Drugs Details

Drugs Info of Nasonex
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Feb 2015 03:50 am
  • Brand Name : Nasonex
  • Generic Name : mometasone nasal (Pronunciation: moe MET a sone)
Descriptions

Mometasone furoate monohydrate, the active component of NASONEX (mometasone furoate nasal spray) Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, and the following chemical structure:

 

NASONEX® (mometasone furoate nasal spray) 
  (mometasone furoate) Structural Formula Illustration

Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6•H2O, and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5000.

NASONEX (mometasone furoate nasal spray) Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The pH is between 4.3 and 4.9.

What are the possible side effects of mometasone nasal (Nasonex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • vision problems; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • headache;
  • stuffy nose, sore throat, cough;
  • muscle or joint...

Read All Potential Side Effects and See Pictures of Nasonex »

What are the precautions when taking mometasone furoate (nasal spray) (Nasonex)?

Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis, herpes eye infection), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make...

Read All Potential Precautions of Nasonex »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Treatment of Allergic Rhinitis

NASONEX® (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Prophylaxis of Seasonal Allergic Rhinitis

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.

Treatment of Nasal Polyps

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older.

Dosage Administration

Administer NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.

Treatment of Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 2 sprays (50 mcg of mometasone furcate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray (50 mcg of mometasone furcate in each spray) in each nostril once daily (total daily dose of 100 mcg).

Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

Prophylaxis of Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older

The recommended dose for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

Treatment of Nasal Polyps

Adults 18 Years of Age and Older

The recommended dose for the treatment of nasal polyps is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.

How Supplied

Dosage Forms and Strengths

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis.

After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mg or 100 microliter of suspension containing mometasone furoate monohydrate equivalent to 50 mcg of mometasone furoate calculated on the anhydrous basis. Each bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg provides 120 sprays.

NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap. It contains 17 g of product formulation, 120 sprays, each delivering 50 mcg of mometasone furoate per actuation.

(NDC 0085-1288-01).

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

When NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg 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. Keep out of reach of children.

Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: January 2011

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, ulcerations, Candida albicans infection, impaired wound healing [see WARNINGS AND PRECAUTIONS]
  • Cataracts and glaucoma [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see WARNINGS AND PRECAUTIONS, Use In Specific Populations]

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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 200 mcg/day vs. placebo and that were more common with NASONEX (mometasone furoate (nasal spray)) 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)

  NASONEX (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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 55% of pediatric patients (ages 3 to 11 years) treated with NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 4% in placebo) and vomiting (5% in NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, 100 mcg/day in a clinical trial vs. placebo including 56 subjects (28 each NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg and placebo) and that was more common with NASONEX (mometasone furoate (nasal spray)) 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 furcate 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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg was comparable to patients with the placebo except for eplstaxls, which was 9% for 200 mcg once dally, 13% for 200 mcg twice dally, and 5% for the placebo.

Nasal ulcers and nasal and oral candldlasls were also reported in patients treated with NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg than in patients with the placebo included sinus headache (1.2% in NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg group vs. 0.2% in placebo) and epistaxis (1 % in NASONEX (mometasone furoate (nasal spray)) 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.

Post-Marketing Experience

The following adverse reactions have been identified during the post-marketing period for NASONEX (mometasone furoate (nasal spray)) 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.

Read the Nasonex (mometasone furoate (nasal spray)) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No formal drug-drug interaction studies have been conducted with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg.

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 CYP 3A4 in the metabolism of this compound. Coadministration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concentrations of mometasone furoate [see CLINICAL PHARMACOLOGY].

Read the Nasonex Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Local Nasal Effects

Epistaxis

In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with NASONEX (mometasone furoate (nasal spray)) Nasal Spray than those who received placebo [see ADVERSE REACTIONS].

Candida Infection

In clinical studies with NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) 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 surgeryor nasal trauma should not use a nasal corticosteroid until healing has occurred.

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 NASONEX (mometasone furoate (nasal spray)) 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 NASONEX (mometasone furoate (nasal spray)) -treated patients in the 12-week study, as compared with 141 placebo-treated patients. No individual NASONEX (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 NASONEX (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.

Hypersensitivity Reactions

Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue Nasonex Nasal Spray if such reactions occur [see CONTRAINDICATIONS].

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.

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 Nasonex (mometasone furoate (nasal spray)) Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.

Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASONEX (mometasone furoate (nasal spray)) Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including NASONEX (mometasone furoate (nasal spray)) Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Use In Specific Populations].

Patient Counseling Information

See FDA-approved labeling

Local Nasal Effect

Patients should be informed that treatment with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg may be associated with adverse reactions which include epistaxis (nose bleed) and nasal septum perforation. Candida infection may also occur. 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 [see WARNINGS AND PRECAUTIONS]. Patients should be cautioned not to spray NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg directly onto the nasal septum.

