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Zenhale

Brand Name

Zenhale

Common Name

formoterol - mometasone

In this drug factsheet:

DIN (Drug Identification Number)

02361760 Zenhale 200/5 inhalation aerosol
02361752 ZENHALE 100/5 INHALATION AEROSOL

How does this medication work? What will it do for me?

This is a combination medication that contains mometasone furoate and formoterol fumarate dihydrate.

Mometasone furoate is a corticosteroid. It is used to prevent asthma attacks because it reduces swelling and irritation in the walls of the small air passages of the lungs.

Formoterol belongs to the class of medications known as bronchodilators. It helps to open airways and make breathing easier. The effect lasts for 12 hours.

The product is for people 5 years of age or older who need treatment for asthma, and for whom the doctor recommends a combination product. It should not be used as a "rescue" medication for sudden asthma symptoms.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

This medication is taken as 2 inhalations twice a day (morning and evening). It should be used regularly to receive the most benefit from the medication.

The effectiveness of the medication depends on the proper use of the inhaler. Have your doctor or pharmacist instruct you in the correct usage of the inhaler. Rinse your mouth and gargle with water after using the inhaler to help prevent thrush (yeast infection of the mouth) from developing.

Many things can affect the dose of a 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.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible 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 this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

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.

What form(s) does this medication come in?

100/5
Each inhalation delivers 100 µg of mometasone furoate and 5 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: ethanol anhydrous, oleic acid, and HFA-227 (propellant).

200/5
Each inhalation delivers 200 µg of mometasone furoate and 5 µg of formoterol fumarate dihydrate. Nonmedicinal ingredients: ethanol anhydrous, oleic acid, and HFA-227 (propellant).

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to formoterol, mometasone, or any ingredients of the medication
  • are experiencing an acute asthma attack
  • have a fast heart rate (tachyarrhythmia)
  • have a fungal, bacterial, viral, or parasitic infection that has not been treated
  • have an active tuberculosis infection
  • have herpes simplex (virus) infection of the eye

What side effects are possible with this medication?

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. Your pharmacist may be able to advise you on managing side effects.

  • disturbed sleep
  • dizziness
  • dry mouth
  • fainting
  • headache
  • hoarseness
  • loss of bone density
  • muscle cramps
  • nausea
  • nervousness
  • rounded face
  • shakiness
  • sore throat
  • tremor

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

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

  • blurred vision
  • cataracts (clouding of the lens of the eye)
  • decreased function of the adrenal glands (e.g., tiredness, weakness, nausea, vomiting, and low blood pressure)
  • decreased potassium in the blood (e.g., irregular heartbeat, muscle weakness, general feeling of being unwell)
  • eye pain
  • fainting
  • fast or uneven heartbeat
  • high blood pressure
  • increased pressure in the eye (glaucoma)
  • Churg-Strauss Syndrome (flu-like illness, rash, pins and needles or numbness of the arms and legs, severe sinus pain, worsening lung or breathing problems)
  • slowed growth (children and adolescents)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • thrush (a fungal infection in the mouth; thrush is less likely to occur if you rinse your mouth with water and spit after using the medication)

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

  • allergic reaction (symptoms include rash, itching, hives, redness or swelling of the eyes, lips or throat, trouble breathing)
  • chest pain
  • sudden coughing, wheezing, and trouble breathing after using inhaler
  • worsening asthma symptoms

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.

Are there any other precautions or warnings for 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 attacks: This medication is not a "reliever" medication. If you start developing asthma symptoms, be sure to use your reliever medication for rapid relief of your asthma symptoms. It is very important that you have your reliever medication with you at all times. If you persistently use more of your reliever medication, contact your doctor.

Diabetes: Both formoterol and mometasone may cause an increase in blood sugar levels. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, 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.

Eye problems: If you are at risk of developing glaucoma or cataracts, have your eyes checked by your doctor before starting long-term treatment with this medication. You should have your eyes monitored at regular intervals while using this medication.

Growth effects: Long-term use of corticosteroids, including inhaled forms such as this medication, may slow the growth of children and adolescents. It is important to use the lowest effective dose for managing asthma symptoms. Talk to your doctor if you have any concerns.

Heart rhythm: Beta-agonists such as formoterol can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.

Formoterol may cause a fluttering of the heartbeat (atrial fibrillation) or rapid heartbeat, increased blood pressure, chest pain, and decreased oxygen reaching the heart muscle.

If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), 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: Corticosteroids, such as mometasone, can reduce your body's ability to fight infections and may hide signs of infection that is developing. Infections such as chickenpox and measles can be more serious for people taking medications such as fluticasone. If you are exposed to someone with chickenpox or measles, contact your doctor.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using formoterol - mometasone, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Medical conditions: 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, if you have any of the following conditions:

  • herpes simplex (virus) infection of the eye
  • liver disease
  • low levels of potassium in the blood
  • problems with thyroid or adrenal glands
  • tuberculosis
  • any other type of untreated infection

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

Osteoporosis: Long-term use of corticosteroids, including inhaled corticosteroids such as mometasone, may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use this medication for a lengthy period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.

Steroid medication use: If you have taken oral steroid medications over the last several months or are still taking oral corticosteroids, consult with your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.

Stopping the medication: This medication contains an inhaled corticosteroid, mometasone furoate. Abruptly stopping inhaled corticosteroids can make asthma worse. Do not stop this medication suddenly. Instead, speak to your doctor about how to stop the medication safely by gradually reducing the dose.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening asthma):

  • decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
  • need for more inhalations than usual of short-acting, inhaled bronchodilators
  • peak flow meter showing results in the below-normal range

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 this medication passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 5 years of age.

What other drugs could interact with this medication?

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

  • aldesleukin
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • atomoxetine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • beta-blocker medications (e.g., atenolol, propranolol) including eye drops (e.g., timolol eye drops)
  • betahistine
  • other long acting bronchodilators (e.g., salmeterol, indacaterol)
  • caffeine
  • cannabis
  • cobicistat
  • conivaptan
  • corticosteroids (by mouth or by injection)
  • decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
  • decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
  • deferasirox
  • desmopressin
  • dexmethylphenidate
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dronedarone
  • epinephrine
  • HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
  • linezolid
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • methylphenidate
  • mifepristone
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • ozanimod
  • procainamide
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, ofloxacin,)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • tetrabenazine
  • theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
  • tricyclic anti-depressants (e.g., amitriptyline, imipramine)
  • tyrosine kinase inhibitors (e.g., ceritinib, idelalisib, lapatinib, pazopanib, sunitinib)

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 this medication. 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/Zenhale