Advair HFA 45/21mcg Oralinh 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). It acts locally in the lung to relax bronchial smooth muscle by stimulating beta2-receptors, leading to bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects.

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 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, severe 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

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 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
Upset stomach or vomiting
Throat irritation
* Signs of a common cold

This list is not exhaustive. If you have questions 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, including any symptoms that occurred.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist to determine if the medication is similar.
Any prescription or over-the-counter (OTC) 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.
Please note that this is not an exhaustive list of all medications or health conditions that may interact with this medication.

To ensure your safety, it is crucial to discuss all of your medications (prescription or OTC, natural products, vitamins) and health conditions with your doctor and pharmacist. This will help determine if it is safe to take this medication with your existing medications and health conditions. Never 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 medication for approximately 1 week.

If you have diabetes (high blood sugar), consult with your doctor, as this medication may cause an increase in blood sugar levels. 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 frequency of this medication, as overdoses have been fatal. Consult with your doctor if you have any questions or concerns.

Special Considerations

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

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 Side Effects

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

Long-term use may also lead to osteoporosis (weak bones). Discuss your individual risk factors with your doctor and undergo bone density tests as advised.

Infection Risk and Prevention

You may be more susceptible to infections while taking this medication. To minimize your risk, practice good hygiene by washing your hands frequently, and avoid close contact with individuals 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, consult with your doctor promptly.

Special Populations

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

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

Pregnancy and Breastfeeding

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

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

• Beta-blockers (especially non-selective): May block the bronchodilatory effect of salmeterol and cause severe bronchospasm in patients with asthma. Use with caution and only if no suitable alternative.
• Other long-acting beta2-agonists (LABAs): Concomitant use is not recommended as it may lead to overdose of LABA.
• 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): May increase systemic exposure of fluticasone and salmeterol, requiring caution and monitoring.
• Other sympathomimetics: Concomitant use may potentiate adverse cardiovascular effects.

• Not specifically listed as minor interactions; most interactions are significant due to the nature of the active ingredients.

• Worsening asthma or COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased frequency of rescue inhaler use
• Decreased peak expiratory flow (PEF) readings
• Nocturnal awakenings due to respiratory symptoms
• Signs of oral candidiasis (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain)
• Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Cardiovascular symptoms (e.g., palpitations, chest pain, rapid heart rate, tremor)
• Signs of infection (e.g., fever, increased sputum production, change in sputum color)

Advair HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma in pregnancy poses a greater risk to both mother and fetus than the potential risks of medication. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects with high doses of fluticasone and salmeterol.

It is not known whether fluticasone propionate or salmeterol xinafoate are excreted in human breast milk. However, other corticosteroids and beta2-agonists are excreted. Caution should be exercised when Advair HFA is administered to a nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Advair HFA and any potential adverse effects on the breastfed infant from Advair HFA or from the underlying maternal condition.

Advair HFA is approved for asthma in patients 12 years of age and older. Safety and effectiveness in children younger than 12 years have not been established. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth rate.

No dosage adjustment is required based on age. However, elderly patients may be more susceptible to the cardiovascular effects of beta2-agonists and may have age-related decreases in hepatic or renal function, which could affect drug clearance. Monitor for comorbidities and potential drug interactions.

• Advair HFA is a maintenance medication and should not be used for acute bronchospasm. Patients should always have a rescue inhaler available.
• Proper inhaler technique is critical for drug delivery and efficacy. Patients should be instructed and regularly re-evaluated on their technique.
• Rinsing the mouth with water and spitting after each dose helps prevent oral candidiasis (thrush).
• Patients should be advised not to stop Advair HFA abruptly, especially if they have been on high doses or for prolonged periods, due to the risk of adrenal insufficiency.
• Monitor for signs of pneumonia in COPD patients, as ICS use may increase this risk.
• Patients should be aware of the Black Box Warning regarding LABAs and asthma-related death, but also understand that the combination with an ICS mitigates this risk for asthma patients.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide)
• Long-Acting Muscarinic Antagonist (LAMA) monotherapy (e.g., tiotropium, umeclidinium) for COPD
• Short-Acting Beta2-Agonists (SABAs) for rescue (e.g., albuterol)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations or refractory disease)

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.