Foster Dosage/Direction for Use

The drug is for inhalation use.
ASTHMA: It is not intended for the initial management of asthma. The dosage of the components of the drug is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta₂-agonists and/or corticosteroids by individual inhalers should be prescribed.
There are 2 treatment approaches: A. Maintenance Therapy: Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) is taken as regular maintenance treatment and patients are advised to have their separate "as needed" rapid-acting bronchodilator available for rescue use at all times.
Dose recommendations for adults 18 years and above: One or two inhalations twice daily.
The maximum daily dose is 4 inhalations.
B. Maintenance and Reliever Therapy: Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) is taken as a regular maintenance treatment and as needed in response to asthma symptoms. Patients are advised to always have Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) available for rescue use.
Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) maintenance and reliever therapy should especially be considered for patients with: not fully controlled asthma and in need of reliever medication; asthma exacerbations in the past requiring medical intervention.
Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.
The maximum dose is 8 inhalations.
Patients requiring frequent use of rescue inhalations daily should be strongly recommended to seek medical advice. Their asthma should be reassessed and their maintenance therapy should be reconsidered.
Dose recommendations for children and adolescents under 18 years: The safety and efficacy of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) in children and adolescents under 18 years of age have not been established yet. No data are available with the drug in children under 12 years of age.
Therefore the drug is not recommended for children and adolescents under 18 years until further data become available.
Patients should be regularly reassessed by a doctor, so that the dosage of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) 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. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
Patients should be advised to take Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) every day even when asymptomatic.
COPD: Dose recommendations for adults 18 years and above: Two inhalations twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients. There are no data available for use of Beclometasone dipropionate/Formoterol fumarate dihydrate (Foster) in patients with hepatic or renal impairment.
Method of Administration: To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professional. Correct use of the pressurized metered dose inhaler is essential in order that treatment is successful.
The patient should be advised to read the package insert carefully and follow the instructions for use as given in the insert.
Before using the inhaler for the first time or if the inhaler has not been used for 14 days or more, the inhaler should be tested to make sure it is working properly.
1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece at the bottom.
3. Direct the mouthpiece away from the patient and firmly depress the canister to release one puff.
4. Check the dose counter. If the patient is testing the inhaler for the first time, the counter should read 120.
How to use the inhaler: Whenever possible, stand or sit in an upright position when inhaling.
1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through the mouth and, just after starting to breathe in press down firmly on the top of the inhaler to release one puff.
5. Hold the breath for as long as possible and, finally, remove the inhaler from the mouth and breathe out slowly. Do not breath out into the inhaler.
Should a further puff be needed, keep the inhaler in a vertical position for about half a minute and repeat steps 2 to 5.
IMPORTANT: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose counter.
The inhaler should be replaced when the counter shows the number 20. Stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to give a full dose.
If mist appears following inhalation, either from the inhaler or from the sides of the mouth, this means that Foster will not be getting into the lungs as it should. Take another puff, following the instruction starting again from step 2.
For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.
Patients should rinse their mouth or gargle with water or brush the teeth after inhaling.
Cleaning: Patients should clean the inhaler once a week. When cleaning, do not remove the canister can from the actuator and do not use water or other liquids to clean the inhaler.
To clean the inhaler: 1. Remove the protective cap from the mouthpiece by pulling it away from the inhaler.
2. Wipe inside and outside of the mouthpiece and the actuator with a clean, dry cloth or tissue.
3. Replace the mouthpiece cover.
Patients who find it difficult to synchronise aerosol actuation with inspiration of breath, may use a spacer device. They should be advised by their doctor, pharmacist or a nurse in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs. This may be obtained by the patients using the spacer device by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.