Fluticasone/salm Disk 100/50mcg 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, lymphocytes, macrophages, neutrophils) 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 on bronchial smooth muscle, leading to bronchodilation by increasing cyclic AMP levels, which relaxes smooth muscle and inhibits the release of mediators from mast cells in the airway.

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, 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

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 persist, contact your doctor:

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

This list is not exhaustive, and you may experience other 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 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.
If you have a milk allergy.
* 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 or over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether 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 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. It may take approximately 1 week to experience the full effects of the medication.

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.

Dosage and Administration

Do not exceed the recommended dose or use this medication more often than prescribed. Overdosing on this type of medication has been associated with fatal outcomes. Consult with 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 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 signs.

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 that you may need extra steroids in these situations.

Long-term Use and Potential Side Effects

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

Additionally, long-term use may lead to osteoporosis (weak bones). Discuss your 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 the 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 to chickenpox or measles, consult with your doctor promptly.

Special Considerations

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.

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.

COPD Considerations

If you have Chronic Obstructive Pulmonary Disease (COPD), be aware that your risk of developing pneumonia is higher. This medication may further increase this risk, so consult with your doctor to discuss the potential benefits and risks.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Acute bronchospasm (not for rescue)

• 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 cardiovascular and systemic corticosteroid adverse effects.
• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and produce severe bronchospasm in patients with asthma or COPD.

• Diuretics (thiazide or loop): May potentiate hypokalemia and/or ECG changes associated with beta-agonists.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of salmeterol.
• Other sympathomimetics: Additive effects may occur.

• Not available

• Increased wheezing
• Shortness of breath
• Chest tightness
• Increased cough
• Increased need for rescue inhaler (e.g., albuterol)
• Oral candidiasis (thrush)
• Hoarseness/dysphonia
• Palpitations
• Tremor
• Muscle cramps
• Blurred vision
• Signs of infection (e.g., fever, increased sputum)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Poorly controlled asthma in pregnancy poses risks to both mother and fetus. Fluticasone/salmeterol should be considered if the benefits outweigh the risks.

Caution should be exercised when administered to a nursing woman. Fluticasone and salmeterol are excreted in animal milk; it is unknown if they are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Approved for asthma in children 4 years and older. 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 overall differences in safety or effectiveness have been observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Use with caution in patients with cardiovascular disease or diabetes, which may be more prevalent in the elderly.

• This medication is a controller medication and should be used daily, not for acute relief of bronchospasm. Patients should always have a short-acting beta-agonist (SABA) for rescue.
• Proper inhalation technique is crucial for efficacy. Patients should be instructed on how to use the Diskus device correctly.
• Rinsing the mouth after each dose helps prevent oral candidiasis (thrush) and dysphonia.
• The black box warning regarding increased risk of asthma-related death with LABAs should be discussed with patients, emphasizing that the benefit of combination therapy (ICS/LABA) generally outweighs this risk when used appropriately for maintenance.
• Regular follow-up is important to assess asthma/COPD control, monitor for adverse effects, and ensure adherence.

• Inhaled corticosteroids (e.g., fluticasone propionate, budesonide, mometasone) as monotherapy for asthma.
• Long-acting beta-agonists (LABAs) as monotherapy (not recommended for asthma without ICS due to black box warning).
• Leukotriene receptor antagonists (e.g., montelukast).
• Oral corticosteroids (for severe exacerbations).
• Long-acting muscarinic antagonists (LAMAs) for COPD (e.g., tiotropium).
• Triple therapy (ICS/LABA/LAMA) for severe COPD.

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 your 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.