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Pulmicort Respules

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Pulmicort Respules

PULMICORT RESPULES®
(budesonide) Inhalation suspension

Pulmicort Respules

DRUG DESCRIPTION

Budesonide, the active component of PULMICORT RESPULES® (budesonide inhalation suspension) , 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:

PULMICORT RESPULES® (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 RESPULES (budesonide inhalation suspension) is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (Respules™ ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL RESPULES ampule. For PULMICORT RESPULES (budesonide inhalation suspension) , like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. PULMICORT RESPULES should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see DOSAGE AND ADMINISTRATION].

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...

Read All Potential Side Effects and See Pictures of Pulmicort Respules »

What are the precautions when taking budesonide inhalation suspension (Pulmicort Respules)?

Before using budesonide, tell your doctor 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), 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...

Read All Potential Precautions of Pulmicort Respules »

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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Pulmicort Respules - User Reviews

Pulmicort Respules User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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