Zenhale

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Zenhale

Treatment option: Asthma, Bronchospasm

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Zenhale

Property Description
Active Ingredients Mometasone Furoate and Formoterol Fumarate Dihydrate
Form Inhalation aerosol (Pressurized Metered-Dose Inhaler or pMDI)
Pharmacological Class Inhaled Corticosteroid (ICS) / Long-Acting Beta2-Adrenergic Agonist (LABA) Combination
General Purpose Provides maintenance therapy for chronic conditions
Origin Synthetic

Defining Zenhale: Combination Therapy and Delivery Type

Zenhale is a fixed-dose combination product designed for oral inhalation, delivered specifically as an inhalation aerosol from a pressurized metered-dose inhaler (pMDI). This mechanism is a targeted approach that ensures the synthetic active substances are administered directly into the lungs. This design positions Zenhale as a prescription-only medicine for routine management. Unlike medications that contain only a single agent, this combination product integrates two distinct therapeutic substances into one device for concurrent application, supporting long-term, comprehensive chronic condition management.

Composition and Pharmacological Class of Zenhale

The core identity of Zenhale stems from its two active ingredients: Mometasone Furoate and Formoterol Fumarate Dihydrate. The drug is classified as an ICS/LABA combination therapy. Mometasone Furoate functions as the anti-inflammatory agent component, which works to reduce internal swelling in the airways. Formoterol Fumarate Dihydrate functions as the bronchodilator component, a substance that helps open the airways. This dual-drug synthetic approach utilizes these two distinct mechanisms to support airway stability.

General Therapeutic Purpose and Functional Benefit

The general therapeutic purpose of Zenhale is to provide maintenance therapy that targets both major underlying factors of chronic airway conditions. This prophylactic approach leverages two complementary physiological actions: the Mometasone Furoate component aims for sustained airway inflammation reduction, while the Formoterol component works to achieve bronchial smooth muscle relaxation. By delivering these synergistic effects as a combination inhaled therapy, the medication is designed to support stable, unobstructed respiratory function over time. This makes it a typical intervention for patients requiring long-term asthma control.

Regulatory References

  1. ZENHALE/Dulera Drug Label (DailyMed)

What side effects are possible with Zenhale?

Possible Side Effects and Safety Information: Zenhale

This section details adverse reactions and safety constraints for Zenhale (mometasone furoate/formoterol fumarate dihydrate), based strictly on government regulatory labeling, such as FDA and Health Canada documents.


Documented Adverse Reactions

Adverse reactions are classified by frequency and affected body system (System-Organ Class or SOC).

Frequency Category Common Side Effects (Examples) Serious Adverse Reactions (Examples)
Common Nasopharyngitis (cold symptoms), Sinusitis, Headache, Oral Candidiasis (Thrush), Dysphonia, Palpitations Paradoxical Bronchospasm, Immediate Hypersensitivity (e.g., Angioedema), Serious Cardiovascular Events, Adrenal Suppression
Rare Hyperglycemia, Hypokalemia, Glaucoma, Cataracts

The Infections and Infestations SOC commonly includes Oral Candidiasis; the Cardiac Disorders SOC includes Tachycardia and QTc prolongation. The most frequently reported reactions include Headache and Upper Respiratory Tract Infections.


Regulatory Safety Constraints

Official labeling includes specific safety considerations and limitations:

  • Acute Treatment Restriction: Zenhale is not indicated for the relief of acute bronchospasm or for treating acutely worsening asthma symptoms.
  • Hypersensitivity: The product is contraindicated in individuals with a known hypersensitivity to any component.
  • Population-Specific Caution: Caution is advised for use in patients with certain conditions, including cardiovascular disorders or diabetes mellitus.
  • Infections: Use is discouraged or requires extreme caution in the presence of active tuberculous infection, ocular herpes simplex, or untreated systemic fungal, bacterial, viral, or parasitic infections.

Long-Term Exposure Safety Notes

Regulatory documents advise that prolonged use can be associated with systemic risks, including a potential reduction in Bone Mineral Density (BMD) and the development of Glaucoma or Cataracts.

