Nasacort allergy side effects

Nasacort AQ

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

  • Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing
  • Glaucoma and Cataracts
  • Immunosuppression
  • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction

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

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

In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely .

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 entire FDA prescribing information for Nasacort AQ (Triamcinolone Acetonide)

difference.Difference

Important Information When Using Nasacort Allergy 24HR

Along with the needed effects, Nasacort Allergy 24HR may cause some unwanted effects.

Contact your doctor as soon as possible if any of the following occur:

  • any discharge from our nose that is yellow or green (may be a nasal infection)
  • heartburn or indigestion
  • experience an unpleasant taste or smell
  • painful nose or throat, or if you have a severe nose bleed after use
  • flu syndrome (fever, muscle pain, weakness and/or fatigue)
  • inflammation/irritation of the airways, cough, shortness of breath
  • feeling unwell, sick (nausea), dizzy or tired, have sleeping problems or have any other problems

Side effects of Nasacort Allergy 24HR may include: sneezing, headaches, and burning dryness, or other irritation inside the nose. These side effects usually do not need medical attention. They may go away as your body adjusts to the medicine. However, check with your doctor if any of these side effects continue or are bothersome. To reduce risk when using Nasacort Allergy 24HR, use only as directed. Read the product label for dosing instructions and warnings and consult the section on How to use.

The growth rate of some children may be slower. Nasal and inhaled corticosteroids use may result in the development of glaucoma and/or cataracts. In rare instance, it can cause damage to the middle part of the inside of the nose (called ‘nasal septum’). Discuss any worries you may have about this with your doctor or pharmacist.

Other side effects may occur in some patients. If you notice any side effects not listed, please tell your doctor or pharmacist.

Do not use Nasacort Allergy 24HR if you are allergic to any of the ingredients, you have active or dormant tuberculosis or untreated fungal, bacterial, or viral infection. If you are pregnant or breast-feeding, you should not use this medicine unless your doctor has advised you that the benefits of using it are higher than the possible risk to your baby.

Keep out of reach and sight of children. In case of overdose, get medical help or contact your regional Poison control center right away.

Steroid nasal sprays

How and when to use steroid nasal sprays

Steroid nasal sprays can be used as a long-term treatment or just when they’re needed.

For hay fever, it’s best to use them from 1 to 2 weeks before you think your symptoms will start, as they can take a few days to work.

The leaflet that comes with your spray should explain how to use it and how often. Ask a pharmacist or doctor if you’re not sure.

It’s important to use your spray regularly, even if you’re feeling better. It will only help if it’s used every day.

If you miss a dose or take too much

If you forget to take a dose, take it as soon as you remember. If it’s nearly time for your next dose, skip the one you missed.

Do not take a double dose to make up for a forgotten dose.

Accidentally using too much steroid nasal spray is unlikely to be harmful if it’s a one-off. Speak to a pharmacist or doctor if you’re worried.

Using a steroid nasal spray too much over a long period can increase your risk of getting side effects.

Stopping treatment

If you’ve bought a steroid nasal spray from a pharmacy or shop, stop using it when you think you no longer need it. Do not use it continuously for more than a month without speaking to a doctor.

If you’re taking a prescription spray, do not stop using it unless the doctor advises you to do so. You may need to reduce your dose gradually.

This can help avoid unpleasant side effects (withdrawal symptoms), such as severe tiredness, joint pain, being sick and dizziness.

Nasacort Allergy 24HR Side Effects

Generic Name: triamcinolone nasal

Medically reviewed by Drugs.com. Last updated on Oct 31, 2018.

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Note: This document contains side effect information about triamcinolone nasal. Some of the dosage forms listed on this page may not apply to the brand name Nasacort Allergy 24HR.

For the Consumer

Applies to triamcinolone nasal: nasal spray

Along with its needed effects, triamcinolone nasal (the active ingredient contained in Nasacort Allergy 24HR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking triamcinolone nasal:

More common

  • Body aches or pain
  • chills
  • congestion
  • diarrhea
  • dryness or soreness of the throat
  • fever
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • increased cough
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • runny nose
  • shivering
  • sweating
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble with swallowing
  • unexplained nosebleeds
  • unusual tiredness or weakness
  • voice changes
  • vomiting

Less common

  • Cough producing mucus
  • difficulty with breathing
  • noisy breathing
  • shortness of breath
  • tightness in the chest

