Drugs Details

Drugs Info of Nasacort AQ
Drugs Details
  • Drugs Type  : Multum
  • Date : 23rd Feb 2015 02:31 am
  • Brand Name : Nasacort AQ
  • Generic Name : triamcinolone (nasal) (Pronunciation: TRYE am SIN oh lone)
Descriptions

Triamcinolone acetonide, USP, the active ingredient in NASACORT AQ Nasal Spray, is a corticosteroid with a molecular weight of 434.51 and with the chemical designation 9-Fluoro11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (C24H31FO6).

 

Nasacort® AQ (triamcinolone acetonide) Structural Formula Illustration

NASACORT AQ Nasal Spray is a thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of triamcinolone acetonide in an aqueous medium. Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0.

What are the possible side effects of triamcinolone nasal (Nasacort AQ)?

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:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your nose or mouth, or on your lips; or
  • blurred vision, eye pain, or seeing halos around lights.

Less...

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What are the precautions when taking triamcinolone acetonide (Nasacort AQ)?

Before using nasal triamcinolone, 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), 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...

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

Indications

NASACORT AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.

Dosage Administration

Administer NASACORT AQ Nasal Spray by the intranasal route only. Shake NASACORT AQ Nasal Spray well before each use.

Adults and Adolescents 12 Years of Age and Older

The recommended starting and maximum dose is 220 mcg per day as two sprays in each nostril once daily. Titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 mcg per day (one spray in each nostril once a day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms.

Children 2 to 12 Years of Age

Children 6 to 12 years of age

The recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. Children not responding adequately to 110 mcg per day may use 220 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be decreased to 110 mcg once daily [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Children 2 to 5 years of age

The recommended and maximum dose is 110 mcg per day given as one spray in each nostril once daily [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].

NASACORT AQ Nasal Spray is not recommended for children under 2 years of age.

Administration Information

Priming

Prime NASACORT AQ Nasal Spray before using for the first time by shaking the contents well and releasing 5 sprays into the air away from the face. It will remain adequately primed for two weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. Shake NASACORT AQ Nasal Spray well before each use.

If adequate relief of symptoms has not been obtained after 3 weeks of treatment, NASACORT AQ Nasal Spray should be discontinued [see WARNINGS AND PRECAUTIONS, PATIENT INFORMATION, and ADVERSE REACTIONS].

How Supplied

Dosage Forms And Strengths

NASACORT AQ Nasal Spray is a metered-dose pump spray containing the active ingredient triamcinolone acetonide. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays. Each 16.5 gram bottle (120 actuations) contains 9.075 mg of triamcinolone acetonide. The bottle should be discarded when the labeled-number of actuations have been reached even though the bottle is not completely empty.

Storage And Handling

NASACORT AQ Nasal Spray, 55 mcg per spray, is supplied in a white high-density polyethylene container with a metered-dose pump unit, white nasal adapter, and patient instructions (NDC 0075-1506-16).

The contents of one 16.5 gram bottle provide 120 actuations. After 120 actuations, the amount of triamcinolone acetonide delivered per actuation may not be consistent and the unit should be discarded. Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays [see DOSAGE AND ADMINISTRATION Information]. In the Patient Package Information, patients are provided with a check-off form to track usage [see PATIENT INFORMATION].

Keep out of reach of children.

Storage

Store at Controlled Room Temperature, 20 to 25°C (68 to 77°F)

sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A Sanofi Company. Revised: July 2013

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, Candida albicans infection, nasal septal perforation, impaired wound healing [see WARNINGS AND PRECAUTIONS]
  • Glaucoma and Cataracts [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 and CLINICAL PHARMACOLOGY]

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 clinical practice.

In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with NASACORT AQ Nasal Spray. These patients were treated for an average duration of 51 days. In the controlled trials (2-5 weeks duration) from which the following adverse reaction data are derived, 1394 patients were treated with NASACORT AQ Nasal Spray for an average of 19 days. In a long-term, open-label study, 172 patients received treatment for an average duration of 286 days. Adverse reactions from 12 studies in adults and adolescent patients 12 to 17 years of age receiving NASACORT AQ Nasal Spray 27.5 mcg to 440 mcg once daily are summarized in Table 1.

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

Table 1 : Adverse drug reactions > 2% and greater than placebo with NASACORT AQ Nasal Spray 220 mcg treatment in studies in adults and adolescents 12 years and older

Adverse reaction Placebo
(N=962)
%
NASACORT AQ 220 mcg
(N=857)
%
Pharyngitis 3.6 5.1
Epistaxis 0.8 2.7
Cough increased 1.5 2.1
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).

