Fluticasone/salm Inh 45/21mcg 120s

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) 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 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 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 Side Effects

Most medications can cause side effects, but many people experience none or only mild side effects. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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 symptoms 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.
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 the following with your doctor and pharmacist:

All medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Any health problems you have.
* You must verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dose 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 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.

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 a different form of steroid, there is a risk of severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and seek medical attention 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 medical professionals 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. To minimize this 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 previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even fatal in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult with your doctor promptly.

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 potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Other long-acting beta2-adrenergic agonists (LABAs)
• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required

• 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 (loop or thiazide): May potentiate ECG changes and/or hypokalemia associated with beta-agonists.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the effect of salmeterol on the cardiovascular system.
• 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 (SABA)
• Chest pain or palpitations
• Tremor or nervousness
• Signs of oral thrush (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain)
• Signs of allergic reaction (e.g., rash, hives, swelling of face/mouth/tongue, severe dizziness, trouble breathing)

Category C. 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.

L3 (Moderately Safe). Both fluticasone and salmeterol are excreted in breast milk in small amounts. The benefits of breastfeeding should be weighed against the potential risks to the infant. Monitor breastfed infants for adverse effects.

Not indicated for children under 12 years of age for the HFA formulation. For children 12 years and older, use the lowest effective dose. Monitor growth velocity regularly, as inhaled corticosteroids can affect growth. Monitor for signs of adrenal suppression.

No specific dosage adjustment is required based on age. However, elderly patients may be more susceptible to the cardiovascular effects of salmeterol (e.g., tremor, palpitations) and systemic corticosteroid effects (e.g., bone density loss, cataracts, glaucoma). Monitor closely for adverse effects.

• Fluticasone/salmeterol is a maintenance medication and should be used regularly, twice daily, even when symptoms are well-controlled. It is NOT a rescue inhaler.
• Patients should always have a short-acting beta-agonist (SABA) available for acute asthma symptoms.
• Proper inhaler technique is crucial for effective delivery of the medication. Patients should be instructed and re-instructed on how to use the inhaler correctly.
• Rinsing the mouth and gargling with water (and spitting it out) after each dose helps prevent oral candidiasis (thrush).
• Patients should be advised not to exceed the prescribed dose due to the risk of systemic corticosteroid effects and cardiovascular effects from salmeterol.
• The black box warning regarding increased risk of asthma-related death with LABAs should be discussed with patients, emphasizing that the combination product is generally safe when used as prescribed for maintenance therapy and not for acute exacerbations.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide)
• Long-Acting Muscarinic Antagonist (LAMA) (for COPD, e.g., tiotropium)
• Triple therapy (ICS/LABA/LAMA) for severe COPD
• Leukotriene receptor antagonists (e.g., montelukast)
• Oral corticosteroids (for severe exacerbations or refractory disease)
• Biologic therapies (e.g., omalizumab, mepolizumab, dupilumab) for severe asthma

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.