Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.
The effects of renal impairment, hepatic impairment, age, or gender on mometasone furoate pharmacokinetics have not been adequately investigated. Three clinical pharmacology studies have been conducted in humans to assess the effect of mometasone furoate at various doses on adrenal function. In one study, daily doses of and mug of mometasone furoate and 10 mg of prednisone were compared to placebo in 64 patients with allergic rhinitis. Adrenal function before and after 36 consecutive days of treatment was assessed by measuring plasma cortisol levels following a 6-hour Cortrosyn ACTH infusion and by measuring hour urinary-free cortisol levels.
Mometasone furoate, at both the and mug dose, was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion or a statistically significant decrease in the hour urinary-free cortisol levels compared to placebo. A statistically significant decrease in the mean plasma cortisol levels post-Cortrosyn infusion and hour urinary-free cortisol levels was detected in the prednisone treatment group compared to placebo. The hour plasma cortisol area under the curve AUC , during and after an 8-hour Cortrosyn infusion and hour urinary-free cortisol levels were determined at baseline and after 29 days of treatment.
No statistically significant differences of adrenal function were observed with mometasone furoate compared to placebo. Dose administrations were separated by at least 72 hours.
Determination of serial plasma cortisol levels at 8 AM and for the hour period following each treatment were used to calculate the plasma cortisol area under the curve AUC In addition, hour urinary-free cortisol levels were collected prior to initial treatment administration and during the period immediately following each dose.
No statistically significant decreases in the plasma cortisol AUC, 8 AM cortisol levels, or hour urinary-free cortisol levels were observed in volunteers treated with either mometasone furoate or oral mometasone, as compared with placebo treatment.
The efficacy and safety of mometasone furoate in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have been evaluated in 18 controlled trials, and one uncontrolled clinical trial, in approximately adults age and adolescents age These trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing.
A total of patients have been treated with mometasone furoate for 1 year or longer. In patients with seasonal allergic rhinitis, mometasone furoate demonstrated improvement in nasal symptoms vs. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. These studies were designed such that patients received 4 weeks of prophylaxis with mometasone furoate prior to the anticipated onset of the pollen season, however, some patients received only 2 to 3 weeks of prophylaxis.
Patients receiving 2 to 4 weeks of prophylaxis with mometasone furoate demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients. Mometasone furoate is indicated for the prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and the treatment of the nasal symptoms of perennial allergic rhinitis, in adults and children 12 years of age and older.
In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylaxis with mometasone furoate is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal i.
Careful attention must be given when patients previously treated for prolonged periods with systemic corticosteroids are transferred to topical corticosteroids, with careful monitoring for acute adrenal insufficiency in response to stress. This is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroid dosing may cause a severe exacerbation of their symptoms.
If recommended doses of intranasal corticosteroids are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare cases of menstrual irregularities, acneiform lesions, and cushingoid features. If such changes occur, topical corticosteroids should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
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 affects the risk of developing a disseminated infection is 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. If chickenpox develops, treatment with antiviral agents may be considered.
In clinical studies with mometasone furoate, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops, use of mometasone furoate should be discontinued and appropriate local or systemic therapy instituted, if needed. Nasal 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.
Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of mometasone furoate monohydrate.
Extreme rare instances of wheezing have been reported. Rare instances of nasal septum perforation and increased intraocular pressure have also been reported following the intranasal application of aerosolized corticosteroids. Nasonex mometasone furoate monohydrate is a nasal spray used for the treatment of allergy symptoms such as runny nose, sneezing, congestion , nasal polyps , and itchy nose.
Nasonex is in a class of medication called corticosteroids. Most healthy individuals over the age of two can safely use Nasonex. This medication may soon be available over the counter in the U. In either form, you should talk to a healthcare provider before using it, especially for children, on a long-term basis, or if you're pregnant or nursing.
Nasonex can cause or worsen certain eye conditions such as cataracts or glaucoma. Research from , however, indicates that newer versions of corticosteroids, like Nasonex, may have significantly reduced risk of these outcomes.
Regardless, Nasonex and other corticosteroids should be used with caution in patients who have a history of these conditions. Nasonex should not be taken by anyone who has had a previous allergic reaction to mometasone furoate. Nasonex should not be used if you have nasal ulcers, or have had recent nasal surgery or nasal trauma. Nasonex may exacerbate certain viral and bacterial infections. According to the manufacturer, the following side effects occurred during clinical studies: headaches, viral infections, pharyngitis inflammation of the pharynx or throat , nosebleeds , bloody mucous, upper respiratory tract infections, coughing, sore muscles, painful menstruation, and sinusitis.
Less common side effects include suppression of the immune system, thrush a fungal infection of the mouth and throat , growth disturbances, taste disturbances, nasal septal perforation, nasal burning and irritation, and slow wound healing. All medications are capable of producing a life-threatening allergic reaction called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, difficulty swallowing or drooling, swelling of the tongue, lips, or face, blue lips or skin cyanosis , wheezing, rash, or hives.
Symptoms usually develop rapidly within a short time of using a new medication. If you have any of these symptoms after using Nasonex, call or go to the nearest emergency room. Rebound congestion or addiction is a common side effect of nasal sprays.
However, the manufacturer of Nasonex claims that this is not a side effect of Nasonex. Nasonex is a nasal spray and should not be used orally or in any other manner. Nasonex works best when it is taken regularly. A typical adult dose of Nasonex is two sprays in each nostril one time daily. Learn more about vaccine availability.
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