A total of 602 children 6 to 12 years of age were studied in 3 double-blind, placebo-controlled clinical trials. Of these, 172 received 110 mcg/day and 207 received 220 mcg/day of NASACORT AQ Nasal Spray for two, six, or twelve weeks. The longest average durations of treatment for patients receiving 110 mcg/day and 220 mcg/day were 76 days and 80 days, respectively. One percent of patients treated with NASACORT AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day and one patient receiving 220mcg/day discontinued due to a serious adverse event. A similar adverse reaction profile was observed in pediatric patients 6-12 years of age as compared to adolescents and adults with the exception of epistaxis which occurred in less than 2% of the children studied. Adverse reactions from 2 studies in children 4 to 12 years of age receiving NASACORT AQ Nasal Spray 110 mcg once daily are summarized in Table 2.

Table 2 : Adverse drug reactions > 2% and greater than placebo with NASACORT AQ Nasal Spray 110 mcg treatment in US studies in patients 4 to 12 years of age

Adverse reaction Placebo
(N=202)
%
NASACORT AQ 110 mcg
(N=179)
%
Flu syndrome 7.4 8.9
Cough increased 6.4 8.4
Pharyngitis 6.4 7.8
Bronchitis 1.0 3.4
Dyspepsia 1.0 3.4
Tooth disorder 1.0 3.4
Coding dictionary for adverse events is Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).

A total of 474 children 2 to 5 years of age were studied in a 4-week double-blind, placebo-controlled clinical trial. Of these, 236 received 110 mcg/day of NASACORT AQ Nasal Spray for a mean duration of 28 days. No patient discontinued due to a serious adverse event. Adverse reactions from the single placebo-controlled study in children 2 to 5 years of age receiving NASACORT AQ Nasal Spray 110 mcg once daily are summarized in Table 3.

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

Adverse reactions Placebo
(N=238)
%
NASACORT AQ 110 mcg
(N=236)
%
Headache 4.2 5.5
Pharyngolaryngeal pain 4.2 5.5
Epistaxis 5.0 5.1
Nasopharyngitis 3.8 5.1
Abdominal upper pain 0.8 4.7
Diarrhea 1.3 3.0
Asthma 2.1 2.5
Rash 1.7 2.5
Excoriation 0.0 2.5
Rhinorrhea 1.7 2.1
Coding dictionary for adverse events is Medical Dictionary for Regulatory Activities terminology (MedDRA) Version 8.1

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].

Post-Marketing Experience

In addition to the adverse drug reactions reported during clinical studies and listed above, the following adverse reactions have been identified during post-approval use of NASACORT AQ Nasal Spray. 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. Reactions that have been reported during post-marketing experience include: nasal discomfort and congestion, sneezing, alterations of taste and smell, nausea, insomnia, dizziness, fatigue, dyspnea, decreased blood cortisol, cataract, glaucoma, increased ocular pressure, pruritus, rash, and hypersensitivity.

Read the Nasacort AQ (triamcinolone acetonide) Side Effects Center for a complete guide to possible side effects

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Interactions

No reported drug interactions in the prescribing information.

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 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.

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

OverDose

Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. There are no data on the effects of acute or chronic overdosage with NASACORT AQ Nasal Spray. 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.

Acute overdosing with the intranasal dosage form is unlikely in view of the total amount of active ingredient present and low bioavailability of triamcinolone acetonide. In the event that the entire contents of the bottle were administered all at once, via either oral or nasal application, clinically significant systemic adverse events would most likely not result.

ContrainDications

NASACORT AQ should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation.

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

Clinical Pharamacology

Mechanism of Action

Triamcinolone acetonide is a synthetic fluorinated corticosteroid with approximately 8 times the potency of prednisone in animal models of inflammation.

Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Pharmacodynamics

In order to determine if systemic absorption plays a role in the effect of NASACORT AQ Nasal Spray on allergic rhinitis symptoms, a two week double-blind, placebo-controlled clinical study was conducted 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 Nasal Spray can be attributed to the topical effects of triamcinolone acetonide.

Adrenal Function

In order to evaluate the effects of systemic absorption on the Hypothalamic-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.

