Alvesco

DRUG DESCRIPTION

The active component of ALVESCO (ciclesonide inhalation aerosol) 80 mcg Inhalation Aerosol, and ALVESCO 160 mcg Inhalation Aerosol is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy) ,(11?, 16?). The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:

ALVESCO® (ciclesonide) Structural Formula Illustration

Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform.

ALVESCO (ciclesonide inhalation aerosol) 80 mcg Inhalation Aerosol and ALVESCO (ciclesonide inhalation aerosol) 160 mcg Inhalation Aerosol are pressurized, metered-dose aerosol units fitted with a dose indicator. ALVESCO (ciclesonide inhalation aerosol) is intended for oral inhalation only. Each unit contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ALVESCO 80 mcg delivers 100 mcg from the valve and 80 mcg of ciclesonide from the actuator. ALVESCO 160 mcg delivers 200 mcg from the valve and 160 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as a fine particle mist from the valve with each actuation. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. ALVESCO (ciclesonide inhalation aerosol) should be “primed” by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Avoid spraying in the eyes or face while priming ALVESCO (ciclesonide inhalation aerosol) .

What are the possible side effects of ciclesonide inhalation (Alvesco)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • wheezing, choking, or other breathing problems after using this medication;
  • sores or white patches in your mouth or throat;
  • vision problems, such as tunnel vision or blurred vision; or
  • worsening asthma symptoms.

Less serious side effects...

Read All Potential Side Effects and See Pictures of Alvesco »

What are the precautions when taking ciclesonide inhalation aerosol (Alvesco)?

Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., beclomethasone, fluticasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis, untreated infections (e.g., fungus, bacteria), certain eye problems (glaucoma, cataracts, herpes infection of the eye), liver disease, adrenal gland problems (e.g., adrenal insufficiency), underactive thyroid (hypothyroidism), bone loss (osteoporosis).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to...

Read All Potential Precautions of Alvesco »


Alvesco Consumer (continued)

SIDE EFFECTS: See also Precautions section.

Dry/irritated throat, hoarseness, a bad taste in the mouth, or coughing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: white patches in your mouth or on your tongue.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, unusual/persistent headache, poor wound healing, puffy face, unexpected weight gain, muscle pain/weakness, mental/mood changes (e.g., depression, agitation), increased thirst/urination.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., beclomethasone, fluticasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis, untreated infections (e.g., fungus, bacteria), certain eye problems (glaucoma, cataracts, herpes infection of the eye), liver disease, adrenal gland problems (e.g., adrenal insufficiency), underactive thyroid (hypothyroidism), bone loss (osteoporosis).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Avoid exposure to chickenpox or measles infection while taking this medication unless you have previously had these infections (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

This medication may mask signs of infection or put you at greater risk of developing an infection. Report any signs of infection (e.g., persistent sore throat, fever, cough, changes in sputum color) that occur during treatment.

When used for extended periods, medications similar to ciclesonide may affect bone strength, especially in people who smoke, have a family history of brittle bones (osteoporosis), or take other medications that may weaken bones (e.g., phenytoin). Bone density tests may help to determine whether you need medication to treat or prevent this problem. Consult your doctor for more information.

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell the doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

It is not known whether this drug passes into breast milk. Therefore, consult your doctor before breast-feeding.


Alvesco Patient Information Including Side Effects

Brand Names: Alvesco

Generic Name: ciclesonide (inhalation) (Pronunciation: sye KLES oh nide)

  • What is ciclesonide (Alvesco)?
  • What are the possible side effects of ciclesonide inhalation (Alvesco)?
  • What is the most important information I should know about ciclesonide (Alvesco)?
  • What should I discuss with my health care provider before using ciclesonide (Alvesco)?
  • How should I use ciclesonide inhalation (Alvesco)?
  • What happens if I miss a dose (Alvesco)?
  • What happens if I overdose (Alvesco)?
  • What should I avoid while using ciclesonide inhalation (Alvesco)?
  • What other drugs will affect ciclesonide inhalation (Alvesco)?
  • Where can I get more information?

What is ciclesonide (Alvesco)?

Ciclesonide is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Ciclesonide is used to prevent asthma attacks in adults and children 12 years and older.

Ciclesonide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ciclesonide inhalation (Alvesco)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • wheezing, choking, or other breathing problems after using this medication;
  • sores or white patches in your mouth or throat;
  • vision problems, such as tunnel vision or blurred vision; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • unpleasant taste in your mouth;
  • dry mouth, burning or irritation in your mouth;
  • white patches or sores inside your mouth;
  • runny or stuffy nose, sore throat;
  • hoarse voice;
  • mild itching or skin rash;
  • joint pain, back pain; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ciclesonide (Alvesco)?

Do not use ciclesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

You should not use this medication if you are allergic to ciclesonide.

Before using ciclesonide, tell your doctor if you have tuberculosis, an infection of your mouth or throat (such as oral thrush), glaucoma or history of cataracts, herpes infection of your eyes, or a personal or family history of osteoporosis.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

Call your doctor right away if you feel that ciclesonide inhalation makes your condition worse.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

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