Advair HFA 115/21mcg Oralinh 120s

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 selective, long-acting beta2-adrenergic agonist (LABA). It acts locally in the lung to stimulate beta2-receptors in bronchial smooth muscle, leading to bronchodilation by increasing cyclic AMP levels, which relaxes bronchial smooth muscle.

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, 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
+ Excessive 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
Rapid or irregular 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

Respiratory Warning

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 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: 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 the symptoms that occurred.
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 conditions like HIV, infections, and depression 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 drug.

To ensure your safety, it is crucial to discuss all of your medications (prescription and OTC), natural products, vitamins, and health conditions with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effect of this drug may not be apparent until after 1 week of use.

If you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels. Monitor your breathing problems closely, and immediately contact your doctor if they worsen, if your rescue inhaler becomes less effective, or if you need to use it more frequently.

Do not exceed the prescribed dose or frequency of this medication, as overdoses of this type of drug have been fatal. Consult with your doctor if you have any concerns.

When transitioning from an oral steroid to another form of steroid, there is a risk of 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 indicating that you may need extra steroids in such situations.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor and undergo regular eye exams as recommended.

Prolonged use of this medication may also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor and undergo bone density tests as advised.

You may be more susceptible to infections while taking this medication. Practice good hygiene by washing 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 diseases, 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 with your doctor.

If you are 65 years 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 with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat): Can significantly increase systemic exposure of fluticasone and salmeterol, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) and cardiovascular effects (e.g., QT prolongation, arrhythmias) from salmeterol. Concomitant use is not recommended.
• Non-selective beta-blockers (e.g., propranolol): Can antagonize the bronchodilatory effect of salmeterol and may produce severe bronchospasm in patients with asthma. Avoid concomitant use.

• Other sympathomimetics: May potentiate adverse cardiovascular effects of salmeterol.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the cardiovascular effects of salmeterol. Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs.
• Diuretics (e.g., loop or thiazide diuretics): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at high doses of salmeterol.
• Other QTc-prolonging drugs: Increased risk of ventricular arrhythmias with salmeterol.

• Not specifically identified as minor, but general caution with drugs affecting electrolyte balance or cardiac rhythm.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased frequency of rescue inhaler use (e.g., more than 2 days a week, not including exercise-induced bronchospasm)
• Nocturnal asthma symptoms or awakenings
• Signs of oral candidiasis (white patches in mouth/throat)
• Hoarseness or dysphonia
• Tremor or nervousness
• Palpitations or rapid heart rate
• Muscle cramps

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 HFA in pregnant women. Animal studies have shown teratogenic effects with high doses of fluticasone and salmeterol. Monitor infants born to mothers receiving corticosteroids during pregnancy for signs of hypoadrenalism.

Low levels of fluticasone and salmeterol are expected to be present in human milk. 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. Caution is advised.

Safety and effectiveness established for asthma in patients 4 years of age and older. Monitor growth velocity in pediatric patients receiving ICS, as long-term use may affect growth. Use the lowest effective dose. Proper inhaler technique is crucial.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Monitor for cardiovascular effects and bone mineral density.

• Advair HFA is a maintenance medication and should be used consistently, twice daily, for optimal asthma control. It is NOT a rescue inhaler for acute symptoms.
• Proper inhaler technique is critical for drug delivery. Patients should be instructed and regularly re-evaluated on their technique. Using a spacer (valved holding chamber) is recommended, especially for children and those with difficulty coordinating actuation and inhalation.
• Always rinse mouth with water and spit after each dose to minimize the risk of oral candidiasis (thrush) and dysphonia.
• Patients should be provided with a fast-acting beta2-agonist (e.g., albuterol) for acute asthma symptoms.
• The dose counter on the inhaler indicates the number of remaining actuations. Discard the inhaler when the counter reads zero or after the expiration date.
• If asthma symptoms worsen or the need for rescue inhaler increases, patients should contact their healthcare provider immediately, as this may indicate worsening asthma control requiring re-evaluation of therapy.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., Flovent HFA/Diskus, Pulmicort Flexhaler, Qvar RediHaler)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations or refractory asthma)
• Immunomodulators (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 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.