Asmanex

Asmanex Twisthaler is a prescription medication used for the prevention and treatment of asthma in people aged 4 years and older. Asmanex Twisthaler 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 Twisthaler comes as an inhaler and is inhaled once to twice daily. 

Common side effects of Asmanex Twisthaler include headaches and nasal allergy symptoms.  

Asmanex Twisthaler is a prescription medication used for the prevention and treatment of asthma in people aged 4 years and older.

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.

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 Twisthaler. See "Asmanex Twisthaler Precautions" section. 

The most common side effects of Asmanex Twisthaler include:

• headache
• nasal allergy symptoms
• sore throat
• upper respiratory tract infection
• sinus infection
• fungal infections in the mouth
• painful menstrual periods
• muscle and bone pain
• back pain
• upset stomach

This is not a complete list of Asmanex Twisthaler 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:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delaviridine (Rescriptor), and nefazadone

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

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

• Fungal infections in the mouth and throat. Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Rinse your mouth after using Asmanex Twisthaler.
• Worsening asthma or sudden asthma attacks
• Serious allergic reactions. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction, including:
  • Rash
  • Swelling of the face, mouth and tongue
  • Breathing problems
• Possible increased risk of infection due to a weakened immune system with using steroid medicines. Tell your health care provider if you or your child have or had TB, are exposed to anyone with chickenpox or measles, or about any other infections you or your child had before or while using Asmanex Twisthaler.
• Adrenal insufficiency (your adrenal gland cannot produce enough steroids since you were on oral steroid medicine). If you or your child took steroids by mouth and are having them decreased (tapered) or you are being switched to Asmanex Twisthaler, you should be followed closely by your health care professional.
  Death can occur. Tell your health care professional 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.
• Decreased bone mass (bone mineral density). Patients who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Talk with your health care provider about any questions about bone health.
• 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 Twisthaler.
• Increased wheezing right after taking Asmanex Twisthaler. Always have a rescue inhaler with you to treat sudden wheezing.

Do not use Asmanex Twisthaler:

• Are allergic to Asmanex Twisthaler or any of its ingredients
• To treat sudden, severe symptoms of asthma.
• If you have an allergy to milk proteins. Ask your health care provider if you are not sure.

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 Twisthaler, there are no specific foods that you must exclude from your diet when receiving this medication.

Ask your doctor before using Asmanex Twisthaler, if you have an allergy to milk proteins. 

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

• are allergic to Asmanex Twisthaler or any of its ingredients
• need to treat sudden, severe symptoms of asthma
• have an allergy to milk proteins. Ask your health care provider if you are not sure.
• have an immune system problem
• have osteoporosis
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• 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 or planning to breastfeed

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 Twisthaler 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 Twisthaler 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 Twisthaler. 

• Use your Asmanex Twisthaler regularly and at the same time each day, as prescribed by your health care provider. You or your child may not get the most benefit for 1 to 2 weeks or longer after starting Asmanex Twisthaler. If you or your child's symptoms do not improve in that time frame or if your condition gets worse, contact your health care provider.
• The cap is needed to use the Asmanex Twisthaler. Do not twist the mouthpiece with your hand. When the cap is removed from the Asmanex Twisthaler, the dose counter will count down by one, and show the number of doses available after this use.
• The inhaler delivers your medicine as a very fine powder that you or your child may not taste, smell, or feel. Do not take or give extra doses unless your health care provider has told you to.
• It is important to replace the cap after each inhalation to protect the inhaler from moisture.
• Do not use the inhaler if you notice that it is not working correctly. Take it to your health care provider or pharmacist.
• Throw away the inhaler 45 days after this date or when the dose counter reads "00", indicating the final dose has been inhaled, whichever comes first.
• 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.

How to use your Asmanex Twisthaler:

• Step 1: Open inhaler
  • Remove the Asmanex Twisthaler from its foil pouch and write the date on the cap label.
  • Hold the inhaler straight up (upright position) with the colored portion (the base) on the bottom. It is important that you remove the cap of the Asmanex Twisthaler while it is in this upright position to make sure that you get the right amount of medicine with each dose.
  • Holding the colored base, twist the cap in a counterclockwise direction to remove it. As you lift off the cap, the dose counter on the base will count down by one. Removing the cap loads the Asmanex Twisthaler with the medicine that you are now ready to inhale.

• Step 2: Inhale dose

  • Breathe out fully. Then bring the Asmanex Twisthaler up to your mouth or your child's mouth with the mouthpiece facing toward you or your child. Place the mouthpiece in your mouth or your child's mouth, holding it in a horizontal (on its side) position. Firmly close your lips around the mouthpiece and take in a fast, deep breath. Since the medicine is a very fine powder, you may not be able to taste, smell, or feel it after inhalation. Do not cover the ventilation holes while inhaling the dose.

  • Remove the Asmanex Twisthaler from your mouth and hold your breath for about 10 seconds, or as long as you comfortably can. Important: Do not breathe out into the inhaler. After you take your medicine, it is important that you wipe the mouthpiece dry, if needed, and then replace the cap, firmly closing the Asmanex Twisthaler right away. Be sure that the indented arrow is in line with the dose counter. Put the cap back onto the inhaler and turn it in a clockwise direction, as you gently press down. You'll hear a "click" to let you know that the cap is fully closed. This is the only way to be sure that your next dose is loaded the right way.

• Rinse your mouth after using.

How to know when your inhaler is empty:

• The inhaler has a dose counter on the colored base, which shows the number of doses left to use. As you lift off the cap to take your dose, the dose counter on the base will count down by one (if you began with the dose counter reading "30" this will cause the dose counter to now read "29"). Read the numbers from top to bottom.
• When the unit reads "01" this indicates the last remaining dose. After dose "01" the counter will read "00". When you replace the cap, the unit will lock and then must be thrown away. Start using a new Asmanex Twisthaler as instructed by your health care provider.

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 age
• how you respond to this medication
• the severity of the condition being treated

The recommended starting doses of Asmanex Twisthaler based off previous medications and age are as follows:

• Patients 12 years of age and older who have received bronchodilators alone or have received inhaled corticosteroids: 220 mcg once daily in the evening. The highest recommended daily dose is 440 mcg.
• Patients 12 years of age and older who have received oral (by mouth) corticosteroids: 440 mcg twice daily. The highest recommended daily dose is 880 mcg.
• Children 4-11 years of age: 110 mcg once daily in the evening. The highest recommended daily dose is 110 mcg. 

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

• 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 in a dry place at 25°C (77°F).
• Keep your inhaler out of the reach of children.