Drug Profile

Pregnancy Warning

Corticosteroids cause death and malformations in fetuses, including cleft palate, skeletal defects, and central nervous system and/or brain malformations. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women.

Breast-Feeding Warning

Corticosteroids are excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take these drugs while nursing.

FDA BLACK BOX WARNING

TRIAMCINOLONE

Particular care is needed in patients who are transferred from systemically active corticosteroids to Azmacort Inhalation Aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosolized steroids in recommended doses. After withdrawal from systemic corticosteroids, a number of months are usually required for recovery of hypothalamic-pituitary-adrenal (HPA) function (i.e., start producing your own corticosteroids after suppression by systemic corticosteroids). For some patients who have received large doses of oral steroids for long periods of time before therapy with Azmacort Inhalation Aerosol is initiated, recovery may be delayed for one year or longer. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infections, particularly gastroenteritis or other conditions with acute electrolyte loss. Although Azmacort Inhalation Aerosol may provide control of asthmatic symptoms during these episodes, in recommended doses it supplies only normal physiological amounts of corticosteroid systemically and does NOT provide the increased systemic steroid which is necessary for coping with these emergencies.

During periods of stress or a severe asthmatic attack, patients who have been recently withdrawn from systemic corticosteroids should be instructed to resume systemic steroids (in large doses) immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack.

Do not stop any asthma medication without first consulting your physician. Abruptly stopping a medication may result in acutely deteriorating asthma control.

Additional Precautions for Asthma

Avoid exposure to things that trigger your allergies or asthma, such as animals, bedding, chemicals, cosmetics, drugs, dust, mold, foods, pollens, or smoke. Wearing a mask reduces inhalation of drugs, pollens, and smoke.

Aspirin can trigger asthma in people who are aspirin-allergic, as can beta-blockers. Infections aggravate lung problems. During epidemics of respiratory illnesses, avoid crowded places and wash your hands frequently to help prevent infection. If you have asthma, get a flu vaccination.

Note: The information in this profile addresses the care of asthma that is not serious enough to need emergency treatment.

Do not use if you are:

• pregnant or breast-feeding
• allergic to lactose (fluticasone)

Tell your doctor if you have or have had:

• glaucoma
• infections (bacterial, fungal, parasitic, or viral)
• liver problems, such as cirrhosis
• osteoporosis
• hypothyroidism
• tuberculosis

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• Request training for self-management of asthma.[19]
• Read patient instructions carefully.
• Limit exposure to triggers of asthma. Wear protective devices or masks. Stop smoking.
• Avoid exposure to chicken pox or measles.
• Contact your doctor if symptoms do not improve, or if you increase use of short-acting beta agonists.
• If you are being transferred from systemic oral tablets of steroids to inhaled steroids, carry identification with you stating that supplemental systemic steroid therapy may be required in emergencies, periods of unusual stress, or acute asthma attack.
• Use every day in regularly spaced doses.
• Tell any doctor, dentist, emergency help, pharmacist, or surgeon you see that you use a steroid inhaler.

• Do not use for acute attacks of asthma.
• Success depends on technique. Follow printed instructions that accompany the particular inhaler device carefully about when and how to prime the container, inhalation technique by mouth, and disposal precautions.
• Children should use a spacer device.
• Do not spray in eyes or nose.
• Gargle and rinse mouth with water after use. Spit out. Do not swallow. This reduces dry mouth, hoarseness, and risk of systemic absorption.
• Schedule doses at even intervals.
• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Space any remaining doses of the day at regular intervals. Do not take double doses.
• Do not stop taking this drug suddenly. Contact your doctor.
• Do not share your medication with others.
• Do not use actuator for other inhalation drugs.
• Store inhalers in dry place at room temperature. Coldness can reduce the amount of drug inhaled. Do not freeze. Protect from sunlight. Do not use or store near heat or open flame. High temperatures may cause bursting. Keep out of reach of children for whom not prescribed.
• Store fluticasone with nozzle end down.
• Dispose after full number of actuations used or indicator reads zero. Follow accompanying instructions precisely. Do not throw into fire or incinerator. Do not reuse Diskus device.
• The triamcinolone canister contains chlorofluorocarbon (CFC) as a propellant.

Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drug’s FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.

Call your doctor immediately if you experience:

• aggressive behavior
• anxiety
• bleeding from rectum
• blood pressure increase
• difficult breathing
• bruises
• chest pain or burning
• diarrhea
• dizziness, fainting
• fat deposits in face, neck, or trunk
• fever
• general feeling of discomfort or illness
• slowed growth (children)
• fast or irregular heartbeat
• menstruation change
• vaginal infection
• mood or mental change
• creamy-white patches in mouth or throat
• nausea or vomiting
• numbness
• pain in abdomen, arms, back, chest, legs, ribs, or stomach
• sense of constant movement of self or surroundings
• diminished or lost senses of smell and taste
• sinus problems
• skin itching, hives, rash
• bloody stools
• painful swallowing or eating
• swelling of ankles, eyelids, face, feet, fingers, lips, lower legs
• unusual thirst
• unusual tiredness or weakness
• frequent, bloody, burning, or painful urination
• blurred or changed vision
• weight gain
• severe wheezing
• osteoporosis (occurs with long-term use; pain in back, ribs, arms, or legs)

Call your doctor if these symptoms continue:

• sinus problems
• cough
• dry mouth or throat
• headache
• sore throat, hoarseness, or voice change
• throat irritation
• constipation
• diarrhea
• trouble sleeping
• nausea or vomiting
• unpleasant taste in mouth
• nosebleeds or other nasal problems
• general aches

Other adverse effects are possible. Contact your doctor with any concerns.

Ask your doctor which of these tests should be done periodically while you are taking this drug:

• adrenal function test
• eye test
• growth and development (in children)
• lung function test
• signs of bruising
• test of technique in using inhaler
• weight