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triamcinolone acetonide aerosol, metered
|Treatment Group (n)||Baseline Mean Score (SEM)*||Mean Change From Baseline (SEM)†||Placebo Comparison (p-value)|
|Nasacort HFA 440 mcg
Once Daily (111)
|6.78 (0.1)||-2.64 (0.18)||< 0.05|
|Nasacort HFA 110 mcg
Once Daily (105)
|6.41 (0.1)||-2.29 (0.18)||< 0.05|
|Placebo (109)||6.75 (0.1)||-1.39 (0.18)|
Individual patients will experience a variable time to onset and degree of symptom relief when using Nasacort HFA Nasal Aerosol. After starting patients on appropriate doses of Nasacort HFA Nasal Aerosol (see DOSAGE AND ADMINISTRATION) it is recommended that the effect be assessed in 4 to 7 days. If adequate relief has not been obtained by a reasonable time, alternate forms of treatment should be considered.
The maximum total daily dose should not exceed 440 mcg (4 sprays in each nostril) in patients 12 years of age and older and 220 mcg (2 sprays in each nostril) in patients 6 through 11 years of age. There is no evidence that exceeding the recommended dose is more effective. In general, it is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. (See WARNINGS, PRECAUTIONS: Information for Patients, and ADVERSE REACTIONS.)
Nasacort HFA Nasal Aerosol is indicated for the treatment of the nasal symptoms of allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
Safety and effectiveness of Nasacort HFA Nasal Aerosol in children below 6 years of age have not been adequately established.
Nasacort HFA Nasal Aerosol is contraindicated in patients with a hypersensitivity to any of the ingredients.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of 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, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
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 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.
Avoid spraying in eyes.
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use).
Triamcinolone acetonide administered intranasally has been shown to be absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers.
Rarely, immediate hypersensitivity reactions or contact dermatitis occur after the administration of Nasacort HFA Nasal Aerosol. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including triamcinolone acetonide. Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, a corticosteroid should be used with caution until healing has occurred.
In clinical studies with triamcinolone acetonide administered intranasally, 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 discontinuance of treatment with Nasacort HFA Nasal Aerosol. As with any long-term topical treatment of the nasal cavity, patients using Nasacort HFA Nasal Aerosol over several months or longer should be examined periodically for evidence of Candida infection or other adverse effects on the nasal mucosa.
Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract or in patients with untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.
When used at higher than recommended doses or in rare individuals at recommended doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. Therefore, larger than recommended doses of Nasacort HFA Nasal Aerosol should be avoided. If signs or symptoms of hypercorticism and/or suppression of HPA function occur, Nasacort HFA Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
Patients being treated with Nasacort HFA Nasal Aerosol should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.
Patients should use Nasacort HFA Nasal Aerosol at regular intervals since its effectiveness depends on regular use (see DOSAGE AND ADMINISTRATION). Individual patients will experience a variable time to onset and degree of symptom relief, and generally takes 1 week of treatment to reach maximum benefit. The patient should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve by a reasonable time, or if the condition worsens. Nasal irritation occurred in 6.2% of adults who used 440 mcg/day, the maximum recommended daily intranasal dose. The patient should contact the physician if nasal irritation occurs. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.
For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. Spraying Nasacort HFA Nasal Aerosol directly into the eyes or onto the nasal septum should be avoided. It is important to shake the canister well prior to each actuation to insure that a consistent amount is dispensed per actuation. The canister should be discarded after 100 actuations.
No drug interaction studies with triamcinolone acetonide have been performed.
In a 2-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis). In a 2-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m2 basis).
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 mcg/kg (approximately 1/3 of 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 (approximately 1/10 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). At 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis), it did not induce the above mentioned effects.
Pregnancy category C.
Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2/5 of the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). In rabbits, triamcinolone acetonide was also teratogenic at inhalation doses of 20 mcg/kg and above (approximately 4/5 of 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 20 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 monkeys were cranial malformations.
There are no adequate and well-controlled studies in pregnant women. Therefore, Nasacort HFA Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction 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 an increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
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 this product is administered to nursing women.