Incidence not known

  • Blindness
  • bloody mucus
  • blurred vision
  • changes in vision
  • darkening of the skin
  • decreased vision
  • eye pain
  • fainting
  • fast heartbeat
  • hives
  • irritation
  • itching
  • joint stiffness or swelling
  • loss of appetite
  • lower back or side pain
  • mental depression
  • painful or difficult urination
  • rash
  • redness of the skin
  • slowing of normal growth in children
  • swelling of the eyelids, face, lips, hands, or feet
  • tearing
  • trouble healing
  • white patches in the throat

Some side effects of triamcinolone nasal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
  • tooth problems
  • upper abdominal or stomach pain

Incidence not known

  • Change in sense of smell or taste

For Healthcare Professionals

Applies to triamcinolone nasal: nasal aerosol, nasal aerosol with adapter, nasal spray

General

Triamcinolone nasal (the active ingredient contained in Nasacort Allergy 24HR) has been generally well tolerated and, due to the nature of its administration, has not been inclined to produce the systemic adverse effects generally associated with the use of corticosteroids.

Nervous system

The central nervous system side effect of headache has been reported in 18% of patients.

Respiratory

Respiratory side effects have included nasal irritation, pharyngitis, dry mucous membranes, burning and stinging, congestion, epistaxis, sneezing, and rarely, nasal septal perforations.

Endocrine

Endocrine side effects have included rare reports of suppression of the hypothalamus-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and is generally only of concern when using higher than recommended doses or in patients who may be particularly sensitive.

Ocular

Ocular adverse effects are more commonly seen with systemic administration of corticosteroids. However, posterior capsular cataracts have been occasionally reported with triamcinolone, especially with long-term use. In addition, prolonged use of high-dose inhaled corticosteroids ( >= 440 mcg of triamcinolone nasal (the active ingredient contained in Nasacort Allergy 24HR) may be associated with increased risk of ocular hypertension and open angle glaucoma.

1. Kobayashi RH, Beaucher WN, Koepke JW, Luskin A, Ransom JH, Rosen JP, Sullivan MJ, Alderfer VB, Simpson B, Smith JA “Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study.” Clin Ther 17 (1995): 503-13

2. “Intranasal triamcinolone for allergic rhinitis.” Med Lett Drugs Ther 33 (1991): 116-7

3. “Product Information. Nasacort (triamcinolone nasal).” Rhone-Poulenc Rorer, Collegeville, PA.

4. Howland WC, Dockhorn R, Gillman S, Gross GN, Hille D, Simpson B, Furst JA, Feiss G, Smith JA “A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis.” J Allergy Clin Immunol 98 (1996): 32-8

5. Munk ZM, Laforce C, Furst JA, Simpson B, Feiss G, Smith JA “Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis.” Ann Allergy Asthma Immunol 77 (1996): 277-81

6. Settipane G, Korenblat PE, Winder J, Lumry W, Murphree J, Alderfer VB, Simpson B, Smith JA “Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study.” Clin Ther 17 (1995): 252-63

7. Bernstein DI, Creticos PS, Busse WW, Cohen R, Graft DF, Howland WC, Lumry WR, Pedinoff AJ, Ratner PH, Lim J, Stokes A, M “Comparison of triamcinolone acetonide nasal inhaler with astemizole in the treatment of ragweed-induced allergic rhinitis.” J Allergy Clin Immunol 97 (1996): 749-55

8. Banov CH, Silvers WS, Green AV, Vanbavel JH, Winder JA, Feiss G, Simpson B, Furst JA, Smith JA “Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis.” Clin Ther 18 (1996): 265-72

9. Wilson AM, McFarlane LC, Lipworth BJ “Effects of repeated once daily dosing of three intranasal corticosteroids on basal and dynamic measures of hypothalamic-pituitary-adrenal-axis activity.” J Allergy Clin Immunol 101 (1998): 470-4

10. Cumming RG, Mitchell P, Leeder SR “Use of inhaled corticosteroids and the risk of cataracts.” N Engl J Med 337 (1997): 8-14

11. Spaeth GL, Rodrigues MM, Weinreb S “Steroid-induced glaucoma: A. Persistent elevation of intraocular pressure B. Histopathological aspects.” Trans Am Ophthalmol Soc 75 (1977): 353-81

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Nasacort Allergy 24HR (triamcinolone nasal)

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  • Drug class: nasal steroids

Consumer resources

  • Nasacort Allergy 24HR Nasal Spray
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Other brands: Nasacort, Nasacort AQ, Allernaze

Professional resources

  • Triamcinolone Acetonide eent (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Allergic Rhinitis

How does this medication work? What will it do for me?

