Ellipta
Ellipta Uses, Dosage, Side Effects, Food Interaction and all others data.
Ellipta is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. Like other corticosteroids Ellipta is found to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g.- histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.
Systemically, in vitro experiments show fluticasone furoate activates glucocorticoid receptors, inhibits nuclear factor kappa b, and inhibits lung eosinophilia in rats.
| Trade Name | Ellipta |
| Generic | Fluticasone Furoate |
| Fluticasone Furoate Other Names | Fluticasone furoate, Fluticasonum furoas, Furoate de fluticasone, Furoato de fluticasona |
| Type | |
| Formula | C27H29F3O6S |
| Weight | Average: 538.576 Monoisotopic: 538.163693965 |
| Protein binding | Fluticasone furoate is >99% protein bound in serum and may be as high as 99.6%. |
| Groups | Approved |
| Therapeutic Class | Nasal Steroid Preparations |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ellipta nasal spray is used for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
Ellipta is also used to associated treatment for these conditions: Asthma, Bacterial Sinusitis, Chronic Obstructive Pulmonary Disease (COPD), Chronic Sinusitis, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis
How Ellipta works
Fluticasone furoate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. In vitro experiments show fluticasone furoate activating glucocorticoid receptors, inhibiting nuclear factor kappa b, and inhibiting lung eosinophilia in rats.
Dosage
Ellipta dosage
Adults & Children over 12 years: 2 sprays in each nostril once a day. In some cases 2 sprays into each nostril twice daily, not exceeding 4 sprays.
Children under 12 years (2-11 Years): 1 spray in each nostril once a day. Patients should use Ellipta nasal spray at regular intervals as directed since its effectiveness depends on its regular use.
Children (under 2 years of age): There are no data to recommend use of Ellipta Nasal Spray for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.
How to use the Nasal Spray
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine mist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/other nostril for consecutive doses.
Side Effects
Eosinophilic conditions, adrenal insufficiency, growth retardation, Cushing's syndrome, decreased bone density, cataract, glaucoma. Rarely, psychological effects.
Toxicity
Fluticasone furoate administered nasally may be associated with adrenal suppression or an increase in QTc interval though the association has not been well demonstrated in studies. Fluticasone furoate requires no dosage adjustment in renal impairment but must be used in caution in hepatic impairment due to the elimination mechanisms. Fluticasone furoate is not associated with carcinogenicity, mutagenicity, or impairment of fertility. There are no well controlled studies in pregnancy or lactation though animal studies have shown teratogenicity and hypoadrenalism in the offspring of treated mothers and other corticosteroids are known to be excreted in breast milk. Generally, there are no reported adverse effects with fluticasone in pregnancy. Pediatric patients should be given the lowest possible dose and monitored for reduction in growth velocity. There is insufficient evidence to determine whether geriatric patients respond differently to other patients. Systemic exposure may be 27-49% higher in Japanese, Korean, and Chinese patients compared to Caucasian patients. Caution should be exercised in these patients and the benefit and risk should be assessed before deciding on a treatment.
Precaution
Patients taking Ellipta nasal spray should be periodically monitored for signs of adverse effects on the nasal mucosa such as epistaxis, nasal ulceration and impaired wound healing. Avoid using the drug in patients with recent nasal ulcers, nasal surgery, or nasal trauma. Closely monitor patients with a history of increased intraocular pressure, glaucoma and hypersensitivity reactions (including anaphylaxis, angioedema, rash, and urticaria). Besides, potential worsening of existing fungal, bacterial, viral, or parasitic infections or ocular herpes simplex, hypercorticism and growth retardation may occur after the administration of Ellipta nasal spray.
Interaction
Potent inhibitors of cytochrome P450 3A4 (CYP3A4) may increase exposure to Ellipta. Coadministration of ritonavir is not recommended. Use caution with coadministration of other potent CYP3A4 inhibitors, such as ketoconazole.
Special instruction: Patients should be instructed that the device must be primed: before first use, and if the cap is left off or if the device does not seem to be working or if the nasal spray has not been used for 30 days or more. In order to prime the device, the nasal spray needs to be shaken vigorously for about 10 seconds with the cap on. The patient must then press the button firmly all the way in, approximately 6 times until a fine mist is seen. Once primed, the patient must shake the nasal spray vigorously each time before use.
Food Interaction
No interactions found.Volume of Distribution
608L at steady state for intravenous administration of fluticasone furoate. Other reports suggest the mean volume of distribution at steady state is 661L. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 704L following intravenous administration.
Elimination Route
Intranasal exposure of fluticasone furoate results in patients swallowing a larger portion of the dose. However, absorption is poor and metabolism is high, therefore there is negligible systemic exposure with a nasal bioavailability of 0.50% and oral bioavialability of 1.26%. Inhaled bioavailability is 13.9%. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 6.3-18.4%.
