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Nasacort® aq (triamcinolone acetonide)

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NASACORT AQ safely and
• Epistaxis, nasal septal perforation, Candida albicans infection, impaired wound healing.
Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in effectively. See full prescribing information for NASACORT AQ.
patients with recent nasal septal ulcers, nasal surgery, or trauma. (5.1) Nasacort® AQ (triamcinolone acetonide)
• Development of glaucoma or posterior subcapsular cataracts. Monitor patients closely with a Nasal Spray
change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Initial U.S. Approval: 1957
• Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in INDICATIONS AND USAGE
susceptible patients. Use caution in patient with the above because of the potential for • NASACORT AQ Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms of worsening of these infections. (5.3) seasonal and perennial allergic rhinitis in adults and children 2 years of age and older. (1) • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue NASACORT AQ Nasal Spray • Adults and adolescents ≥ 12 years: Starting and maximum dose is 220 mcg/day (two sprays • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients in each nostril once daily). (2.1) receiving NASACORT AQ Nasal Spray. (5.5, 8.4) • Children 6 to 12 years of age: Starting dose is 110 mcg/day (one spray in each nostril once daily). Maximum dose is 220 mcg/day (two sprays per nostril once daily). (2.2) • Most common adverse reactions (>2% incidence) were pharyngitis, epistaxis, flu syndrome, • Children 2 to 5 years of age: Starting and maximum dose 110 mcg/day (one spray in each cough increased, bronchitis, dyspepsia, tooth disorder, headache, pharyngolaryngeal pain, nostril once daily). (2.2) nasopharyngitis, abdominal upper pain, diarrhea, and excoriation. (6.1) • Priming/Use: For intranasal use only. Shake well before each use. Before using for the first • Other adverse reactions, including serious adverse reactions, have been reported. (6.1) time, release 5 sprays into the air away from the face. If the product is not used for more than2 weeks, release 1 spray into the air before using. (2.3) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at
1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
———————————— DOSAGE FORMS AND STRENGTHS ————————————
USE IN SPECIFIC POPULATIONS
• Nasal Spray: 55 mcg triamcinolone acetonide in each spray. (3) NASACORT AQ should be used during pregnancy only if potential benefit justifies potential risk tofetus. (8.1) • Do not administer to patients with history of hypersensitivity to triamcinolone acetonide or any See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
ingredients of this product. (4) FULL PRESCRIBING INFORMATION: CONTENTS*
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
Adults and Adolescents 12 Years of Age and Older Children 2 to 12 Years of Age DOSAGE FORMS AND STRENGTHS
Mechanism of Action WARNINGS AND PRECAUTIONS
Local Nasal Effects Glaucoma and Cataracts Carcinogenesis, Mutagenesis, Impairment of Fertility Hypothalamic-Pituitary-Adrenal Axis Effects Animal Toxicology and/or Pharmacology HOW SUPPLIED/STORAGE AND HANDLING
Clinical Trials Experience USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION
If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray.
INDICATIONS AND USAGE
Shake NASACORT AQ Nasal Spray well before each use.
NASACORT AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and If adequate relief of symptoms has not been obtained after 3 weeks of treatment, NASACORT AQ Nasal perennial allergic rhinitis in adults and children 2 years of age and older.
Spray should be discontinued [see Warnings and Precautions (5), Patient Counseling Information (17), DOSAGE AND ADMINISTRATION
and Adverse Reactions (6)].
Administer NASACORT AQ Nasal Spray by the intranasal route only. Shake NASACORT AQ Nasal Spray well before each use.
DOSAGE FORMS AND STRENGTHS
Adults and Adolescents 12 Years of Age and Older
NASACORT AQ Nasal Spray is a metered-dose pump spray containing the active ingredient The recommended starting and maximum dose is 220 mcg per day as two sprays in each nostril once triamcinolone acetonide. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal daily. Titrate an individual patient to the minimum effective dose to reduce the possibility of side effects.
actuator after an initial priming of 5 sprays. Each 16.5 gram bottle (120 actuations) contains 9.075 mg When the maximum benefit has been achieved and symptoms have been controlled, reducing the dose of triamcinolone acetonide. The bottle should be discarded when the labeled-number of actuations have to 110 mcg per day (one spray in each nostril once a day) has been shown to be effective in maintaining been reached even though the bottle is not completely empty.
control of the allergic rhinitis symptoms.
