Flutic/vilan 200-25mcg Oral Inh(30)

Manufacturer PRASCO LABORATORIES Active Ingredient Fluticasone and Vilanterol(floo TIK a sone & VYE lan ter ol) Pronunciation floo TIK a sone & VYE lan ter ol
It is used to treat COPD (chronic obstructive pulmonary disease).It is used to treat asthma.Do not use this drug to treat intense flare- ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
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Drug Class
Corticosteroid/Long-Acting Beta2-Adrenergic Agonist (LABA) Combination
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Pharmacologic Class
Inhaled Corticosteroid (ICS) / Selective Beta2-Adrenergic Agonist
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Pregnancy Category
Not available
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FDA Approved
May 2013
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medicine is an inhaler that contains two different medications: a corticosteroid (fluticasone) to reduce inflammation in your lungs and a long-acting bronchodilator (vilanterol) to help open your airways. It is used once a day to help prevent asthma symptoms and improve breathing. It is NOT for sudden breathing problems.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. This medication is for inhalation only. Take it at the same time every day to establish a routine. Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling better.

Important Usage Instructions

Do not remove the inhaler from its foil tray until you are ready to use it for the first time.
After each use, close the device to preserve the medication and prevent contamination. Only open the device when you are ready to take a dose.
Avoid taking the device apart or washing it, as this can damage the mechanism and affect the medication's potency.
Do not use this inhaler with a spacer, as it is designed for direct inhalation.
Refrain from breathing out into the device to prevent moisture buildup and ensure accurate dosing.
After each use, rinse your mouth with water to remove any residual medication. Do not swallow the rinse water; instead, spit it out.

Using Multiple Inhaled Medications

If you are taking more than one inhaled medication, consult your doctor to determine which medication to use first. This will help you establish a safe and effective routine.

Storing and Disposing of Your Medication

Store your inhaler at room temperature in a dry place, away from bathrooms and areas exposed to heat and sunlight. The inhaler features a dose counter that tracks the number of doses remaining. Dispose of the inhaler when the counter reaches "0", six weeks after opening the foil container, or after the expiration date, whichever occurs first.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or use extra doses to make up for a missed one.
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Lifestyle & Tips

  • Use the inhaler exactly as prescribed, once daily, at the same time each day.
  • Do not use more than one inhalation per day.
  • Do not use this medicine for sudden breathing problems; always carry a rescue inhaler (e.g., albuterol) for acute symptoms.
  • Rinse your mouth with water and spit it out after each dose to help prevent oral thrush (a fungal infection in the mouth). Do not swallow the water.
  • Do not stop using this medicine suddenly without talking to your doctor, even if you feel better.
  • Avoid exposure to triggers that worsen your asthma (e.g., allergens, smoke, pollution).
  • Maintain good hydration and nutrition.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One inhalation (fluticasone furoate 200 mcg and vilanterol 25 mcg) once daily
Dose Range: 200 - 25 mg

Condition-Specific Dosing:

asthma: One inhalation (200/25 mcg) once daily
COPD: One inhalation (100/25 mcg) once daily (Note: 200/25 mcg is not indicated for COPD)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (for 200/25 mcg dose, 12 years and older for asthma)
Adolescent: For asthma, 12 years and older: One inhalation (200/25 mcg) once daily
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary
Moderate: No dosage adjustment necessary
Severe: No dosage adjustment necessary
Dialysis: No dosage adjustment necessary

Hepatic Impairment:

Mild: No dosage adjustment necessary
Moderate: Use with caution; consider 100/25 mcg dose if clinically appropriate
Severe: Use with caution; consider 100/25 mcg dose if clinically appropriate

Pharmacology

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Mechanism of Action

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing hyperresponsiveness. Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects.
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Pharmacokinetics

Absorption:

Bioavailability: Fluticasone furoate: ~15.2% (oral), Vilanterol: ~27.3% (oral)
Tmax: Fluticasone furoate: 0.5-2 hours, Vilanterol: 5-10 minutes
FoodEffect: Not applicable (inhaled)

Distribution:

Vd: Fluticasone furoate: 661 L, Vilanterol: 165 L
ProteinBinding: Fluticasone furoate: >99%, Vilanterol: >99%
CnssPenetration: Limited

Elimination:

