Azmacort

Name: Azmacort

Kenalog Side Effects

Common Side Effects of Kenalog

Tell your doctor if any of the following side effects become severe or don't go away:

  • Burning, itching, or peeling of the skin
  • Skin redness
  • Dry or cracking of the skin
  • Change in skin color
  • Acne
  • Thinning of the skin
  • Blistering skin
  • Stretch marks

Serious Side Effects of Kenalog

Tell your doctor immediately if you experience any of the following serious side effects:

  • A severe skin rash
  • Signs of a skin infection, which may include swelling or oozing pus
  • Irregular heartbeat
  • Blurred vision or vision changes
  • Difficulty breathing or swallowing
  • Wheezing
  • Mood changes
  • Sleep problems
  • Weight gain
  • Puffiness in the face
  • Feeling extremely tired

What else should I know about triamcinolone acetonide inhaler?

What preparations of triamcinolone acetonide inhaler are available?

Metered Dose Inhaler: 60 mg (75 mcg/actuation)

How should I keep triamcinolone acetonide inhaler stored?

Triamcinolone inhaler should be kept at room temperature, 20 C - 25 C (68 F - 77 F) and protected from direct light. Exposure to temperatures above 38.8 C (120 F) may cause bursting of the canister. The canister should never be thrown into a fire or incinerator.

Side effects

The table below describes the incidence of common adverse experiences based upon three placebo-controlled, multicenter US clinical trials of 507 patients (297 female and 210 male adults (age range 18-64)). These trials included asthma patients who had previously received inhaled beta2-agonists alone, as well as those who previously required inhaled corticosteroid therapy for the control of their asthma. The patients were treated with Azmacort (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol (including doses ranging from 150 to 600 mcg twice daily for 6 weeks) or placebo.

Adverse Events Occurring at an Incidence of Greater Than 3% and Greater Than Placebo

Adverse Event 150 mcg
bid
(n=57)
Azmacort (triamcinolone acetonide (inhalation aerosol)) Dose
300 mcg bid
(n=170)
600 mcg
bid
(n=57)
Placebo
(n=167)
Sinusitis 5 (9%) 7 (4%) 1 (2%) 6 (4%)
Pharyngitis 4 (7%) 42 (25%) 10 (18%) 19 (11%)
Headache 4 (7%) 35 (21%) 7 (12%) 24 (14%)
Flu Syndrome 2 (4%) 8 (5%) 1 (2%) 5 (3%)
Back Pain 2 (4%) 3 (2%) 2 (4%) 3 (2%)

Adverse events that occurred at an incidence of 1-3% in the overall Azmacort (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol treatment group and greater than placebo included:

Body as a whole: facial edema, pain, abdominal pain, photosensitivity

Digestive system: diarrhea, oral monilia, toothache, vomiting

Metabolic and Nutrition: weight gain

Musculoskeletal system: bursitis, myalgia, tenosynovitis

Nervous system: dry mouth

Organs of special sense: rash

Respiratory system: chest congestion, voice alteration

Urogenital system: cystitis, urinary tract infection, vaginal monilia

In older controlled clinical trials of steroid dependent asthmatics, urticaria was reported rarely. Anaphylaxis was not reported in these controlled trials. Typical steroid withdrawal effects including muscle aches, joint aches, and fatigue were noted in clinical trials when patients were transferred from oral steroid therapy to Azmacort (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol. Easy bruisability was also noted in these trials.

Hoarseness, dry throat, irritated throat, dry mouth, facial edema, increased wheezing, and cough have been reported. These adverse effects have generally been mild and transient. Cases of oral candidiasis occurring with clinical use have been reported. (See WARNINGS.) Cases of growth suppression have been reported for orally inhaled corticosteroids (see PRECAUTIONS, Pediatric Use section).

Post Marketing: In addition to adverse events reported from clinical trials, the following events have been identified during post approval use of Azmacort (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol where these events were reported voluntarily from a population of unknown size, and the frequency of occurrence cannot be determined precisely. These include rare reports of anaphylaxis, cataracts, glaucoma and very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.

