Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Asmanex Twisthaler 200 micrograms Inhalation Powder is indicated in adults and adolescents 12 years of age and older for regular treatment to control persistent asthma.
Dosage recommendations are based on severity of asthma (see criteria below).
The recommended starting dose for most of these patients is 400 micrograms once daily. Data suggest that better asthma control is achieved if once daily dosing is administered in the evening. Some patients may be more adequately controlled on 400 micrograms daily, given in two divided doses (200 micrograms twice daily).
The dose of Asmanex Twisthaler 200 micrograms Inhalation Powder should be individualised and titrated to the lowest dose at which effective control of asthma is maintained. Dose reduction to 200 micrograms once daily given in the evening may be an effective maintenance dose for some patients.
The recommended starting dose is 400 micrograms twice daily, which is the maximum recommended dose. When symptoms are controlled, titrate Asmanex Twisthaler 200 micrograms Inhalation Powder to the lowest effective dose.
In patients with severe asthma and previously receiving oral corticosteroids, Asmanex Twisthaler 200 micrograms Inhalation Powder will be initiated concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid can be initiated by reducing the daily or alternate daily dose. The next reduction is made after an interval of one to two weeks, depending on the response of the patient. Generally, these decrements are not to exceed 2.5 mg of prednisone daily, or its equivalent.
A slow rate of withdrawal is strongly recommended. During withdrawal of oral corticosteroids, patients must be carefully monitored for signs of unstable asthma, including objective measures of airway function, and for adrenal insufficiency (see 4.4).
The patient should be instructed that Asmanex Twisthaler 200 micrograms Inhalation Powder is not intended to be used “on demand” as a reliever medication to treat acute symptoms and that this product must be taken regularly to maintain therapeutic benefit even when he or she is asymptomatic.
Mild asthma: symptoms >1 time a week but <1 time per day; exacerbations may affect activity and sleep; night-time asthma symptoms >2 times a month; PEF or FEV1 >80% predicted, variability 20–30%.
Moderate asthma: symptoms daily; exacerbations affect activity and sleep; night-time asthma symptoms >1 time a week; daily use of short-acting beta2–agonist; PEF or FEV1 >60 - <80% predicted, variability >30%.
Severe asthma: continuous symptoms; frequent exacerbations; frequent night-time asthma symptoms; physical activities limited by asthma symptoms; PEF or FEV1 ≤60% predicted, variability >30%.
The safety and efficacy of Asmanex Twisthaler 200 mcg in children less than 12 years of age have not been established. No data are available.
No dosage adjustment is necessary.
This product is for inhalation use only.
The patient needs to be instructed how to use the inhaler correctly (see below).
Patients should be in an upright position when inhaling the product.
Prior to removing the cap, be sure the counter and the pointer on the cap are aligned. The inhaler can be opened by removing the white cap while holding unit upright (the pink-coloured base down), gripping the base, and twisting the cap counterclockwise. The counter will register the number down by one count. Instruct the patient to place the inhaler in the mouth, closing the lips around the mouthpiece, and to breathe in rapidly and deeply. Then, the inhaler is removed from the mouth, and the breath held for about 10 seconds, or as long as is comfortable. The patient is not to breathe out through the inhaler. To close, while holding the unit in an upright position, replace the cap immediately after each inhalation, loading for the next dose by rotating the cap clockwise while gently pressing down until a click sound is heard and the cap is fully closed. The arrow on the cap will be fully aligned with the counter window. After inhalation, patients are advised to rinse the mouth and spit out the water. This helps to reduce the risk of candidiasis.
The digital display will indicate when the last dose has been delivered; after dose 01, the counter will read 00 and the cap will lock, at which time the unit must be discarded. The inhaler is to be kept clean and dry at all times. The outside of the mouthpiece can be cleaned with a dry cloth or tissue; do not wash the inhaler; avoid contact with water.
For detailed instructions see Package Leaflet.
Because of the low systemic bioavailability of this product, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage. Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Management of the inhalation of mometasone furoate in doses in excess of the recommended dose regimens should include monitoring of adrenal function. Mometasone furoate therapy in a dose sufficient to control asthma can be continued.
As packaged for sale: 2 years.
After first opening: 3 months.
Store in original package in order to protect from moisture.
Do not refrigerate or freeze.
Do not store above 30°C.
Multi-dose powder inhaler.
A counter on the device indicates the number of doses remaining.
The 200 microgram powder inhaler is coloured white with a pink base, and is a multi-component device composed of polypropylene copolymer, polybutylene terephthalate, polyester, acrylonitrile-butadiene-styrene, bromo-butyl rubber and stainless steel. It contains a silica gel desiccant cartridge in the white polypropylene cap. The inhaler device is enclosed in an aluminium foil laminate pouch.
Pack sizes:
Pack of 1 pouched inhaler containing 30 delivered doses.
Pack of 1 pouched inhaler containing 60 delivered doses.
Pack of 3 individually packed and pouched inhalers with each inhaler containing 60 delivered doses.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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