Pulmicort Flexhaler

DRUG DESCRIPTION

Budesonide, the active component of PULMICORT FLEXHALER (budesonide inhalation powder) , is a corticosteroid designated chemically as (RS)-11?, 16?, 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 FLEXHALER (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 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;...

Read All Potential Side Effects and See Pictures of Pulmicort Flexhaler

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,...

Read All Potential Precautions of Pulmicort Flexhaler


Pulmicort Flexhaler 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.


Pulmicort Flexhaler Patient Information Including Side Effects

Brand Names: Pulmicort Flexhaler, Pulmicort Respules

Generic Name: budesonide inhalation (Pronunciation: byoo DES oh nide)

  • What is budesonide inhalation (Pulmicort Flexhaler)?
  • What are the possible side effects of budesonide inhalation (Pulmicort Flexhaler)?
  • What is the most important information I should know about budesonide inhalation (Pulmicort Flexhaler)?
  • What should I discuss with my healthcare provider before using budesonide inhalation (Pulmicort Flexhaler)?
  • How should I use budesonide inhalation (Pulmicort Flexhaler)?
  • What happens if I miss a dose (Pulmicort Flexhaler)?
  • What happens if I overdose (Pulmicort Flexhaler)?
  • What should I avoid while taking budesonide inhalation (Pulmicort Flexhaler)?
  • What other drugs will affect budesonide inhalation (Pulmicort Flexhaler)?
  • Where can I get more information?

What is budesonide inhalation (Pulmicort Flexhaler)?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Budesonide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Budesonide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of budesonide inhalation (Pulmicort Flexhaler)?

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 (especially in your arms, legs, face, neck, breasts, and waist).

Less serious side effects may include:

  • white patches or sores inside your mouth or on your lips;
  • runny or stuffy nose, sneezing;
  • sore throat, cough;
  • nausea, vomiting, diarrhea, stomach pain;
  • nosebleed; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about budesonide inhalation (Pulmicort Flexhaler)?

Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.

Call your doctor right away if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

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  • Pulmicort Flexhaler
  • Pulmicort Respules


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