DRUG DESCRIPTION
Budesonide, the active component of PULMICORT TURBUHALER (budesonide) 200 mcg, is a corticosteroid
designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione
cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture
of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6
and its molecular weight is 430.5. Its structural formula is:
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Budesonide is a white to off-white, tasteless, odorless powder that is practically
insoluble in water and in heptane, sparingly soluble in ethanol, and freely
soluble in chloroform. Its partition coefficient between octanol and water at
pH 7.4 is 1.6 x 103.
PULMICORT TURBUHALER (budesonide) is an inhalation-driven multi-dose dry powder inhaler
that contains only micronized budesonide. Each actuation of PULMICORT TURBUHALER
provides 200 mcg budesonide per metered dose, which delivers approximately 160
mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min
for 2 sec).
In vitro testing has shown that the dose delivery for PULMICORT TURBUHALER (budesonide)
is substantially dependent on airflow through the device. Patient factors such
as inspiratory flow rates will also affect the dose delivered to the lungs of
patients in actual use (see Patient's Instructions
for Use). In adult patients with asthma (mean FEV1 2.9 L
[0.8 - 5.1 L]) mean peak inspiratory flow (PIF) through PULMICORT TURBUHALER (budesonide)
was 78 (40-111) L/min. Similar results (mean PIF 82 [43-125] L/min) were obtained
in asthmatic children (6 to 15 years, mean FEV1 2.1 L [0.9 - 5.4
L]). Patients should be carefully instructed on the use of this drug product
to assure optimal dose delivery.
What are the precautions when taking budesonide (Pulmicort Turbuhaler)?
Before using budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins found in some brands), 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), high blood pressure, 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,...
Read All Potential Precautions of Pulmicort Turbuhaler »
Pulmicort Turbuhaler Consumer (continued)
SIDE EFFECTS: See also Precautions section.
Dry/irritated throat, hoarseness, voice changes, bad taste in the mouth, runny nose, or nosebleeds 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 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: 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 budesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose, milk proteins found in some brands), 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), high blood pressure, 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.
Budesonide 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.
Tell your doctor if you are pregnant before using this medication. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness.
This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breast-feeding.
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