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Pulmicort Turbuhaler

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Pulmicort Turbuhaler

PULMICORT TURBUHALER®
(budesonide) Inhalation Powder 200 mcg

For Oral Inhalation Only.

Pulmicort Turbuhaler

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:

Pulmicort Turbuhaler (Budesonide) structural formula illustration

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 »

Last reviewed on RxList: 9/11/2007
This monograph has been modified to include the generic and brand name in many instances.

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