Pronunciation:

sye-KLES-oh-nide

Brand Names:

• Alvesco

Dosage Forms:

• Aerosol Liquid

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Ciclesonide is used to help prevent the symptoms of asthma. When used regularly every day, inhaled ciclesonide decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started .

Ciclesonide is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ciclesonide in children below 12 years of age. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ciclesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving ciclesonide .

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin
• Atazanavir
• Bemiparin
• Cobicistat
• Darunavir
• Itraconazole
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Nirmatrelvir
• Ritonavir
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute—Should not be used in patients with this condition .

• Cataracts, history of or
• Glaucoma, history of—May make these conditions worse. Regular eye examinations are suggested .

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections, active or untreated (fungus, bacteria, virus, or parasite) or
• Measles (including recent exposure) or
• Tuberculosis, active or history of—This medicine can reduce the body's ability to fight these infections .

• Gastroenteritis (inflamed stomach or intestine with diarrhea or vomiting) or
• Stress or
• Surgery or
• Trauma—Oral steroids may be needed .

• Osteoporosis (bone disease)—High doses may make this condition worse .

Proper Use of This Medicine:

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 .

This medicine is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using this medicine. 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 this medicine 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 this medicine .

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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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 this medicine 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.

Precautions While Using This Medicine:

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

This medicine 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 .

This medicine 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 .

This medicine 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 .

This medicine 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 this medicine .

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 this medicine .

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

difficulty in breathing

ear congestion

fever

headache

loss of voice

muscle aches

nasal congestion

pain or tenderness around eyes and cheekbones

shortness of breath or troubled breathing

sneezing

sore throat

stuffy or runny nose

tightness of chest or wheezing

unusual tiredness or weakness

Rare

Sore mouth or tongue

white patches in mouth and/or on tongue

Incidence not known

Blindness

blurred vision

creamy white, curd-like patches in mouth or throat

darkening of skin

decreased vision

diarrhea

dizziness

eye pain

fainting

hoarseness

lack or slowing of normal growth in children

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

lower back or side pain

mental depression

nausea

pain when eating or swallowing

painful or difficult urination

skin rash

tearing

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

difficulty in moving

muscle pain or stiffness

pain in arms or legs

pain in joints

Rare

Chest discomfort

dry mouth or throat

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.