Safety and effectiveness have not been established in pediatric patients below the age of 6 years.
A placebo-controlled clinical growth study in children has not been conducted with Nasacort HFA Nasal Aerosol. 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 this reduction in growth velocity associated with intranasal corticosteroids, including the impact on 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 HFA Nasal Aerosol, 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 HFA Nasal Aerosol, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.
Clinical studies of Nasacort HFA Nasal Aerosol 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.
A total of 1176 patients with allergic rhinitis were enrolled in placebo-controlled and open-label clinical studies of Nasacort HFA Nasal Aerosol.
In the placebo-controlled trial, 220 patients were treated with Nasacort HFA Nasal Aerosol for an average of 15 days (range 1–19 days). No changes in mucous membranes were noted from physical and visual examinations during this trial.
Adverse events occurring with an incidence of 3% or greater and more commonly with Nasacort HFA Nasal Aerosol arms compared to placebo irrespective of drug relationship are presented in the following table:
|Adverse Event||Nasacort HFA Nasal Aerosol
|Nasacort HFA Nasal Aerosol
Of the 396 patients enrolled in the 12-month open-label study, 75% received treatment for greater than 6 months. In this study, patients were treated with Nasacort HFA Nasal Aerosol at 220 mcg once daily for the first 2 weeks and 440 mcg once daily for remainder of the study. Adverse events that were considered possibly or probably related to Nasacort HFA Nasal Aerosol and reported at an incidence of 3% or greater included: headache, epistaxis, nasal septum discomfort, rhinitis, nasal burning, and sneezing.
In the open-label study only 2% of patients receiving recommended doses discontinued due to nasal adverse effects. In the rest of the patients the nasal adverse events usually did not interfere with treatment. Seven of the 18 patients who reported nasal septum discomfort had objective evidence of ulceration, abrasion, erosion, or excoriation of the nasal septum, and 22 of the 396 (5.5%) enrolled patients developed nasal septum disorders, of whom 8 had evidence of ulceration, erosion, or excoriation of the septum, and 14 had epistaxis. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.
If recommended doses are exceeded, or if individuals taking Nasacort HFA Nasal Aerosol are particularly sensitive or take the drug in conjunction with other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.
In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely (see OVERDOSAGE).
In addition to adverse events reported from clinical trials, the following events have been identified during use of Nasacort Nasal Inhaler (triamcinolone acetonide CFC formulation) in clinical practice: nasal septal perforation, infection of the nose and pharynx with Candida albicans, cataracts, glaucoma, increased intraocular pressure, wheezing, rash, pruritus, urticaria, dizziness, paresthesia, dry mouth, nausea, coughing, dyspnea, and allergic reaction. Because they were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or possible causal connection to triamcinolone acetonide or a combination of these factors.
The recommended starting dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. If needed, the dose may be increased to 440 mcg per day given as 4 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.
The recommended dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.
Safety and effectiveness have not been established in pediatric patients below the age of 6 years (see PRECAUTIONS, Pediatric Use).
Chronic overdosage may result in signs/symptoms of hypercorticism (see PRECAUTIONS).
The acute topical application of the entire 15 mg contents of the canister may cause nasal irritation and headache. Acute overdosage with this dosage form is unlikely since one canister of Nasacort HFA Nasal Aerosol contains 15 mg of triamcinolone acetonide.
Nasacort HFA Nasal Aerosol is supplied with an aerosol canister which provides 100 metered dose actuations. The correct amount of medication delivered per actuation cannot be assured after 100 actuations have been dispensed, after which the unit should be discarded. Each actuation delivers 55 mcg triamcinolone acetonide through the nasal actuator. The Nasacort HFA Nasal Aerosol canister and accompanying nasal actuator are designed to be used together. The Nasacort HFA Nasal Aerosol canister should not be used with other nasal actuators and the supplied nasal actuator should not be used with other products' canisters. Nasacort HFA Nasal Aerosol is supplied with a molecular sieve sachet as a propellant adsorbent and a white plastic protective cap, and enclosed in a foil laminate overwrap pouch. Patient instructions are also provided. Net weight of the canister contents is 9.3 grams.
