Mometasone Inhalation, oral / nebulization

In the U.S.

• Asmanex HFA
• Asmanex Twist

In Canada

• Asmanex Twisthaler
• Azmax Twisthaler

Available Dosage Forms:

• Aerosol Powder
• Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Mometasone

Mometasone is used to help prevent the symptoms of asthma and improve breathing in patients 4 years of age and older. When used regularly every day, inhaled mometasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Mometasone HFA is used as a maintenance treatment for the prevention and control of asthma symptoms in patients 12 years of age and older.

Inhaled mometasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

mometasone is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mometasone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mometasone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled mometasone to prevent asthma in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled mometasone HFA to prevent asthma in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mometasone in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mometasone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mometasone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using mometasone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Nadroparin
• Pixantrone

Using mometasone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of mometasone. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or
• Glaucoma—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, fungus, or parasite) or
• Measles or
• Tuberculosis, active or history of—Inhaled mometasone can reduce the body's ability to fight off these infections.

• Immobilization for long periods of time or
• Osteoporosis, family history of—Mometasone may make your bones weaker and increase the chance of a broken bone after a minor fall or injury.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Milk protein allergy—Should not be used in patients with these conditions.

Inhaled mometasone is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled mometasone is used with a special inhaler that comes with patient directions. Read the directions carefully before using mometasone. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use mometasone only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using mometasone without telling your doctor. To do so may increase the chance of side effects.

In order for mometasone to help prevent asthma attacks, it must be used every day in regularly spaced doses and be used at the same time each day, as ordered by your doctor.

To use the Twisthaler®:

• Take the Twisthaler® out of the pouch before you use it for the first time.
• Write down the date on the cap label when you first open the foil pouch. The medicine is good for only 45 days once the pouch is opened.
• The Twisthaler® has a small window on the side with numbers showing. This is the dose counter. It keeps track of how many more times you can use the inhaler before you need to open a new one. When the dose counter reaches "00", the Twisthaler® will lock itself. If the dose counter is not working correctly, do not use the Twisthaler® and return it to your pharmacy or doctor.
• Remove the cap while it is in upright position to make sure you get the right amount of medicine with each dose.
• Hold the Twisthaler® upright and twist the cap in a counterclockwise direction to open it. The dose counter should change to a lower number when you take off the cap. The arrow on the Twisthaler® should be pointing to the dose counter.
• To inhale mometasone, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Take the Twisthaler® out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly.
• Do not breathe out into the inhaler.
• Wipe the mouthpiece dry with a cloth or tissue. Do not wash it with water. Put the cap back on right away and twist it in a clockwise direction. You should hear a "click" when the cap is fully closed.
• Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

To use the Asmanex® HFA inhaler:

• mometasone comes in 2 strengths. Your doctor will decide which dosage strength is best for you.
• The Asmanex® HFA aerosol canister provides about 124 inhalations, depending on the size of the canister your doctor ordered.
• The Asmanex® HFA inhaler has a small window on the side with numbers showing. This is the dose counter. It keeps track of how many more times you can use the inhaler before you need to open a new one.
• Before using mometasone, remove the cap from the mouthpiece.
• When you use the inhaler for the first time, or if you have not used it in a while, test or prime it by releasing 4 test sprays into the air, away from the face.
• Shake well before each spray.
• To inhale mometasone, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Do not use Asmanex® HFA canister or actuator with any other medicines. Do not remove the canister from the actuator.
• Rinse your mouth with water after each dose. Do not swallow the water after rinsing.
• Do not wash the inhaler in water. The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Dosing

The dose of mometasone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of mometasone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (aerosol powder):
  • For preventing an asthma attack:
    • For patients who have received inhaled corticosteroids and bronchodilators:
      • Adults and children 12 years of age and older—One puff once a day, in the evening. Each puff contains 220 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 440 mcg per day.
      • Children 4 to 11 years of age—One puff once a day, in the evening. Each puff contains 110 mcg of mometasone.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    • For patients who have received oral corticosteroids:
      • Adults and children 12 years of age and older—Two puffs two times a day, in the evening. Each puff contains 220 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 880 mcg per day.
      • Children 4 to 11 years of age—One puff once a day, in the evening. Each puff contains 110 mcg of mometasone.
      • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For preventing an asthma attack (HFA):
    • For patients who have received inhaled corticosteroids:
      • Adults and children 12 years of age and older—Two puffs two times a day (in the morning and in the evening). Each puff contains 100 or 200 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 to 800 mcg per day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For patients who have received oral corticosteroids:
      • Adults and children 12 years of age and older—Two puffs two times a day, (in the morning and in the evening). Each puff contains 200 micrograms (mcg) of mometasone. Your doctor may increase your dose as needed. However, the dose is usually not more than 800 mcg per day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of mometasone, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep mometasone inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the inhaler when the dose counter is at "00" or 45 days after you opened the package. Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used inhaler and any leftover medicine.

If you will be using mometasone for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

mometasone may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the mouth or throat, or pain when eating or swallowing.

You should not use mometasone if your asthma attack has already started. Your doctor will prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using mometasone for 2 weeks or if they become worse.
• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

mometasone may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using mometasone.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using mometasone. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

Using too much of mometasone for a long period of time can cause problems with your adrenal gland. Talk to your doctor if you or your child have more than one of these symptoms while you are using mometasone: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or weight loss.

Follow your doctor's directions carefully if you are switching from an oral corticosteroid to mometasone.

mometasone may decrease bone mineral density when used for a long time. Low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

mometasone may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

mometasone may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using mometasone. Use a short acting inhaler right away to treat your symptoms.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.