HalfLife: Fluticasone furoate: ~24 hours (terminal), Vilanterol: ~11 hours (terminal)
Clearance: Fluticasone furoate: 65.4 L/hr, Vilanterol: 108 L/hr
ExcretionRoute: Fluticasone furoate: Feces (primarily), Vilanterol: Feces (primarily), Urine (minor)
Unchanged: Fluticasone furoate: <1% (urine), Vilanterol: <2% (urine)
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Pharmacodynamics

OnsetOfAction: Vilanterol: Within minutes (typically 10-15 minutes)
PeakEffect: Vilanterol: 1-2 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, increase the risk of asthma-related death. Data from a large, randomized, placebo-controlled clinical trial in asthma showed that LABAs increase the risk of asthma-related death. This finding is considered a class effect of LABAs. The safety and effectiveness of BREO ELLIPTA in patients with asthma have not been established in patients <12 years of age. BREO ELLIPTA is not indicated for the relief of acute bronchospasm.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, or a rapid heartbeat
Shakiness or feeling nervous and excitable
Bone pain
Changes in vision, eye pain, or severe eye irritation
Mouth irritation or mouth sores
Redness or white patches in the mouth or throat
Feeling extremely tired or weak

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache
Runny nose
Nose or throat irritation
Common cold symptoms
Flu-like symptoms
Voice changes
Back pain
* Joint pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening breathing problems or asthma attacks despite using the medicine
  • Chest pain or fast/irregular heartbeat
  • Severe tremor or nervousness
  • Signs of infection (fever, chills, increased mucus, change in mucus color)
  • White patches in your mouth or throat (oral thrush)
  • Blurred vision or eye pain
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Muscle cramps or weakness (signs of low potassium)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a milk allergy.
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Blood Sugar Control
If you have diabetes (high blood sugar), this medication may cause your blood sugar levels to rise. Discuss with your doctor how to manage your blood sugar levels effectively. Monitor your breathing problems closely, and contact your doctor immediately if they worsen, if your rescue inhaler becomes less effective, or if you need to use it more frequently.

Dosage and Administration
Do not exceed the recommended dose or use this medication more often than prescribed. Overdose can be fatal. Consult your doctor if you have any concerns.

Transitioning from Oral Steroids
When switching from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor immediately.

Stressful Situations
In cases of severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in such situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this risk with your doctor and schedule regular eye exams as recommended.

Bone Health
Long-term use of this medication may also lead to osteoporosis (weak bones). Consult your doctor to determine if you are at higher risk or have any questions. Have a bone density test as advised by your doctor.

Infection Risk
You may be more susceptible to infections while taking this medication. Practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu.

Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, contact your doctor immediately.

Growth and Development in Children and Teens
This medication may affect growth in some cases. Children and teens may require regular growth checks. Discuss this risk with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

COPD Patients
If you have chronic obstructive pulmonary disease (COPD), you are at a higher risk of developing pneumonia, which can be severe or even fatal. This medication may increase this risk, and you may be more likely to require hospitalization for pneumonia. Discuss this risk with your doctor.
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Overdose Information

Overdose Symptoms:

  • Chest pain
  • Fast or irregular heartbeat (palpitations)
  • Tremor
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Weakness
  • Seizures
  • Hypokalemia (low potassium)
  • Hyperglycemia (high blood sugar)
  • Signs of adrenal suppression (e.g., fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, cobicistat-containing products): May significantly increase systemic exposure to fluticasone furoate and vilanterol, leading to increased risk of cardiovascular and systemic corticosteroid adverse effects.
  • Other long-acting beta2-adrenergic agonists (LABAs): Concomitant use is not recommended due to risk of additive cardiovascular effects.
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Moderate Interactions

  • Beta-blockers (non-cardioselective): May antagonize the effect of vilanterol and cause severe bronchospasm in patients with asthma. Use with caution; consider cardioselective beta-blockers if necessary.
  • Diuretics (thiazide or loop): May potentiate hypokalemia and/or ECG changes associated with beta-agonists. Use with caution.
  • Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of vilanterol on the cardiovascular system. Use with extreme caution.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pulmonary function tests (FEV1)

Rationale: To establish baseline lung function and assess disease severity.

Timing: Prior to initiation of therapy

Adrenal function (e.g., morning cortisol)

Rationale: To assess for potential adrenal suppression, especially in patients transitioning from oral corticosteroids or on high doses.

