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 Nasacort HFA indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nasacort HFA (Triamcinolone)

Review Article Examines Sublingual Immunotherapy For Treatment Of Allergic Rhinitis And Asthma
Source: Allergy News From Medical News Today [2013.03.28]
In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by the U.S. Food and Drug Administration, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to an article in the March 27 issue of JAMA...

News From The Annals Of Internal Medicine: Feb. 19, 2013
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2013.02.20]
1. Acupuncture May be an Effective Alternative for Treating Seasonal Allergies Patients receiving acupuncture treatments for seasonal allergic rhinitis reported statistically significant improvements in symptoms and decreased use of medication compared to patients having standard treatment or sham acupuncture, but the clinical significance of the observed improvements is uncertain...

more news >>

Published Studies Related to Nasacort HFA (Triamcinolone)

Comparison of the efficacy of intralesional triamcinolone acetonide and 5-fluorouracil tattooing for the treatment of keloids. [2012]
for treatment of keloids... CONCLUSION: 5-FU tattooing was more effective than intralesional TAC for the

Intravitreal triamcinolone versus laser photocoagulation as a primary treatment for diabetic macular oedema - a comparative pilot study. [2011.11.23]
ABSTRACT: BACKGROUND: Diabetic macular oedema is the leading causes of blindness. Laser photocoagulation reduces the risk of visual loss. However recurrences are common and despite laser treatment, patients with diabetic macular oedema experienced progressive loss of vision. Stabilization of the blood retinal barrier introduces a rationale for intravitreal triamcinolone treatment in diabetic macular oedema. This study is intended to compare the best corrected visual acuity (BCVA) and the macular oedema index (MEI) at 3 month of primary treatment for diabetic macular oedema between intravitreal triamcinolone acetonide (IVTA) and laser photocoagulation... CONCLUSIONS: IVTA demonstrates good outcome comparable to laser photocoagulation as a primary treatment for diabetic macular oedema at three months post treatment. TRIAL REGISTRATION: ISRCTN05040192 (http://www.controlled-trial.com).

Adding Triamcinolone to Endoscopic Ultrasound-Guided Celiac Plexus Blockade Does Not Reduce Pain in Patients With Chronic Pancreatitis. [2011.09.22]
BACKGROUND & AIMS: The efficacy of endoscopic ultrasound-guided celiac plexus blockade (EUS-CPB) for painful chronic pancreatitis (CP) is uncertain. Triamcinolone is often mixed with bupivacaine to lengthen the analgesic effect. We investigated whether addition of triamcinolone increases and lengthens pain relief compared with EUS-CPB with only bupivacaine... CONCLUSIONS: Triamcinolone does not increase pain relief or lengthen the effects of EUS-CPB. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Effects of intracameral triamcinolone and gentamicin injections following cataract surgery. [2011.07]
CONCLUSION: Intracameral injections of triamcinolone acetonide and gentamicin appear to be a promising treatment option for the control of post-operative inflammation following cataract surgery.

Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation. [2011.06]
PURPOSE: To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation... CONCLUSION: The addition of 1 intravitreal triamcinolone injection or 2 intravitreal ranibizumab injections in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation is associated with better visual acuity and decreased macular edema by 14 weeks. Whether continued long-term intravitreal treatment is beneficial cannot be determined from this study.

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.

Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata [Recruiting]
The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal glands.

Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery? [Recruiting]
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Intraocular Bevacizumab Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema [Recruiting]
The purpose of this study is to investigate the change in macular edema and the absolute change in visual acuity following intravitreal administered injections of Bevacizumab (Avastin®) compared with Triamcinolone (Volon A®) in patients with clinical significant diabetic macular edema.

The investigators monitor the change in macular edema measured with standard optical coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS).

more trials >>