Aroflo

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Medically reviewed

Marina Burgos

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 Aroflo

Property Description
Active ingredients Fluticasone Propionate, Salmeterol
Form Inhalation powder (DPI), Inhalation aerosol (MDI)
Pharmacological class Combination Antiasthmatic and COPD Preparation
Common use Regular maintenance for persistent airway obstruction
Origin Synthetic (chemically manufactured components)

Aroflo is a brand-specific fixed-dose combination product containing the active agents Fluticasone Propionate and Salmeterol. This is a prescription-only medication classified as a Combination Antiasthmatic and Chronic Obstructive Pulmonary Disease (COPD) Preparation. The formulation is structurally identical to the well-established combination widely utilized for chronic airway management and is primarily intended to exert a topical effect directly on the lungs.

Core Composition and Therapeutic Rationale

The medicine's identity is defined by its two principal synthetic components: Fluticasone Propionate, an Inhaled Corticosteroid (ICS), and Salmeterol, a Long-Acting beta2-Agonist (LABA). This rationale for combining an anti-inflammatory agent with a bronchodilator is clinically recognized by major respiratory guidelines as a standard of care for patients whose chronic condition requires both symptom control and sustained inflammation management. This dual-agent strategy ensures the medication addresses both underlying inflammatory processes and the tightening of bronchial muscles.

Available Forms and Therapeutic Positioning

Aroflo is administered to the lungs via the route of oral inhalation. It is manufactured as a pressurized inhalation aerosol in a metered-dose inhaler (MDI) or as a dry powder inhalation (DPI) system. This medication is positioned for long-term maintenance treatment; its distinguishing feature is its established long duration of action, which is designed to provide regular, predictable control of airflow obstruction for patients requiring consistent therapeutic input throughout the day.

Regulatory References

  1. EMA Referral
  2. NIH Review
  3. Mayo Clinic

What side effects are possible with Aroflo?

Possible Side Effects and Safety Information

The safety profile for Aroflo (Fluticasone Propionate/Salmeterol) is based on official classifications from government regulatory documents, outlining adverse reactions by frequency and affected body system.

Adverse Reactions by Frequency

Adverse reactions documented in regulatory sources are classified based on how often they may occur:

Frequency Examples of Officially Listed Adverse Reactions
Very Common Headache, Nasopharyngitis.
Common Oral candidiasis, Hoarseness (dysphonia), Muscle cramps, Arthralgia, Hypokalaemia. In patients with COPD, pneumonia is classified as common.
Uncommon Tremor, Palpitations, Tachycardia, Anxiety, Hyperglycaemia, Cataract.
Rare Paradoxical bronchospasm, Glaucoma, Adrenal suppression, Cushing’s syndrome, Severe hypersensitivity reactions.

Serious Adverse Reactions and Systemic Concerns

The regulatory label highlights the potential for Paradoxical Bronchospasm, a rapid, severe worsening of breathing documented as a rare but serious adverse reaction. Systemic effects of the corticosteroid component, such as Hypercorticism and Adrenal Suppression, are officially noted risks, particularly with prolonged use.

Population and Duration Safety Notes

The safety profile includes specific considerations for certain patient groups. An increased risk of Pneumonia is documented for patients using this medication for COPD. For pediatric patients, the possibility of Growth Retardation is noted. Furthermore, long-term exposure to inhaled corticosteroids is associated with the risk of developing Glaucoma, Cataracts, and Decreased Bone Mineral Density.

Safety Restrictions

This medication is not authorized for use to treat acute, sudden shortness of breath. It is officially restricted from being used concomitantly with any other medicine containing a Long-Acting Beta₂-Agonist (LABA) component.

Overdose and Emergency Response

Overdose Manifestations and Required Actions

The official overdose profile for Aroflo is defined by the effects of its two components, Salmeterol and Fluticasone Propionate, as documented in government regulatory sources.

Category Documented Official Information
Acute Overdose Symptoms Primarily includes exaggerated beta2-agonist effects such as tachycardia, palpitations, tremor, hypokalemia, and hyperglycemia. Severe outcomes may include ventricular arrhythmias or cardiac arrest.
Chronic Overdose Risk Repeated excessive dosing of the Fluticasone component is associated with adrenal suppression, potentially leading to a temporary loss of HPA axis function.
Immediate Help-Seeking Immediate medical attention must be sought for any suspected overdose or when severe symptoms are present. Urgent care is required.

