Product Description.:
ASMANEX TWISTHALER is approved for the maintenance treatment of asthma in patients 4 years of age and older. ASMANEX TWISTHALER will not relieve sudden asthma symptoms and is not for children under the age of 4.
ASMANEX TWISTHALER is available in 2 dose strengths, 110 mcg for children 4 to 11 years old, and 220 mcg for patients 12 and older.
Indications
ASMANEX? TWISTHALER? is approved for the maintenance treatment of asthma in patients 4 years of age and older. ASMANEX? TWISTHALER? will not relieve sudden asthma symptoms and is not for children under the age of 4.
ASMANEX? TWISTHALER? is available in 2 dose strengths, 110 mcg for children 4 to 11 years old, and 220 mcg for patients 12 and older.
Important Safety Information
ASMANEX? TWISTHALER? (mometasone furoate inhalation powder) is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.
ASMANEX? should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.
ASMANEX? is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX?. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.
Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX?.
It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX? 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? should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX?, 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.
Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any other infections before or while using ASMANEX?. Contact your health care provider immediately if you or your child has been exposed.
Patients who use inhaled steroids, including ASMANEX?, 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?, 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? may increase the risk of some eye problems such as cataracts, glaucoma, and increased intraocular pressure. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
Use ASMANEX? 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.
The most common side effects with ASMANEX? in patients 4-11 years old include fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection, and bruise.
The most common side effects with ASMANEX? in patients �� years old include headache, allergic rhinitis, sore throat, and upper respiratory infection.