Timing: Prior to initiation, if clinically indicated

Ophthalmologic exam (e.g., for cataracts, glaucoma)

Rationale: Corticosteroids can increase risk of ocular effects.

Timing: Prior to initiation, especially in patients with risk factors or long-term use

Bone mineral density

Rationale: Long-term corticosteroid use can affect bone density.

Timing: Prior to initiation, especially in patients with risk factors for osteoporosis

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Routine Monitoring

Pulmonary function tests (FEV1)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)

Target: Improvement from baseline, maintenance of optimal lung function

Action Threshold: Worsening FEV1, increased symptoms, or lack of improvement may indicate need for re-evaluation of therapy.

Symptoms of asthma control (e.g., frequency of rescue inhaler use, nocturnal awakenings)

Frequency: Regularly (e.g., at each follow-up visit)

Target: Minimal symptoms, infrequent rescue inhaler use

Action Threshold: Increased symptoms, increased rescue inhaler use, or exacerbations may indicate inadequate control.

Signs/symptoms of oral candidiasis

Frequency: At each follow-up visit

Target: Absence of oral thrush

Action Threshold: Presence of thrush requires treatment and proper rinsing technique reinforcement.

Growth in pediatric patients

Frequency: Periodically (e.g., every 3-6 months)

Target: Normal growth velocity

Action Threshold: Growth retardation may necessitate re-evaluation of therapy.

Signs/symptoms of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression)

Frequency: Periodically, especially with high doses or long-term use

Target: Absence of systemic effects

Action Threshold: Presence of effects requires dose reduction or alternative therapy.

Serum potassium, blood glucose, ECG

Frequency: Periodically, especially in patients with pre-existing cardiovascular disease or on concomitant medications that can affect these parameters

Target: Normal ranges

Action Threshold: Significant abnormalities may require intervention or therapy adjustment.

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Symptom Monitoring

  • Increased shortness of breath
  • Increased wheezing
  • Increased cough
  • Increased need for rescue inhaler
  • Chest pain or palpitations
  • Tremor
  • Nervousness
  • Blurred vision
  • Oral thrush (white patches in mouth/throat)
  • Signs of infection (fever, chills, increased sputum)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma in pregnancy poses risks to both mother and fetus. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Limited data; animal studies show some developmental toxicity at high doses.
Second Trimester: Limited data.
Third Trimester: Limited data; potential for beta-agonist effects on labor (inhibition) and neonatal effects (e.g., hyperglycemia, hypokalemia, tremor) if systemic exposure is high.
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Lactation

Caution should be exercised when administered to a nursing woman. It is unknown if fluticasone furoate or vilanterol are excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Infant Risk: Low systemic exposure expected with inhaled administration, but potential for adverse effects on infant is unknown. Monitor for signs of systemic corticosteroid effects or beta-agonist effects in the infant.
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Pediatric Use

Safety and effectiveness for asthma have been established in patients 12 years of age and older. Not indicated for patients younger than 12 years of age for asthma. Not indicated for pediatric patients for COPD. Monitor growth in pediatric patients receiving corticosteroids.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is generally not required based on age alone.

Clinical Information

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Clinical Pearls

  • Breo Ellipta is a once-daily maintenance therapy and should not be used for acute bronchospasm.
  • Patients should be instructed on proper inhaler technique and to rinse their mouth after each use to minimize the risk of oral candidiasis.
  • The 200/25 mcg dose is specifically for asthma; the 100/25 mcg dose is indicated for COPD and asthma.
  • Due to the LABA component, a Black Box Warning exists regarding increased risk of asthma-related death. It should only be used in asthma patients as combination therapy with an ICS.
  • Monitor for systemic corticosteroid effects, especially with long-term use or in patients with risk factors for adrenal suppression.
  • Caution with strong CYP3A4 inhibitors due to increased systemic exposure of both components.
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Alternative Therapies

  • Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone)
  • Long-Acting Beta2-Adrenergic Agonists (LABA) monotherapy (e.g., salmeterol, formoterol) - NOT recommended for asthma without ICS
  • Long-Acting Muscarinic Antagonists (LAMA) (e.g., tiotropium, umeclidinium)
  • Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
  • Oral corticosteroids (for severe exacerbations or refractory disease)
  • Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma
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Cost & Coverage

Average Cost: $300 - $400 per 30 doses (1 inhaler)
Insurance Coverage: Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.