Children 2 to 12 Years of Age
NASACORT AQ should not be administered to patients with a history of hypersensitivity to triamci- Children 6 to 12 years of age: The recommended starting dose is 110 mcg per day given as one spray nolone acetonide or to any of the other ingredients of this preparation.
in each nostril once daily. Children not responding adequately to 110 mcg per day may use 220 mcg WARNINGS AND PRECAUTIONS
(2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be Local Nasal Effects
decreased to 110 mcg once daily [see Warnings and Precautions (5.5), Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].
Epistaxis: In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in Children 2 to 5 years of age: The recommended and maximum dose is 110 mcg per day given as one patients treated with NASACORT AQ Nasal Spray than those who received placebo [see Adverse spray in each nostril once daily [see Warnings and Precautions (5.5), Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].
Nasal Septal Perforation: In clinical trials, nasal septum perforation was reported in one adult patient NASACORT AQ Nasal Spray is not recommended for children under 2 years of age.
treated with NASACORT AQ Nasal Spray.
Candida Infection: In clinical studies with NASACORT AQ Nasal Spray, the development of localized Priming: Prime NASACORT AQ Nasal Spray before using for the first time by shaking the contents well infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection and releasing 5 sprays into the air away from the face. It will remain adequately primed for two weeks.
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 reactions from 2 studies in children 4 to 12 years of age receiving NASACORT AQ Nasal Spray 110 months or longer should be examined periodically for evidence of Candida infection or other signs of mcg once daily are summarized in Table 2.
adverse effects on the nasal mucosa.
Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients Table 2 - Adverse drug reactions . 2% and greater than placebo with NASACORT AQ
who have experienced recent nasal ulcers, surgery, or trauma should not use NASACORT AQ Nasal Nasal Spray 110 mcg treatment in US studies in patients 4 to 12 years of age
Spray until healing has occurred.
NASACORT AQ 110 mcg
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 Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms 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 withvaricella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with A total of 474 children 2 to 5 years of age were studied in a 4-week double-blind, placebo-controlled pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for clinical trial. Of these, 236 received 110 mcg/day of NASACORT AQ Nasal Spray for a mean duration complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents of 28 days. No patient discontinued due to a serious adverse event. Adverse reactions from the single may be considered.
placebo-controlled study in children 2 to 5 years of age receiving NASACORT AQ Nasal Spray 110 Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis mcg once daily are summarized in Table 3.
infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemicviral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these Table 3 - Adverse drug reactions . 2% and greater than placebo with NASACORT AQ
Nasal Spray 110 mcg treatment in children 2 to 5 years of age
NASACORT AQ 110 mcg
Hypercorticism and Adrenal Suppression: When intranasal steroids are used at higher than recom- mended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effectssuch 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 Pharyngolaryngeal pain 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 Abdominal upper pain transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency inresponse 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 Coding dictionary for adverse events is Medical Dictionary for Regulatory Activities terminology NASACORT AQ Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including (MedDRA) Version 8.1 NASACORT AQ Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controlshis/her symptoms [see Use in Specific Populations (8.4)].
In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely [see Overdosage (10)]. Systemic and local corticosteroid use may result in the following: • Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing [see In addition to the adverse drug reactions reported during clinical studies and listed above, the following Warnings and Precautions (5.1)] adverse reactions have been identified during post-approval use of NASACORT AQ Nasal Spray.
• Glaucoma and Cataracts [see Warnings and Precautions (5.2)] Because these reactions are reported voluntarily from a population of uncertain size, it is not always • Immunosuppression [see Warnings and Precautions (5.3)] possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Reactions that have been reported during post-marketing experience include: nasal discomfort and Precautions (5.4, 5.5), Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)] congestion, sneezing, alterations of taste and smell, nausea, insomnia, dizziness, fatigue, dyspnea, Clinical Trials Experience
decreased blood cortisol, cataract, glaucoma, increased ocular pressure, pruritus, rash, and hyper- 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 USE IN SPECIFIC POPULATIONS
and may not reflect the rates observed in clinical practice.
