Asmanex HFA

Asmanex HFA is a prescription medication used for the prevention and treatment of asthma in people aged 12 years and older. Asmanex HFA belongs to a group of drugs called corticosteroids, more commonly known as steroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Asmanex HFA comes as an inhaler and is inhaled two times twice daily. 

Common side effects of Asmanex HFA include inflammation of the nose and throat (nasopharyngitis), headache, and inflammation of the sinuses (sinusitis).

Asmanex HFA is a prescription medication used for the prevention and treatment of asthma in people aged 12 years and older.

• Asmanex HFA is not used to treat sudden severe symptoms of asthma.
• Asmanex HFA should not be used as a rescue inhaler.
• It is not known if Asmanex HFA is safe and effective in children less than 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with Asmanex HFA. See "Asmanex HFA Precautions" section. 

The most common side effects of Asmanex HFA include:

• inflammation of the nose and throat (nasopharyngitis)
• headache
• inflammation of the sinuses (sinusitis)
• bronchitis
• flu infection (influenza)

This is not a complete list of Asmanex HFA side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take macrolide antibiotics, antifungal medicines, or anti-HIV medicines such as:

• ritonavir
• atazanavir
• clarithromycin
• telithromycin
• indinavir
• ketoconazole
• itraconazole
• nefazodone
• nelfinavir
• saquinavir

This is not a complete list of Asmanex HFA drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Asmanex HFA including the following:

• Thrush in your mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water after using Asmanex HFA to help prevent an infection in your mouth or throat.
• Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as:
  • fever
  • feeling tired
  • pain
  • nausea
  • body aches
  • vomiting
  • 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 HFA 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
  • weakness
  • nausea and vomiting
  • low blood pressure (hypotension)
  • dizziness or feeling faint
• Increased wheezing right after taking Asmanex HFA. Always have a rescue inhaler with you to treat sudden wheezing.
• Serious allergic reactions. Stop taking Asmanex HFA 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
  • hives
  • swelling, including swelling of the face, mouth, and tongue
  • breathing problems
• 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 and cataracts. You should have regular eye exams while using Asmanex HFA.

Do not use Asmanex HFA:

• are allergic to Asmanex HFA or any of its ingredients
• to treat sudden severe symptoms of asthma

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Asmanex HFA, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Asmanex HFA, tell your doctor if you:

• are allergic to Asmanex HFA or any of its ingredients
• need to treat sudden severe symptoms of asthma
• have liver problems
• have osteoporosis
• have an immune system problem
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are allergic to any medicines
• are exposed to chickenpox or measles
• have or had tuberculosis (TB)
• have any other medical problems
• are pregnant or planning to become pregnant. 
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Asmanex HFA falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known whether Asmanex HFA crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Asmanex HFA. 

Use Asmanex HFA exactly as prescribed. Do not use Asmanex HFA more often than prescribed.

• You must use Asmanex HFA regularly. It may take 1 week or longer after you start using Asmanex HFA for your asthma symptoms to get better. Do not stop using Asmanex HFA even if you are feeling better, unless your healthcare provider tells you to.
• Do not change or stop using Asmanex HFA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.
• Asmanex HFA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between Asmanex HFA and your other inhaled medicines, including their prescribed use and the way they look.
• Take Asmanex HFA every day, with 2 puffs in the morning and 2 puffs in the evening.
• If you miss a dose of Asmanex HFA, skip your missed dose and take your next dose at your regular time. Do not take Asmanex HFA more often or use more puffs than you have been prescribed.
• If you take more Asmanex HFA than your healthcare provider has prescribed, call your healthcare provider right away.
• Asmanex HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of Asmanex HFA. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you.
• Do not use the Asmanex HFA canister or actuator with any other medicines. Do not use any other medicine canister or actuator with Asmanex HFA.
• Rinse your mouth with water after each dose (2 puffs) of Asmanex HFA. This will help to lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
• Do not spray Asmanex HFA in your eyes. If you accidentally get Asmanex HFA in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.
• Call your healthcare provider or get medical care right away if:
  • your breathing problems worsen with Asmanex HFA.
  • you need to use your rescue inhaler more often than usual
  • your rescue inhaler does not work as well for you at relieving symptoms
  • you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row
  • you use 1 whole canister of your rescue inhaler within 8 weeks
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • you have asthma and your symptoms do not improve after using Asmanex HFA regularly for 1 to 2 weeks

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• previous medications you have taken
• your response to this medication
• the severity of the condition being treated

The recommended doses of Asmanex HFA for asthma based on previous medications are as follows:

• Previously on inhaled medium-dose corticosteroids: Asmanex HFA 100 mcg, 2 inhalations twice daily.
• Previously on inhaled high-dose corticosteroids or on oral corticosteroids: Asmanex HFA 200 mcg, 2 inhalations twice daily.

If you have taken too much Asmanex HFA, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Asmanex HFA at room temperature between 68°F to 77°F (20°C to 25°C).
• The contents of your Asmanex HFA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst.
• Do not throw container into fire or incinerator.
• Keep Asmanex HFA and all medicines out of the reach of children.