Azmacort Precautions

Serious side effects have been reported with Azmacort including the following:

  • ​Slowed growth in children. A child's growth should be checked often.
  • Steroid withdrawal from oral steroids. Tell your healthcare provider if you or your child experiences:
    • ​joint or muscular pain
    • lack of energy
    • depression
  • ​Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of Azmacort than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:
    • feeling tired or exhausted (fatigue)
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure (hypotension)
    • dizziness or feeling faint

Do not take Azmacort if you are allergic to Azmacort or to any of its ingredients.

Azmacort Overdose

If you take too much Azmacort, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Other Requirements

  • Store Azmacort, including the metal canister, at room temperature.
  • Protect from freezing temperatures and direct sunlight.
  • For best results, the canister should be at room temperature before use.
  • DO NOT use after the date shown as DO NOT “EXP” on the label or box.
  • Azmacort canisters are for use with Azmacort Inhalation Aerosol actuators and spacer-mouthpieces only. The actuator and spacer-mouthpiece should not be used with other aerosol medications.
  • Keep this and all medicines out of the reach of children.
  • This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

Precautions

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use). Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects including suppression of growth in children. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of a decrease in adrenal function.

During withdrawal from oral steroids, some patients may experience symptoms of systemically active steroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. (See DOSAGE AND ADMINISTRATION.) Although steroid withdrawal effects are usually transient and not severe, severe and even fatal exacerbation of asthma can occur if the previous daily oral corticosteroid requirement had significantly exceeded 10 mg/day of prednisone or equivalent.

In responsive patients, inhaled corticosteroids will often permit control of asthmatic symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since triamcinolone acetonide is absorbed into the circulation and can be systemically active, the beneficial effects of Azmacort Inhalation Aerosol in minimizing or preventing HPA dysfunction may be expected only when recommended dosages are not exceeded.

Suppression of HPA function has been reported in volunteers who received 4000 mcg daily of triamcinolone acetonide by oral inhalation. In addition, suppression of HPA function has been reported in some patients who have received recommended doses for as little as 6 to 12 weeks. Since the response of HPA function to inhaled corticosteroids is highly individualized, the physician should consider this information when treating patients.

When used at excessive doses or at recommended doses in a small number of susceptible individuals, systemic corticosteroid effects such as hypercorticoidism and adrenal suppression may appear. If such changes occur, Azmacort ® Inhalation Aerosol should be discontinued slowly, consistent with accepted procedures for reducing systemic steroid therapy and for management of asthma symptoms.

Azmacort Inhalation Aerosol should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.

The long-term local and systemic effects of Azmacort Inhalation Aerosol in human subjects are still not fully known. While there has been no clinical evidence of adverse experiences, the effects resulting from chronic use of Azmacort Inhalation Aerosol on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown.

Information for Patients: Patients being treated with Azmacort Inhalation 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 complete disclosure of all possible adverse or intended effects.

Patients should use Azmacort Inhalation Aerosol at regular intervals as directed. Results of clinical trials indicate that significant improvement in asthma may occur by 1 week, but maximum benefit may not be achieved for 2 weeks or more. The patient should not increase the prescribed dosage but should contact the physician if symptoms do not improve or if the condition worsens.

In clinical studies and post-marketing experience with Azmacort Inhalation Aerosol, local infections of the oropharynx with Candida albicans have occurred. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while remaining on treatment with Azmacort Inhalation Aerosol. However, at times therapy with Azmacort Inhalation Aerosol may need to be interrupted.

Patients should be instructed to track their use of Azmacort Inhalation Aerosol and to dispose of the canister after 240 actuations since reliable dose delivery cannot be assured after 240 doses.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of treatment-related carcinogenicity was demonstrated after two years of once daily gavage of triamcinolone acetonide at doses of 0.05, 0.2, and 1.0 mcg/kg (approximately 0.02, 0.07, and 0.4% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) in the rat and 0.1, 0.6, and 3.0 mcg/kg (approximately 0.02, 0.1, and 0.6% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) in a mouse.

Mutagenesis studies with triamcinolone acetonide have not been carried out.

No evidence of impaired fertility was manifested when oral doses of up to 15.0 mcg/kg (8% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) were administered to female and male rats. However, triamcinolone acetonide at oral doses of 8 mcg/kg (approximately 4% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) caused dystocia and prolonged delivery and at oral doses of 5.0 mcg/kg (approximately 2.5% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) and above caused increases in fetal resorptions and stillbirths and decreases in pup body weight and survival. At a lower dose of 1.0 mcg/kg (approximately 0.5% of the maximum recommended human daily inhalation dose on a mcg/m2 basis) it did not induce the above mentioned effects.