Glaucoma and Cataracts

Patients should be informed that 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. Patients should be cautioned not to spray NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg into the eyes [see WARNINGS AND PRECAUTIONS].

Immunosuppression

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and patients should also be advised that if they are exposed, medical advice should be sought without delay [see WARNINGS AND PRECAUTIONS].

Use Regularly for Best Effect

Patients should use NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg on a regular basis for optimal effect. Improvement in nasal symptoms of allergic rhinitis has been shown to occur within 1 to 2 days after initiation of dosing. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing. Patients should not increase the prescribed dosage but should contact their physician if symptoms do not improve, or if the condition worsens. Administration to young children should be aided by an adult.

If a patient missed a dose, the patient should be advised to take the dose as soon as they remember. The patient should not take more than the recommended dose for the day.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 1 and 2 times the maximum recommended daily intranasal dose [MRDID] in adults [400 mcg] and children [100 mcg], respectively, on a mcg/m2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 2 times the MRDID in adults and children, respectively, on a mcg/m2 basis).

Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary-cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse-lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DMA synthesis in vivo in rat hepatocytes.

In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (less than the MRDID in adults on a mcg/m basis).

Use In Specific Populations

Pregnancy

Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

In mice, mometasone furoate caused cleft palate at subcutaneous doses (less than the MRDID in adults on a mcg/m2 basis). Fetal survival was reduced at approximately 2 times the MRDID in adults on a mcg/m2 basis. No toxicity was observed at less than the MRDID in adults on a mcg/m2 basis.

In rats, mometasone furoate produced umbilical hernia at topical dermal doses approximately 10 times the MRDID in adults on a mcg/m2 basis. A topical dermal dose approximately 6 times the MRDID in adults on a mcg/m2 basis produced delays in ossification, but no malformations.

In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly) at topical dermal doses approximately 6 times the MRDID in adults on a mcg/m2 basis. In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly or domed head) at approximately 30 times the MRDID in adults on a mcg/m2 basis. At approximately 110 times the MRDID in adults on a mcg/m2 basis, most litters were aborted or resorbed. No toxicity was observed at approximately 6 times the MRDID in adults on a mcg/m2 basis.

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, a dose less than the MRDID in adults on a mcg/m2 basis caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival.

Nonteratogenic Effects: Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

Nursing Mothers

It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg is administered to nursing women.

Pediatric Use

The safety and effectiveness of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for allergic rhinitis in children 12 years of age and older have been established [see ADVERSE REACTIONS and Clinical Studies]. Use of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for allergic rhinitis in pediatric patients 2 to 11 years of age is supported by safety and efficacy data from clinical studies. Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in controlled clinical trials [see ADVERSE REACTIONS and Clinical Studies]. Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in a controlled trial to evaluate safety [see ADVERSE REACTIONS]. Safety and effectiveness of Nasonex (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for allergic rhinitis in children less than 2 years of age have not been established.

The safety and effectiveness of Nasonex (mometasone furoate (nasal spray)) Nasal Spray for the treatment of nasal polyps in children less than 18 years of age have not been established. One 4-month trial was conducted to evaluate the safety and efficacy of Nasonex (mometasone furoate (nasal spray)) in the treatment of nasal polyps in pediatric patients 6 to 17 years of age. The primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. A total of 127 patients with nasal polyps were randomized to placebo or Nasonex (mometasone furoate (nasal spray)) Nasal Spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). The results of this trial did not support the efficacy of Nasonex (mometasone furoate (nasal spray)) Nasal Spray in the treatment of nasal polyps in pediatric patients. The adverse events reported in this trial were similar to the adverse events reported in patients 18 years of age and older with nasal polyps.

Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, each patient should be titrated to his/her lowest effective dose.

A clinical study to assess the effect of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. No statistically significant effect on growth velocity was observed for NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg compared to placebo following one year of treatment. No evidence of clinically relevant HPA axis suppression was observed following a 30minute cosyntropin infusion.

The potential of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.

Geriatric Use

A total of 280 patients above 64 years of age with allergic rhinitis or nasal polyps (age range 64 to 86 years) have been treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for up to 3 or 4 months, respectively. The adverse reactions reported in this population were similar in type and incidence to those reported by younger patients.

Hepatic Impairment

Concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see CLINICAL PHARMACOLOGY]

This monograph has been modified to include the generic and brand name in many instances.

OverDose

There are no data available on the effects of acute or chronic overdosage with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Intranasal administration of 1600 mcg (4 times the recommended dose of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for the treatment of nasal polyps in patients 18 years of age and older) daily for 29 days, to healthy human volunteers, showed no increased incidence of adverse events. Single intranasal doses up to 4000 mcg and oral inhalation doses up to 8000 mcg have been studied in human volunteers with no adverse effects reported. Chronic over dosage with any corticosteroid may result in signs or symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. Acute overdosage with this dosage form is unlikely since one bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg contains approximately 8500 mcg of mometasone furoate.