Triamcinolone belongs to the family of medications called corticosteroids. Triamcinolone nasal spray is used to treat perennial (year-round) and seasonal allergic rhinitis.

Triamcinolone works by reducing inflammation in the nasal passages and helps to eliminate or reduce symptoms such as runny nose, stuffy nose, itching, and sneezing.

This medication usually starts to work within 2 or 3 days, but for some people, it may take up to 2 weeks to work.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Nasacort Allergy 24HR

Each actuation releases approximately 55 µg triamcinolone acetonide from the nasal actuator (estimated from in vitro testing) in an unscented, water-based spray formulation. Nonmedicinal ingredients: benzalkonium chloride, carboxymethylcellulose sodium, dextrose, edetate disodium, microcrystalline cellulose, and polysorbate 80. Hydrochloric acid or sodium hydroxide may be added to adjust the pH to between 4.5 and 6.0. This medication comes in a non-chlorofluorocarbon (CFC)-containing metered-dose pump spray which will provide 120 actuations.

How should I use this medication?

For adults and children 12 years of age and older, the usual starting dose is 2 sprays in each nostril once a day. The dose may be decreased to 1 spray in each nostril once a day once the desired effect is obtained.

For children 4 to 12 years of age, the usual starting dose is 1 spray in each nostril once a day. Your doctor may increase the dose to 2 sprays in each nostril once a day if symptoms don’t improve. Once symptoms are controlled, the dose may be decreased to 1 spray in each nostril once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to understand how to use this medication properly. Read the package insert information carefully and talk to your doctor or pharmacist if you have any questions or are not sure how to use this medication.

Before using this medication for the first time, you will need to prime the pump. To do this, pull the cover and the clip off the spray pump and shake the pump gently. Then, put two fingers on the “shoulders” of the bottle. While holding the bottle away from you, push the bottle with the thumb firmly and quickly until a fine mist appears (about 5 pumps). Repriming is only needed when the spray pump has not been used for more than 14 days. To reprime, shake the bottle gently and pump only once while holding the bottle away from you.

To use the medication:

  1. Gently blow the nose to clear the nostrils if needed.
  2. Pull the cover and clip off the spray pump and gently shake the spray pump.
  3. Hold the spray pump firmly with the index finger and middle finger on the “shoulders” on either side of the spray tip and thumb on the bottom of the bottle. Rest the back of the index finger against the upper lip.
  4. Put the spray tip into one nostril (the tip should not reach far into the nose) and bend your head forward slightly.
  5. Point the tip straight back into the nose and close the other nostril with a finger. Pump the spray by pushing the thumb firmly and quickly for a full stroke and gently sniff at the same time. Repeat for the other nostril.
  6. If you are using more than one spray, repeat steps 3 to 5.
  7. Wipe the nozzle with a tissue and replace the cap.
  8. Avoid blowing the nose for 15 minutes after a dose.

To obtain the full benefit from this medication, it is important that it be used regularly and exactly as prescribed by your doctor. Do not stop using this medication even if you feel better, unless your doctor recommends that you do so.

If you miss a dose and you remember within an hour or so, administer a dose and continue with your regular schedule. If it has been more than an hour or so since your missed dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children. Discard the bottle after 120 sprays or after 2 months of starting the bottle.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to triamcinolone or any ingredients of the medication
  • have active or dormant tuberculosis
  • have an untreated fungal, bacterial, or viral infection

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • burning, dryness, or irritation of the nose
  • headache
  • nosebleed
  • sneezing
  • sore throat

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • feel generally unwell
  • nose or throat pain
  • severe nosebleed
  • unpleasant taste or smell
  • yellow or green nasal discharge

Stop using the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Growth in adolescents and children: Corticosteroids taken by mouth may impair the growth of adolescents and children. Although the use of nasal corticosteroids is less likely to cause this effect, your doctor will monitor for this. If you have any concerns, talk to your doctor.

Infection: Corticosteroids such as triamcinolone nasal spray may worsen existing infections, mask the signs of infection, and cause new infections. If you use this medication for several months or longer, your doctor will monitor you periodically for signs of infection. If you have not had chicken pox or measles or have not been vaccinated against these infections, take special care to avoid exposure to them.

Other corticosteroid medications: If you have been taking oral corticosteroids and are starting triamcinolone nasal spray, your doctor should carefully monitor your condition. Changing from the oral form to the nasal spray can cause symptoms such as tiredness, aches, pains, and depression. Tell your doctor if you have used or are using other corticosteroids. Your doctor will monitor you while you are taking this medication.

