Pulmicort Flexhaler

The active ingredient in Pulmicort Flexhaler is budesonide. This medication belongs to a class of medications known as inhaled corticosteroids (ICS) and is considered to be a dry powder inhaler. Inhaled budesonide may be used with other asthma medicines such as short-acting bronchodilators, which are used to open up narrowed breathing passages in the lungs.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Pulmicort Flexhaler. However, the following is a synopsis of the general guidelines for the use of Pulmicort Flexhaler:

• Use this medication exactly as directed by your physician.
• Patients 18 Years of Age and Older: The recommended starting dosage is 360 mcg twice daily. The maximum dosage should not exceed 720 mcg twice daily.
• Patients 6 to 17 Years of Age: The recommended starting dosage is 180 mcg twice daily. The maximum dosage should not exceed 360 mcg twice daily.
• If you have sudden trouble breathing during an asthma attack, use your rescue inhaler (albuterol) instead.
• The inhaler does not need to be shaken but primed before it’s used for the first time.
• Hold Pulmicort Flexhaler upright and remove the white cover. Twist the brown grip in one direction as far as it will go. Twist it fully back again in the other direction. A "click" during one of the twists will be heard. Breathe out as long as you can away from the inhaler. Place your lips firmly around the mouthpiece and breathe in quickly and deeply.
• After inhalation, try to hold your breath for 10 seconds, or for as long as you comfortably can.
• After the inhaler is used, rinse your mouth with water and spit to prevent fungal infections (thrush) in your mouth and throat.
• Never use a spacer device with the Pulmicort Flexhaler.

The most common side effects of Pulmicort Flexhaler include:

• Sore throat.
• Stuffy nose.
• Nausea.
• Stomach flu.
• Ear infection.

Some individuals may experience serious side effects while using Pulmicort Flexhaler. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reactions - hives, itching, swelling, rash.
• Oral thrush - white patches in the mouth or on the tongue.
• Sudden breathing problems.
• Vision problems - narrow-angle glaucoma and cataracts.
• Reduced adrenal gland function (adrenal insufficiency).
• Increased risk of serious infections, including tuberculosis, fungal, bacterial, viral, or parasitic, or ocular herpes infection.
• Decreased bone mineral density.
• Slowed growth in children.

These are not all of the possible side effects of Pulmicort Flexhaler. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Pulmicort Flexhaler, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Liver problems.
• Weak bones (osteoporosis).
• Problems with your immune system.
• Eye problems (glaucoma, cataracts).
• No vaccination against chickenpox or measles.
• Tuberculosis.

• Primary treatment of status asthmaticus or other acute episodes of asthma, where intensive measures are required.
• Previous severe allergic reaction/hypersensitivity to milk proteins and any of the ingredients in Pulmicort Flexhaler.

For this medicine to help prevent asthma attacks and severe asthma symptoms from developing, it must be used every day in regularly spaced doses, as ordered by your doctor. This medicine usually begins to work in about 24 to 48 hours, but up to 2 to 6 weeks may pass before you feel the full effects.

When Pulmicort Flexhaler is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ketoconazole.
• Certain medications that control seizures.
• Corticosteroid.
• Medications that suppress your immune system.

Pulmicort Flexhaler comes in the following dosage forms and strengths:

• Budesonide (90 mcg or 180 mcg) per actuation as an inhalation powder.

Store this medication at room temperature and keep it out of reach of children. Additionally, store with the mouthpiece cover on, in a cool, dry place.

CHEPLAPHARM is the pharmaceutical company that manufactures Pulmicort Flexhaler.

There are no lower-cost generics available for the brand-name Pulmicort Flexhaler.

Do not stop or adjust your use of this medication without first consulting your doctor.

It is unknown if or how Pulmicort Flexhaler could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Pulmicort Flexhaler is known to pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.