Azmacort

DRUG DESCRIPTION

Proprietary name: Azmacort
Established name: Triamcinolone acetonide
Route of administration: RESPIRATORY (INHALATION) (C38216)
Active ingredients (moiety): Triamcinolone acetonide (Triamcinolone)

# Strength Form Inactive ingredients
1 60 MILLIGRAM AEROSOL, METERED (C42960) Dehydrated alcohol, dichlorodifluoromethane

Triamcinolone acetonide, USP, the active ingredient in Azmacort® (triamcinolone acetonide inhalation aerosol) Inhalation Aerosol, is a corticosteroid with a molecular weight of 434.5 and with the chemical designation 9- Fluoro-11?,16?,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. (C24H31FO6).

Azmacort (triamcinolone acetonide inhalation aerosol) Inhalation Aerosol is a metered-dose aerosol unit containing a microcrystalline suspension of triamcinolone acetonide in the propellant dichlorodifluoromethane and dehydrated alcohol USP 1% w/w. Each canister contains 60 mg triamcinolone acetonide. The canister must be primed prior to the first use. After an initial priming of 2 actuations, each actuation delivers 200 mcg triamcinolone acetonide from the valve and 75 mcg from the spacer-mouthpiece under definedin vitro test conditions. The canister will remain primed for 3 days. If the canister is not used for more than 3 days, then it should be reprimed with 2 actuations. There are at least 240 actuations in one Azmacort (triamcinolone acetonide inhalation aerosol) Inhalation

Aerosol canister. After 240 actuations, the amount delivered per actuation may not be consistent and the unit should be discarded.

What are the possible side effects of triamcinolone inhalation (Azmacort)?

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

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • pain or burning when you urinate;
  • changes...

Read All Potential Side Effects and See Pictures of Azmacort »

What are the precautions when taking triamcinolone acetonide (inhalation aerosol) (Azmacort)?

Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as...

Read All Potential Precautions of Azmacort »


Azmacort Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/sore throat, hoarseness, headache, or voice changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as ear pain, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush (yeast infection). Contact your doctor if you notice white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing, increased thirst/urination.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Triamcinolone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known if triamcinolone passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Azmacort Patient Information Including Side Effects

Brand Names: Azmacort

Generic Name: triamcinolone inhalation (Pronunciation: trye am SIH no lone)

  • What is triamcinolone inhalation (Azmacort)?
  • What are the possible side effects of triamcinolone inhalation (Azmacort)?
  • What is the most important information I should know about triamcinolone inhalation (Azmacort)?
  • What should I discuss with my healthcare provider before using triamcinolone inhalation (Azmacort)?
  • How should I use triamcinolone inhalation (Azmacort)?
  • What happens if I miss a dose (Azmacort)?
  • What happens if I overdose (Azmacort)?
  • What should I avoid while using triamcinolone inhalation (Azmacort)?
  • What other drugs will affect triamcinolone inhalation (Azmacort)?
  • Where can I get more information?

What is triamcinolone inhalation (Azmacort)?

Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Triamcinolone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of triamcinolone inhalation (Azmacort)?

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

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • pain or burning when you urinate;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
  • worsening asthma symptoms.

Less serious side effects may include:

  • nausea, diarrhea, stomach pain;
  • joint or muscle pain;
  • dryness in your mouth, nose, or throat;
  • white patches or sores inside your mouth or on your lips;
  • stuffy nose, sinus pain, sore throat, cough; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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.

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