Stopping treatment: Do not stop this medication suddenly. It should be stopped gradually as directed by your doctor.

Vision problems: Long-term use of corticosteroids such as triamcinolone nasal spray may cause glaucoma or cataracts. Report any vision changes to your doctor immediately.

Wound healing: Corticosteroids such as triamcinolone can reduce the ability of wounds to heal. If you have ulcers in your nose, have had nasal surgery, or have had nasal trauma, talk to your doctor about how this medication will affect these conditions. Your doctor may recommend stopping this medication, or waiting until wounds have completely healed to start using it.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if triamcinolone passes into breast milk, but it is suspected that it does. If you are breast-feeding mother and using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 4 years of age. Children between 4 and 12 years of age should only use this medication under the direction of a doctor.

What other drugs could interact with this medication?

There may be an interaction between triamcinolone and any of the following:

  • other nasal sprays

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Nasacort-Allergy-24HR

Nasacort Allergy 24HR Nasal Spray

Generic Name: triamcinolone (nasal) (TRYE am SIN oh lone)
Brand Names: Nasacort Allergy 24HR

Medically reviewed by Drugs.com. Last updated on Jul 30, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • More

What is Nasacort Allergy 24HR?

Nasacort Allergy 24HR Nasal Spray contains triamcinolone, a corticosteroid medicine that prevents the release of substances in the body that cause inflammation.

Nasacort Allergy 24HR is used to treat sneezing, itching, and runny or stuffy nose caused by seasonal allergies or hay fever.

Nasacort Allergy 24HR may also be used for purposes not listed in this medication guide.

Important information

Nasacort Allergy 24HR should not be given to a child younger than 2 years old.

Nasacort side effects

Get emergency medical help if you have signs of an allergic reaction to Nasacort: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills, body aches, flu symptoms;

  • nosebleeds; or

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights.

Nasacort Allergy 24HR can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Nasacort side effects may include:

  • sneezing after use of the medicine; or

  • mild stinging or burning in your nose.

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.

Before taking this medicine

You should not use Nasacort Allergy 24HR if you are allergic to triamcinolone.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

  • any type of infection, including active tuberculosis;

  • asthma;

  • glaucoma or cataracts;

  • ulcers in your nose; or

  • recent surgery or injury to your nose.

Ask a doctor before using this medicine if you are pregnant or breast-feeding.

Nasacort Allergy 24HR should not be given to a child younger than 2 years old.

How should I use Nasacort Allergy 24HR?

Use Nasacort exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Shake the medicine well just before using it.

To use the nasal spray:

  • Blow your nose gently. Keep your head upright and insert the tip of the bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

  • The usual dose is 1 to 2 sprays per nostril once daily.

  • Do not blow your nose for at least a few minutes after using the nasal spray.

  • Do not use the nasal spray more than one time in 24 hours.

  • Keep the nozzle of the nasal spray bottle clean, following the cleaning instructions provided with your medicine.

  • If the nasal spray has not been used for longer than 2 weeks, prime it by spraying 1 or 2 times into a tissue.

Do not share the nasal spray with another person, or you could spread germs or disease.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Nasacort Allergy 24HR dosing information

Usual Adult Dose of Nasacort Nasal Spray for Allergic Rhinitis:

Nasal aerosol:
2 actuations in each nostril once a day; may increase after 4 to 7 days up to 4 actuations in each nostril once a day, or 2 actuations in each nostril twice daily, or 1 actuation in each nostril 4 times a day.
Nasal spray:
2 sprays in each nostril once a day; titrate to lowest effective dose after symptoms are controlled. Usual maintenance dose is 1 spray in each nostril once a day.

Usual Pediatric Dose of Nasacort Nasal Spray for Allergic Rhinitis:

Nasal spray:
2 years to 5 years: 1 spray in each nostril once a day;
6 years to 11 years: 1 spray in each nostril once a day; maximum dose is 2 sprays in each nostril once a day, titrate to lowest effective dose after symptoms are controlled.
12 years or older: 2 sprays in each nostril once a day; titrate to lowest effective dose after symptoms are controlled. Usual maintenance dose is 1 spray in each nostril once a day.

What happens if I miss a dose?

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?

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

An overdose of Nasacort Allergy 24HR is not expected to produce life threatening symptoms. 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 using Nasacort Allergy 24HR?

