoms of corticosteroid withdrawal, such as joint and/or muscular pain, lassitude, and depression may occur, requiring supplemental systemic corticosteroids. Patients switched from prolonged systemic corticosteroid therapy to intranasal or topical therapy should be monitored carefully for acute adrenal insufficiency in response to stress (i.e., surgery). This is particularly important in those patients who have associated asthma or other clinical conditions where abrupt discontinuation in systemic corticosteroid dosing may cause a severe exacerbation of their symptoms.
Children may absorb proportionally larger amounts of topical corticosteroids and therefore are more susceptible to developing systemic toxicity. Cushing’s syndrome, hypothalamic-pituitary-adrenal (HPA) axis suppression, and increased intracranial pressure have been reported in children receiving other topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and absence of response to ACTH stimulation. The manufacturer reports that topical mometasone products cause HPA axis suppression in children aged 6 to 23 months who had normal adrenal function by Cortrosyn test before starting treatment (see Adverse Reactions). In pediatric patients, administration of topical corticosteroids should be limited to the least amount compatible with an effective therapeutic regimen; application of topical corticosteroids to > 20% of body surface area places pediatric patients increases the risk of HPA axis suppression. Chronic corticosteroid therapy in children may interfere with growth and development. The use of topical mometasone products is not recommended in children < 12 years of age for the lotion or in children < 2 years of age for the ointment and cream. For children > 2 years, the duration of treatment with mometasone ointment or cream should be limited to no more than 3 weeks. Avoid the use of mometasone topical products for the treatment of diaper dermatitis; mometasone should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute an occlusive dressing. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when treated with topical corticosteroids. The safe and effective use of intranasal mometasone in children less than 2 years of age has not been established. No statistically significant effect on growth velocity was observed after one -year of use of mometasone nasal spray (100 mcg/day) to children aged 2 - 9 years old after 1 year, and clinically relevant HPA axis suppression did not occur. To minimize the systemic effects of intranasal or topical corticosteroids, each patient should be titrated to the lowest effective dose.
Topical and inhaled corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical or inhaled corticosteroid. 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. Further, 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.
Although not reported with intranasal mometasone, cataracts and/or glaucoma have occurred in patients receiving nasal and inhaled corticosteroids. Studies have shown that intranasal mometasone was not associated with cataract formation or an increase in intraocular pressure. Nonetheless, prolonged use of corticosteroids can cause posterior subcapsular cataracts and glaucoma. Patients receiving corticosteroids chronically should be periodically assessed for cataract formation, glaucoma, or any other visual disturbance. In general, mometasone preparations should not be applied to the face, groin, or axillae. Care should be taken to avoid use around the eyes; ophthalmic administration is contraindicated. Visual impairment, ocular hypertension and worsened cataracts have been reported with ocular exposure to high potency topical corticosteroids. Preexisting glaucoma may be aggravated if mometasone is used in the periorbital area.
The normal inflammatory response to infections can be masked by mometasone. Use of inhaled or application of topical mometasone to areas of infection, including tuberculosis of the skin or in patients with a history of active tuberculosis, fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, or varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. 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. During clinical studies, rare cases of localized infections of the nose and pharynx with Candida albicans did occur with intranasal mometasone. Topical corticosteroids should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis as they may exacerbate these conditions.
Mometasone is classified as FDA pregnancy risk category C. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in laboratory animals. There are no adequate and well-controlled studies of teratogenic effects from intranasal or topical application of corticosteroids in pregnant women. If these drugs must be used during pregnancy, the potential risks should be discussed with the patient. Intranasal or topical corticosteroids should not be used in large amounts or for prolonged periods in pregnant women. Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Low-dose inhaled corticosteroids are considered first line therapy for control of mild persistent asthma during pregnancy according to the 2004 guidelines of the National Asthma Education and Prevention Program (NAEPP) Asthma and Pregnancy Working Group. Data on the use of medium to high dose inhaled corticosteroid use during pregnancy are limited. However, dose titration may be considered for those with moderate to severe persistent asthma, preferably using budesonide. Budesonide (FDA pregnancy category B) is preferred over other inhaled corticosteroids due to availability of more safety information during pregnancy. However, there are no data to indicate safety concerns with other inhaled corticosteroids, and maintaining a previously established treatment regimen may be more beneficial to the patient.[8627] Selection of any pharmacologic treatment for asthma control during pregnancy should include the specific needs of the patient, based on an individual evaluation, and consideration of the potential benefits or risks to the fetus.
It is not known whether intranasal or topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are excreted in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because many drugs are excreted in human milk, caution should be exercised when intranasal or topical mometasone is administered to a woman who is breast-feeding.
Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to mometasone should not receive any form of mometasone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.[4323]
[ Last revised: 1/11/2006 10:03:00 PM ]
References
. Butani L. Corticosteroid-induced hypersensitivity reactions. Ann Allergy Asthma Immunol 2002;89:439 - 45.
. NAEPP Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment - Update 2004. NIH Publication No. 05-3279. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute, 2004
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