Advair Diskus 100/50mcg (green)60s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways by inhibiting multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic mediated inflammation. Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA). It selectively stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. The long duration of action is due to its lipophilic side chain, which binds to an 'exosite' on the receptor, allowing the active portion of the molecule to repeatedly interact with the receptor.

Urgent 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 immediate medical attention:

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 or low blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure
Rapid or abnormal heartbeat
Shakiness
Feeling nervous or agitated
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Abnormal burning, numbness, or tingling sensations
Choking
Changes in voice
Seizures
Bone pain
Sleep disturbances
Feeling extremely tired or weak
Vaginal itching or discharge
Weight gain
Mouth irritation or mouth sores
Redness or white patches in the mouth or throat

Important Warning: This medication can cause severe breathing problems, which may be life-threatening. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek immediate medical attention.

Other Possible 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
Upset stomach 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. 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 drug. Certain medications used to treat HIV, infections, depression, and other conditions should not be taken with this medication. Your doctor or pharmacist can advise you on potential interactions.
If you have a milk allergy.
* It is crucial to note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.

To ensure your safety, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage 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 your blood sugar levels. Immediately contact your doctor if your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently.

Dosage and Administration
Do not exceed the prescribed dose or use this medication more often than directed. 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.

Additional Steroid Needs
In cases of severe injury, surgery, or infection, you may require extra doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need additional steroids in such 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 lead to weak bones (osteoporosis). 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 avoid close contact with individuals 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.

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) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of Cushing's syndrome, adrenal suppression, and cardiovascular events (e.g., QTc prolongation, palpitations, tachycardia).

• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and produce severe bronchospasm, especially in patients with asthma. Cardioselective beta-blockers should be used with caution.
• Diuretics (loop or thiazide): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at high doses.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of salmeterol (e.g., QTc prolongation, arrhythmias).

• Other sympathomimetics: Concomitant use may potentiate adverse cardiovascular effects.
• Other long-acting beta2-agonists (LABAs): Do not use with other LABA-containing products (e.g., formoterol, arformoterol, indacaterol, olodaterol) due to risk of overdose.
• QTc-prolonging drugs: Increased risk of ventricular arrhythmias with salmeterol.

• Not specifically identified for minor interactions with significant clinical impact.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, chest tightness)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Nocturnal asthma symptoms
• Signs of oral candidiasis (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, mood changes)
• Signs of adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, dizziness, hypotension) especially during stress or withdrawal
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Signs of pneumonia (fever, increased cough, change in sputum, chest pain)
• Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate, tremor)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma poses a greater risk to both mother and fetus than potential risks from medication. Monitor for signs of adrenal insufficiency in neonates exposed to ICS in utero.

L3 (Moderately Safe). Fluticasone and salmeterol are excreted into human milk in small amounts. The amount of drug transferred to the infant is likely low due to low systemic absorption in the mother. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for Advair Diskus and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. Monitor breastfed infants for signs of systemic corticosteroid effects (e.g., growth suppression) or beta-agonist effects (e.g., irritability, tremor).

Approved for children 4 years and older. Monitor growth velocity regularly as inhaled corticosteroids can cause a reduction in growth velocity in some pediatric patients. The lowest effective dose should be used. Risk of oral candidiasis and pneumonia (less common than in adults).

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in patients with cardiovascular disease or risk factors for osteoporosis.

• Advair Diskus is a maintenance inhaler and should be used regularly, not for acute asthma attacks. Patients must have a separate rescue inhaler (e.g., albuterol).
• Proper inhalation technique is crucial for efficacy. Ensure patients understand how to use the Diskus device.
• Always instruct patients to rinse their mouth and spit out the water after each dose to minimize the risk of oral candidiasis (thrush) and systemic absorption of fluticasone.
• The black box warning regarding increased risk of asthma-related death with LABAs is important to discuss with patients, emphasizing that Advair should only be used as part of a combination therapy for asthma, not as monotherapy.
• Monitor for signs of systemic corticosteroid effects, especially with long-term, high-dose use, including adrenal suppression, bone mineral density changes, cataracts, and glaucoma.
• Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors, which can significantly increase systemic exposure to both fluticasone and salmeterol.
• In patients with COPD, Advair Diskus has been associated with an increased risk of pneumonia; monitor for signs and symptoms of respiratory infection.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone, beclomethasone)
• Long-Acting Beta2-Adrenergic Agonists (LABA) monotherapy (e.g., salmeterol, formoterol) - NOT recommended for asthma without ICS
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations)
• Biologic therapies (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) for severe asthma
• Short-acting beta2-agonists (SABAs) for rescue relief

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. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.