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Local Nasal Effects
Epistaxis: In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with NASACORT AQ (triamcinolone acetonide) Nasal Spray than those who received placebo [see ADVERSE REACTIONS].
Candida Infection: In clinical studies with NASACORT AQ (triamcinolone acetonide) Nasacort AQ (triamcinolone acetonide) 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 (triamcinolone acetonide) Nasal Spray. Therefore, patients using NASACORT AQ (triamcinolone acetonide) 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 experience recent nasal ulcers, surgery, or trauma should not use NASACORT AQ (triamcinolone acetonide) 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.
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 exomplete 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 hypercoticism and adrenal suppression may appear. If such changes occur, the dosage of NASACORT AQ (triamcinolone acetonide) 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 may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving NASACORT AQ (triamcinolone acetonide) Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including NASACORT AQ (triamcinolone acetonide) Nasal Spray, titrate each patient's dose west dosage that effectively controls his/her symptoms [see Use in Specific Populations].
Patient Counseling Information
See FDA-Approved Patient Labeling accompanying the product.
Local Nasal Effects
Patients should be informed that treatment with NASACORT AQ (triamcinolone acetonide) Nasal Spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with NASACORT AQ (triamcinolone acetonide) 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 (triamcinolone acetonide) 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 (triamcinolone acetonide) Nasal Spray [see WARNINGS AND PRECAUTIONS].
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].
Use Daily for Best Effect
Patients should use NASACORT AQ (triamcinolone acetonide) 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 (triamcinolone acetonide) 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 (triamcinolone acetonide) Nasal Spray in their eyes.
Patient Package Information
IMPORTANT: Please read the PATIENT INFORMATION carefully before using your NASACORT® AQ (triamcinolone acetonide) Nasal Spray
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
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 (triamcinolone acetonide) 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.
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 (triamcinolone acetonide) Nasal Spray is administered to nursing women.
The safety and effectiveness of NASACORT AQ (triamcinolone acetonide) 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 (triamcinolone acetonide) 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 of 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 (triamcinolone acetonide) Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged 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 (triamcinolone acetonide) Nasal Spray, each should be titrated to the lowest dosage that effectively controls his/her symptoms.
The potential for NASACORT AQ (triamcinolone acetonide) Nasal Spray to cause growth suppression in susceptible patients and when given at higher than recommended dosages cannot be ruled out.
Clinical studies of NASACORT AQ (triamcinolone acetonide) 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: 10/27/2008
This monograph has been modified to include the generic and brand name in many instances.
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