Beclomethasone Inhalation

If you will be using beclomethasone for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

beclomethasone may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

You should not use beclomethasone if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using beclomethasone for 2 weeks or if they become worse.
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Using too much of beclomethasone for a long period of time can cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using beclomethasone: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or weight loss.

Follow your doctor's directions carefully if you are switching from an oral corticosteroid to beclomethasone.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using beclomethasone. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

beclomethasone may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using beclomethasone and check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using beclomethasone. Use a short acting inhaler right away to treat your symptoms.

If you or your child develop a skin rash, hives, or any allergic reaction to beclomethasone, stop using the medicine and check with your doctor as soon as possible.

beclomethasone may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

beclomethasone may decrease bone mineral density when used for a long time. Low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Beclomethasone inhalation is used to prevent asthma attacks in adults and children who are at least 5 years old. This medication will not treat an asthma attack that has already begun.

Beclomethasone inhalation may also be used for purposes not listed in this medication guide.

No adjustment recommended

Administration advice:
For oral inhalation only; prime the pump before first use; prime again if not used for more than 10 days
-To prime the inhaler, release 2 sprays into the air
-Rinse mouth with water (without swallowing) after each use

Storage requirements:
-Store with the product resting on the concave end of the canister with plastic actuator on top
-Contents are under pressure; do not use or store near heat or open flame; exposure to temperatures above 49C (120F) may cause bursting; do not throw into fire or incinerate.
-Mouthpiece of inhaler should be cleaned weekly with a clean, dry tissue or cloth; do not wash or put any part of inhaler in water.

Preparation techniques:
-Dose counter: The dose counter will have a black dot in the viewing window until it has been primed. Once primed, the number of sprays left will be displayed in the viewing window in units of 2; the color in the viewing window will change to red when the number of sprays left is 20; when the dose counter reaches 0 (or after the expiration date of the product) discard product.

General:
-This drug should not be used for the relief of acute bronchospasm.
-Use with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
-Anticipate degree of adrenal suppression and what changes in systemic steroid levels may occur when switching between different corticosteroids, different formulations, or upon changing route of administration; patients switching from corticosteroid treatment with higher systemic effects to corticosteroids with lower systemic effects should be reduced gradually while monitoring HPA axis functions regularly.
-When changing from corticosteroids with high systemic effect to corticosteroids that are less systemically available, allergies (e.g., rhinitis, eczema) that were previously controlled may be unmasked.

Monitoring:
-Regularly assess lung-function
-Periodically assess oral cavity for signs and symptoms of Candida albicans infection
-Monitor for signs and symptoms of hypercorticism
-Monitor for signs and symptoms of adrenal insufficiency
-Monitor adrenocortical function in patients transferring from corticosteroids with higher systemic effects.
-Monitor bone mineral content in patients at high risk of decreased bone mineral density
-Monitor growth regularly in pediatric patients
-Regular eye examinations should be considered, especially in patients with a history of ocular changes or those experiencing visual changes
-Periodically assess oral cavity for signs and symptoms of Candida albicans infection

Patient advice:
-Patients should be instructed on proper inhaler technique and the importance of regular use; patients should be instructed to rinse and spit after oral inhalation use to avoid infection; if infection develops, they should contact their healthcare professional.
-Patients should understand this drug is not intended to relieve acute asthma symptoms and a short acting bronchodilator should be used for that; if asthma symptoms do not respond to a short acting bronchodilator, or require higher or more frequent dosing, they should contact their healthcare professional for reevaluation of therapy.
-Patients should understand that this drug is a corticosteroid; they should know the signs and symptoms of hypercorticism and adrenal suppression.
-Patients should understand that during times of stress, such as surgery or infection, additional oral supplementation may be necessary; they should discuss with their healthcare professional whether they need to carry a medical identification card identifying their corticosteroid use.
-Patients on immunosuppressant doses of corticosteroids should understand that a greater risk of infection exists; they should avoid exposure to chickenpox or measles and if exposed, they should consult their healthcare professional promptly.