Overdose and Emergency Response

The manifestations of overdose are primarily determined by the pharmacological class of the two active ingredients, with acute symptoms mainly associated with excessive beta-adrenergic stimulation from the Formoterol component. Documented clinical signs may include cardiovascular effects such as tachycardia (fast heartbeat), palpitations, chest pain, and fluctuations in blood pressure (both hypertension and hypotension). Central Nervous System (CNS) effects that may be observed include tremor, nervousness, and headache, with a documented potential for seizures and life-threatening cardiovascular collapse. Metabolic abnormalities officially listed include hypokalemia (low potassium) and hyperglycemia (high blood sugar). Chronic use significantly above the recommended dose may lead to signs of hypercorticism or adrenal suppression from the Mometasone component.

Immediate medical attention is required for suspected overdose or if severe symptoms occur. Individuals must contact emergency services or a poison control center right away for any rapid, irregular heartbeat, severe dizziness, or chest pain. The regulatory label strictly cautions against using this product in combination with other long-acting beta2-agonists due to the increased risk of overdose. Official management protocols focus on symptomatic and supportive treatment. This includes required procedures such as continuous ECG monitoring for cardiac arrhythmias and blood testing for metabolic effects. A cardioselective beta-blocker may be considered, but only with extreme caution due to the risk of precipitating bronchospasm.

Therapeutic Uses of Zenhale

What Zenhale treats: main uses and benefits

Zenhale is generally used as a long-term maintenance treatment for asthma in adults and adolescents, addressing the issues that lead to the manifestations of the disease. This type of therapy is commonly applied when the condition is not adequately controlled on an inhaled corticosteroid alone and in situations involving persistent asthma symptoms. The primary indications include long-term asthma control and use in patients requiring both an inhaled corticosteroid and a long-acting bronchodilator.

This combination therapy supports the management of symptoms that interfere with daily functioning, such as wheezing, chest tightness, and chronic cough. The goal is to provide supportive relief to help ease the symptomatic burden that often interferes with daily comfort. The treatment is relevant for managing symptoms that are recurrent and create noticeable physiological strain.

Quick Fact: Relief for Airway Symptoms

This therapy is relevant for conditions characterized by periods of heightened symptoms and may assist with easing the experience of acute symptomatic flare-ups.

Zenhale plays a role in managing conditions characterized by periods of heightened symptoms by focusing on prophylaxis (prevention). The treatment is relevant for easing acute symptomatic episodes and may assist with reducing the impact of these manifestations. It is commonly used to help with maintaining functional stability and supports general well-being during symptomatic periods. This is particularly relevant in clinical settings that involve recurrent and episodic breathing difficulty.

Regulatory References

  1. NIH DailyMed Drug Information

Eligibility and Restrictions for Use

Zenhale (mometasone furoate/formoterol fumarate dihydrate) is subject to specific regulatory eligibility and non-eligibility rules. Its use is defined by age, current health status, and pre-existing conditions.

Contraindications and Prohibitions

The medicine is contraindicated and must not be used by:

  • Patients with a known hypersensitivity to either mometasone furoate, formoterol fumarate, or any component of the formulation.
  • Patients experiencing acute episodes of asthma or status asthmaticus (it is not a rescue medication).
  • Patients with certain untreated active systemic infections, including active tuberculosis of the respiratory tract, systemic fungal, bacterial, or parasitic infections, or ocular herpes simplex.

Age-Based Eligibility

Age Group Eligibility Status
Adults and Adolescents Approved for use in patients 12 years of age and older for maintenance asthma treatment.
Children Safety and efficacy have not been established in children younger than 5 years of age.

Conditional Use and Restrictions

Use requires caution and monitoring in patients with conditions such as pre-existing cardiovascular disorders (e.g., cardiac tachyarrhythmias, hypertension), diabetes mellitus, and hepatic impairment (liver disease or cirrhosis). The regulatory label states that pregnancy and lactation use for the combination product have not been studied in humans.

What should I know about interactions with other medicines?