Official Management and Monitoring

Management of overdose is symptomatic and supportive, as described in regulatory labeling.

Category Regulator-Mandated Action
Monitoring Continuous cardiac monitoring, assessment of serum potassium and glucose levels, and evaluation of adrenocortical function are required.
Antidote Status No specific antidote is known for the Fluticasone component. For severe Salmeterol effects, the use of cardioselective beta-blockers may be considered, but only with extreme caution due to the documented risk of precipitating bronchospasm.

The official information strictly outlines these documented manifestations and the subsequent regulator-mandated supportive procedures for the management of an overdose.

Therapeutic Uses of Aroflo

What Aroflo Treats: Main Uses and Benefits

This medication may be part of the long-term management of chronic respiratory diseases. It is commonly used for the regular maintenance of conditions presenting with episodic or fluctuating manifestations, such as asthma and Chronic Obstructive Pulmonary Disease (COPD), including its manifestations like chronic bronchitis and emphysema.


Symptom Management and Functional Support

This medication may be used to address symptom clusters that may become intense or disruptive, providing support that helps ease the overall symptom load of obstructive symptoms like persistent wheezing, chronic cough, and noticeable shortness of breath. It is relevant for adults, adolescents, and may also be used in pediatric patients with asthma.

“The medication may assist with providing supportive relief that helps patients cope more steadily with symptom fluctuations.”

In clinical scenarios, Aroflo is applied across domains where additional symptomatic support is needed to help maintain a sense of stability. The treatment may assist with providing supportive relief to manage challenging, recurrent manifestations that disrupt daily stability, contributing to the management of frequency and severity of future disease exacerbations.

Quick Fact: Relief for Persistent Symptoms
This medication is relevant for conditions characterized by persistent airflow obstruction associated with chronic maintenance contexts.

This may provide functional support that assists with maintaining stability and contributes to improved day-to-day comfort.

Regulatory References

  1. NIH MedlinePlus overview of Fluticasone and Salmeterol

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Aroflo — Official Regulatory Information

Eligibility scope

Category Official Regulatory Statement
Populations for whom use is allowed Asthma: Adults, adolescents (aged ge 12 years), and children (aged ge 4 years). COPD: Only adults. Must be patients whose condition is not adequately controlled on an inhaled corticosteroid alone.
Populations for whom use is contraindicated Patients experiencing acute asthma or COPD deterioration; individuals with known severe hypersensitivity to milk proteins (DPI) or any excipients; patients concurrently using another Long-Acting beta2-Agonist.
Age-related eligibility rules Safety and efficacy have not been established in children younger than 4 years of age for asthma treatment.
Condition-specific eligibility rules Use with caution in patients with Hepatic Impairment (liver disease) due to reduced drug clearance. No specific dose adjustment is needed for Renal Impairment (kidney disease).
Pregnancy and lactation eligibility status During pregnancy, use is considered only if the potential benefit justifies the potential risk. It is unknown if the components are excreted into human milk during lactation.
Eligibility-related restrictions Use with caution in patients with severe cardiovascular disorders, active or quiescent infections (e.g., tuberculosis), Diabetes Mellitus, and Thyrotoxicosis.

Eligibility classifications (high-level)

Category Official Regulatory Statement
Eligibility severity classification Contraindicated (Acute Status, Allergy, Concurrent LABA use); Use with Caution (Comorbidities, Hepatic Impairment); Not Established (Pediatric lt 4 years).
Eligibility-context constraints Restricted to long-term maintenance treatment; prohibited for rescue use.

Resulting eligibility structure

Official eligibility statements:

  • Use is restricted to long-term maintenance in adults and children aged 4 years and older for asthma, and adults only for COPD, limited to patients requiring dual therapy.
  • The medicine is contraindicated for the treatment of acute asthma attacks and in patients with a history of severe milk protein allergy or simultaneous use of another LABA.
  • Caution is mandated in patients with severe cardiovascular disorders, existing infections, or systemic conditions such as diabetes and hepatic impairment.