In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years Teratogenic Effects: Pregnancy Category C
and older received treatment with NASACORT AQ Nasal Spray. These patients were treated for an There are no adequate and well-controlled studies of NASACORT AQ Nasal Spray in pregnant women.
average duration of 51 days. In the controlled trials (2–5 weeks duration) from which the following Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. NASACORT AQ Nasal Spray, adverse reaction data are derived, 1394 patients were treated with NASACORT AQ Nasal Spray for like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the an average of 19 days. In a long-term, open-label study, 172 patients received treatment for an average potential risk to the fetus. Since their introduction, experience with oral corticosteroids in pharmacologic duration of 286 days. Adverse reactions from 12 studies in adults and adolescent patients 12 to 17 as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from years of age receiving NASACORT AQ Nasal Spray 27.5 mcg to 440 mcg once daily are summarized 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 In clinical trials, nasal septum perforation was reported in one adult patient who received will not need corticosteroid treatment during pregnancy.
NASACORT AQ Nasal Spray.
In reproduction studies in rats and rabbits, triamcinolone acetonide administered by inhalation producedcleft palate and/or internal hydrocephaly and axial skeletal defects at exposures less than and 2 times, Table 1 - Adverse drug reactions . 2% and greater than placebo with NASACORT AQ
respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis. In a Nasal Spray 220 mcg treatment in studies in adults and adolescents 12 years and older
monkey reproduction study, triamcinolone acetonide administered by inhalation produced cranial NASACORT AQ 220 mcg
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 corticos- teroids are excreted in human milk, caution should be exercised when NASACORT AQ Nasal Spray is administered to nursing women.
8.4
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms 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 [seeClinical Studies (14)]. The safety and effectiveness of NASACORT AQ Nasal Spray in children below A total of 602 children 6 to 12 years of age were studied in 3 double-blind, placebo-controlled clinical 2 years of age have not been established.
trials. Of these, 172 received 110 mcg/day and 207 received 220 mcg/day of NASACORT AQ Nasal Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth Spray for two, six, or twelve weeks. The longest average durations of treatment for patients receiving velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of 110 mcg/day and 220 mcg/day were 76 days and 80 days, respectively. One percent of patients treated HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic with NASACORT AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The and one patient receiving 220mcg/day discontinued due to a serious adverse event. A similar adverse long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the reaction profile was observed in pediatric patients 6–12 years of age as compared to adolescents and impact on final adult height are unknown. The potential for ″catch-up″ growth following discontinuation adults with the exception of epistaxis which occurred in less than 2% of the children studied. Adverse 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 Based upon intravenous dosing of triamcinolone acetonide phosphate ester in adults, the half-life of against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the triamcinolone acetonide was reported to be 88 minutes. The volume of distribution (Vd) reported was systemic effects of intranasal corticosteroids, including NASACORT AQ Nasal Spray, each patient's 99.5 L (SD ± 27.5) and clearance was 45.2 L/hour (SD ± 9.1) for triamcinolone acetonide. The plasma dose should be titrated to the lowest dosage that effectively controls his/her symptoms.
half-life of corticosteroids does not correlate well with the biologic half-life.
The effect of NASACORT AQ Nasal Spray on growth velocity in children was assessed in a 12 month Pharmacokinetic characterization of the NASACORT AQ Nasal Spray formulation was determined in randomized, placebo controlled study conducted in 299 prepubescent children age 3 to 9 years (173 both normal adult subjects and patients with allergic rhinitis. Single dose intranasal administration of males, 126 females) with perennial allergic rhinitis. Treatment groups were NASACORT AQ 110 mcg 220 mcg of NASACORT AQ Nasal Spray in normal adult subjects and patients demonstrated minimal once daily and placebo. Growth velocity was estimated for each patient using the slope of the linear absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 regression of height over time using observed data in the intent to treat population who had at least ng/mL (range: 0.1 to 1.0 ng/mL) and occurred at 1.5 hours post dose. The mean plasma drug 3 height measurements after randomization. Growth velocities were significantly lower in the concentration was less than 0.06 ng/mL at 12 hours, and below the assay detection limit (the minimum NASACORT AQ group compared to placebo, with a mean growth velocity of 6.09 cm/year in the LOQ of the assay was 0.025 ng/ml) at 24 hours. The average terminal half-life was 3.1 hours. The range placebo group and 5.65 cm/year in the NASACORT AQ treated group (difference from placebo -0.45 values was 1.4 ng·hr/mL to 4.7 ng·hr/mL between doses of 110 mcg to 440 mcg in cm/year; 95% CI: -0.78, -0.11).
