Asmanex Twisthaler

Children 4 to 11 years of age: The usual recommended dose of inhaled mometasone is 100 µg inhaled orally (by mouth), once daily in the evening.

Adults and children over 12 years of age: The usual recommended dose of inhaled mometasone is 200 µg to 400 inhaled orally, once daily in the evening. Some people who have previously been using high doses of inhaled steroids may respond better to 200 µg inhaled twice a day. The maximum dose is 800 µg per day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Your doctor may increase or decrease the dose, depending on how well it works for you. Once the breathing difficulties are under control, the dose should be decreased to the lowest possible dose that keeps the asthma under control. If asthma worsens while using Asmanex Twisthaler (Mometasone-furoate-inh), your doctor may instruct you to increase the dose or use the medication more frequently.

The mometasone inhaler is breath activated. The amount of powder inhaled with each dose is very small. You may not be able to taste it or feel in going into your lungs. However, the medication will be getting into your lungs if you follow the instructions on how to use the inhaler. If you are not sure how to use your inhaler, ask your pharmacist or doctor to show you.

Treatment with Asmanex Twisthaler (Mometasone-furoate-inh) should not be stopped abruptly. It should be tapered off gradually to reduce the chance of the symptoms worsening.

To reduce the risk of thrush (yeast) infection in the mouth, rinse and gargle with water after inhaling the medication.

It is important to remember that Asmanex Twisthaler (Mometasone-furoate-inh) will not provide immediate relief for an asthma attack that has already started. Asmanex Twisthaler (Mometasone-furoate-inh) is intended for long-term relief. Inhalers that contain "reliever" medications with fast action (e.g., salbutamol, terbutaline) will still be needed while using Asmanex Twisthaler (Mometasone-furoate-inh) on a regular basis.

Asmanex Twisthaler (Mometasone-furoate-inh) works best when it is used regularly. It is important to take Asmanex Twisthaler (Mometasone-furoate-inh) exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Asmanex Twisthaler (Mometasone-furoate-inh) at room temperature, protect it from light and moisture, and keep it out of the reach of children. The device is packaged in a sealed foil pouch. Keep it in the sealed pouch until you are ready to begin using it. Discard the device and any remaining medication 2 months after opening the package.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause an infection of the mouth or throat, known as thrush; it may cause headaches; it may cause dryness and irritation of the throat; it may cause a sore throat. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 µg/ inhalation
Each metered inhalation from the cap-activated, inhalation driven, dry powder inhaler contains 100 µg of mometasone furoate. Nonmedicinal ingredients: lactose anhydrous.

200 µg/ inhalation
Each metered inhalation from the cap-activated, inhalation driven, dry powder inhaler contains 200 µg of mometasone furoate. Nonmedicinal ingredients: lactose anhydrous.

400 µg/ inhalation
Each metered inhalation from the cap-activated, inhalation driven, dry powder inhaler contains 400 µg of mometasone furoate. Nonmedicinal ingredients: lactose anhydrous.

Do not take inhaled mometasone if you:

• are allergic to mometasone or any ingredients of the medication
• are allergic to milk or lactose
• are having an asthma attack
• have active or inactive lung Tuberculosis
• have an untreated fungal, bacterial, or viral lung infection
• have herpes simplex infection of the eye
• have status asthmaticus (severe, unresponsive asthma)

There may be an interaction between mometasone and any of the following:

• Aldesleukin
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Ceritinib
• clarithromycin
• Cobicistat
• Desmopressin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Idelalisib
• mifepristone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Asmanex Twisthaler (Mometasone-furoate-inh). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Asmanex Twisthaler (Mometasone-furoate-inh).