The official regulatory profile for Zenhale (Mometasone Furoate and Formoterol Fumarate Dihydrate) documents several classes of medicines that require specific regulatory constraints or are restricted due to the potential for pharmacokinetic (PK) or pharmacodynamic (PD) interactions.

A primary restriction is the absolute prohibition of co-administering Zenhale with any other Long-Acting Beta2-Adrenergic Agonist (LABA) due to the officially documented risk of overdose resulting from excessive systemic beta2-adrenergic stimulation.

Officially documented interactions and constraints are classified as follows:

Interaction Classification Interacting Substances / Class Official Outcome
Exposure-Altering (PK) Strong CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole) Increased systemic Mometasone exposure due to reduced clearance, requiring use with caution.
PD Reinforcement MAOIs, TCAs, QTc-Prolonging Drugs Potentiation of effects on the cardiovascular system (Formoterol), requiring extreme caution.
PD Antagonism Beta-Blockers (including eye drops) Decreased Formoterol effectiveness and potential for severe bronchospasm, restricted to use only when medically necessary.
Electrolyte/PD Risk Xanthine Derivatives, Non-Potassium Sparing Diuretics Risk of potentiated ECG changes and/or hypokalemia.

Regulatory information also notes that the clearance of the Mometasone component is officially altered in specific patient groups; exposure is increased with the severity of hepatic impairment. No mandatory dose separation timings are documented for co-administered medicines, and there are no specific, formally documented interactions with food, alcohol, or herbal products.

Mechanism of Action

Zenhale is a combination product composed of Mometasone Furoate and Formoterol Fumarate.

Formoterol Fumarate acts as a long-acting beta2-adrenoceptor agonist (LABA). Upon binding to the beta2-adrenoceptors on the bronchial smooth muscle cell membrane, it stimulates adenyl cyclase. This action increases the intracellular concentration of cyclic adenosine monophosphate (cAMP). Elevated cAMP levels activate Protein Kinase A (PKA), which subsequently leads to the phosphorylation and inactivation of myosin light chain kinase (MLCK). This cascade results in a reduction of intracellular calcium concentration, which induces relaxation of bronchial smooth muscle.

Mometasone Furoate, an inhaled corticosteroid (ICS), acts on intracellular glucocorticoid receptors (GRs). The activated receptor-ligand complex translocates to the nucleus and modulates the transcription of specific genes. This action influences the synthesis of proteins. Specifically, it decreases the synthesis and release of pro-inflammatory mediators such as cytokines and chemokines, and induces the expression of anti-inflammatory proteins such as annexin-1. The combination's actions include beta2-receptor activation and glucocorticoid receptor-mediated genomic effects.

Dosage and Administration Information

How Zenhale is Used: Administration Guidelines

Zenhale, a fixed-dose combination product, is administered exclusively by oral inhalation via a pressurized metered-dose inhaler (pMDI). The medicine is prescribed for regular, continuous use as a long-term maintenance treatment, meaning it is not intended for the relief of sudden, acute breathing difficulties.


Standard Administration Protocol

The typical administration frequency for adults and adolescents (age 12 years and older) is two inhalations twice daily, taken in the morning and evening. The available dosage strengths are generally either 100 mcg / 5 mcg or 200 mcg / 5 mcg (Mometasone/Formoterol) per actuation, with the maximum recommended daily dose being 800 mcg of mometasone furoate and 20 mcg of formoterol fumarate in total. Pediatric patients aged 5 to less than 12 years are directed to use the 50 mcg / 5 mcg strength, two inhalations twice daily, where approved.


Procedural Requirements

Specific steps must be followed to ensure proper use. The inhaler must be primed by releasing four test sprays into the air if it is being used for the first time or if it has not been used for five or more days. Following each twice-daily dose, the patient is required to rinse their mouth with water and spit it out without swallowing to manage local residue. If a dose is missed, the standard protocol is to skip the missed dose and take the next dose at the regular time, without taking a double dose. This medication must not be used concurrently with any other long-acting beta2-agonist to avoid exceeding the maximum recommended dose of that drug class.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Zenhale

Evidence for Use in Persistent Asthma Maintenance

The clinical evaluation of Zenhale was studied for use as maintenance therapy in adults and adolescents with persistent asthma. The core research primarily relies on randomized controlled trials (RCTs), which are the standard method for testing new medicines. These studies were applied in research contexts involving fluctuating or unstable symptoms in patients whose asthma was observed to be not well-controlled using only an inhaled steroid monotherapy.

