Advair HFA 230/21mcg Oral Inh 120s

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing bronchial hyperresponsiveness. 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 Immediately

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 right away:

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
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

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 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 contact your doctor or seek medical help if you notice any of the following:

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, contact 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 symptoms you experienced.
If you are currently using 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.
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 crucial to:

Inform your doctor and pharmacist about all your medications (prescription or over-the-counter), natural products, vitamins, and health conditions.
Verify that it is safe to take this medication with your existing medications and health conditions.
* Do not start, stop, or change the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. You may not feel the full effects of this drug for about 1 week.

Special Considerations

If you have diabetes (high blood sugar), discuss this with your doctor, as this medication may increase your blood sugar levels. Monitor your breathing problems closely, and contact your doctor immediately if they worsen, if your rescue inhaler is not effective, or if you need to use it more frequently.

Safe Use

Do not exceed the recommended dose or frequency of this medication. Taking too much of this type of drug can be fatal. Consult your doctor if you have any questions or 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, and contact your doctor immediately if you experience any of these.

In the event of a severe injury, surgery, or infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert healthcare providers of this potential need.

Long-term Use and Potential Risks

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

Long-term use may also lead to weak bones (osteoporosis). 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. To minimize this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.

If you have not had chickenpox or measles before, avoid exposure to these illnesses, 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.

Special Populations

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. Discuss this with your doctor.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to you and your baby.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, telithromycin, nefazodone) due to increased systemic exposure to fluticasone and salmeterol, leading to increased risk of cardiovascular and systemic corticosteroid effects.

• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and cause severe bronchospasm, especially in patients with asthma. Use with caution, consider cardioselective beta-blockers if necessary.
• Other long-acting beta2-agonists (LABAs): Concomitant use is not recommended due to increased risk of adverse cardiovascular effects.
• 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., arrhythmias, hypertension). Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice): May increase systemic exposure to fluticasone and salmeterol. Use with caution.
• Sympathomimetics: Concomitant use may potentiate cardiovascular effects.
• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia and cardiovascular effects.

• Not available

• Increased wheezing
• Shortness of breath
• Chest tightness
• Increased cough
• Increased need for rescue inhaler
• Nocturnal awakenings due to asthma
• Signs of oral candidiasis (thrush)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain)
• Palpitations
• Tremor
• Muscle cramps

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Asthma control is important during pregnancy, as poorly controlled asthma can lead to adverse maternal and fetal outcomes. There are no adequate and well-controlled studies of Advair HFA in pregnant women. Animal studies have shown teratogenic effects with high doses of fluticasone and salmeterol.

Caution should be exercised when Advair HFA is administered to a nursing mother. It is not known whether fluticasone or salmeterol are excreted in human milk. However, other corticosteroids and beta2-agonists are excreted in human milk. The benefits of breastfeeding should be weighed against the potential risks.

Advair HFA 230/21 mcg is not approved for pediatric patients under 12 years of age. Lower strengths (45/21 mcg, 115/21 mcg) are approved for asthma in children 12 years and older. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth rate. The lowest effective dose should be used.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised in elderly patients with concomitant cardiovascular disease or other conditions that may be exacerbated by beta-agonists.

• Advair HFA is a maintenance inhaler and should be used regularly, twice daily, not for acute asthma attacks. Patients should always carry a rescue inhaler.
• Proper inhaler technique is crucial for effective delivery of the medication. Educate patients on how to use the HFA inhaler correctly, including shaking before each spray, slow deep inhalation, and breath-holding.
• Rinsing the mouth and spitting out water after each dose helps prevent oral candidiasis (thrush).
• Patients should be advised not to exceed the prescribed dose or use other LABA-containing products.
• Monitor for signs of systemic corticosteroid effects, especially with long-term use or higher doses, such as adrenal suppression, bone mineral density loss, and ocular effects (glaucoma, cataracts).
• The black box warning regarding increased risk of asthma-related death with LABAs should be discussed with patients. Advair HFA should only be used when an ICS alone is insufficient.
• Patients should be instructed to contact their healthcare provider if their asthma symptoms worsen or if their rescue inhaler use increases.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone, beclomethasone, ciclesonide)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Long-Acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium, umeclidinium) - generally for COPD, but tiotropium can be add-on for severe asthma.
• Oral Corticosteroids (for severe exacerbations or refractory asthma)
• Biologic therapies (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) for severe asthma.

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 details. 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 information about the medication taken, the amount, and the time it occurred.