Flutic/salmeterol 113/14mcg Inh(60)

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes) and suppressing the migration of inflammatory cells (e.g., eosinophils, mast cells, lymphocytes). Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA). It selectively binds to beta2-adrenergic receptors in the bronchial smooth muscle, leading to activation of adenyl cyclase, increased intracellular cyclic AMP (cAMP) levels, and subsequent relaxation of bronchial smooth muscle, resulting in bronchodilation.

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, 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, 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

Respiratory Problems: A Life-Threatening Condition

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. Many people may not experience any side effects or may only have mild 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:

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

Reporting Side Effects

This is not an exhaustive list of possible 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently using 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 conditions like HIV, infections, or depression may be contraindicated 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 OTC), 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 your existing medications and health conditions.
* Never start, stop, or adjust 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.

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 with 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 directed. 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 with your doctor and undergo regular eye exams as recommended.

Bone Health
Long-term use 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 the 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, consult with your doctor.

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

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

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

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, so consult with your doctor to discuss the potential risks and benefits.

• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, cobicistat-containing products)

• Other long-acting beta2-adrenergic agonists (LABAs)
• Non-selective beta-blockers (e.g., propranolol, carvedilol)
• Diuretics (non-potassium sparing, e.g., thiazides, loop diuretics) - risk of hypokalemia
• Tricyclic antidepressants (TCAs) and Monoamine oxidase inhibitors (MAOIs) - risk of cardiovascular effects

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice)
• Sympathomimetics (additive effects)
• Xanthine derivatives (e.g., theophylline) - increased risk of arrhythmias

• Not typically listed as clinically significant for this drug

• Asthma/COPD symptom control (e.g., frequency of shortness of breath, wheezing, cough, nocturnal awakenings)
• Frequency of rescue inhaler use
• Signs of oral candidiasis (white patches in mouth/throat)
• Hoarseness or dysphonia
• Tremor or palpitations
• Muscle cramps
• Blurred vision or eye pain
• Signs of infection (e.g., fever, increased sputum)

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. Asthma control is important during pregnancy, as uncontrolled asthma poses risks to both mother and fetus.

It is not known whether fluticasone propionate or salmeterol are excreted in human breast milk. However, other corticosteroids and beta2-agonists are excreted. Caution should be exercised when 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 of fluticasone propionate and salmeterol inhalation powder 113/14 mcg have not been established in pediatric patients younger than 12 years of age. Growth velocity should be monitored in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. The lowest effective dose should be used.

No dosage adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of beta2-agonists (e.g., tremor, palpitations, increased blood pressure) and may have comorbidities (e.g., cardiovascular disease, diabetes, glaucoma, cataracts) that require careful monitoring.

• This medication is a controller medication and should be used consistently, not for acute relief of symptoms. Patients must have a separate rescue inhaler.
• Proper inhalation technique is crucial for efficacy. Patients should be instructed on how to use the Diskus device correctly and to rinse their mouth after each dose.
• Patients should be advised not to exceed the prescribed dose or frequency, as this increases the risk of adverse effects without additional benefit.
• Monitor for signs of adrenal suppression, especially when transitioning from oral corticosteroids or with prolonged high-dose use.
• Be aware of potential drug interactions, particularly with strong CYP3A4 inhibitors, which can significantly increase systemic exposure to both components.
• For asthma, this combination is indicated for patients not adequately controlled on an inhaled corticosteroid alone or whose disease severity warrants initiation of both an ICS and a LABA.

• Inhaled corticosteroids (e.g., fluticasone propionate, budesonide, mometasone)
• Long-acting beta2-adrenergic agonists (e.g., salmeterol, formoterol, indacaterol, olodaterol) - *Note: LABAs should not be used as monotherapy for asthma.*
• Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium) - primarily for COPD, sometimes add-on for asthma
• 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'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 taken, the amount, and the time it happened.