"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...
(Budesonide Inhalation Powder) 90 MCG, 180 MCG
Budesonide, the active component of PULMICORT FLEXHALER (budesonide inhalation powder) , is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20dione 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:
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 FLEXHALER (budesonide inhalation powder) is an inhalation-driven multi-dose dry powder inhaler containing a formulation of 1 mg per actuation of micronized budesonide and micronized lactose monohydrate which contains trace levels of milk proteins [see CONTRAINDICATIONS and Post-marketing Experience]. Each actuation of PULMICORT FLEXHALER (budesonide inhalation powder) 180 mcg delivers 160 mcg budesonide from the mouthpiece and each actuation of PULMICORT FLEXHALER 90 mcg delivers 80 mcg budesonide from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec). Each PULMICORT FLEXHALER (budesonide inhalation powder) 180 mcg contains 120 actuations and each PULMICORT FLEXHALER (budesonide inhalation powder) 90 mcg contains 60 actuations.
In vitro testing has shown that the dose delivery for PULMICORT FLEXHALER (budesonide inhalation powder) is dependent on airflow through the device, as evidenced by a decrease in the fine particle dose at a flow rate of 30 L/min to a value that is approximately 40 - 50% of that produced at 60 L/min. At a flow rate of 40 L/min, the fine particle dose is approximately 70% of that produced at 60 L/min. Patient factors such as inspiratory flow rates will also affect the dose delivered to the lungs of patients in actual use [see PATIENT INFORMATION and Instructions for Use]. In asthmatic children age 6 to 17 (N=516, FEV1 2.29 [0.97– 4.28]) peak inspiratory flow (PIF) through PULMICORT FLEXHALER (budesonide inhalation powder) was 72.5 [19.1 – 103.6] L/min). Inspiratory flows were not measured in the adult pivotal study. Patients should be carefully instructed on the use of this drug product to assure optimal dose delivery.
What are the possible side effects of budesonide inhalation (Pulmicort Flexhaler, Pulmicort Respules)?
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, vomiting, feeling like you might pass out;
- wheezing or breathing problems after using this medication;
- worsening respiratory symptoms;
- ear pain with fever;
- vision problems; or
- changes in the shape or location of body fat...
What are the precautions when taking budesonide inhalation powder (Pulmicort Flexhaler)?
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,...
Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.
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