Connection to the overall eligibility profile (2–4 sentences): Regulatory documentation defines eligibility for Aroflo by specifying that its role is strictly for long-term maintenance, establishing a clear line that its use is contraindicated for any acute breathing problems. Eligibility is further defined by mandatory age cut-offs, the severity of the patient's condition, and conditional restrictions related to cardiovascular, hepatic, and metabolic comorbidities, requiring caution in those populations.

What should I know about interactions with other medicines?

Aroflo Interactions with other medicines and products

This section details documented interaction patterns for Aroflo (Fluticasone Propionate/Salmeterol) based on official regulatory labeling. The medicine's interaction profile is categorized by its two active components.

Interaction Category Interacting Agents / Restrictions Officially Documented Outcome
Co-Administration Prohibited Other Long-Acting beta2-Agonists (LABAs) Risk of overdose from additive beta-adrenergic effects.
Metabolic Restriction Strong Cytochrome P450 3A4 (CYP3A4) Inhibitors (e.g., Ritonavir, Ketoconazole) Use is not recommended. Increases systemic exposure to both active ingredients, raising the risk of systemic corticosteroid and cardiovascular effects.
Pharmacodynamic Antagonism Non-selective beta-Blockers Can oppose the bronchodilatory effect of Salmeterol and may precipitate severe bronchospasm.
Pharmacodynamic Potentiation Non-Potassium-Sparing Diuretics, MAOIs, TCAs Diuretics may worsen hypokalemia or ECG changes. MAOIs and TCAs may potentiate the vascular effects of Salmeterol.
Food/Substance Grapefruit Juice Acts as a CYP3A4 inhibitor, which can increase the systemic plasma concentration of Fluticasone Propionate.

Both Fluticasone Propionate and Salmeterol are primarily cleared by hepatic metabolism, which defines the most clinically significant pharmacokinetic interactions. This pathway results in the formal restriction against strong CYP3A4 inhibitors due to increased systemic concentrations. Regulatory documents also note that the impairment of liver function may lead to accumulation of the components in plasma, necessitating monitoring in the hepatic impairment population. The overall profile emphasizes avoiding both metabolic inhibition and additive pharmacologic effects.

Mechanism of Action

Sustained Bronchial Dilation via beta2-Adrenergic Agonism

This domain describes how Salmeterol achieves sustained modulation of smooth muscle tone by acting as a long-acting agonist on the beta2-Adrenergic Receptor (beta2-AR) in the lung. This interaction activates the cAMP signaling pathway, which results in the sustained relaxation of the bronchial smooth muscle. The physiological consequence of this is active airway dilation.


Genomic Suppression of Airway Inflammation

The anti-inflammatory mechanism is controlled by Fluticasone Propionate, which targets the intracellular Glucocorticoid Receptor (GR). Upon binding, the steroid executes Transrepression, a mechanism that directly suppresses the genes responsible for producing pro-inflammatory mediators like cytokines and chemokines. This fundamental action modulates mucosal edema and cellular infiltration, influencing the biological components of airway reactivity.


Functional Synergy and Receptor Stabilization

The mechanism features a vital interaction where the anti-inflammatory component actively upregulates the number and function of the beta2-ARs, enhancing the effect of the bronchodilator. This synergy influences the regulation of beta2-ARs, potentially mitigating the development of receptor desensitization over time.

Dosage and Administration Information

Official Administration Guidelines for Aroflo

Aroflo is a fixed-dose combination medicine (Fluticasone Propionate/Salmeterol) administered exclusively by Oral Inhalation for consistent, long-term maintenance. The medication is available as both an Inhalation Powder (DPI) and a Pressurized Inhalation Aerosol (MDI) system, with specific dosing and procedural instructions.


Administration Scope and Scheduling

Feature Standard Instruction
Route of administration Oral Inhalation only. Delivered directly to the lungs.
Dosing schedule Twice daily (BID), separated by approximately 12 hours (morning and evening). The dose should not exceed two inhalations per 24 hours.
Use Context Designated solely for long-term maintenance treatment. It is not approved for use in relieving acute bronchospasm or sudden breathing problems.

