Ciclesonide inhalation

In the U.S.

• Alvesco

Available Dosage Forms:

• Aerosol Liquid

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Inhaled ciclesonide is used to prevent asthma attacks. It is not used for an attack that has already started. You should use another medicine for an acute asthma attack. If you do not have another medicine to use or if you have any questions about this, check with your doctor .

ciclesonide is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using ciclesonide. If you do not understand the directions or you are not sure how to use the inhaler, check with your doctor or pharmacist .

In order for ciclesonide to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. Up to 4 weeks may pass before you begin to notice improvement in your condition. It may take several months before you feel the full effects of ciclesonide .

When you use the inhaler for the first time, or if you have not used it for 10 days or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it by spraying the medicine three times into the air away from the face. Check the dose indicator on top of the inhaler if it shows that there are either 60 or 120 puffs left. If the dose indicator is not working correctly, do not use the inhaler and return it to your pharmacy or doctor .

To use the inhaler:

• Remove the cap and look at the mouthpiece to make sure it is clean.
• Breathe out fully, trying to get as much air out of the lungs as possible. Do not blow or breathe into the inhaler.
• Hold the inhaler in the upright position. Put the mouthpiece into your mouth over your tongue and close your lips around it.
• Breathe in through your mouth slowly and deeply, and at the same time firmly press down on the center of the dose indicator with your finger. Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs.
• Take your finger off the center of the dose indicator. Remove the inhaler from your mouth, then breathe out slowly.
• Repeat these steps if more than one dose is needed.
• Replace the cap after each use to keep the mouthpiece clean.
• When you have finished all your doses, rinse your mouth with water and spit it out. Do not swallow. This will help prevent infections in your mouth or throat .

Wipe the mouthpiece with a clean, dry tissue or cloth at least once a week. Do not wash or put any part of your inhaler in water.

Do not interrupt or stop taking ciclesonide without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

Dosing

The dose of ciclesonide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ciclesonide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation aerosol:
  • For preventing an asthma attack:
    • Adults and children 12 years of age and older—At first, one or two puffs two times a day. Your doctor may increase your dose if needed.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of ciclesonide, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep ciclesonide inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Discard the inhaler when all doses have been used. The number zero will appear in the dose indicator window.

It is very important that your doctor check your progress at regular visits to make sure ciclesonide is working properly and to check for unwanted effects .

ciclesonide may weaken your immune system. Avoid being around people who are sick or have infections such as chickenpox or measles. Tell your doctor right away if you think you have been exposed to chickenpox or measles .

ciclesonide may also increase your risk of having infections or sores in your mouth or throat. Check with your doctor right away if you notice any signs of a throat infection .

ciclesonide may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think this is a problem .

ciclesonide may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while taking ciclesonide .

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

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using ciclesonide .

If your symptoms do not improve within four weeks, or if they become worse, check with your doctor .

Ciclesonide is used to prevent and reduce the symptoms (wheezing and shortness of breath) caused by asthma. Controlling asthma symptoms may decrease time lost from work or school. This medication belongs to a class of drugs known as corticosteroids. It works by reducing the swelling of the airways in the lungs to make breathing easier.

This medication must be taken regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed. Keep track of how often you need to use your quick-relief inhaler, and tell your doctor. If your quick-relief inhaler does not seem to work as well, if you need to use more than usual of your quick-relief inhaler for 2 or more days in a row, or if you need to use more than one full canister of your quick-relief inhaler over a 2-month period, seek immediate medical attention.

How to use Ciclesonide HFA 80 Mcg/Actuation Aerosol Inhaler

Read the Patient Information Leaflet provided by your pharmacist before you start using ciclesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inhale this medication by mouth as directed by your doctor. No shaking of the inhaler is necessary before use. If the inhaler is new or has not been used for 1 week or more, prime the inhaler for use by spraying 3 puffs into the air. Remove the cover on the mouthpiece. Breathe out as much as you comfortably can. Place the mouthpiece into your mouth and close your lips tightly around it. While breathing in slowly and deeply, press down on the canister with your finger. After inhaling, try to hold your breath for at least 10 seconds to get this medication into your lungs and allow it to work properly.

