Fluticasone / Salmeterol

Fluticasone/salmeterol treats chronic breathing conditions that need ongoing, daily management:

• Asthma — twice-daily control in patients aged 4 and older who are not adequately managed on an inhaled steroid alone
• COPD (chronic obstructive pulmonary disease) — including chronic bronchitis and emphysema, for maintenance treatment and to reduce flare-ups

Not for emergencies: This inhaler does not work fast enough to treat a sudden asthma attack or COPD flare — always have a short-acting rescue inhaler available.

Fluticasone is a synthetic corticosteroid (anti-inflammatory medicine) that acts directly in the lungs. It works on many cell types — including mast cells, eosinophils, and macrophages — to quiet the inflammation that underlies both asthma and COPD. Salmeterol is a selective long-acting beta-agonist (LABA): it binds tightly to receptors on the muscles surrounding the airways, causing those muscles to relax and the airways to stay open for about 12 hours per dose.

Because inflammation and airway tightening both drive breathing problems, combining these two medicines in one inhaler addresses the condition from two angles at once.

Fluticasone/salmeterol is inhaled through the mouth — one inhalation twice daily, taken roughly 12 hours apart. It is a dry powder inhaler; food does not affect how it works. After each inhalation, rinse your mouth with water and spit — do not swallow the water — to reduce the chance of a mouth yeast infection.

• Do not take more than one inhalation per dose
• Do not use a second long-acting beta-agonist (LABA) alongside this inhaler
• If asthma symptoms flare between doses, use your short-acting rescue inhaler
• If you miss a dose, take it as soon as you remember — but if it is almost time for your next dose, skip the missed one and continue your regular schedule

Most side effects from this inhaler are manageable, but it is worth knowing what to watch for:

• Upper respiratory infections or nasal/throat inflammation
• Sore throat (pharyngitis)
• Hoarse or changed voice (dysphonia)
• Oral thrush — yeast infection of the mouth (oral candidiasis); rinsing after each use reduces this risk
• Bronchitis or cough
• Headache
• Nausea or vomiting
• Musculoskeletal (muscle and bone) pain — more common in COPD patients
• Pneumonia — a particular concern in people with COPD

Contact your doctor promptly if you experience chest pain, rapid or irregular heartbeat, sudden worsening of breathing, white patches in your mouth, vision changes, or signs of infection.

• LABA safety: Using salmeterol without an inhaled corticosteroid raises the risk of serious asthma events including death — this combination keeps them together for safety. Never add another LABA.
• Not a rescue inhaler: Do not use this for sudden symptoms — it will not act fast enough. Use a short-acting bronchodilator (like albuterol) for emergencies.
• Increased infection risk: Inhaled corticosteroids can weaken local immune defenses; existing infections (tuberculosis, fungal, viral, herpes) may worsen. Chickenpox and measles can be more severe.
• Adrenal suppression: Switching from oral steroids to this inhaler must be done gradually — stopping oral steroids too quickly can leave your body without enough cortisol.
• Bone density: Long-term use can reduce bone mineral density; your doctor may monitor this periodically.
• Children's growth: Inhaled corticosteroids may slow growth in children — regular monitoring is important.
• Eye health: Long-term use raises the risk of glaucoma (increased eye pressure) and cataracts. Report any vision changes.
• Heart and nervous system: Salmeterol can affect heart rate and rhythm — use with caution if you have cardiovascular disease or a seizure disorder.

Several medicines can interact meaningfully with fluticasone/salmeterol — tell your pharmacist and doctor about everything you take:

• Strong CYP3A4 inhibitors (ritonavir, ketoconazole, clarithromycin, itraconazole, and others): significantly raise fluticasone levels in the blood, increasing the risk of adrenal suppression and other steroid side effects — avoid this combination.
• MAO inhibitors and tricyclic antidepressants: can amplify salmeterol's effect on the cardiovascular system — use with extreme caution.
• Beta-blockers (atenolol, metoprolol, propranolol, etc.): may block salmeterol's bronchodilator (airway-opening) effect and potentially cause severe bronchospasm.
• Non-potassium-sparing diuretics (certain water pills like furosemide): can worsen low potassium levels and heart rhythm changes when combined with salmeterol.
• Other LABAs: Do not use any other long-acting beta-agonist — the overlapping effect raises overdose risk.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not use if you are allergic to fluticasone, salmeterol, or milk proteins (the inhaler contains milk-derived lactose).
• Do not use as the primary treatment for a severe, acute asthma or COPD attack requiring emergency care.
• Tell your doctor if you have heart disease, high blood pressure, or heart rhythm problems.
• Tell your doctor about any history of seizures, thyroid disease, diabetes, or glaucoma/cataracts.
• If you are pregnant: poorly controlled asthma poses risks to mother and baby — your doctor will help weigh the benefits and risks of continuing this medicine.
• If switching from oral corticosteroid pills: do not stop them abruptly; your doctor must taper the dose slowly.
• Liver disease: drug levels may be higher — your doctor should monitor you more closely.
• Children (aged 4–11): approved for asthma use, but growth should be monitored regularly.

Too much salmeterol can cause excessive stimulation of the heart and nervous system — signs include rapid heart rate, chest pain (angina), tremor, headache, muscle cramps, nausea, dizziness, low potassium, high blood sugar, and in severe cases, dangerous heart rhythm problems or cardiac arrest. Too much fluticasone over time can lead to signs of excess steroid in the body (hypercorticism), such as weight gain, easy bruising, or adrenal gland problems.

If you suspect an overdose, stop the inhaler and seek medical care immediately — heart monitoring is recommended, and a doctor will provide appropriate treatment.

At normal therapeutic doses, salmeterol's effects on the heart are not typically noticeable, but at higher doses it can affect pulse rate, blood pressure, heart rhythm (QTc interval), potassium levels, and blood sugar. Studies in healthy volunteers showed that these cardiovascular and metabolic effects were the same whether salmeterol was given alone or as part of this combination inhaler — meaning fluticasone doesn't change how salmeterol acts on the body, and vice versa. The presence of fluticasone also did not significantly alter the body's natural cortisol (adrenal) response in healthy subjects.

Fluticasone acts mainly in the lungs — very little (less than 1%) is absorbed into the bloodstream from swallowing, but a meaningful amount of what reaches the lungs is absorbed systemically. Peak blood levels appear within 1 to 2 hours of inhalation. Salmeterol is also absorbed through the lungs. Both medicines are broken down by a liver enzyme system called CYP3A4, which is why strong inhibitors of that enzyme can raise drug levels significantly and cause extra side effects. Rinsing the mouth after use prevents swallowed drug from being absorbed through the gut.

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) . Store in a dry place away from direct heat or sunlight. Keep out of reach of children.