both patients and healthy volunteers. Dose proportionality was demonstrated in both normal adult subjects and in allergic rhinitis patients following single intranasal doses of 110 mcg or 220 mcg Clinical studies of NASACORT AQ did not include sufficient numbers of subjects aged 65 and over to NASACORT AQ Nasal Spray. The C of the 440 mcg dose increased less than determine whether they respond differently from younger subjects. Other reported clinical experience proportionally when compared to 110 and 220 mcg doses.
has not identified differences in responses between the elderly and younger patients. In general, dose Following multiple dose administration of NASACORT AQ 440 mcg once daily in pediatric patients 6 selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, to 12 years of age, plasma drug concentrations, AUC were similar to those values reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant observed in adult patients receiving the same dose. Intranasal administration of NASACORT AQ 110 disease or other drug therapy.
mcg once daily in pediatric patients 2 to 5 years of age exhibited similar systemic exposure to that achieved in adult patients 20 to 49 years of age with intranasal administration of NASACORT AQ at Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions a dose of 220 mcg once daily. Based on the population pharmacokinetic modeling, the apparent (5.4)]. There are no data on the effects of acute or chronic overdosage with NASACORT AQ Nasal clearance and volume of distribution following intranasal administration of NASACORT AQ in pediatric Spray. Because of low systemic bioavailability and an absence of acute drug-related systemic findings patients 2 to 5 years of age were found to be approximately half of that in adults.
in clinical studies overdose is unlikely to require any therapy other than observation.
In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have beenidentified. They are 6β-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21- Acute overdosing with the intranasal dosage form is unlikely in view of the total amount of active carboxy-6β-hydroxytriamcinolone acetonide. All three metabolites are expected to be substantially less ingredient present and low bioavailability of triamcinolone acetonide. In the event that the entire active than the parent compound due to (a) the dependence of anti-inflammatory activity on the contents of the bottle were administered all at once, via either oral or nasal application, clinically presence of a 21-hydroxyl group, (b) the decreased activity observed upon 6-hydroxylation, and (c) the significant systemic adverse events would most likely not result.
markedly increased water solubility favoring rapid elimination. There appeared to be some quantitative differences in the metabolites among species. No differences were detected in metabolic pattern as Triamcinolone acetonide, USP, the active ingredient in NASACORT AQ Nasal Spray, is a corticosteroid a function of route of administration.
with a molecular weight of 434.51 and with the chemical designation 9-Fluoro-11β,16α,17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (C H FO ).
13.1 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
NASACORT AQ Nasal Spray is a thixotropic, water-based metered-dose pump spray formulation unit basis). Triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreases in pup containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Microc- weight and survival at doses of 5.0 mcg/kg and above (less than the maximum recommended daily rystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, intranasal dose in adults on a mcg/m2 basis). At 1.0 mcg/kg (less than the maximum recommended and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide daily intranasal dose in adults on a mcg/m2 basis), it did not induce the above mentioned effects.
may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0.
13.2 Animal Toxicology and/or Pharmacology
Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide 12.1 Mechanism of Action
was teratogenic at an inhalation dose of 20 mcg/kg and above (approximately 7/10 of the maximum Triamcinolone acetonide is a synthetic fluorinated corticosteroid with approximately 8 times the potency recommended daily intranasal dose in adults on a mcg/m2 basis). In rabbits, triamcinolone acetonide of prednisone in animal models of inflammation.
was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2 times the maximum Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids have recommended daily intranasal dose in adults on a mcg/m2 basis). In monkeys, triamcinolone acetonide been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, was teratogenic at an inhalation dose of 500 mcg/kg (approximately 37 times the maximum neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, recommended daily intranasal dose in adults on a mcg/m2 basis). Dose-related teratogenic effects in cytokines) involved in inflammation.
rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in the monkey were cranial malformations.