Avoid spraying in eyes.
Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP].
Keep out of reach of children.
Rev. April 2004c
Aventis Pharmaceuticals Inc.
Bridgewater, NJ 08807
Aventis Pharma Ltd.
Holmes Chapel, Cheshire CW4 8BE
PATIENT'S INSTRUCTIONS FOR USE
IMPORTANT: Please read these instructions carefully before using your Nasacort® HFA Nasal Aerosol.
Before each use of Nasacort® HFA Nasal Aerosol, gently blow your nose, making sure your nostrils are clear. Then follow these steps:
The Nasacort® HFA Nasal Aerosol device (canister and actuator assembly) is supplied with a protective cap in a pouch. Tear open the pouch and discard it before using the Nasacort HFA Nasal Aerosol device. Remove the white protective cap from the device prior to use. The canister and actuator are designed to be used together. Do not remove the canister from the actuator during regular use of the product.
Figure 1: Nasacort HFA Nasal Aerosol device with protective cap
Shake the device well.
The device must be primed prior to the first use. To prime, hold the device between your thumb and forefinger and press down on the canister to release one spray. Repeat this until you have released a total of 3 sprays. Now your device is primed and ready for use.
Re-priming of the device is only necessary when it has not been used for more than 3 days. To re-prime the device, shake it and release 3 sprays (as described in Step 3 above). Now the device is re-primed. There is no need to re-prime the device between more frequent uses.
To use, hold the device between your thumb and forefinger.
Tilt your head back slightly and insert the end of the actuator into one nostril, pointing it slightly toward the outside nostril wall away from the nasal septum, while holding your other nostril closed with one finger. Avoid spraying in eyes.
Press down on the canister to release one spray and, at the same time, inhale gently through the nostril.
Hold your breath for a few seconds, then breathe out slowly through your mouth.
Withdraw the device from your nostril.
Repeat the process in your other nostril.
NOTE: When the physician prescribes more than one spray per nostril, for each spray repeat steps 5 through 9.
Replace the white protective inhaler cap on the device.
NOTE: AVOID BLOWING YOUR NOSE FOR THE NEXT 15 MINUTES.
DOSAGE: Use only as directed by your physician.
The actuator of your Nasacort® HFA Nasal Aerosol should be cleaned weekly. Remove the white protective cap from the device. Remove the canister from the actuator. Clean the actuator thoroughly in lukewarm water. The use of soap, detergent, or disinfectant is not necessary. Allow the actuator to dry completely. To replace the canister, gently center and insert the canister with the plastic stem downward into the small hole at the bottom of the actuator. Replace the white protective cap. The correct amount of medication delivered per actuation cannot be assured after 100 actuations have been dispensed (see dose check-off chart below). The Nasacort HFA Nasal Aerosol device should be discarded after 100 actuations. The canister and actuator (the device) are designed to be used together. Never use this canister or actuator with those from any other product.
NOTE: Nasacort® HFA Nasal Aerosol is not intended to give immediate relief of your nasal symptoms. Your particular symptoms may require regular use of this drug for a few days or more before improvement. Therefore, it is important that you use the Nasacort® HFA Nasal Aerosol regularly as recommended by your physician.
CAUTION: Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator.
Keep out of the reach of children.
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].
Rev. April 2004c
Aventis Pharmaceuticals Inc.
Bridgewater, NJ 08807
Aventis Pharma Ltd.
Holmes Chapel, Cheshire CW4 8BE
How to check contents of your Nasacort® HFA Nasal Aerosol
Shaking your canister will NOT give you a good estimate of how much is left. We have included a convenient check-off chart to assist you in keeping track of medication sprays used. This will help assure that you receive the 100 "Full Sprays" of medication present.
Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.
triamcinolone acetonide aerosol, metered
Revised: 05/2007 Aventis Pharmaceuticals Inc.
Reproduced with permission of U.S. National Library of Medicine
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