Asmanex Twisthaler

DRUG DESCRIPTION

Mometasone furoate, the active component of the ASMANEX TWISTHALER (mometasone furoate) product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure:

ASMANEX TWISTHALER (mometasone furoate) Structural Formula Illustration

Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons.

The ASMANEX TWISTHALER (mometasone furoate) 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins).

Each actuation of the ASMANEX TWISTHALER (mometasone furoate) 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ? 12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54-77 L/min). In pediatric patients (aged 512 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was > 50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was > 60 L/min (minimum of 48 L/min).

What are the possible side effects of mometasone inhalation (Asmanex Twisthaler 120 Dose, Asmanex Twisthaler 14 Dose, Asmanex Twisthaler 30 Dose, Asmanex Twisthaler 60 Dose, Asmanex Twisthaler 7 Dose)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • ...

Read All Potential Side Effects and See Pictures of Asmanex Twisthaler

What are the precautions when taking mometasone furoate (Asmanex Twisthaler)?

Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or allergic to lactose; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), diabetes, decreased adrenal gland function.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more...

Read All Potential Precautions of Asmanex Twisthaler


Asmanex Twisthaler Consumer (continued)

SIDE EFFECTS: See also Precautions.

Dry or irritated throat, hoarseness or coughing may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as depression, trouble sleeping), vision problems (such as blurred vision), increased thirst/urination.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mometasone, tell your doctor or pharmacist if you are allergic to it; or allergic to lactose; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past infections (such as tuberculosis, herpes), bone loss (osteoporosis), eye problems (such as cataracts, glaucoma), diabetes, decreased adrenal gland function.

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

This medication may slow down a child's growth if used for a long time, but poorly controlled asthma can also slow down growth. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Asmanex Twisthaler Patient Information Including Side Effects

Brand Names: Asmanex Twisthaler 120 Dose, Asmanex Twisthaler 14 Dose, Asmanex Twisthaler 30 Dose, Asmanex Twisthaler 60 Dose, Asmanex Twisthaler 7 Dose

Generic Name: mometasone inhalation (Pronunciation: moe MET a sone)

  • What is mometasone inhalation (Asmanex Twisthaler)?
  • What are the possible side effects of mometasone inhalation (Asmanex Twisthaler)?
  • What is the most important information I should know about mometasone inhalation (Asmanex Twisthaler)?
  • What should I discuss with my healthcare provider before using mometasone inhalation (Asmanex Twisthaler)?
  • How should I use mometasone inhalation (Asmanex Twisthaler)?
  • What happens if I miss a dose (Asmanex Twisthaler)?
  • What happens if I overdose (Asmanex Twisthaler)?
  • What should I avoid while using mometasone inhalation (Asmanex Twisthaler)?
  • What other drugs will affect mometasone inhalation (Asmanex Twisthaler)?
  • Where can I get more information?

What is mometasone inhalation (Asmanex Twisthaler)?

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Mometasone inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Mometasone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mometasone inhalation (Asmanex Twisthaler)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or
  • worsening asthma symptoms.

Less serious side effects may include:

  • headache;
  • runny nose, increased sinus allergy symptoms;
  • stuffy nose, sinus pain, sore throat, nosebleed;
  • muscle or joint pain, back pain;
  • nausea, upset stomach, loss of appetite;
  • changes in menstrual periods;
  • tired feeling; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mometasone inhalation (Asmanex Twisthaler)?

Do not use mometasone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 weeks of treatment.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you were switched from an oral (taken by mouth) steroid to mometasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

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