In order to determine if systemic absorption plays a role in the effect of NASACORT AQ Nasal Spray Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such on allergic rhinitis symptoms, a two week double-blind, placebo-controlled clinical study was conducted infants should be carefully observed.
comparing NASACORT AQ, orally ingested triamcinolone acetonide, and placebo in 297 adult patients with seasonal allergic rhinitis. The study demonstrated that the therapeutic efficacy of NASACORT AQ The safety and efficacy of NASACORT AQ Nasal Spray have been evaluated in 10 double-blind, Nasal Spray can be attributed to the topical effects of triamcinolone acetonide.
placebo-controlled clinical studies of two- to four-weeks duration in adults and children 12 years andolder with seasonal or perennial allergic rhinitis. The number of patients treated with NASACORT AQ Adrenal Function: In order to evaluate the effects of systemic absorption on the Hypothalamic-
Nasal Spray in these studies was 1266; of these patients, 675 were males and 591 were females.
Pituitary-Adrenal (HPA) axis, 4 clinical studies, one each in adults and in children 6–12 years of age,2–5 years of age, and 2–11 years of age, were conducted.
Overall, the results of these clinical studies in adults and children 12 years and older demonstratedthat NASACORT AQ Nasal Spray 220 mcg once daily (2 sprays in each nostril), when compared to The adult clinical study compared 220 mcg or 440 mcg NASACORT AQ per day, or 10 mg prednisone placebo, provides statistically significant relief of nasal symptoms of seasonal or perennial allergic per day with placebo for 42 days. Adrenal response to a six-hour 250 mcg cosyntropin stimulation test rhinitis including sneezing, stuffiness, discharge, and itching.
showed that NASACORT AQ administered at doses of 220 mcg and 440 mcg had no statistically The safety and efficacy of NASACORT AQ Nasal Spray, at doses of 110 mcg or 220 mcg once daily, significant effect on HPA activity versus placebo. Conversely, oral prednisone at 10 mg/day significantly have also been adequately studied in two double-blind, placebo-controlled studies of two- and reduced the response to ACTH.
twelve-weeks duration in children ages 6 through 12 years with seasonal and perennial allergic rhinitis.
A study evaluating plasma cortisol response thirty and sixty minutes after 250 mcg cosyntropin These studies included 341 males and 177 females. NASACORT AQ administered at either dose stimulation in 80 pediatric patients 6 to 12 years of age who received 220 mcg or 440 mcg (twice the resulted in statistically significant reductions in the severity of nasal symptoms of allergic rhinitis.
maximum recommended daily dose) daily for six weeks was conducted. No abnormal response to The safety and efficacy of NASACORT AQ Nasal Spray in children 2 to 5 years of age with perennial cosyntropin infusion (peak serum cortisol <18 mcg/dL) was observed in any pediatric patient after six allergic rhinitis with or without seasonal allergic rhinitis was studied in a single 4 week double blind, weeks of dosing with NASACORT AQ at 440 mcg per day.
placebo controlled clinical study with a 24 week open label extension conducted in the United States.
In pediatric patients 2 to 5 years of age (n = 61) receiving Nasacort AQ 110 mcg per day intranasally, The study included 464 patients (266 males and 198 females) 2 to 5 years of age who received at HPA axis function was assessed by cosyntropin stimulation test; however, the results were inconclusive.