Research examined objective lung function markers, such as forced expiratory volume in one second ( FEV1), a measure relevant to respiratory studies. Findings describe patterns of measured changes observed in the studies where patients receiving the combination were compared to those receiving a placebo or an inhaled steroid alone. Research explored whether the use of the combination therapy in patients with conditions characterized by fluctuating or episodic manifestations was associated with observed patterns related to control outcomes.


How Research Evaluated Asthma Exacerbation and Symptom Control

Beyond measuring lung function, clinical research also explored outcomes related to episodic or acute changes, focusing on the frequency of asthma episodes where symptoms become more noticeable (exacerbations). Research examined the time taken until the first deterioration event, such as an event requiring an emergency room visit or the use of systemic steroids. Findings indicate patterns of less frequent rescue medication use in some observed populations compared to placebo groups. Research provides context regarding short-term changes in these outcomes reflective of daily functioning or activity level.


Research Gaps and Areas of Uncertainty

The majority of clinical trials concentrated on adults and adolescents 12 years of age and older. Data for children under 12 years of age remain insufficient. Furthermore, comparative evidence is lacking for a direct assessment of this combination versus the single-ingredient mometasone product in clinical settings. The long-term stability over many years of chronic use is not fully established by the existing pivotal trials, meaning limited information exists for long-term outcomes beyond one year. Clinical studies focusing on other chronic airway conditions, such as Chronic Obstructive Pulmonary Disease (COPD), are not included in the evidence base for Zenhale.

Key Studies & References

  1. Zenhale Patient Medication Information (Product Monograph) - Canada

Frequently Asked Questions (FAQ)

Common questions about Zenhale (FAQ)


Q: Is it normal to feel shaky or nervous after using Zenhale?

The Formoterol component in Zenhale is a long-acting beta2-agonist (LABA), which can sometimes cause effects on the central nervous and cardiovascular systems. Official documents state that side effects related to this stimulation may include a feeling of tremor or nervousness. Patients who experience these symptoms should have their condition evaluated by a healthcare professional.


Q: Is Zenhale the same as Symbicort?

No, Zenhale and Symbicort are not the same medicine. Both are combination inhalers, but Zenhale contains Mometasone Furoate and Formoterol Fumarate. Symbicort uses a different inhaled corticosteroid, Budesonide, combined with Formoterol. Regulatory information confirms the drugs are distinct due to their specific corticosteroid component.


Q: Does Zenhale lose effectiveness over time?

Zenhale is approved and studied for use as a long-term maintenance treatment. Regulatory documents note that prolonged administration of the inhaled corticosteroid component can rarely be associated with systemic safety effects, such as a decrease in Bone Mineral Density (BMD). Continuous monitoring by a healthcare provider is part of the established long-term management protocol.


Q: What is the maximum duration of treatment with Zenhale?

Official information describes Zenhale as a prescription medicine intended for long-term maintenance treatment of asthma. Regulatory guidance does not specify a maximum duration for this continuous therapy. Clinical monitoring by a healthcare professional is standard practice to evaluate the ongoing stability and appropriateness of the treatment.


Q: How does Zenhale differ from other combination inhalers?

Zenhale is defined by its specific combination of active ingredients: the inhaled corticosteroid Mometasone Furoate and the long-acting bronchodilator Formoterol Fumarate. This specific formulation distinguishes it from other combination products that use different inhaled corticosteroids or bronchodilators.


Q: How quickly does Zenhale start to work?

Zenhale is not a rescue inhaler, but its bronchodilator component, Formoterol, does have a rapid onset of action. According to the official clinical pharmacology information, Formoterol typically begins to open the airways within 2 to 3 minutes after inhalation.