The adult clinical study compared 220 mcg or 440 mcg NASACORT AQ per day, or 10 mg prednisone per day with placebo for 42 days. Adrenal response to a six-hour 250 mcg cosyntropin stimulation test showed that NASACORT AQ administered at doses of 220 mcg and 440 mcg had no statistically significant effect on HPA activity versus placebo. Conversely, oral prednisone at 10 mg/day significantly reduced the response to ACTH.

A study evaluating plasma cortisol response thirty and sixty minutes after 250 mcg cosyntropin stimulation in 80 pediatric patients 6 to 12 years of age who received 220 mcg or 440 mcg (twice the maximum recommended daily dose) daily for six weeks was conducted. No abnormal response to cosyntropin infusion (peak serum cortisol < 18 mcg/dL) was observed in any pediatric patient after six weeks of dosing with NASACORT AQ at 440 mcg per day.

In pediatric patients 2 to 5 years of age (n = 61) receiving Nasacort AQ 110 mcg per day intranasally, HPA axis function was assessed by cosyntropin stimulation test; however, the results were inconclusive.

An effect of Nasacort AQ Nasal Spray on adrenal function in children 2 to 5 years of age cannot be ruled out.

In a 6-week trial in 140 children 2 to 11 years of age with allergic rhinitis, a daily dose of 110 or 220 mcg of NASACORT AQ Nasal Spray was compared to placebo nasal spray. A subset of 24 children 6 to 11 years of age received a higher dose of 220 mcg of NASACORT AQ Nasal Spray. A positive control was not included in this trial. Adrenal function was assessed by measurement of 24 hour serum cortisol levels before and after the treatment. The difference from placebo in the change from baseline in LS mean serum cortisol AUC (0-24 hr) at the end of week 6 for the NASACORT AQ Nasal Spray treatment groups (110 mcg and 220 mcg) was -4.2 mcg•hour/dL (95% CI: -14.7, 6.4).

Pharmacokinetics

Based upon intravenous dosing of triamcinolone acetonide phosphate ester in adults, the half-life of triamcinolone acetonide was reported to be 88 minutes. The volume of distribution (Vd) reported was 99.5 L (SD ± 27.5) and clearance was 45.2 L/hour (SD ± 9.1) for triamcinolone acetonide. The plasma half-life of corticosteroids does not correlate well with the biologic half-life.

Pharmacokinetic characterization of the NASACORT AQ Nasal Spray formulation was determined in both normal adult subjects and patients with allergic rhinitis. Single dose intranasal administration of 220 mcg of NASACORT AQ Nasal Spray in normal adult subjects and patients demonstrated minimal absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/mL (range: 0.1 to 1.0 ng/mL) and occurred at 1.5 hours post dose. The mean plasma drug concentration was less than 0.06 ng/mL at 12 hours, and below the assay detection limit (the minimum LOQ of the assay was 0.025 ng/ml) at 24 hours. The average terminal half-life was 3.1 hours. The range of mean AUC0–∞ values was 1.4 ng•hr/mL to 4.7 ng•hr/mL between doses of 110 mcg to 440 mcg in 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 NASACORT AQ Nasal Spray. The Cmax and AUC0-∞ of the 440 mcg dose increased less than proportionally when compared to 110 and 220 mcg doses.

Following multiple dose administration of NASACORT AQ 440 mcg once daily in pediatric patients 6 to 12 years of age, plasma drug concentrations, AUC0-∞, Cmax and Tmax were similar to those values observed in adult patients receiving the same dose. Intranasal administration of NASACORT AQ 110 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 a dose of 220 mcg once daily. Based on the population pharmacokinetic modeling, the apparent clearance and volume of distribution following intranasal administration of NASACORT AQ in pediatric patients 2 to 5 years of age were found to be approximately half of that in adults.

In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have been identified. They are 6β-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6β-hydroxytriamcinolone acetonide. All three metabolites are expected to be substantially less active than the parent compound due to (a) the dependence of anti-inflammatory activity on the presence of a 21-hydroxyl group, (b) the decreased activity observed upon 6-hydroxylation, and (c) the 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 a function of route of administration.

Animal Toxicology and/or Pharmacology

Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at an inhalation dose of 20 mcg/kg and above (approximately 7/10 of the maximum recommended daily intranasal dose in adults on a mcg/m² basis). In rabbits, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis). In monkeys, triamcinolone acetonide was teratogenic at an inhalation dose of 500 mcg/kg (approximately 37 times the maximum recommended daily intranasal dose in adults on a mcg/m² basis). Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in the monkey were cranial malformations.