Procedural and Population Rules

Dosing Regimens are initiated at a strength appropriate to the patient's condition and titrated to the lowest effective dose. Adult dosing strengths vary (e.g., 100/50 mug to 500/50 mug) for asthma, while a specific dose (e.g., 250/50 mug) is typically approved for COPD maintenance. For pediatric patients (4 to 11 years), a specific low strength is designated for twice-daily asthma use.

Procedural Condition: Immediately after each inhalation, it is a required step to rinse the mouth with water and spit it out to complete the administration process. If a dose is missed, it is advised to skip the missed dose and take the next scheduled dose at the regular time; the dose should not be doubled to compensate.

Recent Clinical Evidence

Research Evidence Overview for Aroflo


Evidence for Use in Chronic Obstructive Pulmonary Disease (COPD) Maintenance

The combination product was studied for the long-term management of COPD. Research was conducted using multi-site Randomized Controlled Trials (RCTs), alongside long-term observational data and systematic reviews. These studies were applied in research contexts involving fluctuating or unstable symptoms of COPD, primarily focusing on adults with moderate to very severe airflow obstruction who had experienced episodes of heightened symptom activity, such as frequent exacerbations, in the past.

Studies monitored the frequency of moderate and severe exacerbations, reporting the observed patterns in the combination group compared to the individual components alone. Studies reported measurements of functional measures like FEV1, describing patterns that differed between observed populations during the study period. However, evidence remains limited regarding what the research measured about the rate of lung function decline over many years. Furthermore, findings were mixed across studies concerning the comparison of the dual therapy versus the long-acting bronchodilator component alone regarding endpoints like long-term survival.


Evidence for Use in Persistent Asthma Management

For the management of persistent asthma, the research includes controlled RCTs designed to compare the combination product against inhaled corticosteroid (ICS) monotherapy. These studies involved adults, adolescents, and pediatric patients (down to four years old) whose asthma was not adequately controlled by an ICS alone. Research monitored asthma control, which includes tracking the frequency of symptom-free days and nights and the amount of rescue medication used. Another primary focus was monitoring the rate of severe asthma exacerbations that necessitated additional interventions.

Studies report how symptoms evolved in the observed populations, describing patterns of outcomes related to measures of asthma control and severe exacerbations in the combination groups compared to patients using ICS alone during the study periods. Research monitored the functional measures of pulmonary airflow (such as FEV1) and patient-reported outcomes describing perceived symptom discomfort.


What Remains Uncertain in the Research Record

While the combination product has been extensively studied, certain aspects remain topics of ongoing research or uncertainty. Data for certain groups remain insufficient; for example, there is limited information regarding the most severe subsets of asthma patients who have a history of life-threatening events. Comparative evidence is lacking for head-to-head, long-term comparisons against other fixed-dose combination treatments.

Findings were mixed or inconsistent in some research regarding the long-term impact on major outcomes, such as the rate of FEV1 decline or all-cause mortality in COPD, when research compared the combination to the long-acting bronchodilator component alone. Therefore, the certainty remains low regarding the full scope of long-term effects beyond the outcomes related to episodic or acute changes described in the trials.

Key Studies & References

  1. Label: FLUTICASONE PROPIONATE AND SALMETEROL powder, metered (FDA/DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Aroflo (FAQ)

Q: How long does it typically take to feel the effects of Aroflo?

Regulatory documents indicate that patients may start to see an improvement in their asthma control within about 30 minutes of starting treatment. However, official information also notes that the full, maximum benefit of the medication may take a week or longer to become apparent. The specific time to symptom relief can vary from person to person.

Q: Are children eligible to use Aroflo for specific conditions?

Official drug labels state that Aroflo (Fluticasone/Salmeterol) is indicated for the maintenance treatment of asthma in patients who are 4 years of age and older. Specific doses and formulations are defined in the regulatory labeling for pediatric patients (such as those 4 to 11 years old) compared to adults. Its approved use in children is generally limited to asthma.

Q: How do official sources describe the process of stopping Aroflo?

The decision to stop Aroflo is generally made following consultation with a healthcare professional. For individuals whose condition is well-controlled, a doctor may assess whether stepping down the therapy is appropriate. Regulatory documents advise against suddenly stopping the medication without professional guidance due to the potential risk of systemic effects.