Pregnancy: Pregnancy Category C. Triamcinolone acetonide has been shown to be teratogenic at inhalational doses of 20, 40, and 80 mcg/kg in rats (approximately 0.1, 0.2, and 0.4 times the maximum recommended human daily inhalation dose on a mcg/m2 basis, respectively), in rabbits at the same doses (approximately 0.2, 0.4, and 0.8 times the maximum recommended human daily inhalation dose on a mcg/m2 basis, respectively) and in monkeys, at an inhalational dose of 500 mcg/kg (approximately 5 times the maximum recommended human daily inhalation dose 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 teratogenic effects observed in the monkey were CNS and/or cranial malformations. There are no adequate and well controlled studies in pregnant women. Triamcinolone acetonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Experience with oral glucocorticoids since their introduction in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from glucocorticoids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous steroid dose and many will not need glucocorticoid 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 Azmacort Inhalation Aerosol is administered to nursing women.

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

Controlled clinical studies have shown that orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately one centimeter (cm) per year (range 0.3 to 1.8 cm per year; 0.12 to 0.71 inches) and appears to depend upon dose and duration of exposure. [The specific growth effects of Azmacort have also been studied in a controlled clinical trial (see data below)]. This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (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.

To assess if Azmacort has an effect on growth, a one-year, randomized, open-label study of pre-pubescent boys and girls ages 6-11 with moderate to severe asthma was conducted. Children with moderate asthma were randomized to a nonsteroidal treatment or to Azmacort, children with severe asthma to Azmacort plus prednisone or just prednisone alone. A sex and age matched group of healthy non-asthmatic children was also included. The average daily dose of Azmacort was 400 mcg (range 75 to 1600 mcg/day, dose adjustments were permitted). Non-asthmatic children (mean 8.2 years) grew 5.93 cm/year (n=96). In the moderate asthma groups, the Azmacort children (mean 8.2 years) grew 5.34 cm/year (n=101) and the nonsteroidal children (mean 8.5 years) grew 6.13 cm/year (n=95). In the severe groups, the Azmacort plus prednisone children (mean 8.2 years) grew 5.46 cm/year (n=33) and the prednisone only children (mean 8.0 years) grew 5.59 cm/year (n=31). Due to low enrollment in the severe patient groups, there was insufficient power to interpret the statistical analyses on these groups.

The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. The growth of children and adolescents receiving orally inhaled corticosteroids, including Azmacort, 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 risk associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including Azmacort , each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

Geriatric Use: Clinical studies of Azmacort Inhalation 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

How supplied

Azmacort Inhalation Aerosol contains 60 mg triamcinolone acetonide in a 20 gram package which delivers at least 240 actuations. It is supplied with a white plastic actuator, a white plastic spacer-mouthpiece and patient's leaflet of instructions: box of one. NDC 0074–3014–60. Each actuation delivers 200 mcg triamcinolone acetonide from the valve and 75 mcg from the spacer-mouthpiece under defined in vitro test conditions.

Avoid spraying in eyes.

For best results, the canister should be at room temperature before use.

Shake well before using.

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 reach of children unless otherwise prescribed. Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

WARNING: Contains CFC-12, a substance which harms public health and the environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the “Information For The Patient” portion of this package insert under the Environmental Protection Agency's (EPA's) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.


©2007 Abbott Laboratories
Manufactured for:
Abbott Laboratories
North Chicago, IL 60064 U.S.A.

INFORMATION FOR THE PATIENT

Your Guide to the

Azmacort®
(triamcinolone acetonide)
Inhalation Aerosol

Special Delivery System

Rx Only

Your doctor has prescribed Azmacort ® (triamcinolone acetonide) Inhalation Aerosol to help control your asthma. Your Azmacort Inhalation Aerosol is one of the most efficient and easy-to-use devices available to help you take your prescribed medication. Used properly, it will effectively and reliably relieve your asthma symptoms.

To receive the maximum benefit, it is very important that you carefully read and follow all the instructions contained in this booklet for the daily use and care of your Azmacort Inhalation Aerosol.