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Clinical Studies

The safety and efficacy of NASACORT AQ Nasal Spray have been evaluated in 10 double-blind, placebo-controlled clinical studies of two-to four-weeks duration in adults and children 12 years and older with seasonal or perennial allergic rhinitis. The number of patients treated with NASACORT AQ Nasal Spray in these studies was 1266; of these patients, 675 were males and 591 were females.

Overall, the results of these clinical studies in adults and children 12 years and older demonstrated that NASACORT AQ Nasal Spray 220 mcg once daily (2 sprays in each nostril), when compared to placebo, provides statistically significant relief of nasal symptoms of seasonal or perennial allergic rhinitis including sneezing, stuffiness, discharge, and itching.

The safety and efficacy of NASACORT AQ Nasal Spray, at doses of 110 mcg or 220 mcg once daily, have also been adequately studied in two double-blind, placebo-controlled studies of two-and twelve-weeks duration in children ages 6 through 12 years with seasonal and perennial allergic rhinitis. These studies included 341 males and 177 females. NASACORT AQ administered at either dose resulted in statistically significant reductions in the severity of nasal symptoms of allergic rhinitis.

The safety and efficacy of NASACORT AQ Nasal Spray in children 2 to 5 years of age with perennial allergic rhinitis with or without seasonal allergic rhinitis was studied in a single 4 week double blind, placebo controlled clinical study with a 24 week open label extension conducted in the United States. The study included 464 patients (266 males and 198 females) 2 to 5 years of age who received at least one dose of study medication (233 placebo, 231 NASACORT AQ 110 mcg once daily). Efficacy 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), congestion, itching, rhinorrhea, and sneezing on a 0-3 categorical severity scale (0=absent, 1=mild, 2=moderate, and 3=severe) once daily. Reflective scoring (rTNSS) required recording symptom severity over the previous 24 hours; the instantaneous scoring (iTNSS) required recording symptom severity at the time just prior to dosing. Baseline symptom severity was comparable between NASACORT AQ and placebo respectively, for iTNSS (7.52, 7.61) and rTNSS (7.96, 7.87). While the 24-hour iTNSS over the 4-week double-blind period was numerically improved with NASACORT AQ (-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 period, NASACORT A Q 110 mcg once daily provided statistically significantly greater improvement from baseline (-2.31) versus placebo (-1.87) (difference from placebo 0.44; 95% CI [-0.84, -0.04]; p value = 0.033).

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

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.

Who should use Nasacort AQ?

Do not use Nasacort AQ if you have had a reaction to triamcinolone acetonide or to any of the other ingredients in Nasacort AQ. See the end of this leaflet for a complete list of ingredients in Nasacort AQ.

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 AQ or take it more often than your healthcare provider tells you.
  • The prescription label will usually tell you how many sprays to take and how often. If it does not or if you are unsure, ask your healthcare provider or pharmacist.
    • For people aged 12 years and older, the usual dose is 2 sprays in each nostril, one time each day.
    • For children aged 6 to 12 years, the usual dose is 1 spray in each nostril, one time each day. Your healthcare provider may tell you to take 2 sprays in each nostril one time each day.
    • For children aged 2 to 5 years, the usual dose is 1 spray in each nostril, one time each day.
    • An adult should help a young child use this medicine.
      Do not stop taking Nasacort AQ without telling your healthcare provider. Before you throw 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 or expired bottle and use a new bottle of Nasacort AQ.
  • For detailed instructions, see the “Instructions for Use” at the end of this leaflet.
  • Some symptoms may get better on the first day of treatment. It generally takes one week of use to feel the most benefit.
  • Protect your eyes from the spray. If you get the spray in your eyes, rinse your eyes well with water.
  • If your symptoms do not improve, or if they become worse, contact your healthcare provider.
  • Tell your healthcare provider if you have irritation, burning or stinging inside your nose that does not go away when using Nasacort AQ.

What are the possible side effects of Nasacort AQ?

Common side effects of Nasacort AQ include:

Sore throat, headache, and nosebleeds. If you have an increase in nosebleeds after using Nasacort AQ or the inside of your nose hurts, contact your healthcare provider.

What are the other risks of using Nasacort AQ?

Hole in the cartilage inside the nose (nasal septal perforation). Tell your healthcare provider if you have a whistling sound from your nose when you breathe.

Fungal infection in your nose.

Slow wound healing. You should not use Nasacort AQ until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.

Eye problems such as glaucoma and cataracts. Tell your healthcare provider if you have a change 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 infections if you take medicines that weaken your body's ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while using Nasacort AQ. Symptoms of infection may include fever, pain, aches, chills, feeling tired, nausea and vomiting.