Dosage is based on your medical condition and response to treatment.

A spacer device may be used with this medication if you find it difficult to use this inhaler. Ask your doctor or pharmacist for more information.

If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug (the corticosteroid) last.

To prevent dry mouth, hoarseness, and yeast infections in the mouth (thrush), gargle and rinse your mouth with water after each use. Do not swallow the rinse water.

Clean the mouthpiece once a week with a dry tissue. Do not wet the mouthpiece to clean it.

Use this medication regularly to get the most benefit from it. This medication works best when used at evenly spaced intervals. To help you remember, use it at the same time each day. Do not increase your dose, use this inhaler more frequently, or stop using it without first consulting your doctor.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

You may begin to feel this medication working within 24 hours, but it may take several weeks or longer before the full benefit of this drug takes effect. Tell your doctor if your symptoms do not improve or if they worsen.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using ciclesonide, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aldesleukin, corticosteroids taken by mouth (e.g., prednisone, dexamethasone), mifepristone, drugs affecting the removal of ciclesonide from your system (potent CYP 3A4 inhibitors such as ketoconazole, itraconazole, nelfinavir, ritonavir).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

Tell all your doctors that you use, or have used, this medication.

Keep all medical appointments. Laboratory and/or medical tests (e.g., morning cortisol levels, eye exams, bone density tests) may be performed to monitor your progress and check for side effects.

Avoid allergens (e.g., pollen), irritants, smoking/secondhand smoke, and other factors that make asthma worse.

Most people with asthma or ongoing lung disease should receive a flu shot every year. Discuss this with your doctor.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

-For patients previously receiving bronchodilators alone:
Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 160 mcg twice a day
-For patients previously receiving inhaled corticosteroids:
Initial dose: 80 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day
-For patients previously receiving oral corticosteroids:
Initial dose: 320 mcg via oral inhalation twice a day
Maximum dose: 320 mcg twice a day

Comments:
-Not indicated for the relief of acute bronchospasm.
-For patients who do not respond adequately to the starting dose after 4 weeks, may increase dose without exceeding maximum dose; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.
-For patients receiving oral corticosteroids, taper oral corticosteroids no more than once weekly beginning after the first week of inhaled therapy; patients should be carefully monitored for asthma instability during transition; once oral corticosteroid taper is complete, inhalation dose should be reduced to the lowest effective dose.
-In some countries, product labeling describes ex-valve dosing while some describes actuator dosing; 80 mcg from the actuator is 100 mcg from the valve, 160 mcg from the actuator is 200 mcg from the valve.

Use: As prophylactic therapy for the maintenance treatment of asthma

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-For oral inhalation only
-Patients should rinse mouth with water (without swallowing) after each use
-Patients should receive instruction on proper use

Storage requirements:
-Store at 25C (77F); excursions between 15C and 30C (59F and 86F) are permitted.
-Contents under pressure: do not puncture; do not store or use near heat or open flame; or throw canister into fire or incinerator.

Preparation techniques: The manufacturer product information should be consulted for complete instructions.
-Inhaler should be primed prior to first use and when unused for 10 days in a row.
-Do not use actuator with a canister of medicine from any other inhaler; do not use inhalation aerosol canister with an actuator from any other inhaler.

General:
-This drug is not intended for acute asthma exacerbations; patients should treat acute asthma symptoms with an inhaled, short-acting beta 2-agonist, such as albuterol.
-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.
-Patients switching from oral corticosteroid treatment should do so gradually while monitoring HPA axis functions regularly; oral corticosteroid supplementation may be needed during periods of stress.

Monitoring:
-Monitor asthma signs and symptoms including serial objective measures of airflow
-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
-Monitor for signs and symptoms of adrenal insufficiency
-Monitor adrenocortical function in patients transferring from corticosteroids with higher systemic effects.

Patient advice:
-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.
-Patients should be instructed on proper inhaler technique and the importance of regular use.
-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 be instructed to rinse and spit after oral inhalation use to avoid infection; if infection develops, they should contact their healthcare professional.