IMPORTANT NOTE: If you've used other metered-dose inhalers before, you may expect the Azmacort Inhalation Aerosol to deliver a noticeable “blast” of medication into your mouth.

Your Azmacort Inhalation Aerosol, however, is designed to provide a gentle mist, not a “blast,” when used.

This gentle action makes it possible for your medication to be more effectively delivered into the passageways to your lungs, with very little left to linger in your mouth. In fact, you may not even feel the medication entering your mouth, but rest assured, that is how the Azmacort Inhalation Aerosol works.

IMPORTANT: Please read all instructions in this guide carefully before using your Azmacort Inhalation Aerosol.

BEFORE STARTING TO TAKE THIS MEDICINE, TELL YOUR DOCTOR:

  • If you are pregnant or intending to become pregnant.
  • If you are breast-feeding a baby.
  • If you are allergic to Azmacort Inhalation Aerosol or any other orally inhaled glucocorticoid.
  • If you are taking other medications. In some circumstances, this medication may not be suitable and your doctor may wish to give you a different medicine.

PREPARE YOUR Azmacort INHALATION AEROSOL

INHALER FOR USE

STEP 1

1. Line up the arrows on the inhaler.

STEP 2

2. Gently pull the inhaler to its fully extended position. You will see the valve (small hole) where the medication will come out.

STEP 3

3. Adjust the inhaler into an “L” shape. It is hinged to swing in one direction only.

STEP 4

4. The ridge on the top part of the inhaler should fit into the notch on the bottom part.

STEP 5

5. Remove the mouthpiece cap. To prepare your Azmacort Inhalation Aerosol for use, the inhaler must be primed prior to the first use. To prime, hold the inhaler upright, with the mouthpiece facing away from you. Shake the inhaler gently, then press the canister firmly and quickly. Repeat this procedure again so a total of 2 puffs are released. Your Azmacort Inhalation Aerosol is now ready for use.

Repriming is only necessary when your inhaler has not been used for more than 3 days. To reprime, shake the inhaler and release one puff. Repeat this procedure again so a total of two puffs are released.

USING YOUR Azmacort INHALATION AEROSOL INHALER

STEP 6

6. The metal Azmacort canister has already been inserted into the inhaler. Once you have opened the inhaler, shake it well before each use. IMPORTANT: You must shake the inhaler each and every time before inhaling the medication. If your doctor has instructed you to take more than one breath of medication at a time, you must shake the inhaler EACH TIME before each inhalation of medication, NOT JUST ONCE.

STEP 7

7. Breathe out to empty your lungs completely before using the inhaler! This is important to make sure that you can breathe the medication deeply into your lungs.

STEP 8

8. Place mouthpiece into your mouth, and close your lips tightly around it. Press down firmly and steadily on the metal canister while breathing in slowly and deeply THROUGH YOUR MOUTH ONLY. (If necessary, pinch your nose closed.) Be sure to release your finger pressure from the top of the canister after the medication is released.

Remember, the Azmacort Inhalation Aerosol delivers a gentle mist of medication, so don't be surprised if you hardly feel it.

Do not remove the inhaler from your mouth after breathing in the medication. Hold your breath for 10 seconds with the inhaler STILL in your mouth, THEN remove the inhaler and breathe out very slowly.

Unlike the other inhalers you may have used, you will not feel the medication impact the back of your mouth. This is because of the unique design of the Azmacort Inhalation Aerosol delivery system.

STEP 9

9. If your doctor has told you to take more than one breath of medication at a time: WAIT AT LEAST 60 SECONDS between each one, then start again at Step 6.

STEP 10

10. After the prescribed number of inhalations, thoroughly rinse out your mouth with water. NOTE: If your mouth becomes sore or develops a rash, be sure to mention this to your physician, but do not stop using your inhaler unless instructed to do so.

DOSAGE: USE ONLY AS DIRECTED BY YOUR PHYSICIAN

WARNING: Azmacort® (triamcinolone acetonide) Inhalation Aerosol contains medication that is intended for treatment of your asthma. It does not contain medication intended to provide rapid relief of your breathing difficulties during an asthma attack.

It is very important that you use Azmacort Inhalation Aerosol regularly at the intervals recommended by your doctor, and not as an emergency measure. Your physician will decide whether other medication is needed, should you require immediate relief.