Asthma control: Asmanex Twisthaler (Mometasone-furoate-inh) is not for use as a "reliever" medication. If you start to have an asthma attack, be sure to use your "reliever" medication for rapid relief of your asthma symptoms. Contact your doctor immediately if you find you are using your "reliever" medications (e.g., salbutamol, terbutaline, formoterol) more often or if they are not working as well as they used to. This may mean your asthma is not controlled. Your doctor may want you to temporarily change the dose of Asmanex Twisthaler (Mometasone-furoate-inh) or may start you on an oral corticosteroid.

Eye problems: Prolonged use of mometasone or other inhaled corticosteroids may cause glaucoma with possible damage to the optic nerves or it may produce cataracts. It may also increase the risk of Eye Infections due to fungi or viruses. You should discuss with your doctor how Asmanex Twisthaler (Mometasone-furoate-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Asmanex Twisthaler (Mometasone-furoate-inh), and whether any special monitoring is needed.

Infections: Mometasone may hide some signs of infection, and new infections may appear while mometasone is being used. Infections such as Chickenpox and Measles can be more serious for people taking medications such as mometasone. Contact your doctor if you notice any symptoms of an infection (e.g., fever, chills, cough, sore throat), or if you are in contact with someone who has measles or chickenpox.

Liver function: Mometasone may have increased effects on people who have cirrhosis of the liver. If you have reduced liver function or liver disease, discuss with your doctor how Asmanex Twisthaler (Mometasone-furoate-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Asmanex Twisthaler (Mometasone-furoate-inh), and whether any special monitoring is needed.

Oral hygiene: Adequate oral hygiene, such as rinsing your mouth with water after using Asmanex Twisthaler (Mometasone-furoate-inh), helps reduce the chances of developing thrush, a yeast (fungal) infection of the mouth or throat. If you develop symptoms of thrush, such as white patches in your mouth, contact your doctor.

Osteoporosis: Over time, Asmanex Twisthaler (Mometasone-furoate-inh) can increase the risk of osteoporosis (brittle bones), just as any corticosteroid can. Talk to your doctor about ways to help prevent osteoporosis. Your doctor will monitor your bone density if you need to take Asmanex Twisthaler (Mometasone-furoate-inh) for a long period of time.

Steroid medication use: If you have taken or are still taking an oral steroid medication (e.g., Prednisone) during the last several months, consult your doctor before using Asmanex Twisthaler (Mometasone-furoate-inh). In times of stress or during a severe asthma attack, your doctor may want you to start your steroid medication again.

Stopping medication: Do not stop Asmanex Twisthaler (Mometasone-furoate-inh) abruptly. When Asmanex Twisthaler (Mometasone-furoate-inh) is stopped, it should be stopped gradually, as directed by your doctor.

Thyroid disease: The effects of mometasone may be increased for people with decreased thyroid function (Hypothyroidism). If you have hypothyroidism, discuss with your doctor how Asmanex Twisthaler (Mometasone-furoate-inh) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Asmanex Twisthaler (Mometasone-furoate-inh), and whether any special monitoring is needed.

Wheezing: Asmanex Twisthaler (Mometasone-furoate-inh) may cause the airways to spasm immediately after using the inhaler. If this happens, use your rescue inhaler as soon as possible to relieve the symptoms, then call your doctor as soon as possible.

Pregnancy: Asmanex Twisthaler (Mometasone-furoate-inh) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Asmanex Twisthaler (Mometasone-furoate-inh), contact your doctor immediately.

Breast-feeding: It is not known if mometasone passes into breast milk. If you are a breast-feeding mother and are taking Asmanex Twisthaler (Mometasone-furoate-inh), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Inhaled mometasone may slow the growth and development of adolescents using Asmanex Twisthaler (Mometasone-furoate-inh). This will be closely monitored by your child's doctor. The safety and effectiveness of inhaled mometasone has not been determined for children less than 4 years of age.

This product must be inhaled by mouth. Carefully follow the package's instructions. If needed, ask your pharmacist for additional information or for a demonstration. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. Using this product may cause throat irritation and coughing. You can avoid these problems by thoroughly rinsing your mouth and gargling after each dose. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up.