least one dose of study medication (233 placebo, 231 NASACORT AQ 110 mcg once daily). Efficacy An effect of Nasacort AQ Nasal Spray on adrenal function in children 2 to 5 years of age cannot be was determined over a four-week double-blind, placebo-controlled treatment period and was based on patient's parent or guardian recording of four nasal symptoms (total nasal symptom score, TNSS), In a 6-week trial in 140 children 2 to 11 years of age with allergic rhinitis, a daily dose of 110 or 220 congestion, itching, rhinorrhea, and sneezing on a 0–3 categorical severity scale (0=absent, 1=mild, mcg of NASACORT AQ Nasal Spray was compared to placebo nasal spray. A subset of 24 children 2=moderate, and 3=severe) once daily. Reflective scoring (rTNSS) required recording symptom 6 to 11 years of age received a higher dose of 220 mcg of NASACORT AQ Nasal Spray. A positive severity over the previous 24 hours; the instantaneous scoring (iTNSS) required recording symptom control was not included in this trial. Adrenal function was assessed by measurement of 24 hour serum severity at the time just prior to dosing. Baseline symptom severity was comparable between cortisol levels before and after the treatment. The difference from placebo in the change from baseline NASACORT AQ and placebo respectively, for iTNSS (7.52, 7.61) and rTNSS (7.96, 7.87). While the in LS mean serum cortisol AUC at the end of week 6 for the NASACORT AQ Nasal Spray 24-hour iTNSS over the 4-week double-blind period was numerically improved with NASACORT AQ treatment groups (110 mcg and 220 mcg) was -4.2 mcg·hour/dL (95% CI: -14.7, 6.4).
(-2.28) vs. placebo (-1.92), the difference was not statistically significant (difference from placebo -0.36;

95% CI [-0.77, 0.06]; p value = 0.095). For the 24-hour rTNSS over the 4 week double-blind treatment „ For children aged 6 to 12 years, the usual dose is 1 spray in each nostril, one time each
period, NASACORT A Q 110 mcg once daily provided statistically significantly greater improvement day. Your healthcare provider may tell you to take 2 sprays in each nostril one time each
from baseline (-2.31) versus placebo (-1.87) (difference from placebo -0.44; 95% CI [-0.84, -0.04]; p value = 0.033).
„ For children aged 2 to 5 years, the usual dose is 1 spray in each nostril, one time each
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
„ An adult should help a young child use this medicine.
NASACORT AQ Nasal Spray, 55 mcg per spray, is supplied in a white high-density polyethylene Do not stop taking Nasacort AQ without telling your healthcare provider. Before you throw container with a metered-dose pump unit, white nasal adapter, and patient instructions (NDC away Nasacort AQ, talk to your healthcare provider to see if you need another prescription.
If your healthcare provider tells you to continue using Nasacort AQ, throw away the empty The contents of one 16.5 gram bottle provide 120 actuations. After 120 actuations, the amount of or expired bottle and use a new bottle of Nasacort AQ.
triamcinolone acetonide delivered per actuation may not be consistent and the unit should be discarded.
• For detailed instructions, see the ″Instructions for Use″ at the end of this leaflet.
Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming • Some symptoms may get better on the first day of treatment. It generally takes one week of use of 5 sprays [see Dosage and Administration Information (2.3)].
to feel the most benefit.
In the Patient Package Information, patients are provided with a check-off form to track usage [seePatient Counseling Information (17)].
• Protect your eyes from the spray. If you get the spray in your eyes, rinse your eyes well with water.
Keep out of reach of children.
• If your symptoms do not improve, or if they become worse, contact your healthcare provider.
16.2 Storage
• Tell your healthcare provider if you have irritation, burning or stinging inside your nose that does Store at Controlled Room Temperature, 20 to 25°C (68 to 77°F) not go away when using Nasacort AQ.
PATIENT COUNSELING INFORMATION
What are the possible side effects of Nasacort AQ?
See FDA-approved patient labeling (Patient Information and Instructions for Use).
Common side effects of Nasacort AQ include: 17.1 Local Nasal Effects
Sore throat, headache, and nosebleeds. If you have an increase in nosebleeds after using Nasacort
Patients should be informed that treatment with NASACORT AQ Nasal Spray may lead to adverse AQ or the inside of your nose hurts, contact your healthcare provider.
reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment What are the other risks of using Nasacort AQ?
with NASACORT AQ Nasal Spray. In addition, nasal corticosteroids are associated with nasal septal Hole in the cartilage inside the nose (nasal septal perforation). Tell your healthcare provider if you
perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal have a whistling sound from your nose when you breathe.
surgery, or nasal trauma should not use NASACORT AQ Nasal Spray until healing has occurred [seeWarnings and Precautions (5.1)]. Fungal infection in your nose.