Avoid getting this medicine in your eyes or mouth.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Nasacort.

What other drugs will affect Nasacort?

Other drugs may interact with triamcinolone nasal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Nasacort only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 10.02.

Medical Disclaimer

  • Side Effects
  • During Pregnancy or Breastfeeding
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  • Drug class: nasal steroids
  • Nasacort Allergy 24HR

Other brands: Nasacort, Nasacort AQ, Allernaze

  • Triamcinolone Acetonide eent (AHFS Monograph)
  • … +1 more
  • Allergic Rhinitis

Prescribing Information as of March 2004a

DESCRIPTION

Nasacort AQ Nasal Spray is an unscented, 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.

Each actuation delivers 55 mcg triamcinolone acetonide from the nasal actuator after an initial priming of 5 sprays. It will remain adequately primed for 2 weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. The contents of one 6.5 gram sample bottle provide 30 actuations, and the contents of one 16.5 gram bottle provide 120 actuations. After either 30 actuations or 120 actuations, the amount of triamcinolone acetonide delivered per actuation may not be consistent and the unit should be discarded. Each 30 actuation sample bottle contains 3.575 mg of triamcinolone acetonide and each 120 actuation bottle contains 9.075 mg of triamcinolone acetonide.

In the Information for Patients tear-off sheet, patients are provided with a check-off form to track usage.

CLINICAL PHARMACOLOGY

Triamcinolone acetonide is a more potent derivative of triamcinolone. Although triamcinolone itself is approximately one to two times as potent as prednisone in animal models of inflammation, triamcinolone acetonide is approximately 8 times more potent than prednisone.

Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective. However, when allergic symptoms are very severe, local treatment with recommended doses (microgram) of any available topical corticosteroid are not as effective as treatment with larger doses (milligram) of oral or parenteral formulations.

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 at 24 hours. The average terminal half-life was 3.1 hours. The range of mean AUC 0-(infinity) 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 C max and AUC of the 440 mcg dose increased less than proportionally when compared to 110 and 220 mcg doses. Following multiple doses in pediatric patients receiving 440 mcg/day, plasma drug concentrations, AUC, C max and T max were similar to those values observed in adult patients.

In animal studies using rats and dogs, three metabolites of triamcinolone acetonide have been identified. They are 6(beta)-hydroxytriamcinolone acetonide, 21-carboxytriamcinolone acetonide and 21-carboxy-6(beta)-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.

In order to determine if systemic absorption plays a role in Nasacort AQ’s treatment of 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.

In order to evaluate the effects of systemic absorption on the Hypothalamic-Pituitary-Adrenal (HPA) axis, a clinical study was performed in adults comparing 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 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 cosyntropin stimulation in 80 pediatric patients 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.

CLINICAL TRIALS

The safety and efficacy of Nasacort AQ Nasal Spray have been evaluated in 10 double-blind, placebo-controlled clinical trials 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 trials 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 trials of two- and twelve-weeks duration in children ages 6 through 12 years with seasonal and perennial allergic rhinitis. These trials 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.

INDICATIONS AND USAGE

Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

WARNINGS

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.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella-zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

PRECAUTIONS

General: In clinical studies with triamcinolone acetonide 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 discontinuance of treatment with Nasacort AQ Nasal Spray.

Nasacort AQ Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract or in patients with untreated fungal, bacterial, or systemic viral infections or ocular herpes simplex.

Because of the inhibitory effect of corticosteroids, in patients who have experienced recent nasal septal ulcers, nasal surgery, or trauma, a corticosteroid should be used with caution until healing has occurred. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances.

When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, Nasacort AQ Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Information for Patients: Patients being treated with Nasacort AQ Nasal Spray should receive the following information and instructions. 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 AQ Nasal Spray at regular intervals since its effectiveness depends on its regular use. (See DOSAGE AND ADMINISTRATION .)

An improvement in some patient symptoms may be seen within the first day of treatment, and generally, it takes one week of treatment to reach maximum benefit. Initial assessment for response should be made during this time frame and periodically until the patient’s symptoms are stabilized.

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 after three weeks, or if the condition worsens. Patients who experience recurrent episodes of epistaxis (nose bleeds) or nasal septum discomfort while taking this medication should contact their physician. For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully.

It is important to shake the bottle well before each use. Also, the bottle should be discarded after either 30 actuations or 120 actuations since the amount of triamcinolone acetonide delivered thereafter per actuation may be substantially less than 55 mcg of drug. Do not transfer any remaining suspension to another bottle.

