Flutic/salmet 232-14mcg 60 Puffs

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It reduces inflammation in the airways, decreasing bronchial hyperreactivity and mucus production. Salmeterol xinafoate is a long-acting selective beta2-adrenergic agonist. It acts locally in the lung to relax bronchial smooth muscle, resulting in bronchodilation, by stimulating adenyl cyclase, which converts ATP to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels lead to relaxation of 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 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

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 medical help immediately.

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 or seek medical attention:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 or health problems that may affect the use of this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications (prescription or over-the-counter), natural products, and vitamins you are taking, as well as any health problems you have.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never 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 effects of this medication. If you have diabetes (high blood sugar), consult 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.

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

In situations where you have a severe injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in these situations.

Long-term Use and Potential Risks

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk. It is also recommended that you undergo regular eye exams as advised by your doctor.

Additionally, long-term use may lead to weak bones (osteoporosis). Discuss your risk factors with your doctor and undergo bone density tests as recommended.

Infection Risk and Prevention

You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently and avoiding close contact with people 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 your doctor immediately.

Special Considerations

If you are 65 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. Consult your doctor to discuss this potential risk.

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

COPD Considerations

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

• Concomitant use of other long-acting beta2-adrenergic agonists (LABAs)

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat-containing products): May significantly increase systemic exposure to fluticasone and salmeterol, leading to increased risk of systemic corticosteroid effects and cardiovascular effects of salmeterol.
• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of salmeterol and produce severe bronchospasm in patients with asthma or COPD. Cardioselective beta-blockers should be used with caution.

• 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; use with extreme caution or avoid within 2 weeks of discontinuing MAOIs.
• Other sympathomimetics: May potentiate adverse cardiovascular effects.

• Not many specific minor interactions commonly cited for this combination.

• Worsening shortness of breath or wheezing
• Increased need for rescue inhaler (e.g., albuterol)
• Chest tightness or pain
• Palpitations or rapid heart rate
• Tremor or nervousness
• Oral thrush (white patches in mouth/throat)
• Hoarseness or dysphonia
• Blurred vision or eye pain (rare, long-term)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness)
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluticasone/salmeterol is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women.

Caution should be exercised when Fluticasone/Salmeterol is administered to a nursing mother. Both fluticasone and salmeterol are excreted in human milk, but systemic exposure in the infant is expected to be low due to low maternal systemic absorption and poor oral bioavailability.

Not indicated for children under 4 years of age. For children 4-11 years, lower strengths are typically used. Monitor growth velocity closely, as inhaled corticosteroids can cause a reduction in growth rate. Monitor for signs of adrenal suppression.

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the cardiovascular effects of beta-agonists (e.g., tremor, palpitations, increased blood pressure) and should be monitored.

• This medication is a controller medication, not a rescue inhaler. Patients should always have a short-acting beta-agonist (SABA) available for acute symptoms.
• Proper inhalation technique is crucial for efficacy. Patients should be instructed and periodically re-evaluated on their technique.
• Rinsing the mouth and spitting after each dose is essential to minimize the risk of oral candidiasis (thrush) and systemic corticosteroid absorption.
• Patients should be advised not to stop therapy abruptly, especially if on high doses, due to the risk of adrenal insufficiency.
• Monitor for signs of pneumonia in COPD patients, as ICS use may increase this risk.
• Regular follow-up is important to assess asthma/COPD control, adjust therapy if needed, and monitor for adverse effects.

• Inhaled Corticosteroid (ICS) monotherapy (e.g., fluticasone propionate, budesonide)
• Long-acting Beta2-Adrenergic Agonist (LABA) monotherapy (not for asthma without ICS)
• Long-acting Muscarinic Antagonist (LAMA) (e.g., tiotropium, umeclidinium) for COPD
• Oral corticosteroids (for severe exacerbations or refractory disease)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• 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 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.