17.2 Cataracts and Glaucoma
Slow wound healing. You should not use Nasacort AQ until your nose has healed if you have a sore
Patients should be informed that glaucoma and cataracts are associated with nasal and inhaled in your nose, if you have had surgery on your nose, or if your nose has been injured.
corticosteroid use. Patients should inform his/her heath care provider if a change in vision is noted while Eye problems such as glaucoma and cataracts. Tell your healthcare provider if you have a change
using NASACORT AQ Nasal Spray [see Warnings and Precautions (5.2)]. in vision or have a history of increased intraocular pressure, glaucoma, or cataracts.
Immune system problems that may increase your risk of infections. You are more likely to get
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure infections if you take medicines that weaken your body's ability to fight infections. Avoid contact with to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be people who have contagious diseases such as chicken pox or measles while using Nasacort AQ.
informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, Symptoms of infection may include fever, pain, aches, chills, feeling tired, nausea and vomiting.
or ocular herpes simplex [see Warnings and Precautions (5.3)]. Effect on how fast children grow. Nasacort AQ may cause your child's growth to slow down. If your
17.4 Effect on Growth
child is taking Nasacort AQ, your healthcare provider will need to regularly check the height of your Parents should be advised that NASACORT AQ Nasal Spray may slow growth in children. A child taking child and adjust the dose as appropriate.
NASACORT AQ Nasal Spray should have his/her growth checked regularly [see Warnings and These are not all the possible side effects of Nasacort AQ. Tell your healthcare provider if you have Precautions (5.5) and Pediatric Use (8.4)]. any side effect that bothers you or that does not go away. Call your doctor for medical advice about 17.5 Use Daily for Best Effect
side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Patients should use NASACORT AQ Nasal Spray on a regular once-daily basis for optimal effect. It Instructions for Use
is also important to shake the bottle well before each use. Do not blow your nose for 15 minutes after Read these instructions carefully before using your Nasacort AQ.
using the spray. NASACORT AQ Nasal Spray, like other corticosteroids, does not have an immediateeffect on rhinitis symptoms. Although improvement in some patient symptoms may be seen within the Before using the spray pump bottle:
first day of treatment, maximum benefit may not be reached for up to one week. The patient should 1. Pull the blue cover and remove the clip from the spray pump unit. See figure A.
not increase the prescribed dosage but should contact the physician if symptoms do not improve or If the top part of the spray pump comes off of the bottle when removing the cover, then re-insert if the condition worsens.
the stem back into the pump.
17.6 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
Patient Information
Nasacort® AQ (na' za-cort)
(triamcinolone acetonide)
Nasal Spray
These instructions provide important information about Nasacort AQ. Ask your healthcare
provider or pharmacist if you have any questions.
Important: For use as a nasal spray only.
What is Nasacort AQ?
Nasacort®AQ Nasal Spray is a prescription medicine called a corticosteroid used to treat nasal
symptoms of seasonal and year around allergies in adults and children 2 years of age and older. When
Nasacort AQ is sprayed in your nose, this medicine helps to lessen the symptoms of sneezing, runny
nose, nasal itching and stuffy nose.
Nasacort AQ is not for children under the age of 2 years.
2. Shake the spray pump bottle before each use.
Who should use Nasacort AQ?
Priming the Spray Pump Bottle
Do not use Nasacort AQ if you have had a reaction to triamcinolone acetonide or to any of the other
3. Before using the spray pump bottle for the first time, it must be primed. To prime, put your thumb
ingredients in Nasacort AQ. See the end of this leaflet for a complete list of ingredients in Nasacort on the bottom of the bottle and your index and middle fingers on the ″shoulders″ of the bottle, and hold it upright. See figure B.
What should I tell my healthcare provider before using Nasacort AQ?
Tell your healthcare provider if you are:
• pregnant or planning to become pregnant• breastfeeding• exposed to chickenpox or measles• feeling unwell or have any symptoms that you do not understand Tell your healthcare provider about all of the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.
How do I use Nasacort AQ?
• Use Nasacort AQ exactly as your healthcare provider tells you.
• You will get the best results if you use Nasacort AQ regularly and without missing a dose. Do not take extra doses.
• Nasacort AQ should be used as a nasal spray only. Do not spray it in your eyes or mouth.