ContrainDications

NASONEX (mometasone furoate (nasal spray)) Nasal Spray is contraindieated in patients with known hypersensitivity to mometasone furoate or any of its ingredients.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg is a corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

In two clinical studies utilizing nasal antigen challenge, NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg decreased some markers of the early- and late-phase allergic response. These observations included decreases (vs. placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known.

The effect of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (e.g., eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells).

Pharmacodynamics

Adrenal Function in Adults: Four clinical pharmacology studies have been conducted in humans to assess the effect of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg at various doses on adrenal function. In one study, daily doses of 200 and 400 mcg of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg and 10 mg of prednisone were compared to placebo in 64 patients (22 to 44 years of age) 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 24-hour urinary free cortisol levels. NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, at both the 200- and 400-mcg dose, was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. A statistically significant decrease in the mean plasma cortisol levels post-Cortrosyn infusion and 24-hour urinary free cortisol levels was detected in the prednisone treatment group compared to placebo.

A second study assessed adrenal response to NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg (400 and 1600 mcg/day), prednisone (10 mg/day), and placebo, administered for 29 days in 48 male volunteers (21 to 40 years of age). The 24-hour plasma cortisol area under the curve (AUC0-24), during and after an 8-hour Cortrosyn infusion and 24-hour urinary free cortisol levels were determined at baseline and after 29 days of treatment. No statistically significant differences in adrenal function were observed with NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg compared to placebo.

A third study evaluated single, rising doses of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg (1000, 2000, and 4000 mcg/day), orally administered mometasone furcate (2000,4000, and 8000 mcg/day), orally administered dexamethasone (200, 400, and 800 mcg/day), and placebo (administered at the end of each series of doses) in 24 male volunteers (22 to 39 years of age). Dose administrations were separated by at least 72 hours. Determination of serial plasma cortisol levels at 8 AM and for the 24-hour period following each treatment were used to calculate the plasma cortisol area under the curve (AUC0-24). In addition, 24-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 24-hour urinary free cortisol levels were observed in volunteers treated with either NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg or oral mometasone, as compared with placebo treatment. Conversely, nearly all volunteers treated with the three doses of dexamethasone demonstrated abnormal 8 AM cortisol levels (defined as a cortisol level < 10 mcg/dL), reduced 24-hour plasma AUC values, and decreased 24-hour urinary free cortisol levels, as compared to placebo treatment.

In a fourth study, adrenal function was assessed in 213 patients (18 to 81 years of age) with nasal polyps before and after 4 months of treatment with either NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, (200 mcg once or twice daily) or placebo by measuring 24-hour urinary free cortisol levels. NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, at both doses (200 and 400 mcg/day), was not associated with statistically significant decreases in the 24-hour urinary free cortisol levels compared to placebo.

Three clinical pharmacology studies have been conducted in pediatric patients to assess the effect of mometasone furcate nasal spray on the adrenal function at daily doses of 50,100, and 200 mcg vs. placebo. In one study, adrenal function before and after 7 consecutive days of treatment was assessed in 48 pediatric patients with allergic rhinitis (ages 6 to 11 years) by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray, at all three doses, was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. In the second study, adrenal function before and after 14 consecutive days of treatment was assessed in 48 pediatric patients (ages 3 to 5 years) with allergic rhinitis by measuring plasma cortisol levels following a 30-minute Cortrosyn infusion. Mometasone furoate nasal spray, 50 mcg, at all three doses (50,100, and 200 mcg/day), was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion compared to placebo. All patients had a normal response to Cortrosyn. In the third study, adrenal function before and after up to 42 consecutive days of once-daily treatment was assessed in 52 patients with allergic rhinitis (ages 2 to 5 years), 28 of whom received mometasone furoate nasal spray, 50 mcg per nostril (total daily dose 100 mcg), by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo.

Pharmacokinetics

Absorption

Mometasone furoate monohydrate administered as a nasal spray suspension has very low bioavailability ( < 1%) in plasma using a sensitive assay with a lower quantitation limit (LOQ) of 0.25 pcg/mL.

Distribution

The in vitro protein binding for mometasone furoate was reported to be 98% to 99% in concentration range of 5 to 500 ng/mL

Metabolism

Studies have shown that any portion of a mometasone furoate dose which is swallowed and absorbed undergoes extensive metabolism to multiple metabolites. There are no major metabolites detectable in plasma. Upon in vitro incubation, one of the minor metabolites formed is 6β-hydroxy-mometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P-450 3A4 (CYP3A4).

