Relvar Ellipta

Relvar Ellipta Dosage/Direction for Use

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Posology: Asthma: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists.
Adults and adolescents aged 12 years and over: One inhalation of Relvar Ellipta 100/25 micrograms once daily.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta.
However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
A starting dose of Relvar Ellipta 100/25 micrograms should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long- acting beta2-agonist. If patients are inadequately controlled on Relvar Ellipta 100/25 micrograms, the dose can be increased to 200/25 micrograms, which may provide additional improvement in asthma control.
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Relvar Ellipta 200/25 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Children aged under 12 years: The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
No data are available.
200/2.5 mcg: The maximum recommended dose is Relvar Ellipta 200/25 micrograms once daily.
Asthma: patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Adults aged 18 years and over: One inhalation of Relvar Ellipta 100/25 micrograms once daily.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta. However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Relvar Ellipta 200/25 micrograms should be considered for adults 18 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Adolescents aged under 18 years: The safety and efficacy of Relvar Ellipta in adolescents under 18 years of age has not yet been established for this indication.
200/2.5 mcg: Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Relvar Ellipta.
100/2.5 mcg: COPD: Adults aged 18 years and over: One inhalation of Relvar Ellipta 100/25 micrograms once daily.
Relvar Ellipta 200/25 micrograms is not indicated for patients with COPD. There is no additional benefit of the 200/25 micrograms dose compared to the 100/25 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see Precautions and Adverse Reactions).
Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Relvar Ellipta.
Paediatric population: There is no relevant use of Relvar Ellipta in the paediatric population for the indication of COPD.
Special populations: Elderly patients (>65 years): No dose adjustment is required in this population (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in this population (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see Pharmacology: Pharmacokinetics under Actions).
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
For patients with moderate or severe hepatic impairment the maximum dose is 100/25 micrograms (see Precautions).
Method of administration: Relvar Ellipta is for inhalation use only.
It should be administered at the same time of the day, each day.
The final decision on evening or morning dosing should be left to the discretion of the physician.
If a dose is missed the next dose should be taken at the usual time the next day.
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
After inhalation, patients should rinse their mouth with water without swallowing.
When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way. The step-by-step instructions should be followed.
The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. Once opened the desiccant sachet should be discarded.
The patient should be advised to not open the tray until they are ready to inhale a dose.
When the inhaler is taken out of its tray, it will be in the 'closed' position. The "Discard by" date should be written on the inhaler label in the space provided. The "Discard by" date is 1 month from the date of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
Instructions for use: The ELLIPTA inhaler contains pre-dispensed doses and is ready to use.
When the patient first uses the Ellipta inhaler the patient does not need to check that it is working properly, and the patient does not need to prepare it for use in any special way. The patient just has to follow the instructions as follows.
The inhaler is packaged in a tray. The patient should be advised to not open the tray until they are ready to inhale a dose. When the patient is ready to use the inhaler, the lid should be peeled back to open the tray. The tray contains a desiccant sachet, to reduce moisture. The desiccant sachet should be thrown away and it should not be open, eaten or inhaled.
The inhaler will be in the 'closed' position when it is first taken out of its sealed tray. The patient should be advised not to open the inhaler until ready to inhale a dose of medicine. The "Discard by" date should be written on the inhaler label in the space provided. The "Discard by" date is 1 month from the date of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
The step-by-step instructions shown as follows for the 30-dose (30 day supply) Ellipta inhaler also apply to the 14-dose (14 day supply) Ellipta inhaler.
Read this before starting: If the inhaler cover is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take extra medicine or a double dose in one inhalation.
How to prepare a dose: Open the cover when ready to take a dose. Do not shake the inhaler.
Slide the cover down until you hear a 'click'.
The medicine is now ready to be inhaled.
The dose counter counts down by 1 to confirm.
If the dose counter does not count down as the patient hears the 'click', the inhaler will not deliver medicine. Take it back to a pharmacist for advice.
Do not shake the inhaler at any time.
How to inhale the medicine: Hold the inhaler away from the mouth and breathe out as far as is comfortable.
Do not breathe out into the inhaler.
Put the mouthpiece between the lips and close the lips firmly around it.
Do not block the air-vents with the fingers.
Take one long, steady, deep breath in. Hold this breath for as long as possible (at least 3-4 seconds).
Remove the inhaler from the mouth.
Breathe out slowly and gently.
It may not be possible to taste or feel the medicine, even when using the inhaler correctly.
If the patient wants to clean the mouthpiece, use a dry tissue, before closing the cover.
Close the inhaler and rinse the mouth: Slide the cover upwards as far as it will go to cover the mouthpiece.
Rinse the mouth with water after using the inhaler.
This will make it less likely to develop a sore mouth or throat as side effects.
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