Flixotide Nebules

(Fluticasone Propionate)

The active ingredient in Flixotide Nebules is fluticasone propionate, an anti-inflammatory inhaled corticosteroid. It works by targeting swelling in the lungs, preventing the release of inflammatory chemicals that cause the symptoms of asthma.

Inhaled steroids are used for long-term asthma control. This medication is not intended for sudden breathing problems (acute exacerbations of asthma) and will not replace your rescue bronchodilator like albuterol sulfate.

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 Flixotide Nebules. However, the following is a synopsis of the general guidelines for the use of Flixotide Nebules:

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

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

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

4. Do not dilute the nebule content unless advised by a doctor. Use only sterile sodium chloride injection BP for dilution.

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

6. Always use the nebulizer in a well-ventilated room.

7. Always rinse your mouth and spit after using any inhaled corticosteroid.

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

9. Keep the nebules in the pack until you are ready to use them. Once removed from the foil wrap, use within 3 months. Do not use past the expiry date.

The most common side effects of Flixotide Nebules include:

• Upper respiratory tract infection.
• Hoarseness of the voice.
• Throat irritation or sore throat.
• Dry mouth.

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

• Fungal infections (candidiasis) of the mouth/throat (thrush) - white patches on the roof of your mouth - to avoid/ reduce this risk, always rinse your mouth after using these nebules, and spit out the water (don’t swallow).
• Adrenal suppression - fatigue, weakness, nausea, vomiting, and low blood pressure. This can be brought on by discontinuation of an oral corticosteroid such as prednisone.
• Serious allergic reactions - rash, hives, swelling of the face, mouth, or tongue, anaphylaxis, and trouble breathing.
• Cushing’s syndrome, which can cause thinning of the bones and eye problems (such as cataracts and glaucoma which is high pressure in the eye).

This medication also has the potential to cause an initial worsening of your asthma symptoms (increased wheezing), 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 Flixotide Nebules. 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 Flixotide Nebules, 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:

• Weak bones (osteoporosis).
• Medical conditions affecting the immune system.
• Eye conditions such as glaucoma or cataracts.
• Diabetes Mellitus.
• Liver dysfunction.

• Treatment of a sudden or severe asthma attack (rescue use).
• Allergy to fluticasone or inactive ingredients: polysorbate 20, sorbitan monolaurate, monosodium phosphate dihydrate, dibasic sodium phosphate anhydrous, sodium chloride, and water for injection.

With the first dose of Flixotide Nebules, you may notice improvements in your breathing within 30 minutes, but the maximum benefits from this medication are seen after a week of regular use.

When Flixotide Nebules 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:

• Strong CYP3A4 inhibitors, such as azole antifungals (ketoconazole, posaconazole, voriconazole), antibiotics (clarithromycin), and antivirals (ritonavir), may increase the levels of the drug and induce heart-related side effects.
• Oral corticosteroid therapy - inhaled fluticasone may increase the side effects of systemic corticosteroids.

They are available as flixotide nebules 0.5mg/ 2 mL (500 micrograms/ ampoule) or 2.0mg/ 2mL (2000 micrograms/ ampoule). They are provided as strips of 5 nebules in a foil flow wrap. Each carton contains 10 nebules.

Flixotide Nebules should be stored at room temperature and protected from extreme heat, cold, or humidity. It should be kept out of reach of children and pets. Opened nebules should be protected from light and used within 28 days.

Flixotide Nebules is manufactured by GlaxoSmithKline Australia Pty Ltd (GSK).

No, there is no generic version of this product, but it is available from other brands such as Armonair Respiclick or in combination nebules such as the AirDuo Digihaler.

This medication should not be discontinued abruptly, as you will have an increased risk of asthma symptoms. If, after a two-week trial, you feel this medication is not effective or you are experiencing significant side effects, talk with your physician to discuss next steps for managing your condition.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a growing fetus.

Fluticasone is reported to be compatible with pregnancy, and experts suggest that there is a minimal risk of exposure to a growing fetus when the parent uses inhaled fluticasone. There were also no reports of effects of pre-term labour, low birth weight, or malformations.

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.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a nursing infant.

There is no human data on fluticasone exposure to a nursing infant, but the properties of the drug suggest it poses minimal risk.

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.