• Your healthcare provider will tell you how and when to use Nasacort AQ. Do not use more Nasacort 4. Point the bottle away from your eyes. Push the bottle up with your thumb and against your two
AQ or take it more often than your healthcare provider tells you.
fingers firmly and quickly until a fine spray appears. Do this pumping action 5 times.
• The prescription label will usually tell you how many sprays to take and how often. If it does not Now your spray pump bottle is primed and ready for use.
or if you are unsure, ask your healthcare provider or pharmacist.
A fine mist can only be made by a rapid and firm pumping action.
„ For people aged 12 years and older, the usual dose is 2 sprays in each nostril, one time
5. Repeat priming the pump, if it has not been used for more than 2 weeks. To reprime, shake the
each day.
spray pump bottle and pump it just one time. Now the spray pump bottle is reprimed.

Using the spray:
Each Nasacort AQ bottle contains 120 doses of medicine plus a little extra for priming the pump. A 6. Gently blow your nose to clear it, if needed. For small children, be sure to help them gently blow
check-off chart is included with your Nasacort AQ to help you keep track of the number of sprays. This their nose, as much as possible.
will help make sure that you receive 120 sprays of Nasacort AQ.
7. Pull off the blue cover and clip as shown in figure C. Shake the spray pump well.
8. Hold the spray pump firmly, with the index and middle finger on either side of the spray tip. Place
your thumb on the bottom of the bottle. Be careful so that your fingers will not slip off the spray
pump as you spray inside your nose. See figure D.
How should I store Nasacort AQ?
• Store Nasacort AQ between 68° to 77°F (20° to 25° C).
• After using 120 sprays, throw the medicine away, as directed by your healthcare provider, even if the bottle is not empty. You may not get enough medicine if you use the bottle after 120 sprays.
Keep Nasacort and all medicines out of the reach of children. General information about the safe
and effective use of Nasacort AQ.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do
not use Nasacort AQ for a condition for which it was not prescribed. Do not give Nasacort AQ to other
people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about Nasacort AQ. If you would like more
information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for
information about Nasacort AQ that is written for health professionals.
For more information call 1-800-633-1610.
9. Put the spray tip into one side of your nose. The tip should not reach far into the nose. Rest the
What are the ingredients in Nasacort AQ?
side of your index finger against your upper lip. Tip your head back a little and aim the spray Active ingredient: triamcinolone acetonide toward the back of your nose. See figure E.
Inactive ingredients: Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dex-trose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydro-chloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of4.5 and 6.0.
sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY 10. Press against the other side of your nose with your finger so the nostril is closed. Pump the spray
2013 sanofi-aventis U.S. LLC
bottle by pushing on the bottom of the bottle with your thumb firmly and quickly for the full dose
of medicine. Sniff gently at the same time to help the medicine get to the back of your nose.
See figure F. Repeat this step for the other side.
11. Repeat steps 8, 9 and 10 if your healthcare provider tells you to use more than one spray in
each nostril.
12. Do not blow your nose for 15 minutes after using the spray.
13. After use, wipe the nozzle on the spray bottle with a clean tissue, and replace the blue cover.
14. Keep the cover and the clip on the spray pump bottle when not in use.
Cleaning the spray pump bottle:
15. To clean the spray pump bottle, remove the blue cover and the spray nozzle only. Soak the cover
and spray nozzle in warm water for a few minutes, and then rinse under cold water. See figureG.
16. Shake or tap off the excess water and allow to air dry. Once the cap and spray nozzle are dry,
put the nozzle back onto the bottle, and prime the bottle as necessary until a fine mist is made.
Use the spray as directed by your healthcare provider.
If the spray bottle does not work:
The hole in the tip of the nozzle may be blocked. Never try to unblock the spray hole or enlarge it with
a pin or other sharp object. This will make the spray mechanism not work correctly. Changing the size
of the opening can change the amount of medicine you or your child will receive. This could cause an
overdose of the medicine. To clean nasal spray pump bottle, refer to Step 15.
Important information
Repriming the spray pump is only necessary when it has not been used for more than 2 weeks. To
reprime, shake the bottle and only pump the spray bottle one time. Do not reprime if you use the spray
more often than every two weeks.

Source: http://www.nasacortaq.com/