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Nasacort AQ

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Nasacort AQ

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Nasal Effects

Epistaxis

In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with NASACORT AQ Nasal Spray than those who received placebo [see ADVERSE REACTIONS].

Nasal Septal Perforation

In clinical trials, nasal septum perforation was reported in one adult patient treated with NASACORT AQ Nasal Spray.

Candida Infection

In clinical studies with NASACORT AQ Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local or systemic therapy and discontinuation of NASACORT AQ Nasal Spray. Therefore, patients using NASACORT AQ Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Impaired Wound Healing

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, surgery, or trauma should not use NASACORT AQ Nasal Spray 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.

Immunosuppression

Persons who are using drugs that 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 susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, 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 globulin (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 tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

Hypothalamic-Pituitary-Adrenal Axis Effects

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 NASACORT AQ Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

Effect on Growth

Corticosteroids, including NASACORT AQ Nasal Spray, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASACORT AQ Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including NASACORT AQ 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 patient labeling (PATIENT INFORMATION and Instructions for Use).

Local Nasal Effects

Patients should be informed that treatment with NASACORT AQ Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with NASACORT AQ Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use NASACORT AQ Nasal Spray until healing has occurred [see WARNINGS AND PRECAUTIONS].

Cataracts and Glaucoma

Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use. Patients should inform his/her heath care provider if a change in vision is noted while using NASACORT AQ Nasal Spray [see WARNINGS AND PRECAUTIONS].

Immunosuppression

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex [see WARNINGS AND PRECAUTIONS].

Effect on Growth

Parents should be advised that NASACORT AQ Nasal Spray may slow growth in children. A child taking NASACORT AQ Nasal Spray should have his/her growth checked regularly [see WARNINGS AND PRECAUTIONS and Pediatric Use].

Use Daily for Best Effect

Patients should use NASACORT AQ Nasal Spray on a regular once-daily basis for optimal effect. It is also important to shake the bottle well before each use. Do not blow your nose for 15 minutes after using the spray. NASACORT AQ Nasal Spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms. Although improvement in some patient symptoms may be seen within the first day of treatment, maximum benefit may not be reached for up to one week. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

Keep Spray Out of Eyes

Patients should be informed to avoid spraying NASACORT AQ Nasal Spray in their eyes.

IMPORTANT: Please read these instructions carefully before using your NASACORT®AQ Nasal Spray

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a two-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis, respectively). In a two-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mcg/m² basis, respectively).

No evidence of mutagenicity was detected from in vitro tests (a reverse mutation test in Salmonella bacteria and a forward mutation test in Chinese hamster ovary cells) conducted with triamcinolone acetonide.

In male and female rats, triamcinolone acetonide caused no change in pregnancy rate at oral doses up to 15.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/m² basis). Triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreases in pup weight and survival at doses of 5.0 mcg/kg and above (less than the maximum recommended daily intranasal dose in adults on a mcg/m² basis). At 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/m² basis), it did not induce the above mentioned effects.

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

There are no adequate and well-controlled studies of NASACORT AQ Nasal Spray in pregnant women. Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. NASACORT AQ Nasal Spray, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Since their introduction, experience with oral corticosteroids 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 glucocorticoid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

In reproduction studies in rats and rabbits, triamcinolone acetonide administered by inhalation produced cleft palate and/or internal hydrocephaly and axial skeletal defects at exposures less than and 2 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m² basis. In a monkey reproduction study, triamcinolone acetonide administered by inhalation produced cranial malformations at an exposure approximately 37 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis.

Nursing Mothers

It is not known whether triamcinolone acetonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when NASACORT AQ Nasal Spray is administered to nursing women.

Pediatric Use

The safety and effectiveness of NASACORT AQ Nasal Spray has been evaluated in 464 children 2 to 5 years of age, 518 children 6 to 12 years of age, and 176 adolescents 12 to 17 years of age [see Clinical Studies]. The safety and effectiveness of NASACORT AQ Nasal Spray in children below 2 years of age have not been established.

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of 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 reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height are unknown. The potential for “catchup” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including NASACORT AQ Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including NASACORT AQ Nasal Spray, each patient's dose should be titrated to the lowest dosage that effectively controls his/her symptoms.

The effect of NASACORT AQ Nasal Spray on growth velocity in children was assessed in a 12 month randomized, placebo controlled study conducted in 299 prepubescent children age 3 to 9 years (173 males, 126 females) with perennial allergic rhinitis. Treatment groups were NASACORT AQ 110 mcg once daily and placebo. Growth velocity was estimated for each patient using the slope of the linear regression of height over time using observed data in the intent to treat population who had at least 3 height measurements after randomization. Growth velocities were significantly lower in the NASACORT AQ group compared to placebo, with a mean growth velocity of 6.09 cm/year in the placebo group and 5.65 cm/year in the NASACORT AQ treated group (difference from placebo -0.45 cm/year; 95% CI: -0.78, -0.11).

Geriatric Use

Clinical studies of NASACORT AQ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 7/22/2013
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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