Asmanex Twisthaler

What is Asmanex Twisthaler?

Asmanex Twisthaler (mometasone furoate) is a corticosteroid used as maintenance treatment for the prevention and control of asthma symptoms in people 4 years of age and older.

Mometasone furoate

Mometasone furoate ball-and-stick

What are the uses of this medicine?

• Asmanex Twisthaler (mometasone furoate) is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 4 years of age and older.

Limitations of use:

• ASMANEX TWISTHALER is not used to treat sudden severe symptoms of asthma.
• ASMANEX TWISTHALER should not be used as a rescue inhaler.
• It is not known if ASMANEX TWISTHALER is safe and effective in children less than 4 years of age.

How does this medicine work?

• Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity.
• The precise mechanism of corticosteroid action on asthma is not known.
• Corticosteroids have been shown to have a wide range of inhibitory effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation and in the asthmatic response.
• Corticosteroids do not affect asthma symptoms immediately.
• Maximum improvement in symptoms following inhaled administration of mometasone furoate may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Who Should Not Use this medicine ?

This medicine cannot be used with:

• status asthmaticus or other acute episodes of asthma where intensive measures are required.
• a known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER.

What drug interactions can this medicine cause?

• ASMANEX TWISTHALER may affect the way other medicines work, and other medicines may affect how ASMANEX TWISTHALER works.

Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as:

• ritonavir
• atazanavir
• cobicistat-containing products
• ketoconazole
• clarithromycin
• nefazodone
• saquinavir
• nelfinavir
• telithromycin
• indinavir
• itraconazole
• For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your healthcare provider may wish to monitor you carefully.

Is this medicine FDA approved?

• Mometasone furoate was patented in 1981 and came into medical use in 1987. It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage: The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are as fallows: Patients ≥12 years who received bronchodilators alone:

• Recommended Starting Dose is 220 mcg once daily in the evening.
• Highest Recommended Daily Dose is 440 mcg.

Patients ≥12 years who received inhaled corticosteroids:

• Recommended Starting Dose is 220 mcg once daily in the evening.
• Highest Recommended Daily Dose is 440 mcg.

Patients ≥12 years who received oral corticosteroids:

• Recommended Starting Dose is 440 mcg twice daily.
• Highest Recommended Daily Dose is 880 mcg.

Children 4-11 years of age:

• Recommended Starting Dose is 110 mcg once daily in the evening.
• Highest Recommended Daily Dose is 110 mcg.

Administration:

• You must use ASMANEX TWISTHALER regularly. It may take 1 week to 2 weeks or longer after you start using ASMANEX TWISTHALER for your asthma symptoms to get better. Do not stop using ASMANEX TWISTHALER even if you are feeling better, unless your healthcare provider tells you to.
• Do not change or stop using ASMANEX TWISTHALER or other asthma medicines used to control or threat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.
• ASMANEX TWISTHALER comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between ASMANEX TWISTHALER and your other inhaled medicines, including their prescribed use and the way they look.
• ASMANEX TWISTHALER gives the medicine in a fine powder that you or your child may not taste, smell, or feel.
• If you take more ASMANEX TWISTHALER than your healthcare provider has prescribed, call your healthcare provider right away.
• ASMANEX TWISTHALER does not relieve sudden asthma symptoms. Always have a rescue inhaler such as albuterol with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX TWISTHALER. If you do not have a rescue inhaler such as albuterol, call your healthcare provider to have a rescue inhaler prescribed for you.
• Rinse your mouth with water after each dose of ASMANEX TWISTHALER. Spit out the water. Do not swallow it. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
• Call your healthcare provider or get medical care right away if you have asthma and your symptoms do not improve after using ASMANEX TWISTHALER regularly for 1 to 2 weeks.
• Do not use the ASMANEX TWISTHALER if the inhaler or any of its parts are not working properly. Take it to your healthcare provider or pharmacist.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Inhalation powder:

• 220 mcg TWISTHALER: delivers 200 mcg mometasone furoate per actuation.
• 110 mcg TWISTHALER: delivers 100 mcg mometasone furoate per actuation

This medicine is available in fallowing brand namesː

• ASMANEX TWISTHALER

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Other side effects may include:

• Worsening asthma
• sudden asthma attack

What special precautions should I follow?

• Localized infections of the mouth and pharynx with Candida albicans occurred in patients treated with ASMANEX TWISTHALER. Monitor patients periodically for signs of adverse effects in the mouth and pharynx. After administration, advise patients to rinse mouth with water and spit out contents without swallowing.
• ASMANEX TWISTHALER should not be used for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma.
• Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of ASMANEX TWISTHALER. Discontinue ASMANEX TWISTHALER if such reactions occur.
• Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections.
• Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER.
• Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function, with very high dosages or at the regular dosage in susceptible individuals. If such changes occur discontinue ASMANEX TWISTHALER slowly.
• Reduction in bone mineral density with long-term administration. Monitor patients with major risk factors for decreased bone mineral content.
• Orally inhaled corticosteroids, including ASMANEX TWISTHALER, may cause a reduction in growth velocity when administered to pediatric patients. Monitor growth routinely in pediatric patients receiving ASMANEX TWISTHALER.
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the administration of ASMANEX TWISTHALER. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term.
• Paradoxical bronchospasm may occur with ASMANEX TWISTHALER. Treat bronchospasm immediately with a fast-acting inhaled bronchodilator and discontinue use of ASMANEX TWISTHALER.
• Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypercorticism

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.
• Because of low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, acute overdose is unlikely to require any treatment other than observation.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of ASMANEX TWISTHALER in pregnant women.
• It is not known if ASMANEX TWISTHALER may harm your unborn baby.

Can this medicine be used in children?

• The safety and effectiveness of ASMANEX TWISTHALER for maintenance treatment of asthma as prophylactic therapy have been established in children 4 years of age and older.
• It is not known if ASMANEX TWISTHALER is safe and effective in children less than 4 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mometasone furoate
• Inactive ingredient: anhydrous lactose (which contains trace amounts of milk proteins).

Who manufactures and distributes this medicine?

Manufactured for: Organon LLC, a subsidiary of

• ORGANON & Co.,
• Jersey City, NJ, USA

Manufactured by:

• MSD International GmbH (Singapore Branch)
• Singapore

What should I know about storage and disposal of this medication?

• Store in a dry place at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Discard the inhaler 45 days after opening the foil pouch or when dose counter reads "00", whichever comes first.

• Dailymed label info on Asmanex Twisthaler
• FDA Asmanex Twisthaler

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