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 µg inhaled orally, once daily in the evening. Some people who have previously been using high doses of inhaled steroids may respond better to 400 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 this medication, 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 this medication 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 this medication will not provide immediate relief for an asthma attack that has already started. This medication is intended for long-term relief. Inhalers that contain "reliever" medications with fast action (e.g., salbutamol, terbutaline) will still be needed while using this medication on a regular basis.

This medication works best when it is used regularly. It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular 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 this medication 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.

**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)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome.

• burning or painful feeling of the tongue

• constipation

• decreased appetite

• diarrhea

• dizziness

• dry mouth or throat

• ear pain

• fatigue

• headache

• hoarseness or loss of voice

• increased saliva production

• increased sweating

• muscle and joint pain or stiffness

• nasal congestion

• nausea

• sore throat or mouth

• red or itchy eyes

• sneezing

• stomach ache

• thirst

• trouble breathing

• upset stomach

• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• cough

• distorted or blurred vision

• exhaling takes longer than usual

• fever

• irregular menstrual bleeding

• migraine

• osteoporosis or bone fractures

• pain in the muscle and bone in the chest area

• physical or emotional symptoms before menstrual period

• pins and needles or numbness of arms or legs, sinus pain and congestion, worsening breathing problems (Churg-Strauss Syndrome)

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of respiratory tract infection (e.g., fever or chills, shortness of breath, prolonged dizziness, headache, weight loss, tightness in chest, difficulty breathing, or wheezing)

• skin problems (e.g., rash, hives, chafing, itching, bruising)

• slowed growth (children and adolescents)

• symptoms of adrenal insufficiency (tiredness, headache, nausea, vomiting, muscle or joint pain)

• symptoms of glaucoma or cataracts (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)

• wheezing or difficulty breathing right after inhaling the medication

• white patches in the mouth or throat (fungal infection)

• worsening asthma

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain

• increased heart rate

• severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the face, mouth, or tongue)

• worsening asthma or sudden asthma attacks (e.g., cough, difficulty breathing, wheezing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

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 this medication.

Asthma control: This medication 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 this medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Oral hygiene: Adequate oral hygiene, such as rinsing your mouth with water after using this medication, 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, this medication 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 this medication 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 this medication. 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 this medication abruptly. When this medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Wheezing: **This medication 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: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

**Breast-feeding: **It is not known if mometasone passes into breast milk. If you are breast-feeding and taking this medication, 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 this medication. 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.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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 if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Asmanex-Twisthaler