NOTE:
The recommended total daily dose of Respocort is lower than that for current beclometasone dipropionate containing products and should be adjusted to the needs of the individual patient.
ADULTS ANND ADOLESCENTS OVER 12 YEARS STARTING AND MAINTENANCE DOSE:
It is important to gain control of asthma symptoms and optimise pulmonary function as soon as possible. When patients’ symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.
To be effective inhaled Respocort must be used on a regular basis even when patients are asymptomatic.
Therapy in new patients should be initiated at the following dosages:
Mild asthma: 100 to 200 micrograms per day in two divided doses Moderate asthma: 200 to 400 micrograms per day in two divided doses Severe asthma: 400 to 800 micrograms per day in two divided doses Patients on budesonide inhalers may be transferred to Respocort as described below: The general approach to switching patients to Respocort involves two steps as detailed below.
Specific guidance on switching well-controlled and poorly controlled (symptomatic) patients is given below the table.
Step 1:
Consider the dose of budesonide-containing inhalers appropriate to the patient’s current condition.
Step 2:
Convert the budesonide dose to the Respocort dose according to the table below. Daily Dose of Beclometasone Dipropionate (micrograms) Budesonide Inhaler 200- 250 300 400- 500 600- 750 800- 1000 1100 1200- 1500 1600- 2000 Respocort 100 150 200 300 400 500 600 800 Patients with well-controlled asthma using budesonide inhaler products should be switched to Respocort at a dose in accordance with the table above.
For example:
Patients on 2 puffs twice daily of budesonide 200 micrograms would change to 2 puffs twice daily of Respocort 100 micrograms. Patients with poorly-controlled asthma may be switched from budesonide inhaler products to Respocort at the same microgram for microgram dose up to 800 micrograms daily.
Alternatively the patient’s current budesonide inhalee dose can be doubled and this dose can be converted to the Respocort dose according to the table above. Patients on fluticasone inhalers may be transferred to the same total daily dose of Respocort up to 800 micrograms daily.
Once transferred to Respocort the dose should be adjusted to meet the needs of the individual patient. The maximum recommended dose is 800 micrograms per day in divided doses.
CHILDREN AGED 5 YEARS AND OVER STARTING AND MAINTENANCE DOSE:
Therapy in new patients should be initiated at the following dosages: Mild asthma: 100 micrograms per day in two divided doses Moderate asthma: 100 to 200 micrograms per day in two divided doses Severe asthma: 200 micrograms per day in two divided doses The minimum recommended dose is 50 micrograms twice daily and the maximum recommended dose is 100 micrograms twice daily, representing a total daily dose of 100 and 200 micrograms, respectively.
Children with well-controlled asthma on doses of up to 400 micrograms per day of beclometasone dipropionate administered from other currently available beclometasone dipropionate inhalers or equivalent may be titrated to a dose of 100-200 micrograms (in two divided doses) per day of Respocort.
During periods of deterioration in asthma control, the dose of beclometasone dipropionate may be increased to 200 micrograms per day in two divided doses. The dose should then be reduced to the minimum needed to maintain effective control of asthma.
Patients on fluticasone or budesonide inhalers may be switched to Respocort using the approach described earlier for adults and adolescents. Once transferred to Respocort the dose should be adjusted to meet the needs of the individual patient.
Special patient groups No special dosage recommendations are made for elderly or patients with hepatic or renal impairment. Method of administration Respocort is for inhalation use. Patients and carers should be instructed in the proper use of the inhaler, including rinsing out the mouth with water after use.
Patients should be advised that Respocort may have a different taste and feel compared to other inhalers. Respocort Autohaler is a breath-actuated inhaler which automatically releases the metered dose of medication during a patient’s inhalation through the mouthpiece and overcomes the need for patients to have good manual co- ordination.
The parent/guardian/carer as well as the patient should read the instruction leaflet before use. Before first use of the inhaler, or if the inhaler has not been used for two weeks or more, prime the inhaler by releasing two puffs into the air.
Respocort delivers a consistent dose, at temperatures as low as -10°C, without the need for the patient to wait between individual actuations. Instructions for use There is no need to shake the inhaler before use, as it is a solution.
Instruct the patient, parent or guardian/carer to remove the mouthpiece cover and check that the inhaler is clean and free from foreign objects. The Autohaler device should be held upright. The lever should be pushed to the upward position.
As this is an automatic device, the dose will automatically be released when the patient begins breathing with the inhaler. The patient should be advised to breathe out as far as is comfortable before placing the inhaler into their mouth.
They should then close their lips tightly around the mouthpiece and breathe in steadily and deeply through the mouth. After starting to breathe in, the patient should not stop breathing when there is a slight click and when they feel the actuation in their mouth as it is important to carry on breathing after the puff is released.
Whilst the patient is still breathing in, the inhaler should be removed from their mouth and they should hold their breath for 10 seconds and then breathe out slowly. The patient should not breathe out into the inhaler. After receiving the puff, the lever must be lowered […]