Nasacort HFA (Triamcinolone Acetonide) - Summary

NASACORT HFA SUMMARY

NASACORT^® HFA
[na' za-cort]
(triamcinolone acetonide)
Nasal Aerosol

Triamcinolone acetonide, USP, the active ingredient in Nasacort® HFA Nasal Aerosol, is a glucocorticosteroid.

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.

PATIENT'S INSTRUCTIONS FOR USE

Using your

Nasacort® HFA

(triamcinolone acetonide)

Nasal Aerosol

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:

Step 1

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

Step 2

Shake the device well.

Step 3

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.

Step 4

To use, hold the device between your thumb and forefinger.

Step 5

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.

Step 6

Press down on the canister to release one spray and, at the same time, inhale gently through the nostril.

Step 7

Hold your breath for a few seconds, then breathe out slowly through your mouth.

Step 8

Withdraw the device from your nostril.

Step 9

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.

Step 10

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].

Rx Only.

Rev. April 2004c

Manufactured for:

Aventis Pharmaceuticals Inc.

Bridgewater, NJ 08807

Manufactured by:

Aventis Pharma Ltd.

Holmes Chapel, Cheshire CW4 8BE

United Kingdom

NASHFA-APRIL04c-F-A

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.

• Retain with medication or affix to convenient location.
• Starting with spray #1, check off after each use.
• DISCARD MEDICATION AFTER 100 SPRAYS.

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.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nasacort HFA (Triamcinolone)

triamcinolone acetonide inhaler, Azmacort
Source: MedicineNet budesonide inhaler Specialty [2009.07.31]
Title: triamcinolone acetonide inhaler, Azmacort
Category: Medications
Created: 12/31/1997
Last Editorial Review: 7/31/2009

Treatment Of Allergic Rhinitis Improves Coexisting Diseases
Source: Allergy News From Medical News Today [2009.11.09]
The treatment of allergic rhinitis is shown to improve co-existing conditions including conjunctivitis, asthma, sinusitis, otitis media with effusion (fluid in the middle ear) and sleep disorders according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.

Allergy drug tackles nasal congestion: study (Reuters)
Source: Y! Health Allergy News [2009.11.12]
Reuters - The "second generation" allergy drug desloratadine (brand name Clarinex) significantly reduces both the runny nose and congestion of seasonal and persistent allergic rhinitis, a study shows.

ACAAI: Drug Combo Effective in Allergic Eye Symptoms (CME/CE)
Source: MedPage Today Allergy & Immunology [2009.11.11]
MIAMI BEACH (MedPage Today) -- A combination of two standard drugs delivered together was safe and effective in treating the itchy and watery eyes associated with seasonal allergic rhinitis, a researcher said.

more news >>

Published Studies Related to Nasacort HFA (Triamcinolone)

A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. [2009.09]
OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO)... CONCLUSIONS: There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. [2009.09]
OBJECTIVE: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO)... CONCLUSIONS: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

Factors associated with variability in response of diabetic macular oedema after intravitreal triamcinolone. [2009.08]
PURPOSE: To identify factors associated with variability in anatomical and functional response of diabetic macular oedema (DMO) after 4 mg of intravitreal triamcinolone acetonide (ivTA), and for recurrence of macular oedema. Design: Pooled analysis of individual data from two randomized controlled trials... CONCLUSION: Baseline OCT-measured retinal thickening and BCVA are important predictors of maximal anatomical and functional response of DMO to ivTA, respectively. Combination treatment strategy using sequential laser therapy may have a role in delaying recurrence of oedema after triamcinolone.

Periocular triamcinolone for prevention of macular edema after plaque radiotherapy of uveal melanoma: a randomized controlled trial. [2009.07]
OBJECTIVE: To determine the efficacy and safety of periocular triamcinolone acetonide (40 mg) for the prevention of macular edema in patients undergoing plaque radiotherapy for uveal melanoma... CONCLUSIONS: Periocular triamcinolone is beneficial in reducing the risk of macular edema up to 18 months after plaque radiotherapy for uveal melanoma and significantly reduces the risk of moderate vision loss and poor visual acuity in these patients.

A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. [2009.07]
PURPOSE: To compare intraoperative injection of triamcinolone and ciprofloxacin in a controlled-release system (DuoCat) with prednisolone and ciprofloxacin eye drops after cataract surgery... CONCLUSIONS: One injection of DuoCat had a therapeutic response and ocular tolerance that were equivalent to conventional eye drops in controlling inflammation after cataract surgery. (ClinicalTrials.gov number, NCT00431028.).

more studies >>

Clinical Trials Related to Nasacort HFA (Triamcinolone)

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular edema involving the center of the macula who have not already been given maximal laser treatment.

Patients with one study eye will be randomly assigned (stratified by prior laser) with equal probability to one of five treatment groups:

1. Focal laser photocoagulation (modified ETDRS technique)

2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)

3. Anterior peribulbar injection of 20 mg triamcinolone

4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser

5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of the five treatment groups listed above. If the right eye was assigned to laser only, then the left eye will be assigned to one of the four triamcinolone groups above with equal probability (stratified by prior laser). If the right eye was assigned to receive triamcinolone, then the left eye will receive laser only.

Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb and is approved by the Food and Drug Administration for intramuscular use for a variety of indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many years.

Two different triamcinolone regimens will be assessed in the study: 40 mg injected posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen will be better. Although the injection behind the eye is more common than the injection near the front of the eye, the injection near the front of the eye has less risk of injuring the eye. However, it is possible that the injection near the front of the eye may increase eye pressure more frequently. Little is known about which of the two injections decreases macular edema and improves vision more often.

Patients enrolled into the study will be followed for three years and will have study visits 1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study treatment. For the first 8 months of the study, patients should only be retreated with their randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or more, then any treatment may be given at the investigator's discretion. After completion of the 8-month visit, treatment is at investigator discretion.

The primary objective of this study is to obtain estimates of efficacy and safety outcomes for each of the treatment groups. These estimates will provide a basis for the sample size estimation and hypothesis generation in a phase III trial.

Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema [Active, not recruiting]
The study involves the enrollment of patients over 18 years of age with diabetic macular edema. Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:

1. Laser photocoagulation

2. 1mg intravitreal triamcinolone acetonide injection

3. 4mg intravitreal triamcinolone acetonide injection

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).

The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.

Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.

Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration [Completed]
To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.

Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR) [Recruiting]
The primary objective of the study is to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ 110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months.

Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study [Active, not recruiting]
This open label extension will treat all the eyes of study participants with active study medication (intravitreal triamcinolone) as well as standard laser treatment where appropriate.

The specific aims will be to test the following hypotheses:

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs

after laser treatment remains efficacious over five years

- That intravitreal triamcinolone for diabetic macular oedema that persists or recurs

after laser treatment retains a manageable and acceptable safety profile over five years

more trials >>