Advair Diskus 250/50mcg (yellow) 60

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts by binding to glucocorticoid receptors, leading to the transcription of anti-inflammatory proteins and inhibition of pro-inflammatory mediators. This reduces airway hyperresponsiveness and inflammation. Salmeterol xinafoate is a long-acting selective beta2-adrenergic agonist (LABA). It acts locally in the lung to stimulate beta2-receptors on airway smooth muscle, leading to bronchodilation by increasing intracellular cyclic AMP (cAMP) levels, which relaxes bronchial smooth muscle.

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 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, difficulty 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
Voice changes
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

Life-Threatening Breathing Problems

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 mild ones. If you notice any of the following side effects or any other symptoms that concern 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 medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, 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.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.

To ensure your safety, inform your doctor and pharmacist about all the following:
All prescription and OTC medications you are taking
Any natural products or vitamins you are using
Your health problems
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never 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 effects of this medication. If you have diabetes (high blood sugar), consult your doctor, as this medication may increase your blood sugar levels. Regularly monitor your condition and contact your doctor immediately 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 recommended dose or use this medication more often than prescribed. Overdosing on this type of medication 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 of 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 Requirements
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 undergo regular eye exams as recommended.

This medication may also cause osteoporosis (weak bones) with long-term use. 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 the 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, 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.

This medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor.

If you are pregnant, planning to become pregnant, or 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. Consult your doctor to discuss the potential risks and benefits.

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Patients with severe hypersensitivity to milk proteins or any component of Advair Diskus.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin): May significantly increase systemic exposure to fluticasone and salmeterol, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) and cardiovascular effects (e.g., QTc prolongation, palpitations, tachycardia). Co-administration is not recommended.
• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and produce severe bronchospasm in patients with asthma. Generally, patients with asthma should not be treated with beta-blockers. If necessary, cardioselective beta-blockers should be used with caution.

• Diuretics (thiazide or loop): ECG changes and/or hypokalemia may result from beta-agonists, especially with concomitant use of non-potassium-sparing diuretics. Use with caution.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of salmeterol on the cardiovascular system. Administer with extreme caution to patients being treated with MAOIs or TCAs, or within 2 weeks of discontinuation of such agents.
• Other sympathomimetics: Concomitant use with other adrenergic drugs may potentiate adverse cardiovascular effects. Avoid concomitant use of other LABAs.

• Not specifically identified as minor interactions with significant clinical impact for Advair Diskus beyond the above categories.

• Worsening asthma or COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (short-acting beta-agonist)
• Nocturnal awakenings due to respiratory symptoms
• Oral candidiasis (white patches in mouth/throat, soreness)
• Hoarseness or dysphonia
• Palpitations or tremor (especially at initiation or with overdose)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness)
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of Advair Diskus in pregnant women. Animal studies have shown teratogenic effects with high doses of fluticasone and salmeterol.

Caution should be exercised when Advair Diskus is administered to a nursing mother. It is unknown if fluticasone propionate or salmeterol are excreted in human breast milk. However, other corticosteroids and beta2-agonists are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Advair Diskus and any potential adverse effects on the breastfed infant from Advair Diskus or from the underlying maternal condition.

Advair Diskus 250/50mcg is indicated for asthma in adolescents 12 years and older. Lower strengths are available for younger children (4-11 years). Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. The lowest effective dose should be used.

No dosage adjustment is generally required based on age. However, elderly patients may be more susceptible to the cardiovascular effects of salmeterol. Monitor for adverse effects and ensure proper inhalation technique.

• Advair Diskus is a maintenance medication and should NOT be used for acute asthma attacks or sudden worsening of COPD symptoms. Patients must have a rescue inhaler available.
• Proper inhalation technique is crucial for efficacy. Patients should be instructed on how to use the Diskus device correctly, including loading the dose and inhaling deeply.
• Always instruct patients to rinse their mouth with water and spit it out after each dose to minimize the risk of oral candidiasis (thrush) and dysphonia.
• The Black Box Warning for LABAs applies to the salmeterol component, emphasizing that for asthma, it must be used in combination with an inhaled corticosteroid (which Advair provides).
• Regular follow-up is important to assess symptom control, lung function, and monitor for potential side effects, especially in children (growth) and long-term users (bone density, eyes).

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone) for mild-moderate persistent asthma.
• Long-Acting Beta2-Agonist (LABA) monotherapy (e.g., salmeterol, formoterol) for COPD (not recommended for asthma monotherapy).
• Long-Acting Muscarinic Antagonist (LAMA) monotherapy (e.g., tiotropium, umeclidinium) for COPD.
• Leukotriene Receptor Antagonists (e.g., montelukast) for asthma.
• Oral corticosteroids (for severe exacerbations or refractory disease).

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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.