Q: Does Aroflo have any known long-term side effects that official studies have investigated?

Yes, official regulatory labeling and clinical trials have investigated potential long-term risks associated with inhaled corticosteroids like the component in Aroflo. These potential effects include a decreased bone mineral density, the development of cataracts, and glaucoma. For children, the potential for effects on growth has also been monitored in studies, and assessment of these concerns is commonly outlined in regulatory guidance.

Q: What is the main difference between Aroflo and other similar medications?

Aroflo is a fixed-dose combination product, meaning it contains two active medications in a single device. One ingredient is a synthetic corticosteroid (Fluticasone Propionate), which helps reduce inflammation, and the other is a long-acting beta-agonist (Salmeterol), which helps relax airway muscles. This dual-action distinguishes it from products that contain only one of these two types of ingredients.

Q: Can Aroflo cause dizziness or lightheadedness?

Official sources list dizziness as an adverse reaction that may potentially occur in some patients. This type of effect is related to the actions of the long-acting beta-agonist component on the body. If this occurs, the official guidance suggests exercising caution.

Q: Do older adults need to use Aroflo differently than younger adults?

Regulatory documents note that dose selection for elderly patients should generally be approached with caution. This is because older patients may have a greater frequency of decreased function in organs like the liver or kidneys, or may be taking multiple medications. Official documents indicate that monitoring of this population may be necessary.

Q: Can Aroflo affect sleep patterns?

Some official adverse reaction lists mention sleep problems, such as insomnia or trouble sleeping. These types of effects can be related to the action of the beta-agonist component on the central nervous system. Awareness of this potential side effect is noted in official information.

Q: Does Aroflo have a withdrawal period if someone stops taking it?

If the medication is stopped, regulatory guidelines caution about the risk of adrenal insufficiency, particularly for patients who have been on high doses or are switching from oral steroid treatment. This is related to the corticosteroid component. Any change in treatment is generally managed and monitored by a healthcare professional.

Q: Is Aroflo safe to use during pregnancy (informational context)?

Official regulatory information states that there is limited human experience with Aroflo (Fluticasone Propionate/Salmeterol) during pregnancy. Therefore, use of the medicine during pregnancy involves weighing the expected benefits against potential risks to the fetus, as documented in the label.

Q: Can Aroflo be taken at the same time as vitamin supplements?

Official interaction sections note the importance of providing a complete list of products, including vitamins and herbal supplements, to the healthcare provider. While no specific restriction is listed for common vitamins, this information is necessary because Aroflo's metabolism can be affected by various other substances.

Q: Why is Aroflo sometimes prescribed for conditions other than its main use (non-directive)?

The official regulatory documentation for Aroflo clearly defines its approved uses, which are the long-term maintenance treatment of asthma and COPD. Regulatory bodies do not provide information or guidance regarding the use of the medicine for conditions that are outside of its official indications.

Q: How long does Aroflo stay in the body after the last dose?

Pharmacokinetic data indicates that the two active components of Aroflo are cleared from the body at different rates. Salmeterol has an estimated terminal half-life of about 5.5 hours, and Fluticasone Propionate has an estimated terminal half-life of 5.8 hours. The half-life refers to the time it takes for the concentration of the substance in the body to be reduced by half.

Q: Can Aroflo be split or crushed if a patient has trouble swallowing?

No. Aroflo is not a solid oral tablet or capsule that can be ingested. It is administered only as an oral inhalation, delivered directly to the lungs via a specially designed powder or aerosol device. Altering the medication in this way would compromise the administration process and effectiveness, as it is only intended for inhalation.

Q: Is Aroflo available over the counter in some countries?

The fixed-dose combination of Fluticasone Propionate and Salmeterol is generally classified by regulatory bodies as a prescription-only medication in countries where it is regulated. It is not typically available for purchase without a prescription.

Q: Can someone who is breastfeeding use Aroflo (informational context)?

Official regulatory sources confirm that there is no data available on whether the components of Aroflo pass into human milk. The use of the medication while breastfeeding involves a professional assessment to weigh the importance of the medicine to the patient against any potential risk to the breastfed infant.

Q: What should be done if someone experiences a severe interaction while on Aroflo?

