Pulmicort Respules

The active ingredient in Pulmicort Respules is budesonide. It is an inhaled corticosteroid that reduces inflammation in the lungs to help you breathe easier.

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 Respules. However, the following is a synopsis of the general guidelines for the use of Pulmicort Respules:

1. These respules are intended to be taken by inhalation from a nebuliser, and not injected or swallowed.

2. Remove one ampule from the sheet and gently shake. Open by twisting the top off.

3. The liquid should be put into the nebuliser machine, with the aerosol inhaled through a face mask or mouthpiece.

4. When using a face mask, use a barrier cream on your face, and wash your face thoroughly after treatment.

5. Do not dilute the nebule content unless advised by a doctor. Use only sterile saline for dilution.

6. Ensure the liquid or mist from the machine does not get into your eyes.

7. Always use the nebuliser in a well-ventilated room.

8. Discard any remaining solution in the nebuliser after use.

9. Always rinse your mouth and spit when you are done with the treatment.

10. Keep the nebules in the foil envelope until you are ready to use them. Any opened respule should be used within 24 hours.

The most common side effects of Pulmicort Respules include:

• Runny nose (rhinitis) or stuffy nose, sore throat, or other common cold symptoms.
• Nosebleeds.
• Cough.
• Ear infections.
• Vomiting.
• Diarrhea.
• Stomach pain.

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

• Oral candidiasis (thrush) may occur, which would present as white patches inside the mouth. This risk can be reduced by always rinsing and spitting after use.
• Suppression of the immune system is more common with long-term use. While taking this drug, you should avoid contact with anyone who has been exposed to or is currently diagnosed with measles or chickenpox. This medication may also make you more susceptible to respiratory infections, ear infections, fungal infections, and viral infections.
• Adrenal insufficiency, which may present with symptoms of fatigue, weakness, nausea, vomiting, and low blood pressure. This is more common with high doses of budesonide.
• Serious life-threatening allergic reactions, which may present as skin rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.
• Eye problems, including conjunctivitis (redness in the eyes), glaucoma, increased intraocular pressure, and cataracts. This is more common with long-term use.
• Slowed growth in pediatric or adolescent populations.

This medication also has the potential to cause an initial worsening of your asthma symptoms (shortness of breath or bronchospasm), requiring you to use your rescue nebules more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks. Contact your physician if this occurs at any time.

These are not all of the possible side effects of Pulmicort Respules. 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 Respules, 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:

• Active or latent tuberculosis.
• Untreated systemic fungal, bacterial, viral, or parasitic infections.
• Ocular Herpes simplex.
• Recent treatment with oral corticosteroids such as prednisone.
• Eye problems, including narrow-angle glaucoma or cataracts.
• Existing problems with your adrenal gland (high cortisol levels).
• Reduced bone mineral density (osteoporosis).

Treatment of a sudden or severe asthma attack (rescue use).

Allergy or hypersensitivity to budesonide.

You should see an effect about one day after using the respules, but the full effect may take up to 2 weeks.

When Pulmicort Respules are 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:

• Antifungal medications such as ketoconazole and itraconazole, as well as cimetidine (used for heartburn), may increase the levels of budesonide in your body and increase side effects when used together.

Brand-name Pulmicort Respules are available as 2mL ampules containing either 0.25mg or 0.5mg doses of budesonide. Each foil envelope contains a strip of five single-dose respules.

Pulmicort Respules should be stored at room temperature and protected from light. It should be kept out of reach of children and pets. Once opened, the foil envelope should be used within 2 weeks.

Pulmicort Respules are manufactured by AstraZeneca.

Yes, there are generic versions of Pulmicort Respules available.

Barring any serious side effects as listed above, or under the direction of a healthcare provider, this medication should not be discontinued suddenly.

Inhaled corticosteroids used in regular doses are not usually associated with risk to a growing fetus. 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.

While it is found in breast milk, inhaled budesonide is generally considered safe during breastfeeding. 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.