Nasacort Aq Information
Nasacort aq (Triamcinolone acetonide) . Indications And Usage
Nasacort aq (Triamcinolone acetonide) 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.
Nasacort aq (Triamcinolone acetonide) . Dosage And Administration
Administer Nasacort aq (Triamcinolone acetonide) Nasal Spray by the intranasal route only. Shake Nasacort aq (Triamcinolone acetonide) Nasal Spray well before each use.
Nasacort aq (Triamcinolone acetonide) . Dosage Forms And Strengths
Nasacort aq (Triamcinolone acetonide) 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.
Nasacort aq (Triamcinolone acetonide) . Contraindications
Nasacort aq (Triamcinolone acetonide) should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation.
Nasacort aq (Triamcinolone acetonide) . Warnings And Precautions
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for exomplete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.
Nasacort aq (Triamcinolone acetonide) . Adverse Reactions
Systemic and local corticosteroid use may result in the following:
In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with Nasacort aq (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) Nasal Spray.
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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) Nasal Spray 110 mcg once daily are summarized in Table 2.
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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) Nasal Spray 110 mcg once daily are summarized in Table 3.
In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely. []
Nasacort aq (Triamcinolone acetonide) . Use In Specific Populations
The safety and effectiveness of Nasacort aq (Triamcinolone acetonide) Nasal Spray has been evaluated in 464 children 2 to 5 years of age, 518 children 6 to 12 years of age, and 176 adolescents 12 to 17 years of age []The safety and effectiveness of Nasacort aq (Triamcinolone acetonide) Nasal Spray in children below 2 years of age have not been established.
Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of reduction in growth velocity associated with intranasal corticosteroids, including the impact of final adult height are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Nasacort aq (Triamcinolone acetonide) Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Nasacort aq (Triamcinolone acetonide) Nasal Spray, each patient's dose should be titrated to the lowest dosage that effectively controls his/her symptoms.
The potential for Nasacort aq (Triamcinolone acetonide) Nasal Spray to cause growth suppression in susceptible patients and when given at higher than recommended dosages cannot be ruled out.
Nasacort aq (Triamcinolone acetonide) . Overdosage
Chronic overdosage may result in signs/symptoms of hypercorticism []There are no data on the effects of acute or chronic overdosage with Nasacort aq (Triamcinolone acetonide) 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.
Nasacort aq (Triamcinolone acetonide) . Description
Triamcinolone acetonide, USP, the active ingredient in Nasacort aq (Triamcinolone acetonide) Nasal Spray, is a corticosteroid 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 (CHFO).
Nasacort aq (Triamcinolone acetonide) 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.
Nasacort aq (Triamcinolone acetonide) . Clinical Pharmacology
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.
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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 AUCvalues 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 (Triamcinolone acetonide) Nasal Spray. The Cand AUCof the 440 mcg dose increased less than proportionally when compared to 110 and 220 mcg doses.
Following multiple dose administration of Nasacort aq (Triamcinolone acetonide) 440 mcg once daily in pediatric patients 6 to 12 years of age, plasma drug concentrations, AUC, Cand Twere similar to those values observed in adult patients receiving the same dose. Intranasal administration of Nasacort aq (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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.
Nasacort aq (Triamcinolone acetonide) . Nonclinical Toxicology
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/mbasis, 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/mbasis, respectively).
No evidence of mutagenicity was detected fromtests (a reverse mutation test inbacteria 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/mbasis). 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/mbasis). At 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/mbasis), it did not induce the above mentioned effects.
Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at inhalation does of 20 mcg/kg and above (approximately 7/10 of the maximum recommended daily intranasal dose in adults on a mcg/mbasis). 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/mbasis). In monkeys, triamcinolone acetonide was teratogenic at an inhalation does of 500 mcg/kg (approximately 37 times the maximum recommended daily intranasal dose in adults on a mcg/mbasis). 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.
Nasacort aq (Triamcinolone acetonide) . Clinical Studies
The safety and efficacy of Nasacort aq (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) 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 (Triamcinolone acetonide) (-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).
Nasacort aq (Triamcinolone acetonide) . How Supplied/storage And Handling
Nasacort aq (Triamcinolone acetonide) 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 discardedEach actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays [].
In the Patient Package Information, patients are provided with a check-off form to track usage [].
Keep out of reach of children.
Nasacort aq (Triamcinolone acetonide) . Patient Counseling Information
See FDA-Approved Patient Labeling accompanying the product.
IMPORTANT:
®
Patient Information:
These instructions provide important information about Nasacort aq (Triamcinolone acetonide) . Ask your healthcare provider or pharmacist if you have any questions.
Important: For use as a nasal spray only.
What is Nasacort aq (Triamcinolone acetonide) ?
NasacortAQ 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 (Triamcinolone acetonide) is sprayed in your nose, this medicine helps to lessen the symptoms of sneezing, runny nose, nasal itching and stuffy nose.
Nasacort is not for children under the age of 2 years.
Who should use Nasacort aq (Triamcinolone acetonide) ?
Do not use Nasacort aq (Triamcinolone acetonide) if you
ingredients
What should I tell my healthcare provider before using Nasacort aq (Triamcinolone acetonide) ?
Tell your healthcare provider if you are:
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 (Triamcinolone acetonide) ?
What are the possible side effects of Nasacort aq (Triamcinolone acetonide) ?
Common side effects of Nasacort aq (Triamcinolone acetonide) include:
Sore throat, headache, and nosebleeds.
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.
Patient Instructions for Use
Read these instructions carefully before using your Nasacort aq (Triamcinolone acetonide) .
Before using the spray pump bottle:
Priming the Spray Pump Bottle
Using the spray:
Cleaning the spray pump bottle:
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 (Triamcinolone acetonide) bottle contains 120 does of medicine plus a little extra for priming the pump. A check-off chart is included with your Nasacort aq (Triamcinolone acetonide) to help you keep track of the number of sprays. This will help make sure that you receive 120 sprays of Nasacort aq (Triamcinolone acetonide) .
How should I store Nasacort aq (Triamcinolone acetonide) ?
Keep Nasacort and all medicines out of the reach of children. General information about the safe and effective use of Nasacort aq (Triamcinolone acetonide) .
Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do not use Nasacort aq (Triamcinolone acetonide) for a condition for which it was not prescribed. Do not give Nasacort aq (Triamcinolone acetonide) 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 (Triamcinolone acetonide) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Nasacort aq (Triamcinolone acetonide) that is written for health professionals.
For more information, go toor call 1-800-633-1610.
What are the ingredients in Nasacort aq (Triamcinolone acetonide) ?
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.
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