Advair Diskus 500/50mcg (red) 60s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing bronchial hyperreactivity and improving lung function. Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA) that selectively 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.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Chest pain or pressure
Abnormal or rapid heartbeat
Shakiness
Nervousness or excitability
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Burning, numbness, or tingling sensations
Choking
Voice changes
Seizures
Bone pain
Sleep disturbances
Fatigue or weakness
Vaginal itching or discharge
Weight gain
Mouth irritation or sores
Redness or white patches in the mouth or throat

Breathing Problems: A Life-Threatening Condition

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 Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:

Headache
Nausea or vomiting
Throat irritation
* Common cold symptoms

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.

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. Be sure to describe the allergic reaction you experienced.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
Any prescription or over-the-counter medications, natural products, or vitamins you are taking that may interact with this medication. Certain medications used to treat HIV, infections, depression, and other conditions should not be taken with this drug. Your doctor or pharmacist can advise you on potential interactions.
If you have a milk allergy.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (prescription and over-the-counter), natural products, vitamins, and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing regimen.

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

Important Warnings and Cautions

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

Effectiveness and Monitoring

It may take approximately 1 week to experience the full effect of this medication. If you have diabetes (high blood sugar), consult your doctor, as this drug may increase blood sugar levels. Immediately contact your doctor if your breathing problems worsen, your rescue inhaler is less effective, or 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, so it is crucial to follow your doctor's instructions. Discuss any concerns with your doctor.

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 oral steroid doses to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in these situations.

Long-term Use and Potential Risks

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor and schedule regular eye exams as recommended.

Additionally, long-term use may cause osteoporosis (weak bones). Discuss your risk factors with your doctor and undergo bone density tests as advised.

Infection Risk

You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoiding 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 to chickenpox or measles, consult your doctor immediately.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more prone to side effects.

In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary, so consult your doctor.

Pregnancy and Breastfeeding

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

COPD Considerations

If you have Chronic Obstructive Pulmonary Disease (COPD), you are at a higher risk of developing pneumonia. This medication may further increase this risk, so consult your doctor to discuss the potential risks and benefits.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) - concomitant use may increase systemic exposure to fluticasone and salmeterol, leading to increased risk of Cushing's syndrome, adrenal suppression, and cardiovascular effects.

• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and cause severe bronchospasm, especially in patients with asthma. Use with caution, and only if no suitable alternatives.
• Diuretics (thiazide or loop): May potentiate hypokalemia and/or ECG changes associated with beta-agonists.
• Tricyclic antidepressants (TCAs) and Monoamine oxidase inhibitors (MAOIs): May potentiate the cardiovascular effects of salmeterol. Administer with extreme caution, or not at all, to patients being treated with these agents or within 2 weeks of discontinuation.

• Other sympathomimetics: May potentiate adverse cardiovascular effects.
• QTc-prolonging drugs: Increased risk of ventricular arrhythmias with salmeterol.
• Other inhaled corticosteroids: Increased risk of systemic corticosteroid effects.
• Other LABAs: Do not use with other LABA-containing products.

• Not available

• Increased shortness of breath
• Increased cough
• Increased wheezing
• Increased sputum production
• Increased need for rescue inhaler (e.g., albuterol)
• Chest pain or palpitations
• Muscle cramps or weakness (hypokalemia)
• Increased thirst or urination (hyperglycemia)
• Blurred vision or eye pain (glaucoma/cataracts)
• Oral white patches (candidiasis)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma/COPD in pregnancy poses risks to both mother and fetus. Fluticasone is generally preferred among inhaled corticosteroids due to lower systemic absorption. Salmeterol data is limited but no clear evidence of harm.

Fluticasone and salmeterol are minimally excreted into breast milk. Benefits of breastfeeding should be weighed against the potential risk of infant exposure. Generally considered compatible with breastfeeding due to low systemic absorption and low levels in milk.

The 500/50mcg strength is not indicated for pediatric patients. Lower strengths (100/50, 250/50) are approved for asthma in children 4 years and older. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids due to potential for growth suppression.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to cardiovascular adverse effects of LABAs and systemic corticosteroid effects. Use with caution in patients with co-morbidities common in the elderly (e.g., cardiovascular disease, osteoporosis, glaucoma, cataracts, diabetes).

• Advair Diskus 500/50mcg is specifically indicated for maintenance treatment of COPD, not for asthma in adults or children.
• Emphasize the importance of daily, consistent use, even when symptoms are well-controlled.
• Educate patients on the proper Diskus inhalation technique and the importance of rinsing the mouth after each dose to prevent oral candidiasis.
• Stress that Advair is NOT a rescue inhaler and patients should always have a short-acting beta-agonist (SABA) available for acute symptoms.
• Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors, beta-blockers, and drugs that prolong the QTc interval.
• Monitor for systemic corticosteroid effects (e.g., adrenal suppression, bone density loss, cataracts, glaucoma, hyperglycemia) with long-term use, especially at higher doses.
• Patients should be advised not to stop therapy abruptly, as this can lead to adrenal insufficiency.

• Single-agent inhaled corticosteroids (e.g., fluticasone propionate, budesonide, mometasone)
• Single-agent long-acting beta2-agonists (e.g., salmeterol, formoterol, indacaterol, olodaterol)
• Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium, glycopyrronium)
• Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast - for severe COPD with chronic bronchitis)
• Oral corticosteroids (for exacerbations or severe cases, not for maintenance)
• Oxygen therapy (for severe hypoxemia)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.