Omnaris (Ciclesonide)

(sye kles' oh nide)

Ciclesonide oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma in adults and children 12 years of age and older. Ciclesonide is in a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

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:

• Be sure that the inhaler is at room temperature.
• Remove the cap from the mouthpiece.
• Be sure the canister is fully and firmly inserted in the actuator. You do not need to shake your inhaler before each use.
• 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.
• Breathe out through your mouth.
• 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.
• 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.
• When you have breathed in fully, remove the inhaler from your mouth and close your mouth.
• Try to hold your breath for about 10 seconds, then breathe out gently.
• Put the cap back on the mouthpiece.
• 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.

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Ciclesonide inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stuffy or runny nose
• sore or irritated throat
• swelling of nose, throat, and sinuses
• painful white patches in the mouth or throat
• hoarseness
• joint pain
• pain in arms, back, and legs

Some side effects can be serious. If you experience any of the following symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• chest pain or tightness

Ciclesonide inhalation may cause children to grow more slowly. Your child's doctor will watch your child's growth carefully while your child is using ciclesonide inhalation. Talk to your child's doctor about the risks of giving this medication to your child. In rare cases, people who used ciclesonide inhalation for a long time developed glaucoma or cataracts. Talk to your doctor about the risks of using ciclesonide inhalation and how often you should have your eyes examined during your treatment. Ciclesonide inhalation may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication. Ciclesonide inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Store your ciclesonide inhaler out of reach of children, at room temperature, and away from excess heat and moisture (not in the bathroom). Do not store the inhaler near a heat source or an open flame. Protect the inhaler from freezing and direct sunlight. Do not puncture the aerosol container and do not throw it away in an incinerator or fire. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.