Effect on how fast children grow. Nasacort AQ may cause your child's growth to slow down. If your child is taking Nasacort AQ, your healthcare provider will need to regularly check the height of your child and adjust the dose as appropriate.

These are not all the possible side effects of Nasacort AQ. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Instructions for Use

Read these instructions carefully before using your Nasacort AQ.

Before using the spray pump bottle:

Pull the blue cover and remove the clip from the spray pump unit. See figure A.

If the top part of the spray pump comes off of the bottle when removing the cover, then re-insert the stem back into the pump.

Figure A

Pull the blue cover and remove the clip - Illustration

2. Shake the spray pump bottle before each use.

Priming the Spray Pump Bottle

3. Before using the spray pump bottle for the first time, it must be primed. To prime, put your thumb 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.

Figure B

Hold spray pump bottle upright - Illustration

4. Point the bottle away from your eyes. Push the bottle up with your thumb and against your two fingers firmly and quickly until a fine spray appears. Do this pumping action 5 times. Now your spray pump bottle is primed and ready for use. A fine mist can only be made by a rapid and firm pumping action.

5. Repeat priming the pump, if it has not been used for more than 2 weeks. To reprime, shake the spray pump bottle and pump it just one time. Now the spray pump bottle is reprimed.

Using the spray:

6. Gently blow your nose to clear it, if needed. For small children, be sure to help them gently blow their nose, as much as possible.

7. Pull off the blue cover and clip as shown in figure C. Shake the spray pump well.

Figure C

Pull off the blue cover and clip - Illustration

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.

Figure D

Holding the pump - Illustration

9. Put the spray tip into one side of your nose. The tip should not reach far into the nose. Rest the side of your index finger against your upper lip. Tip your head back a little and aim the spray toward the back of your nose. See figure E.

Figure E

Tip your head back - Illustration

10. Press against the other side of your nose with your finger so the nostril is closed. Pump the spray 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.

Figure F

Sniff gently - Illustration

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 figure G.

Figure G

Cleaning the spray pump - Illustration

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.

Each Nasacort AQ bottle contains 120 doses of medicine plus a little extra for priming the pump. A check-off chart is included with your Nasacort AQ to help you keep track of the number of sprays. This will help make sure that you receive 120 sprays of Nasacort AQ.

 

View Enlarged Table

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.

What are the ingredients in Nasacort AQ?

Active ingredient: triamcinolone acetonide

Inactive ingredients: Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium are contained in this aqueous medium; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5.0 within a range of 4.5 and 6.0.

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.

 

TRIAMCINOLONE ACETONIDE - NASAL

 

(tri-am-SIN-oh-lone uh-SET-oh-nide)

 

COMMON BRAND NAME(S): Nasacort

 

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

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

 

HOW TO USE: If you are taking the over-the-counter product to self-treat, read and follow all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

This medication is for use in the nose. In adults, the usual dose is 2 sprays in each nostril once or twice a day or as directed by your doctor. In children, the usual dose is 1 to 2 sprays in each nostril once daily or as directed by the doctor. Avoid spraying this medication in your eyes or mouth. Gently blow your nose before using this drug. Shake the spray device well before each use. Follow the package instructions to properly prime the spray.

Remove the protective cap before using the spray. Close one nostril by pressing it with your finger. Tilt your head as directed and carefully insert the nasal applicator into the other nostril. Press down firmly on the device 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. Replace the cap on the nasal inhaler. 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 1 day, but it may take up to 1 week before the full benefit of this drug takes effect. 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 device. Discard the device after you have used the number of sprays specified on the manufacturer's package. Do not pour any remaining medication into another container. Follow the package instructions to unblock or to clean the spray device.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.

Consumer Overview Side Effect

SIDE EFFECTS: Nose/throat dryness or irritation, cough, sneezing, nosebleeds, and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that 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 immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.

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.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as triamcinolone). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/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 Nasacort AQ (triamcinolone acetonide) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using nasal triamcinolone, 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), 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. Rarely, infants born to mothers who have been using corticosteroids (including triamcinolone) for a long time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Check all prescription medicine labels carefully since similar medications (other corticosteroids such as prednisone) may increase your risk of side effects if taken together with this drug. Ask your doctor or pharmacist if you have any questions about your medications.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

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: Keep all regular medical and laboratory appointments.

Do not share this medication with others.

If you use this medication for a long time, laboratory and/or medical tests (such as nose exams, height measurement in children) may be performed to monitor your progress and check for side effects.