Elimination

Following intravenous administration, the effective plasma elimination half-life of mometasone furoate is 5.8 hours. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.

Specific Populations

Hepatic Impairment: Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50 to 105 pcg/mL). The observed peak plasma concentrations appear to increase with severity of hepatic impairment, however, the numbers of detectable levels were few.

Renal Impairment: The effects of renal impairment on mometasone furcate pharmacokinetics have not been adequately investigated.

Pediatric: Mometasone furoate pharmacokinetics have not been investigated in the pediatric population [see Use In Specific Populations].

Gender: The effects of gender on mometasone furoate pharmacokinetics have not been adequately investigated.

Race: The effects of race on mometasone furoate pharmacokinetics have not been adequately investigated.

Drug-Drug Interactions

Inhibitors of Cytochrome P450 3A4: In a drug interaction study, an inhaled dose of mometasone furoate 400 mcg was given to 24 healthy subjects twice daily for 9 days and ketoconazole 200 mg (as well as placebo) were given twice daily concomitantly on Days 4 to 9. Mometasone furoate plasma concentrations were < 150 pcg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate > 200 pcg/mL on Day 9 (211-324 pcg/mL).

Animal Toxicology and/or Pharmacology Reproduction Toxicology Studies

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the MRDID in adults on a mcg/m2 basis). Fetal survival was reduced at 180 mcg/kg (approximately 2 times the MRDID in adults on a mcg/m basis). No toxicity was observed at 20 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/kg and above (approximately 10 times the MRDID in adults on a mcg/m2 basis). A dose of 300 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis) produced delays in ossification, but no malformations. In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/kg and above (approximately 6 times the MRDID in adults on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly or domed head) at 700 mcg/kg (approximately 30 times the MRDID in adults on a mcg/m2 basis). At 2800 mcg/kg (approximately 110 times the MRDID in adults on a mcg/m2 basis), most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis).

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg (less than the MRDID in adults on a mcg/m2 basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

Clinical Studies

Allergic Rhinitis in Adults and Adolescents

The efficacy and safety of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg 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 3000 adults (ages 17 to 85 years) and adolescents (ages 12 to 16 years). Of the total number of patients, there were 1757 males and 1453 females, including a total of 283 adolescents (182 boys and 101 girls) with seasonal allergic or perennial allergic rhinitis. Patients were treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg at doses ranging from 50 to 800 mcg/day. The majority of patients were treated with 200 mcg/day. The allergic rhinitis trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Patients treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, 200 mcg/day had a statistically significant decrease in total nasal symptom scores compared to placebo-treated patients. No additional benefit was observed for mometasone furoate doses greater than 200 mcg/day. A total of 350 patients have been treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for 1 year or longer.

In patients with seasonal allergic rhinitis, NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, demonstrated improvement in nasal symptoms (vs. placebo) within 11 hours after the first dose based on one single-dose, parallel-group study of patients in an outdoor "park" setting (park study) and one environmental exposure unit (EEU) study, and within 2 days in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.

Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg, given at a dose of 200 mcg/day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg 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 NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.

Allergic Rhinitis in Pediatrics

The efficacy and safety of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg in the treatment of seasonal allergic and perennial allergic rhinitis in pediatric patients (ages 3 to 11 years) have been evaluated in four controlled trials. This included approximately 990 pediatric patients ages 3 to 11 years (606 males and 384 females) with seasonal allergic or perennial allergic rhinitis treated with mometasone furcate nasal spray at doses ranging from 25 to 200 mcg/day. Pediatric patients treated with NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg (100 mcg total daily dose, 374 patients) had a significant decrease in total nasal symptom (nasal congestion, rhinorrhea, itching, and sneezing) scores, compared to placebo-treated patients. No additional benefit was observed for the 200-mcg mometasone furoate total daily dose in pediatric patients (ages 3 to 11 years). A total of 163 pediatric patients have been treated for 1 year.

Nasal Polyps in Adults 18 Years of Age and Older

Two studies were performed to evaluate the efficacy and safety of NASONEX (mometasone furoate (nasal spray)) Nasal Spray in the treatment of nasal polyps. These studies involved 664 patients with nasal polyps, 441 of whom received NASONEX (mometasone furoate (nasal spray)) Nasal Spray. These studies were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies in patients 18 to 86 years of age with bilateral nasal polyps. Patients were randomized to receive NASONEX (mometasone furoate (nasal spray)) Nasal Spray 200 mcg once daily, 200 mcg twice daily or placebo for a period of 4 months. The co-primary efficacy endpoints were 1) change from baseline in nasal congestion/obstruction averaged over the first month of treatment; and 2) change from baseline to last assessment in bilateral polyp grade during the entire 4 months of treatment as assessed by endoscopy. Efficacy was demonstrated in both studies at a dose of 200 mcg twice daily and in one study at a dose of 200 mcg once a day (see TABLE 2 below).