CAUTION: CONTENTS OF CANISTER UNDER PRESSURE.

Do not puncture. Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canisters into a fire or incinerator. Please keep out of the reach of children.

Note: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs):

This product contains CFC-12, a substance which harms the environment by destroying ozone in the upper atmosphere.

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.

IMPORTANT TIPS FOR USING YOUR Azmacort INHALATION AEROSOL INHALER

  • Always use only as directed by your physician. Do not use it more often than instructed; do not skip doses.
  • Follow all instructions in this booklet very closely and carefully for best results, especially those for use and cleaning.
  • Remember, repriming is only necessary when the inhaler has not been used for more than 3 days. To reprime, shake the inhaler gently and release one puff. Repeat this procedure again so that a total of two puffs have been released. Do not reprime between more frequent usage.
  • Please Note:
    You will receive a new Azmacort Inhalation Aerosol unit each time you refill your prescription. This is done to assure optimal working order of the unique Azmacort Inhalation Aerosol spacer device/delivery system. In addition, a new Azmacort Inhalation Aerosol will guard against a build-up of the drug on the barrel portion of the device, maximizing the cleanliness of your unit. The cost of Azmacort Inhalation Aerosol is MINIMALLY affected by including a new inhaler with each prescription.

STORING YOUR Azmacort INHALATION AEROSOL INHALER

  • Keep your inhaler out of the reach of children, unless otherwise prescribed.
  • Store your Azmacort Inhalation Aerosol, including the metal canister, at room temperature.
  • Protect from freezing temperatures and direct sunlight.
  • For best results, the canister should be at room temperature before use.
  • DO NOT use after the date shown as “EXP”on the label or box.
  • Azmacort Inhalation Aerosol canisters are for use with Azmacort Inhalation Aerosol actuators and spacer-mouthpieces only. The actuator and spacer-mouthpiece should not be used with other aerosol medications.
  • REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

DAILY CARE OF YOUR Azmacort INHALATION AEROSOL INHALER

Your Azmacort Inhalation Aerosol MUST be cleaned in lukewarm water only once each day to avoid build-up of medication particles in the inhaler that can block the puff of medication and interfere with proper operation. The use of soap, detergents, or disinfectants is unnecessary.

  1. IMPORTANT: Remove metal canister from inhaler. Pull canister straight out from inhaler and place aside. Canister must be removed for proper cleaning of inhaler.
  2. Pull apart remaining two plastic parts of inhaler, remove mouthpiece cap, and gently wash in lukewarm water.
    Dry thoroughly.
  3. Snap the two plastic parts of the inhaler back together; push closed. Replace mouthpiece cap. Reinsert metal canister by gently turning while inserting. The canister should fit snugly without falling out.

HOW TO CHECK CONTENTS OF YOUR CANISTER

Shaking the canister will NOT give you a good estimate of how much Azmacort® (triamcinolone acetonide) Inhalation Aerosol is left.

We have included a convenient check-off chart to assist you in keeping track of medication puffs used. This will help assure that you receive the 240 “Full Puffs” of medication present.

FURTHER INFORMATION

  • This leaflet does not contain the complete information about your medication.
  • If you have any further questions, or are not sure about something, you should ask your doctor or pharmacist.
  • You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished this canister.


©2007 Abbott Laboratories
Manufactured for:
Abbott Laboratories
North Chicago, IL 60064 U.S.A.

Azmacort 
triamcinolone acetonide aerosol, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0074-3014
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Triamcinolone acetonide (Triamcinolone) Triamcinolone 75 ug
Inactive Ingredients
Ingredient Name Strength
Dehydrated alcohol  
dichlorodifluoromethane  
Packaging
# Item Code Package Description
1 NDC:0074-3014-60 240 AEROSOL, METERED (240 SPRAY) in 1 INHALER
Labeler - Abbott Laboratories
Revised: 06/2008   Abbott Laboratories

What is the most important information i should know about triamcinolone inhalation (azmacort)?

Do not use triamcinolone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using triamcinolone inhalation for 2 weeks.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

If you were switched from an oral (taken by mouth) steroid to triamcinolone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

Where can i get more information?

Your pharmacist can provide more information about triamcinolone inhalation.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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