Fluticasone/salmeterol 55/14mcg In

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing hyperresponsiveness. Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA). It 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 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, extreme 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 excitable
Changes in behavior
Vision changes, eye pain, or severe eye irritation
Abnormal burning, numbness, or tingling sensations
Choking
Changes in voice
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

Breathing Problems: A Life-Threatening Side Effect

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 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 is not an exhaustive list of possible side effects. If you have questions or concerns, 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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (prescription and over-the-counter), natural products, vitamins, and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing regimen.

Remember, do not 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 effect of this medication. If you have diabetes (high blood sugar), consult your doctor, as this drug may increase blood sugar levels. Immediately contact your doctor 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 prescribed dose or use this medication more often than recommended. Overdose can be fatal, so it is crucial to follow your doctor's instructions. If you have any concerns, discuss them with your doctor.

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. If you experience any of these symptoms, contact your doctor immediately.

Stressful Situations
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
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor about this potential risk. Additionally, have regular eye exams as recommended by your doctor.

Bone Health
Long-term use of this medication may also lead to weak bones (osteoporosis). 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 this risk, wash your hands frequently and avoid close contact with people 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 to chickenpox or measles, consult 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.

Pediatric Use
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication for you and your baby.

COPD
If you have chronic obstructive pulmonary disease (COPD), you are at a higher risk of developing pneumonia. This medication may further increase this risk, so discuss this with your doctor.

• Other long-acting beta2-adrenergic agonists (LABAs) - risk of overdose.
• Non-selective beta-blockers (e.g., propranolol) - may block the bronchodilatory effect of salmeterol and produce severe bronchospasm in patients with asthma.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat-containing products) - 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., QT prolongation, palpitations, tachycardia) from salmeterol.
• Diuretics (e.g., loop or thiazide diuretics) - 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 effect of salmeterol on the cardiovascular system, increasing the risk of arrhythmias. Use with extreme caution.
• Other sympathomimetics - may potentiate adverse cardiovascular effects.

• Not available

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler (e.g., albuterol)
• Chest pain or palpitations
• Tremor or nervousness
• Oral thrush (white patches in mouth/throat)
• Blurred vision or eye pain (rare, related to glaucoma/cataracts)
• Signs of infection (e.g., fever, increased sputum production)

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both fluticasone and salmeterol have shown teratogenic effects in animal studies at high doses.

L3 (Moderately Safe). It is not known whether fluticasone propionate or salmeterol are excreted in human milk. However, other corticosteroids and beta2-agonists are excreted. Caution should be exercised when fluticasone/salmeterol is administered to a nursing woman. 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 from the drug or from the underlying maternal condition.

Safety and effectiveness in pediatric patients younger than 12 years of age have not been established for this strength. For patients 12 years and older, monitor growth velocity regularly. Risk of systemic corticosteroid effects (e.g., adrenal suppression, growth retardation) should be considered, especially with long-term use. Use the lowest effective dose.

No dosage adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of salmeterol (e.g., arrhythmias, hypertension) and systemic corticosteroid effects. Monitor for comorbidities and concomitant medications.

• This medication is for maintenance treatment only and should not be used for acute bronchospasm. Patients should have a rescue inhaler readily available.
• Proper inhalation technique is critical for drug delivery. Patients should be instructed and periodically re-evaluated on their technique.
• Rinsing the mouth and spitting out water after each dose helps prevent oral candidiasis (thrush).
• Patients should be warned about the black box warning regarding the increased risk of asthma-related death with LABAs, and that this product should not be used as monotherapy for asthma.
• Do not stop therapy abruptly, especially if on high doses, due to the risk of adrenal insufficiency from the corticosteroid component.
• Monitor for signs of systemic corticosteroid effects, especially in children (growth) and with long-term use.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide)
• Long-acting muscarinic antagonist (LAMA) (e.g., tiotropium, umeclidinium) - for COPD
• Leukotriene receptor antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations)
• Biologic therapies (e.g., omalizumab, mepolizumab, 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 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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.