TABLE 2: EFFECT OF NASONEX (mometasone furoate (nasal spray)) NASAL SPRAY IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH NASAL POLYPS

  NASONEX
200 mcg qd
NASONEX
200 mcg bid
Placebo P value for NASONEX 200 mcg qd vs. placebo P value for NASONEX 200 mcg bid vs. placebo
Study 1 N=115 N=122 N=117    
Baseline bilateral polyp grade‡ 4.21 4.27 4.25    
Mean change from baseline in bilateral polyps grade -1.15 -0.96 -0.50 O.001 0.01
Baseline nasal congestion§ 2.29 2.35 2.28    
Mean change from baseline in nasal congestion -0.47 -0.61 -0.24 0.001 < 0.001
Study 2 N=102 N=102 N=106    
Baseline bilateral polyp gradeDagger; 4.00 4.10 4.17    
Mean change from baseline in bilateral polyps grade -0.78 -0.96 -0.62 0.33 0.04
Baseline nasal congestion§ 2.23 2.20 2.18    
Mean change from baseline in nasal congestion -0.42 -0.66 -0.23 0.01 < 0.001
‡polyps in each nasal fossa were graded by the investigator based on endoscopic visualization, using a scale of 0-3 where 0 = no polyps; 1 = polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2 = polyps reaching below the inferior border of the middle turbinate but not the inferior border of the inferior turbinate; 3 = polyps reaching to or below the border of the inferior turbinate, or polyps medial to the middle turbinate (score reflects sum of left and right nasal fossa grades).
§ nasal congestion/obstruction was scored daily by the patient using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.

There were no clinically relevant differences in the effectiveness of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, 50 mcg, in the studies evaluating treatment of nasal polyps across subgroups of patients defined by gender, age, or race.

Nasal Congestion Associated with Seasonal Allergic Rhinitis

The efficacy and safety of NASONEX (mometasone furoate (nasal spray)) Nasal Spray 50 mcg for nasal congestion associated with seasonal allergic rhinitis were evaluated in three randomized, placebo-controlled, double blind clinical trials of 15 days duration. The three trials included a total of 1008 patients 12 years of age and older with nasal congestion associated with seasonal allergic rhinitis, of whom 506 received NASONEX (mometasone furoate (nasal spray)) Nasal Spray 200 mcg daily and 502 received placebo. Of the 1008 patients, the majority 784 (78 %) were Caucasians. The majority of the patients were between 18 to < 65 years of age with a mean age of 38.8 years and were predominantly women (66%). The primary efficacy endpoint was the change from baseline in average morning and evening reflective nasal congestion score over treatment day 1 to day 15. The key secondary efficacy endpoint was the change from baseline in average morning and evening reflective total nasal symptom score (TNSS = rhinorrhea [nasal discharge/runny nose or postnasal drip], nasal congestion/stuffiness, nasal itching, sneezing) averaged over treatment day 1 to 15. Two out of three studies demonstrated that treatment with Nasonex (mometasone furoate (nasal spray)) Nasal Spray significantly reduced the nasal congestion symptom score and the TNSS compared to placebo in patients 12 years of age and older with seasonal allergic rhinitis (see TABLE 3 and 4 below).

TABLE 3: EFFECT OF NASONEX (mometasone furoate (nasal spray)) NASAL SPRAY IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS ON NASAL CONGESTION IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Treatment (Patient Number) Baseline§ LS Mean * Change from Baseline LS Mean * Difference from Placebo LS Mean * P value for NASONEX 200 mcg qd vs. placebo
Study 1
NASONEX 200 mcg qd (N=176) 2.63 -0.64 -0.15 0.006
Placebo (N=175) 2.62 -0.49    
Study 2
NASONEX 200 mcg qd (N=168) 2.62 -0.71 -0.31 0.001
Placebo (N=164) 2.60 -0.40    
§ nasal congestion/obstruction was scored daily by the patient using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms.
* LS Mean and p- value was from an ANCOVA model with treatment, baseline value, and center effects.

TABLE 4: EFFECT OF NASONEX (mometasone furoate (nasal spray)) NASAL SPRAY ON TNSS IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Treatment (Patient Number) Baseline§ LS Mean* Change from Baseline LS Mean* Difference from Placebo LS Mean* P value for NASONEX 200 mcg qd vs. placebo
Study 1
NASONEX 200 mcg qd (N=176) 9.60 -2.68 -0.83 0.001
Placebo (N=175) 9.66 -1.85    
Study 2
NASONEX 200 mcg qd (N=168) 9.39 -3.00 -1.27 0.001
  Placebo (N=164) 9.50 -1.73    
§ TNSS was the sum of four Individual symptom scores: rhinorrhea, nasal congestion/stuffiness, nasal Itching and sneezing. Each symptom was to be rated on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe.
* LS Mean and p- value was from an ANCOVA model with treatment, baseline value, and center effects.

