What is ASMANEX TWISTHALER?

ASMANEX TWISTHALER contains a prescription medicine called mometasone furoate, which is a man-made corticosteroid. This medicine is used as a maintenance treatment that helps prevent and control asthma symptoms.

Is ASMANEX TWISTHALER a bronchodilator an does it replace my rescue inhaler?

No, ASMANEX TWISTHALER is not a bronchodilator and should not be used for sudden symptoms of shortness of breath. Use an inhaled short-acting bronchodilator such as albuterol to relieve sudden symptoms of shortness of breath.

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ASMANEX TWISTHALER

ASMANEX TWISTHALER is approved for the maintenance treatment of asthma in patients 4 years and older.
ASMANEX TWISTHALER will not relieve sudden asthma symptoms and is not for patients under the age of 4 years.
ASMANEX TWISTHALER is available in 2 dose strengths, 110 mcg for patients 4 to 11 years old, and 220 mcg for patients 12 years and older.

Image of ASMANEX® HFA (mometasone furoate) Inhalation Aerosol 50 mcg, 100 mcg, 200 mcg

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Frequently Asked Questions

ASMANEX TWISTHALER can cause serious side effects, including:

Thrush in your mouth and throat. This is a serious but common side effect. You may develop thrush, a yeast (Candida albicans), in your mouth or throat. After each dose of ASMANEX TWISTHALER, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
Increased wheezing right after taking ASMANEX TWISTHALER. Always have a rescue inhaler with you to treat sudden wheezing.
Serious allergic reactions. Stop taking ASMANEX TWISTHALER and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
- rash
- itching
- swelling, including swelling of the face, mouth, and tongue
- breathing problems
Immune system effects and a higher chance for infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using ASMANEX TWISTHALER. Tell your healthcare provider about any signs of infection such as:
- fever
- feeling tired
- body aches
- vomiting
- pain
- nausea
- chills
Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX TWISTHALER than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:
- feeling tired or exhausted (fatigue)
- lack of energy
- low blood pressure (hypotension)
- weakness
- nausea and vomiting
- dizziness or feeling faint
Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
Slowed growth in children. A child’s growth should be checked often.
Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using ASMANEX TWISTHALER.

The most common side effects reported while using ASMANEX TWISTHALER include:

headache
painful menstrual periods
sinus infection
upper respiratory tract infection
upset stomach
muscle and bone pain
back pain
nasal allergy symptoms
sore throat

Other side effects: Worsening asthma or sudden asthma attacks have been reported with the use of inhaled mometasone furoate.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with ASMANEX TWISTHALER. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

ASMANEX TWISTHALER is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 4 years of age and older.

Yes, ASMANEX TWISTHALER contains mometasone furoate, which is a corticosteroid.

No, ASMANEX TWISTHALER is not a bronchodilator and should not be used to treat sudden symptoms of asthma. Use a rescue inhaler, such as albuterol, to relieve sudden asthma symptoms.

ASMANEX TWISTHALER is a dry powder for inhalation available in 2 strengths.

Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Rinse your mouth with water and spit it out after using ASMANEX TWISTHALER.

ASMANEX TWISTHALER is available in 2 dose strengths, 110 mcg and 220 mcg.

Use your ASMANEX TWISTHALER regularly and at the same time each day, as prescribed by your health care provider. Read the step-by-step instructions on How to Use ASMANEX TWISTHALER or Give to Your Child in the ASMANEX TWISTHALER Patient Information.

Keep your inhaler clean and dry at all times. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Do not wash the inhaler. Avoid contact with any liquids.
Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep your inhaler out of the reach of children.

Important Safety Information

Do not use ASMANEX TWISTHALER to treat sudden, severe symptoms of asthma. ASMANEX TWISTHALER is not a rescue inhaler and should not be used to provide relief from a sudden asthma attack. Serious side effects of ASMANEX TWISTHALER may include worsening asthma or sudden asthma symptoms. Use a rescue inhaler (an inhaled short-acting bronchodilator, such as albuterol) to relieve symptoms of a sudden asthma attack.
Do not take ASMANEX TWISTHALER if you have an allergy to milk proteins. Ask your doctor if you are not sure. ASMANEX TWISTHALER is not for patients who have a hypersensitivity (including allergic reactions) to mometasone.
ASMANEX TWISTHALER can cause serious allergic reactions. Call your health care provider or get emergency medical care if you develop any symptoms of a serious allergic reaction, including rash, swelling of the face, mouth and tongue, or breathing problems.
Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX TWISTHALER.
Avoid coming in contact with measles, chickenpox virus, tuberculosis, or any other infections before or while using ASMANEX TWISTHALER. Contact your health care provider immediately if you or your child has been exposed.
If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX TWISTHALER, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again.
It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal glands cannot produce enough steroids) may appear in a small number of patients particularly when ASMANEX TWISTHALER is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider as the dosage of ASMANEX TWISTHALER should be reduced slowly.
Patients who use inhaled steroids, including ASMANEX TWISTHALER, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.
Inhaled steroids, including ASMANEX TWISTHALER, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient’s dose to the lowest dose that effectively controls his/her symptoms.
ASMANEX TWISTHALER may increase the risk of some eye problems such as cataracts, glaucoma, increased intraocular pressure, and visual disturbance. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
The most common side effects with ASMANEX TWISTHALER include: headache, nasal allergy symptoms, sore throat, upper respiratory infection, sinus infection, fungal infections in the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.
Use ASMANEX TWISTHALER as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

Please read the accompanying Patient Information for ASMANEX TWISTHALER and discuss it with your doctor. The physician Prescribing Information also is available.

Indications and Usage

Important Safety Information

ASMANEX TWISTHALER

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Frequently Asked Questions

Indications and Usage

Important Safety Information