Ciclesonide (Oral Inhalation)

Ciclesonide comes as an aerosol to inhale by mouth using an inhaler. Ciclesonide is usually inhaled twice a day. Try to use ciclesonide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ciclesonide inhalation exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with ciclesonide inhalation. If you are using any other inhaled medications, ask your doctor if you should inhale these medications a certain amount of time before and after you inhale ciclesonide inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting at least one week after you begin to use ciclesonide inhalation.

Ciclesonide inhalation helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Do not use ciclesonide inhalation during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks.

Your doctor will probably start you on an average dose of ciclesonide inhalation. Your doctor may increase it if your symptoms have not improved after at least 4 weeks and later may decrease your dose when your symptoms are controlled.

Ciclesonide inhalation controls asthma but does not cure it. It may take 4 weeks or longer before you feel the full benefit of the medication. Continue to use ciclesonide inhalation even if you feel well. Do not stop using ciclesonide inhalation without talking to your doctor.

Tell your doctor if your asthma worsens during your treatment. Call your doctor if you have an asthma attack that does not stop when you use your fast-acting asthma medication, or if you need to use more of your fast-acting medication than usual.

The inhaler that comes with ciclesonide aerosol is designed for use only with a canister of ciclesonide. Never use it to inhale any other medication, and never use any other inhaler to inhale ciclesonide.

Each canister of ciclesonide aerosol is designed to provide 60 inhalations. After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication. Your inhaler comes with an attached counter that will change as every 10 sprays are used. When the number that shows on the counter is 020, you should call your doctor or pharmacist to refill your prescription. When the number that shows on the counter is 000, you should not use that canister anymore. You should also keep track of the number of inhalations you use each day to know the exact amount of sprays that remain in your inhaler. Throw away the canister after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed. If your inhaler is dropped, do not use the number on the counter to predict the number of sprays left in your inhaler.

Before you use your ciclesonide aerosol inhaler the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it.

Do not use your ciclesonide inhaler while you are near an open flame or a heat source. The inhaler may explode if it is exposed to very high temperatures.

To use the aerosol, follow these steps:

1. Be sure that the inhaler is at room temperature.
2. Remove the cap from the mouthpiece.
3. Be sure the canister is fully and firmly inserted in the actuator. You do not need to shake your inhaler before each use.
4. If you are using the inhaler for the first time or if you have not used the inhaler in more than 10 days, prime it by releasing 3 test sprays into the air, away from your face. Be careful not to spray the medication into your eyes or face.
5. Breathe out through your mouth.
6. Hold the inhaler facing you with the mouthpiece on the bottom. Place your thumb under the mouthpiece and your index finger on the center of the dose indicator at the top of the canister. Place the mouthpiece in your mouth and close your lips around it, keeping your tongue below it.
7. Breathe in deeply and slowly through your mouth. At the same time, press down firmly on the center of the dose indicator at the top of the canister with your index finger. Remove your index finger as soon as the spray is released.
8. When you have breathed in fully, remove the inhaler from your mouth and close your mouth.
9. Try to hold your breath for about 10 seconds, then breathe out gently.
10. Put the cap back on the mouthpiece.
11. Rinse your mouth with water and spit the water out. Do not swallow the water.

Clean your inhaler once a week. To clean your inhaler, use a clean, dry tissue or cloth. Do not wash or put any part of your inhaler in water.

Before using ciclesonide inhalation,

• tell your doctor and pharmacist if you are allergic to ciclesonide, any other medications, or any of the ingredients in ciclesonide inhalation. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ketoconazole (Nizoral); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); and medications for seizures. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ciclesonide inhalation, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• do not use ciclesonide during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
• tell your doctor if you have been on bedrest or unable to move around for a long time, or if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily). Tell your doctor if you have or have ever had tuberculosis (TB: a type of lung infection), cataracts (clouding of the lens of the eye), or glaucoma (an eye disease). Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using ciclesonide inhalation, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using ciclesonide inhalation.
• if you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness, or pain; sudden pain in stomach, lower body, or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you recently replaced your oral steroid with ciclesonide inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.
• tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
• you should know that ciclesonide inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use ciclesonide inhalation again unless your doctor tells you that you should.

Unless your doctor tells you otherwise, continue your normal diet.

Use ciclesonide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• For breathing in only.
• Prime by spraying 3 sprays before first use or if ciclesonide has not used for 10 days.
• Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
• Clean mouthpiece by wiping with a dry tissue or cloth. Do not wash or put in water.
• Put the cap back on after you are done using your dose.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• If you are taking more than 1 inhaled drug, talk to your doctor about the best order for taking your drugs.
• Do not use near an open flame or while smoking. It may burst.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

>4 weeks for maximum benefit

Time to Peak

~1 hour (des-ciclesonide)

Half-Life Elimination

Ciclesonide: 0.7 hours; des-ciclesonide: 6-7 hours

Protein Binding

≥99%

Asthma: Maintenance treatment of asthma as prophylactic therapy in patients ≥12 years of age.

Limitations of use: Not indicated for relief of acute bronchospasm.

Guideline recommendations: A low-dose inhaled corticosteroid (in addition to an as-needed, short-acting beta2-agonist) is the initial preferred long-term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a stepwise treatment approach (GINA 2017; NAEPP 2007).

There are no dosage adjustments provided in the manufacturer labeling (has not been studied); however, dose adjustments may not be necessary as ≤20% of drug is eliminated renally.

No dosage adjustment necessary.

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Adult patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: May occur with wheezing after inhalation; if this occurs, stop steroid and treat with a fast-acting bronchodilator.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox and measles should be avoided; use caution in patients with active or quiescent TB infections or in patients with ocular herpes.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Thrush: Candida albicans infections (mostly mild to moderate) of the mouth and pharynx may occur with orally inhaled corticosteroid use; interruption of therapy may be necessary at times while antifungal therapy is employed; advise patients to rinse mouth after use.

• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other eosinophilic conditions (eg, vasculitic rash, decreased pulmonary function, cardiac complications) can occur.

Disease-related concerns:

• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus or for the relief of acute bronchospasm.

• Cardiovascular disease: Use with caution following acute MI; corticosteroids have been associated with myocardial rupture. Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Hepatic impairment: Systemic exposure to the active metabolite is increased in moderate to severe impairment; however, dosage adjustments are not recommended in hepatic impairment; monitor for increased systemic effects, particularly in patients with severe hepatic impairment, including cirrhosis.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred with corticosteroids especially during initial treatment.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use in renally impaired patients has not been studied; however, ≤20% of drug is eliminated renally.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Special populations:

• Elderly: Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in elderly patients in the smallest possible effective dose for the shortest duration.

• Pediatric: Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 cm per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Discontinuation of therapy: Withdraw systemic therapy with gradual tapering of dose. There have been reports of systemic corticosteroid withdrawal symptoms (eg, joint/muscle pain, lassitude, depression) when withdrawing oral inhalation therapy.