Based on results in other studies with NASONEX (mometasone furoate (nasal spray)) Nasal Spray in pediatric patients, effects on nasal congestion associated with seasonal allergic rhinitis in patients below 12 years of age is similar to those seen in adults and adolescents [see Clinical Studies].

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

NASONEX®
[na-za-neks]
(mometasone furoate monohydrate) Nasal Spray, 50 mcg

FOR INTRANASAL USE ONLY

Read the Patient Information that comes with NASONEX (mometasone furoate (nasal spray)) before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your health-care provider about your medical condition or treatment. If you have any questions about NASONEX (mometasone furoate (nasal spray)) , ask your health-care provider.

What is NASONEX (mometasone furoate (nasal spray)) ?

NASONEX (mometasone furoate (nasal spray)) Nasal Spray is a man-made (synthetic) corticosteroid medicine that is used to:

  • to treat the nasal symptoms of seasonal and year-round allergic rhinitis (inflammation of the lining of the nose) in adults and children 2 years of age and older.
  • to treat nasal congestion that happens with seasonal allergic rhinitis in adults and children 2 years of age and older.
  • to prevent nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older.
  • to treat nasal polyps in people 18 years and older.

The safety and effectiveness of NASONEX (mometasone furoate (nasal spray)) has not been shown:

  • In children under 2 years of age to treat allergic rhinitis.
  • In children under 18 years of age to treat nasal polyps.

Who should not use NASONEX (mometasone furoate (nasal spray)) ?

Do not use NASONEX (mometasone furoate (nasal spray)) if you are allergic to any of the ingredients in NASONEX (mometasone furoate (nasal spray)) . See the end of this leaflet for a complete list of ingredients in NASONEX (mometasone furoate (nasal spray)) .

What should I tell my health-care provider before using NASONEX (mometasone furoate (nasal spray)) ?

Before you take NASONEX (mometasone furoate (nasal spray)) , tell your health-care provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury.
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye).
  • have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes.
  • have been near someone who has chickenpox or measles.
  • are not feeling well or have any other symptoms that you do not understand.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if NASONEX (mometasone furoate (nasal spray)) will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or planning to breast-feed. It is not known whether NASONEX (mometasone furoate (nasal spray)) passes into your breast milk.

Tell your health-care provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

NASONEX (mometasone furoate (nasal spray)) and other medicines may affect each other and cause side effects. NASONEX (mometasone furoate (nasal spray)) may affect the way other medicines work, and other medicines may affect how NASONEX (mometasone furoate (nasal spray)) works.

Know the list of medicine you take. Keep a list of your medications with you to show your health-care provider and pharmacist when a new medication is prescribed.

How should I use NASONEX (mometasone furoate (nasal spray)) ?

  • Use NASONEX (mometasone furoate (nasal spray)) exactly as prescribed by your health-care provider.
  • This medicine is for use in the nose only. Do not spray it into your mouth or eyes.
  • An adult should help a young child use this medicine.
  • For best results, you should keep using NASONEX (mometasone furoate (nasal spray)) regularly each day without missing a dose. If you do miss a dose of NASONEX (mometasone furoate (nasal spray)) , take it as soon as you remember. However, do not take more than the daily dose prescribed by your doctor.
  • Do not use NASONEX (mometasone furoate (nasal spray)) more often than prescribed. Ask your health-care provider if you have any questions.
  • For detailed instructions on how to use NASONEX (mometasone furoate (nasal spray)) Nasal Spray, see the "Patient's Instructions for Use" at the end of this leaflet.

See your health-care provider regularly to assess your symptoms while taking NASONEX (mometasone furoate (nasal spray)) and to check for side effects.

What should I avoid while taking NASONEX (mometasone furoate (nasal spray)) ?

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your health-care provider may advise you to stop taking them once you begin using NASONEX (mometasone furoate (nasal spray)) .

What are the possible side effects of NASONEX (mometasone furoate (nasal spray)) ?

NASONEX (mometasone furoate (nasal spray)) may cause serious side effects, including:

  • Thrush (Candida), a fungal infection in your nose and throat. Tell your doctor if you have any redness or white colored patches in your nose or throat.
  • Slow wound healing. Do not use NASONEX (mometasone furoate (nasal spray)) until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
  • Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams.
  • Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using NASONEX (mometasone furoate (nasal spray)) . Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you are using NASONEX (mometasone furoate (nasal spray)) .
  • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea and vomiting and low blood pressure.

