Trelegy Ellipta 100/62.5/25 Mcg Inhaler (30 Dose)

TRELEGY ELLIPTA 100/62.5/25 MCG INHALER

TRELEGY ELLIPTA is a prescription medicine delivered via an inhaler for long-term, once-daily maintenance treatment of certain respiratory conditions.

• Name

  • Brand Name: TRELEGY ELLIPTA
  • Common Name: Fluticasone furoate/Umeclidinium/Vilanterol

• Composition Each single inhalation from the 100/62.5/25 mcg inhaler provides 100 micrograms (mcg) of fluticasone furoate (an inhaled corticosteroid), 62.5 mcg of umeclidinium (a long-acting muscarinic antagonist), and 25 mcg of vilanterol (a long-acting beta2-adrenergic agonist). The inhaler also contains lactose monohydrate (which includes milk protein) and magnesium stearate as inactive ingredients.

• Uses TRELEGY ELLIPTA is indicated for the once-daily maintenance treatment of:

  • Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema, in adults.
  • Asthma in adults. It is important to note that TRELEGY ELLIPTA is not intended to relieve sudden breathing problems or acute bronchospasm and should not be used as a rescue inhaler.

• Dosage and Administration The recommended and maximum dosage for both COPD and asthma in adults is one inhalation once daily, at the same time each day. For asthma, if symptoms are not adequately controlled with the 100/62.5/25 mcg dose, a doctor may consider increasing to the 200/62.5/25 mcg strength. For COPD, the 100/62.5/25 mcg strength is the only approved dose. After inhaling, rinse your mouth with water and spit it out without swallowing to help reduce the risk of oral thrush. Do not use TRELEGY ELLIPTA more than once every 24 hours.

• Side Effects

  • Common Side Effects: Upper respiratory tract infection (e.g., common cold), headache, bronchitis, oral thrush (a fungal infection in the mouth or throat), pneumonia, sore throat, back pain, joint pain, flu, sinus inflammation, cough, hoarseness, altered taste, constipation, and urinary tract infection.
  • Serious Side Effects: May include increased blood pressure, irregular or fast heartbeat, heart palpitations, increased risk of infections (such as chickenpox or measles), decreased adrenal gland function, sudden breathing problems immediately after taking a dose (paradoxical bronchospasm), decreased bone density (osteoporosis), temporary low blood potassium, temporary high blood sugar, tremor, eye problems like glaucoma or cataracts, and severe allergic reactions.

• Precautions TRELEGY ELLIPTA should not be used for acute breathing problems; a short-acting rescue inhaler should always be available. Patients should be cautious if they have pre-existing heart conditions, osteoporosis, liver problems, diabetes, glaucoma, cataracts, or urinary retention. Using TRELEGY ELLIPTA can increase the risk of infections, including pneumonia and oral thrush; rinsing the mouth after use helps prevent thrush. Individuals with a severe milk protein allergy should avoid this medication. Do not suddenly stop taking TRELEGY ELLIPTA without consulting a doctor.

• Storage Store TRELEGY ELLIPTA in its original unopened foil tray at room temperature, between 68°F and 77°F (20°C and 25°C), protected from heat, moisture, and direct light. Do not freeze. The inhaler should be discarded 6 weeks after opening the foil tray or when the dose counter reads "0", whichever comes first.

Here are frequently asked questions about TRELEGY ELLIPTA 100/62.5/25 MCG INHALER:

What is Trelegy Ellipta used for?

Trelegy Ellipta 100/62.5/25 mcg is a prescription medicine used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis and emphysema. It is used to improve breathing, control symptoms such as wheezing, coughing, chest tightness, and shortness of breath, and reduce the number of flare-ups (worsening of COPD symptoms). It is also indicated for the long-term maintenance treatment of asthma in adults aged 18 years and older to prevent and control symptoms and improve lung function. It is important to note that Trelegy Ellipta is not for relieving sudden breathing problems and will not replace a rescue inhaler.

How does Trelegy Ellipta work?

Trelegy Ellipta contains three active medicines: fluticasone furoate, umeclidinium, and vilanterol, which work together to improve breathing and lung function.

