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CICLESONIDE ADVANZ PHARMA is a brand name for Ciclesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ciclesonide Advanz Pharma is indicated in treatment to control persistent asthma in adults and adolescents (12 years and older).
Verbatim from this product's MHRA label. Tap a section to expand.
The medicinal product is for inhalation use only.
Posology Dosing recommendation for adults and adolescents:
The recommended dose of Ciclesonide Advanz Pharma is 160 micrograms once daily, which leads to asthma control in the majority of patients. 1). Patients should be given a dose of inhaled ciclesonide which is appropriate to the severity of their disease.
Symptoms start to improve with Ciclesonide Advanz Pharma within 24 hours of treatment. Once control is achieved, the dose of Ciclesonide Advanz Pharma should be individualised and titrated to the minimum dose needed to maintain good asthma control.
Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Ciclesonide Advanz Pharma should preferably be administered in the evening although morning dosing of Ciclesonide Advanz Pharma has also been shown to be effective.
The final decision on evening or morning dosing should be left to the discretion of the physician. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests.
Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought.
g. 1) or a course of oral corticosteroids). Severe asthma exacerbations should be managed the usual way. To address specific patient needs, such as finding it difficult to press the inhaler and breathe in at the same time, Ciclesonide Advanz Pharma can be used with the AeroChamber Plus Flow-Vu spacer device.
Special populations Elderly and patients with renal or hepatic impairment There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. Paediatric population The safety and efficacy of ciclesonide in children aged under 12 years have not yet been established.
No sufficient data are available. Method of administration Precautions to be taken before handling or administering the medicinal product The patient needs to be instructed how to use the inhaler correctly. If the inhaler is new or has not been used for one week or more, three puffs should be released into the air.
Approximately 5% of patients experienced adverse reactions in clinical trials with Ciclesonide Advanz Pharma given in the dose range 40 to 1280 micrograms per day. In the majority of cases, these were mild and did not require discontinuation of treatment with Ciclesonide Advanz Pharma.
g. theophylline or salbutamol). Paradoxical bronchospasm may occur immediately after dosing and is an unspecific acute reaction to all inhaled medicinal products, which may be related to the active substance, the excipient, or evaporation cooling in the case of metered dose inhalers.
In severe cases, withdrawal of Ciclesonide Advanz Pharma should be considered. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
As with all inhaled corticosteroids, Ciclesonide Advanz Pharma should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal, viral or bacterial infections, and only if these patients are adequately treated.
As with all inhaled corticosteroids, Ciclesonide Advanz Pharma is not indicated in the treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. As with all inhaled corticosteroids, Ciclesonide Advanz Pharma is not designed to relieve acute asthma symptoms for which an inhaled short-acting bronchodilator is required.
Patients should be advised to have such rescue medication available. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include:
Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
It is therefore important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No shaking is necessary as this is a solution aerosol. During inhalation, the patient should preferably sit or stand, and the inhaler should be held upright with the thumb on the base, below the mouthpiece. Instruct the patient to remove the mouthpiece cover, place the inhaler into their mouth, close their lips around the mouthpiece, and breathe in slowly and deeply.
While breathing in through the mouth, the top of the inhaler should be pressed down. Then, patients should remove the inhaler from their mouth, and hold their breath for about 10 seconds, or as long as is comfortable. The patient is not to breathe out into the inhaler.
Finally, patients should breathe out slowly and replace the mouthpiece cover. The mouthpiece should be cleaned with a dry tissue or cloth weekly. The inhaler should not be washed or put in water. 6.
Paediatric population It is recommended that the height of children and adolescents receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible to the lowest dose at which effective control of asthma is maintained.
In addition, consideration should be given to referring the patient to a paediatric respiratory specialist. Hepatic impairment There is no data available in patients with severe hepatic impairment. An increased exposure in patients with severe hepatic impairment is expected and these patients should therefore be monitored for potential systemic effects.
Adrenal impairment The benefits of inhaled ciclesonide should minimise the need for oral steroids. However, patients transferred from oral steroids remain at risk of impaired adrenal reserve for a considerable time after transferring to inhaled ciclesonide.
The possibility of respective symptoms may persist for some time. These patients may require specialised advice to determine the extent of adrenal impairment before elective procedures. The possibility of residual impaired adrenal response should always be considered in an emergency (medical or surgical) and elective situations likely to produce stress, and appropriate corticosteroid treatment considered.
For the transfer of patients being treated with oral corticosteroids:
The transfer of oral steroid-dependent patients to inhaled ciclesonide, and their subsequent management, needs special care as recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, may take a considerable time.
Patients who have been treated with systemic steroids for long periods of time, or at a high dose, may have adrenocortical suppression. With these patients adrenocortical function should be monitored regularly and their dose of systemic steroid reduced cautiously.
After approximately a week, gradual withdrawal of the systemic steroid is started by reducing the dose by 1 mg prednisolone per week, or its equivalent. For maintenance doses of prednisolone in excess of 10 mg daily, it may be appropriate to cautiously use larger reductions in dose at weekly intervals.
Some patients feel unwell in a non-specific way during the withdrawal phase despite maintenance or even improvement of respiratory function. They should be encouraged to persevere with inhaled ciclesonide and to continue withdrawal of systemic steroid, unless there are objective signs of adrenal insufficiency.
g. worsening asthma attacks, chest infections, major intercurrent illness, surgery, trauma, etc. Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies such as allergic rhinitis or eczema previously controlled by systemic drug.
Paradoxical bronchospasm with an immediate increase of wheezing or other symptoms of bronchoconstriction after dosing should be treated with an inhaled short-acting bronchodilator, which usually results in quick relief. The patient should be assessed and therapy with Ciclesonide Advanz Pharma should only be continued, if after careful consideration the expected benefit is greater than the possible risk.
8). Patients inhaler technique should be checked regularly to make sure that inhaler actuation is synchronised with inhaling to ensure optimum delivery to the lungs. Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
5), in which case patients should be […]