The most common side effects of NASONEX (mometasone furoate (nasal spray)) include:

  • Headache
  • viral infection
  • sore throat
  • nosebleeds
  • cough

Tell your health-care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of NASONEX (mometasone furoate (nasal spray)) . For more information ask your health-care provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NASONEX (mometasone furoate (nasal spray)) ?

  • Store NASONEX (mometasone furoate (nasal spray)) at room temperature between 59°F to 86°F (15°C to 30°C).
  • Avoid prolonged exposure NASONEX (mometasone furoate (nasal spray)) container to bright light.
  • Shake well before each use.

Keep NASONEX (mometasone furoate (nasal spray)) and all medicines out of the reach of children.

General information about NASONEX (mometasone furoate (nasal spray))

Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use NASONEX (mometasone furoate (nasal spray)) for a condition for which it was not prescribed. Do not give NASONEX (mometasone furoate (nasal spray)) to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about NASONEX (mometasone furoate (nasal spray)) . If you would like more information, talk with your health-care provider. You can ask your health-care provider or pharmacist for information about NASONEX (mometasone furoate (nasal spray)) that is written for health professionals.

For more information, go to www.NASONEX (mometasone furoate (nasal spray)) .com or call 1-800-526-4099.

What are the ingredients in NASONEX?

Active Ingredients: mometasone furoate monohydrate

Inactive Ingredients: glycerin, microcrystalline cellulose and carboxymethycellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80.

Patient Instructions for Use

For use in your nose only.

Read the Patient Instructions for Use carefully before you start to use your NASONEX (mometasone furoate (nasal spray)) Nasal Spray. If you have any questions, ask your health-care provider.

Shake the bottle well before each use.

1. Remove the plastic cap (Figure 1).

Figure 1

Remove the plastic cap - Illustration

2. Before you use NASONEX (mometasone furoate (nasal spray)) for the first time prime the pump by pressing downward on the shoulders of the white nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (Figure 2). Do Not pierce the nasal applicator. Press down and release the pump 10 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears.

Figure 2

Prime the pump by pressing downward - Illustration

3. Gently blow your nose to clear the nostrils. Close 1 nostril. Tilt your head forward slightly, keep the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3). Do Not spray directly onto the nasal septum (the wall between the two nostrils).

Figure 3

carefully insert the nasal applicator - Illustration

4. For each spray, hold the spray bottle upright and press firmly downward 1 time on the shoulders of the white nasal applicator using your index and middle fingers while supporting the base of the bottle with your thumb. Breathe gently inward through the nostril (Figure 4).

Figure 4

Breathe gently inward - Illustration

Note: It is important to keep the Nasonex (mometasone furoate (nasal spray)) unit in an upright orientation (as seen in Figure 4). Failure to do so may result in an incomplete or non-existent spray.

5. Then breathe out through the mouth.

6. Repeat in the other nostril.

7. Wipe the nasal applicator with a clean tissue and replace the plastic cap.

Each bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of NASONEX (mometasone furoate (nasal spray)) Nasal Spray, and throw away the bottle even if it has medicine still left in. Do not count any sprays used for priming the device. Talk with your health-care provider before your supply runs out to see if you should get a refill of your medicine.

Pediatric Use: Administration to young children should be done by an adult. Steps 1 through 7 from the Patient Instructions for Use, should be followed.

Cleaning: Do not try to unblock the nasal applicator with a sharp object. Please see Applicator Cleaning Instructions.

Patient Instruction for cleaning applicator

1. To clean the nasal applicator, remove the plastic cap (Figure 5). usage illustration

Figure 5

Remove the plastic cap - Illustration

2. Pull gently upward on the white nasal applicator to remove (Figure 6).

Figure 6

Pull gently upward on the white nasal applicator - Illustration

3. Soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry. (Figure 7). Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.

Figure 7

Soak the nasal applicator in cold tap water - Illustration

4. Rinse the plastic cap under cold water and dry (Figure 8).

Figure 8

Rinse the plastic cap-  Illustration

5. Put the nasal applicator back together making sure the pump stem is reinserted into the applicator's center hole (Figure 9).

Figure 9

Put the nasal applicator back together - Illustration

6. Reprime the pump by pressing downward on the shoulders of the white nasal applicator using your index and middle fingers while holding the base of the bottle with your thumb. Press down and release the pump 2 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears (Figure 10).

Figure 10

Reprime by spraying 2 times - Illustration

7. Replace the plastic cap (Figure 11).

Figure 11

  Replace the plastic cap - Illustration

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MOMETASONE SPRAY - NASAL

 

(mow-MET-uh-sown)

 

COMMON BRAND NAME(S): Nasonex

 

USES: Mometasone is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itching, and sneezing). It is also used to treat certain growths in the nose (nasal polyps). Mometasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved US professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat sinus inflammation (sinusitis). It should be used with an antibiotic if sinusitis is caused by a bacterial infection.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using mometasone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication in the nose as directed by your doctor, usually once a day for runny nose (rhinitis) and once or twice a day for polyps. Do not spray in the eyes or mouth. Gently blow your nose before using this drug. Shake the container well before each use. Follow the instructions to properly prime the spray pump.