Half Life
15.1 hours for intranasal fluticasone furoate and 24 hours for the inhaled formulation. A study of 24 healthy Caucasian males showed a half life of 13.6 hours following intravenous administration and 17.3-23.9 hours followed inhalation.
Clearance
57.8L/h for fluticasone furoate. A study of 24 healthy Caucasian males showed a clearance of 71.8L/h following intravenous administration.
Elimination Route
Fluticasone furoate is eliminated ≥90% in the feces and 1-2% in the urine.
Pregnancy & Breastfeeding use
Pregnancy: Plasma Ellipta concentrations were typically non-quantifiable and therefore potential for reproductive toxicity is expected to be very low.
Lactation: The excretion of Ellipta into human breast milk has not been investigated.
Contraindication
Ellipta nasal spray is contraindicated in patients with a hypersensitivity to any of its ingredients.
Special Warning
Pediatric use: The safety and effectiveness of Ellipta in children younger than 2 years have not been established.
Geriatric use: In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Use in hepatic impairment: Use Ellipta with caution in patients with severe hepatic impairment.
Use in renal impairment: No dosage adjustment is required in patients with renal impairment.
Storage Condition
- Store at a temperature not exceeding 30 °C.
- Do not refrigerate.
- Protect from light and moisture.
- Keep out of the reach of children.
Innovators Monograph
You find simplified version here Ellipta
Ellipta contains Fluticasone Furoate see full prescribing information from innovator Ellipta Monograph, Ellipta MSDS, Ellipta FDA label
FAQ
What is Ellipta used for?
Ellipta is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes. It is also available as an inhaled corticosteroid to help prevent and control symptoms of asthma.
How safe is Ellipta?
Ellipta was well tolerated. The incidence of most AEs was similar to that observed with placebo, with the exception of epistaxis, which was more frequently reported on active treatment.
How does Ellipta work?
Ellipta works on your immune system to reduce the symptoms of inflammatory conditions and allergic reactions such as swelling, redness and itching. The nasal spray reduces swelling and mucus in your nose. It can take a little longer to work than antihistamine nasal sprays but the effects last for longer.
What are the common side effects of Ellipta?
Common side effects of Ellipta are include:
- throat irritation.
- dryness of the nose.
- nasal passage irritation.
- headache.
- nosebleed.
Is Ellipta safe during pregnancy?
Ellipta is safe if they are used at the recommended therapeutic dose after a proper medical evaluation.
Is Ellipta safe during breastfeeding?
Expert opinion considers inhaled, nasal and oral corticosteroids acceptable to use during breastfeeding.
Can I drink alcohol with Ellipta?
Yes, you can drink alcohol while taking Ellipta.
How long does Ellipta take to work?
You will not notice an immediate improvement in your symptoms when you first start using Ellipta nasal spray. This is because it takes a few days for Ellipta to take full effect. Tell your doctor if you feel no better after using the spray for 7 days.
How long does Ellipta stay in my system?
Most inhaled steroids have a beneficial effect for 12 hours. The exceptions are Arnuity Ellipta, Asmanex, and Trelegy Ellipa, which last for 24 hours.
When should be taken of Ellipta?
The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.
How long can I take Ellipta?
This is usually between 1 and 3 months. If you are prescribed fluticasone nasal spray, your doctor may advise you to use it for longer. If you are using Ellipta drops to shrink nasal polyps, your doctor will tell you how long to use them for. It will usually be for several weeks.
How much Ellipta can I take in a day?
Adults, The recommended starting dosage in adults is 2 sprays (50 mcg of Ellipta each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective.
Who should not take Ellipta?
You should not use Ellipta nasal if you are allergic to it. Ellipta can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or recently had.
What happens if I miss a dose?
If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
What happen if I overdose on Ellipta?
If you take too much Ellipta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. If Ellipta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.
What happen If I stop taking Ellipta?
If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin using Ellipta.
Can Ellipta cause heart problems?
Ellipta often contain vasoconstrictors that narrow your blood vessels, which can cause heart problems with long-term, frequent use.
Can Ellipta affects my liver?
Long term use of these chemical sprays can also damage the liver and other vital organs.
Is Ellipta bad for my kidneys?
Ellipta Allergy Relief has a well-established safety profile. Ellipta Allergy Relief is not associated with Higher blood pressure and is not contraindicated in patients with hypertension, heart disease, diabetes, liver disease, or kidney disease.
Can Ellipta make me gain weight?
Ellipta are generally not associated with weight gain.
Is Ellipta safe to use everyday?
Use Ellipta every day as full effectiveness is usually achieved after 3 or 4 days of continuous use.