Carcinogenesis, Mutagenesis, and 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 (approximately 1/30 and 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m 2 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 (approximately 1/12 and 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m 2 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 (approximately 1/2 of the maximum recommended daily intranasal dose in adults on a mcg/m 2 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 1/5 of the maximum recommended daily intranasal dose in adults on a mcg/m 2 basis). At 1.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults on a mcg/m 2 basis), it did not induce the above mentioned effects.

Pregnancy: Teratogenic 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 7/10 of the maximum recommended daily intranasal dose in adults on a mcg/m 2 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/m 2 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/m 2 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.

There are no adequate and well-controlled studies in pregnant women. Nasacort AQ Nasal Spray, like other corticosteroids, should be used in 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.

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

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: Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

Corticosteroids have been shown to cause growth suppression in children and teenagers, particularly with higher doses over extended periods. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of corticosteroids should be considered.

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.

ADVERSE REACTIONS

In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with triamcinolone acetonide aqueous 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 events occurring at an incidence of 2% or greater and more common among Nasacort AQ -treated patients than placebo-treated patients in controlled adult clinical trials were:

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. Only 1% of those patients treated with Nasacort AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day discontinued due to a serious adverse event and one patient receiving 220 mcg/day discontinued due to a serious event that was considered not drug related. Overall, these studies found the adverse experience profile for Nasacort AQ to be similar to placebo. A similar adverse event profile was observed in pediatric patients 6-12 years of age as compared to older children and adults with the exception of epistaxis which occurred in less than 2% of the pediatric patients studied.

Adverse events occurring at an incidence of 2% or greater and more common among adult patients treated with placebo than Nasacort AQ were: headache, and rhinitis. In children aged 6 to 12 years these events included: asthma, epistaxis, headache, infection, otitis media, sinusitis, and vomiting.

In clinical trials, nasal septum perforation was reported in one adult patient although relationship to Nasacort AQ Nasal Spray has not been established.

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 .)

DOSAGE AND ADMINISTRATION

Recommended Doses: Adults and children 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.

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. The maximum recommended dose is 220 mcg per day as two sprays per nostril once daily.

Nasacort AQ Nasal Spray is not recommended for children under 6 years of age since adequate numbers of patients have not been studied in this age group.

Individualization of Dosage: It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. In adults, 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 in patients who were initially controlled at 220 mcg/day.

In children six to twelve years of age, the recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. The maximum recommended daily dose in children 6 to 12 years of age is 220 mcg per day (two sprays in each nostril once daily). Some patients who do not achieve maximum symptom control at a dose of 110 mcg per day may benefit from a dose of 220 mcg given as two sprays in each nostril once daily. The minimum effective dose should be used to ensure continued control of symptoms. Once symptoms are controlled, pediatric patients may be able to be maintained on 110 mcg per day (1 spray in each nostril once daily).

An improvement in some patient symptoms may be seen within the first day of treatment, and generally, it takes one week of treatment to reach maximum benefit. Initial assessment for response should be made during this time frame and periodically until the patient’s symptoms are stabilized. If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Nasacort AQ Nasal Spray should be discontinued. (See WARNINGS , PRECAUTIONS , Information for Patients , and ADVERSE REACTIONS .)

Directions For Use: Illustrated Patient’s Instructions for use accompany each package of Nasacort AQ Nasal Spray.

OVERDOSAGE

Like any other nasally administered corticosteroid, acute overdosing is unlikely in view of the total amount of active ingredient present. 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. The patient may experience some gastrointestinal upset.

HOW SUPPLIED

Nasacort AQ Nasal Spray is a nonchlorofluorocarbon (non-CFC) containing metered-dose pump spray. The contents of one 6.5 gram sample bottle provide 30 actuations, and the contents of one 16.5 gram bottle provide 120 actuations. The bottle should be discarded when the labeled number of actuations have been reached even though the bottle is not completely empty.

It 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

Keep out of reach of children.

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

Rx Only.

Manufactured by:

Aventis Pharmaceuticals Puerto Rico, Inc.

Manati, Puerto Rico 00674

And

Aventis Pharma Ltd .

Holmes Chapel, Cheshire CW4 8BE

United Kingdom

Manufactured for:

Aventis Pharmaceuticals Inc.

Bridgewater, NJ 08807 USA

US Pat. Nos. 6,143,329 and 5,976,573.

Other patents pending.

© 2004 Aventis Pharmaceuticals Inc.

Rev. March 2004a

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