To use the spray, remove the protective cap. Close one nostril by pressing it with your finger. Tilt your head slightly forward and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril. Press down firmly on the pump to deliver the prescribed number of sprays. Do not spray directly onto the middle wall of your nose (nasal septum). Breathe in gently through your nose and out through your mouth. Repeat in the other nostril. Wipe the applicator tip and replace the plastic cap. Avoid blowing your nose for 15 minutes after using this medication.

Dosage is based on your medical condition and response to treatment. Younger children may need a smaller dose and help from an adult to use this medication properly. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not increase your dose or use it more frequently than directed.

This medication does not work immediately. Some people will feel this medication working within 2 days, but it may take up to 2 weeks before the full benefit of this drug takes effect. Therefore, when using mometasone to prevent seasonal allergy symptoms, you may need to start this medication 2-4 weeks before pollen season begins. Ask your doctor or pharmacist if you should also use other medications (such as nose drops/spray, allergy drugs taken by mouth) along with this drug until it takes full effect.

Keep track of the number of sprays used from the container. Discard the container after you have used the number of sprays specified on the manufacturer's package. Follow the package instructions to unblock the spray tip if needed and to clean the spray bottle.

Tell your doctor if your symptoms do not improve after 2 weeks or if they worsen.

Consumer Overview Side Effect

SIDE EFFECTS: See also Precautions.

Nose/throat dryness or irritation, blood-tinged mucus/phlegm, and nosebleeds may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: pain/sores in your nose, white patches in your nose/mouth, painful swallowing/trouble swallowing.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Nasonex (mometasone furoate (nasal spray)) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis, herpes eye infection), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Medical examinations (especially of your nose and eyes) should be performed periodically during prolonged use of this medication to monitor your progress or check for side effects. Consult your doctor for more details.

Make sure all of your doctors know that you are using this medication or have used it in the past.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store upright at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.

Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Nasonex

Generic Name: mometasone nasal (Pronunciation: moe MET a sone)

  • What is mometasone nasal (Nasonex)?
  • What are the possible side effects of mometasone nasal (Nasonex)?
  • What is the most important information I should know about mometasone nasal (Nasonex)?
  • What should I discuss with my healthcare provider before using mometasone nasal (Nasonex)?
  • How should I use mometasone nasal (Nasonex)?
  • What happens if I miss a dose (Nasonex)?
  • What happens if I overdose (Nasonex)?
  • What should I avoid while using mometasone nasal (Nasonex)?
  • What other drugs will affect mometasone nasal (Nasonex)?
  • Where can I get more information?

What is mometasone nasal (Nasonex)?

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Mometasone nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Mometasone is also used to treat nasal polyps in adults.

Mometasone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mometasone nasal (Nasonex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • vision problems; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • headache;
  • stuffy nose, sore throat, cough;
  • muscle or joint pain;
  • nausea; or
  • sores or white patches inside or around your nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nasonex (mometasone furoate (nasal spray)) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about mometasone nasal (Nasonex)?

Before using mometasone, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Mometasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using mometasone nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using mometasone nasal.

Side Effects Centers
  • Nasonex

Patient Detailed How Take

What should I discuss with my healthcare provider before using mometasone nasal (Nasonex)?

You should not use this medication if you are allergic to mometasone.

Before using mometasone, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use mometasone nasal until you are well.

Also tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma or cataracts;
  • herpes simplex virus of your eyes;
  • tuberculosis or any other infection or illness;
  • sores or ulcers inside your nose; or
  • if you have recently had injury of or surgery on your nose.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether mometasone passes into breast milk or if it could harm a nursing baby. Do not use mometasone nasal without telling your doctor if you are breast-feeding a baby.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using mometasone nasal.

How should I use mometasone nasal (Nasonex)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of mometasone nasal is 1 to 2 sprays into each nostril once per day. Your doctor may recommend you start using mometasone nasal 2 to 4 weeks before the start of allergy season.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray into the air and away from your face, until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 7 days.

Shake the medicine bottle well just before each use.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication in an upright position at room temperature, away from moisture and heat.

Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.

Side Effects Centers
  • Nasonex

Patient Detailed Avoid Taking

What happens if I miss a dose (Nasonex)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Nasonex)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of mometasone nasal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using mometasone nasal (Nasonex)?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Mometasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using mometasone nasal.

What other drugs will affect mometasone nasal (Nasonex)?

There may be other drugs that can interact with mometasone nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about mometasone nasal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Nasonex

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI