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Nasonex

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Nasonex

Nasonex

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]

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.

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