Q: Do you always need to use the full prescribed dose of Zenhale?

Regulatory guidance describes that use should be strictly as prescribed, noting that the medicine should not be used in greater or lesser amounts than ordered. The guidance also states the medicine should not be stopped without professional consultation. This adherence to the established regimen is consistent with effective long-term maintenance treatment.


Q: Can Zenhale cause weight gain?

While not listed as a common side effect, weight gain that is particularly noticeable in the face, upper back, or belly can be a rare sign of a systemic corticosteroid effect known as Cushing's syndrome. This condition is generally associated with long-term, high-dose exposure to corticosteroids.


Q: Does Zenhale cause mood changes or depression?

Official warnings related to the inhaled corticosteroid component note that mood changes and fatigue can be symptoms of reduced adrenal function (adrenal insufficiency). This is described as a rare, serious systemic effect in official warnings.


Q: Why is Zenhale taken twice a day?

The dosing frequency is determined by the pharmacological properties of its active components. The Formoterol component is a long-acting medicine, and its bronchodilating effect lasts approximately 12 hours. This duration means the medicine's dosage regimen is designed to be administered twice daily (morning and evening) to maintain continuous asthma control.


Q: What happens if I stop using Zenhale suddenly?

Regulatory documents warn against the abrupt cessation of Zenhale, as suddenly stopping the medicine can lead to a worsening of asthma symptoms. Additionally, discontinuation of the corticosteroid component, especially when switching from oral steroids, can rarely cause signs of adrenal insufficiency.


Q: Are there generic versions of Zenhale available?

According to general regulatory data and the most recent product assessments, a generic version of the Mometasone/Formoterol combination product is not available.


Q: Does Zenhale cause dry mouth?

Dry mouth is not listed among the most common adverse effects in regulatory summaries. However, it can occur as a potential symptom of high blood sugar (hyperglycemia), which is a documented systemic side effect of beta2-agonist medicines.


Q: Is Zenhale safe for patients with thyroid problems?

Regulatory documents state that caution is advised for use in patients who have pre-existing thyroid problems (such as hyperthyroidism). This caution is due to the potential for the drug to possibly worsen these conditions.


Q: Will Zenhale affect my ability to drive or operate machinery?

The official label notes that the medication can cause side effects such as dizziness or tremor in some patients. The potential for the medicine to cause these side effects means caution is generally advised when engaging in activities that require mental focus, such as driving or operating machinery.


Q: What happens if I accidentally use Zenhale too many times in one day?

Regulatory warnings indicate that using the medicine too frequently can lead to overdose symptoms related to excessive beta-adrenergic stimulation. These symptoms can include chest pain, fast or irregular heartbeats (palpitations), tremor, or dizziness.


Q: Does Zenhale contain lactose or other common allergens?

Official summaries list the active ingredients. The complete list of all product components, including inactive ingredients (excipients) and potential allergens, is available in the full prescribing label and can be confirmed by a pharmacist.


Q: Is it normal to cough right after taking Zenhale?

Cough is listed in the official documents as a common side effect associated with the use of the medicine. Cough that is severe, persistent, or occurs immediately after use may be a sign of paradoxical bronchospasm, which is noted in official warnings as a condition that requires medical evaluation.

How should Zenhale be stored and disposed of?

How to Store and Dispose of Zenhale?

Storage Requirements

Zenhale (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol must be stored at room temperature, between 15 C and 30 C (59 F and 86 F). The pressurized canister must be kept away from heat or open flame and must not be frozen or refrigerated. It must also be protected from light and moisture. Always keep the inhaler out of the sight and reach of children.

Stability and Disposal

The inhaler must be thrown away when the dose counter reads 0 or if it has been out of the foil pouch for longer than the prescribed stability period (e.g., 2 or 3 months), whichever comes first. The product must not be disposed of in household garbage or wastewater. Consult a pharmacist for instructions on how to properly discard unused or expired inhalers according to local pharmaceutical waste regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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