Official documentation states that in the event of any severe adverse effect, such as an immediate worsening of breathing (paradoxical bronchospasm) or an allergic reaction, the use of Aroflo is advised to be stopped right away. Alternative therapy should then be initiated under the immediate direction of a qualified healthcare professional.

Q: Is the effectiveness of Aroflo dependent on taking it with food?

The official administration instructions for Aroflo do not include any specific requirement to take the medication at the same time as a meal. The instructions primarily focus on the correct inhalation technique, the twice-daily schedule, and rinsing the mouth after use.

Q: Do regulatory documents mention any risk of dependence with Aroflo?

Regulatory documents state that Aroflo has not been studied for its potential to cause physical or psychological dependence or abuse. The medication is not a controlled substance, and there is no known association with drug abuse listed in official labeling.

Q: What is the typical timeframe for a doctor to review the effects of Aroflo?

Official guidelines recommend that a patient's condition should be assessed at regular intervals after starting Aroflo to monitor control. For patients whose asthma is not responding as expected to a starting dose, follow-up for potential dose adjustment is suggested after approximately two weeks.

Q: Is Aroflo considered a high-risk medication by health authorities?

Official labeling includes a boxed warning concerning the Salmeterol component. Long-acting beta-agonists (LABAs) have been associated with an increased risk of asthma-related death when used alone. The labeling specifies that Aroflo is intended for patients whose asthma is not adequately controlled by other standard treatments.

Q: Are there any restrictions on driving or operating machinery while taking Aroflo?

Official documents advise that patients should be cautious, as side effects such as tremor or dizziness, which can occur with Aroflo, may potentially affect the ability to drive or use machinery. The expectation is for patients to be aware of how the medicine affects them before engaging in such activities.

Q: Does taking Aroflo require routine blood tests or monitoring?

Yes, regulatory documents advise that certain systemic effects require monitoring. Patients should be checked periodically for potential changes in blood chemistry, such as potassium levels (hypokalemia) and blood glucose levels (hyperglycemia). Monitoring of bone mineral density is also advised.

Q: Can Aroflo affect the results of lab tests?

The use of Aroflo is associated with potential changes in blood chemistry which could impact lab test results. The regulatory labeling mentions the potential for decreases in blood potassium (hypokalemia) and increases in blood glucose (hyperglycemia). Monitoring of these levels is generally advised.

Q: Are there any specific warnings about kidney or liver function when using Aroflo?

Official documents note that the active components are primarily cleared from the body by the liver. Therefore, monitoring patients with impaired liver function is noted in official documentation. While there is no specified dose adjustment for kidney impairment, caution is generally advised.

Q: What does official data say about Aroflo use in patients with pre-existing heart conditions?

Aroflo should be used with caution in patients with cardiovascular disorders, such as heart rhythm issues, coronary insufficiency, or high blood pressure. This caution is due to the potential for the beta-agonist component to cause cardiovascular effects, including palpitations and an increased heart rate.

Q: Is Aroflo available in a generic version?

The fixed-dose combination of Fluticasone Propionate and Salmeterol has been approved for use under various brand names. In many regulatory regions, approved generic versions are also available.

Q: What are the official sources of information for Aroflo that patients can access?

Official sources of patient information include drug labels published by government health agencies, such as the US Food and Drug Administration (FDA) through platforms like DailyMed or MedlinePlus. Similar patient information leaflets are provided by the European Medicines Agency (EMA) and other national regulatory bodies.

How should Aroflo be stored and disposed of?

Official Storage and Disposal Requirements

Aroflo (Fluticasone Propionate/Salmeterol) must be stored and handled according to specific regulatory guidelines to maintain its stability and effectiveness.

Storage Conditions

Requirement Official Stipulation
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Protect from direct heat, direct sunlight, and moisture. Do not freeze pressurized canisters.
Packaging Keep the Dry Powder Inhaler (DPI) in its original foil pouch until first use. The MDI canister must not be punctured or exposed to fire.

Disposal and Stability

The DPI form must be discarded 1 month after opening the foil pouch or when the dose counter reaches zero. All inhalers must be stored out of the sight and reach of children. Unused or expired product should be disposed of via a drug take-back program or by following specific household trash guidelines.

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

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