• Fluticasone furoate (an inhaled corticosteroid or ICS) reduces inflammation and swelling in your lungs and airways.
• Umeclidinium (a long-acting muscarinic antagonist or LAMA, also an anticholinergic) blocks the tightening of smooth muscles around your airways, helping to keep them open and reducing mucus production.
• Vilanterol (a long-acting beta2-adrenergic agonist or LABA) relaxes the muscles around your airways, opening them further to make breathing easier.

What is the usual dosage?

The recommended dosage for both COPD and asthma is one inhalation of Trelegy Ellipta once daily, at the same time each day. For COPD, Trelegy Ellipta 100/62.5/25 mcg is the only strength indicated. For asthma, your doctor may prescribe either the 100/62.5/25 mcg or 200/62.5/25 mcg dose, depending on the severity of your asthma and how you respond to treatment. Do not use Trelegy Ellipta more than once every 24 hours. After each dose, it is recommended to rinse your mouth with water and spit it out without swallowing to help prevent a fungal infection in your mouth or throat (thrush).

What are the possible side effects?

Trelegy Ellipta can cause side effects that range from mild to serious.

• Common mild side effects may include upper respiratory tract infection (such as the common cold), headache, bronchitis, sore throat, sinus inflammation, runny nose, back pain, joint pain, cough, and changes in voice quality. Oral thrush (a fungal infection in the mouth or throat) is also common and can be reduced by rinsing your mouth after use.
• Serious side effects can include pneumonia, weakened immune system and increased chance of infections, reduced adrenal function, sudden breathing problems immediately after inhaling (paradoxical bronchospasm), serious allergic reactions, effects on the heart (increased blood pressure, fast or irregular heartbeat, chest pain), bone thinning (osteoporosis), and eye problems like glaucoma or cataracts.

Is it safe during pregnancy or breastfeeding?

It is not known whether Trelegy Ellipta is safe to use during pregnancy or while breastfeeding. If you are pregnant, breastfeeding, or planning for either, you should talk to your doctor. They can discuss the potential benefits and risks to you and your baby and recommend the best treatment plan.

Can it be taken with other medications?

Trelegy Ellipta can interact with several types of medications.

• CYP3A4 inhibitors: Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, certain HIV medicines, and other antifungals) can increase the systemic exposure to fluticasone furoate and vilanterol, potentially leading to an increased risk of side effects.
• Beta-blockers: These medications can weaken the effect of vilanterol, one of the active ingredients in Trelegy Ellipta. If beta-blockers are necessary, cardioselective beta-blockers should be considered with caution.
• Anticholinergic medications: Taking Trelegy Ellipta with other anticholinergic drugs can increase the risk of anticholinergic side effects such as irregular heartbeat, urinary retention, and headache.
• Diuretics: Certain diuretics, especially loop diuretics, can cause low blood potassium or affect heart rhythm, and these effects can be worsened if taken with a beta agonist like vilanterol. Always inform your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking to ensure there are no unsafe interactions.

What precautions should be taken?

Several precautions should be considered before and during treatment with Trelegy Ellipta:

• Not for acute symptoms: Trelegy Ellipta is a maintenance inhaler and should not be used for sudden breathing problems or acute asthma/COPD attacks. Always have a rescue inhaler available.
• Allergies: Do not use if you have a severe allergy to milk proteins or any ingredients in Trelegy Ellipta.
• Pre-existing conditions: Inform your doctor if you have heart problems (including high blood pressure, irregular heartbeat), osteoporosis, liver problems, diabetes, eye problems (such as glaucoma or cataracts), bladder or prostate problems, or any active infections (e.g., tuberculosis, herpes simplex, fungal, bacterial, or viral infections).
• Adrenal function: Long-term use of inhaled corticosteroids can affect adrenal gland function.
• Children: Trelegy Ellipta is not recommended for use in children younger than 18 years of age.

What happens if a dose is missed?

If you miss a dose of Trelegy Ellipta, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time to make up for a missed dose, as this can increase the risk of side effects.

How should it be stored?

Store Trelegy Ellipta in a closed container at room temperature, ideally between 68°F and 77°F (20°C and 25°C). Keep it in a dry place, away from heat and direct sunlight, and protect it from freezing. Store the inhaler in its unopened foil tray and only open it when you are ready to use it for the first time. Discard the inhaler 6 weeks after opening the foil tray or when the dose counter reads "0," whichever comes first. Keep Trelegy Ellipta and all medicines out of the reach of children.