Avoid substances (such as pollen, pet dander, dust mites, mold, and smoke) that can worsen allergy symptoms.

 

MISSED DOSE: If you are using this product on a regular schedule and 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 at room temperature away from light and moisture. Do not store in the bathroom. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

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.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Nasacort AQ

Generic Name: triamcinolone (nasal) (Pronunciation: TRYE am SIN oh lone)

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

What is triamcinolone nasal (Nasacort AQ)?

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

Triamcinolone nasal (for the nose) is used to treat sneezing, itching, and runny nose caused by seasonal allergies or hay fever.

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

What are the possible side effects of triamcinolone nasal (Nasacort AQ)?

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:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your nose or mouth, or on your lips; or
  • blurred vision, eye pain, or seeing halos around lights.

Less serious side effects may include:

  • stinging, burning, or bleeding in your nose;
  • sneezing after use of the medicine;
  • sore throat, cough, stuffy nose;
  • watery eyes;
  • headache;
  • nausea, vomiting; or
  • an unpleasant taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nasacort AQ (triamcinolone acetonide) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about triamcinolone nasal (Nasacort AQ)?

Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of triamcinolone nasal are not made for use in children.

Do not use this medication if you are allergic to triamcinolone.

Before using triamcinolone nasal, tell your doctor if you are allergic to any drugs, or if you have tuberculosis, asthma, a history of glaucoma or cataracts, any type of infection, or if you have had recent surgery or injury to your nose.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

Triamcinolone nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

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 steroid medicine.

Do not stop using triamcinolone nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

Side Effects Centers
  • Nasacort AQ

Patient Detailed How Take

What should I discuss with my healthcare provider before using triamcinolone nasal (Nasacort AQ)?

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

If you have any of these other conditions, you may need a triamcinolone dose adjustment or special tests:

  • tuberculosis;
  • asthma;
  • any type of infection;
  • a history of glaucoma or cataracts; or
  • if you have had recent surgery or injury to your nose.

FDA pregnancy category C. It is not known whether triamcinolone nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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

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

Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of triamcinolone nasal are not made for use in children.

How should I use triamcinolone nasal (Nasacort AQ)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. 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.

Before each use, gently blow your nose to clear your nostrils.

Shake the medicine well just before using it.

To use triamcinolone nasal inhaler:

  • Remove the protective cap from the nasal inhaler.
  • Hold the inhaler between your thumb and forefinger, tilt your head back slightly, and insert the inhaler into one nostril while holding the other nostril closed with one finger.
  • Press down on the canister to release the spray and inhale gently at the same time. Hold your breath for a few seconds, then breathe out slowly through the mouth.
  • Replace the white protective inhaler cap.
  • Clean your inhaler weekly by removing the medicine canister and the protective cap, and rinsing the inhaler thoroughly with warm water. Do not use soap. Allow the inhaler to dry completely before replacing the cap and canister.
  • Throw away the nasal inhaler after 100 sprays, even if there is still medicine left in the canister.

To use triamcinolone nasal spray:

  • Before using the spray for the first time, prime the spray pump by spraying the medicine 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 14 days.
  • Hold the nasal spray with the tip pointed into one nostril but not far into your nose. Bend your head forward to aim the spray toward the back of your nose. Hold your other nostril closed with one finger. Pump the spray unit and sniff gently at the same time.
  • Throw away the nasal spray after 120 sprays, even if there is still medicine left in the bottle.

Avoid blowing your nose for 15 minutes after using this medication.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

Do not stop using triamcinolone nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

If you use triamcinolone nasal for several months, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat. Keep the cover and clip on the nasal spray pump unit when not in use. Keep the protective cap on the nasal inhaler when not in use.

Side Effects Centers
  • Nasacort AQ

Patient Detailed Avoid Taking

What happens if I miss a dose (Nasacort AQ)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Nasacort AQ)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of triamcinolone nasal is not expected to be dangerous. 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 taking triamcinolone nasal (Nasacort AQ)?

Triamcinolone nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

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 steroid medicine.

What other drugs will affect triamcinolone nasal (Nasacort AQ)?

Tell your doctor about all other medications you use, especially:

  • cancer medicine (chemotherapy);
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • sirolimus (Rapamune), tacrolimus (Prograf);
  • basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept);
  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
  • other steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and other drugs may interact with triamcinolone nasal. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about triamcinolone 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: 9.04. Revision date: 12/15/2010.

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