Fluticasone/salm Inh 230/21mcg 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 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 long duration of action is due to its lipophilicity, allowing it to bind to an 'exosite' on the receptor, providing continuous stimulation.

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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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: 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 immediate medical attention.

Other Possible Side Effects

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

Headache
Nausea 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 any symptoms that occurred.
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 (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 drug.

To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are taking, including prescription and OTC medications, natural products, and vitamins.
Any health problems you have.
* You must verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change 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. You may not experience the full effects of this drug for approximately 1 week.

If you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your 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.

Do not exceed the recommended dose or use this medication more often than prescribed. Overdosing on this type of medication has been fatal. Consult with your doctor if you have any concerns.

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 symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor 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 indicating that you may need extra steroids in certain situations.

Long-term use of this medication may increase your risk of developing cataracts or glaucoma. Discuss this with your doctor and follow their recommendations for regular eye exams.

Prolonged use of this medication may also lead to osteoporosis (weak bones). Consult with your doctor to determine your risk and address any concerns. Follow your doctor's advice regarding bone density tests.

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 people 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 people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult with your doctor.

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

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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin)

• Beta-blockers (non-cardioselective)
• Diuretics (thiazide or loop) - potential for hypokalemia
• Tricyclic antidepressants (TCAs)
• Monoamine oxidase inhibitors (MAOIs)
• Other long-acting beta2-agonists (LABAs)

• Other adrenergic drugs
• QTc-prolonging drugs
• Xanthine derivatives (e.g., theophylline)
• Corticosteroids (systemic)

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

• Increased shortness of breath
• Increased wheezing
• Increased cough
• Increased need for rescue inhaler (e.g., albuterol)
• Worsening of asthma/COPD symptoms at night
• Chest tightness
• Signs of oral thrush (white patches in mouth/throat)
• Hoarseness or voice changes
• Tremor or nervousness
• Palpitations or rapid heart rate
• Muscle cramps or weakness (potential hypokalemia)
• Blurred vision or eye pain (potential for glaucoma/cataracts)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Asthma control is important during pregnancy. Category C.

Caution should be exercised when administered to a nursing woman. Fluticasone and salmeterol are present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Not indicated for children under 12 years for this specific strength (230/21 mcg). Lower strengths are approved for children 12 years and older with asthma. Monitor growth velocity in pediatric patients receiving inhaled corticosteroids.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the effects of beta2-agonists (e.g., cardiovascular effects) and corticosteroids (e.g., bone density, cataracts, glaucoma). Use with caution and monitor closely.

• This combination inhaler is for maintenance therapy only and should not be used for acute bronchospasm. Patients should always have a short-acting beta2-agonist (SABA) for rescue.
• Proper inhaler 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.
• Patients should be advised not to stop therapy abruptly, especially if on high doses, due to the risk of adrenal insufficiency.
• The black box warning for LABAs applies, emphasizing that this product should not be used as monotherapy for asthma and is generally reserved for patients whose asthma is not adequately controlled on an ICS alone or whose disease severity warrants initiation of both an ICS and LABA.
• Monitor for systemic corticosteroid effects, especially with prolonged use of high doses (e.g., adrenal suppression, bone mineral density changes, cataracts, glaucoma, hyperglycemia).

• Inhaled Corticosteroids (ICS) monotherapy (e.g., fluticasone propionate, budesonide, mometasone)
• Long-acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium, umeclidinium) - primarily for COPD, sometimes add-on for asthma
• Leukotriene Receptor Antagonists (LTRAs) (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 this medication, don't hesitate to discuss them with 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.