inhaler side effects

Hi there,

My 2 1/2 year old daughter suffers from a persistant ""virally induced wheeze"" which the doctor says she'll likely grow out of (no family history of asthma).

It seems to be worse in the cold wet months, she's had 3 ""attacks"" in the last 5 weeks, two hospital trips through breathing difficulties and a trip to the doctors. The attacks started this time last year when she was given Ventolin inhaler to be used as and when required. She's had a few bouts of breathlessness since then but this winter seems to be getting worse. 5 weeks ago she was hospitalised overnight, on oxygen all night and half hourly nebulisers and a course of oral steriods. Attack number 2 we took her to the doctors as soon as she started getting breathless and he gave her oral steriods and told us to use the inhaler. The most recent attack started saturday night and ended with an early hours trip to the hospial, a couple of nebulisers and sent home with oral steriods once again.

After going to the doctors to discuss it again my daughter, Imogen, has been given a low dose Clenil Modulite inhaler to be used twice daily, 2 puffs.

My question is (finally!) is it safe? We spoke to the doctor after attack number two and asked if a preventer inhaler would make a difference to which he said it wouldn't and he wouldn't be happy giving it to her. Today a different Doctor prescribed it straight away and without hesitation (although this came with a recommendation from the Doctor at the hospital).

I'm just a bit confused as why would one Doctor not recommend it and another give it out without a word of warning???? I've read the info with the inhaler and dont know if i'm just being a worrier or if it would be best to leave the preventer inhaler for now and just keep on going to hospital when it happens.

Thank you for taking the time to read this!!!

Su

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Clenil Modulite is for inhalation use only.

The Volumaticâ„¢ spacer device may be used by patients who have difficulty synchronising aerosol actuation with inspiration of breath.

Children:

Clenil Modulite 50 micrograms & 100 micrograms:

The usual starting dose is 100 micrograms twice daily. Depending on the severity of asthma, the daily dose may be increased up to 400 micrograms administered in two to four divided doses.

Clenil Modulite 200 micrograms & 250 micrograms:

Clenil Modulite 200 micrograms & 250 micrograms are not recommended for children.

Clenil Modulite must always be used with the Volumaticâ„¢ spacer device when administered to children and adolescents 15 years of age and under, whatever dose has been prescribed.

Method of Administration

The aerosol spray is inhaled through the mouth into the lungs. The correct administration is essential for successful therapy. The patient must be instructed on how to use Clenil Modulite correctly and advised to read and follow the instructions printed on the Patient Information Leaflet carefully.

Instructions for Use

If the inhaler is new or has not been used for three days or more, one puff should be released into the air. It is not necessary to shake the inhaler before use because this is a solution aerosol.

Instruct the patient to remove the mouthpiece cover and check that it is clean and free from foreign objects. The patient should then be instructed to breathe out before placing the inhaler into their mouth. They should then close their lips around the mouthpiece and breathe in steadily and deeply. They must not bite the mouthpiece. After starting to breathe in through the mouth, the top of the inhaler should be pressed down. Whilst the patient is still breathing in, the patient should then remove the inhaler from their mouth and hold their breath for about 5 to 10 seconds, or as long as is comfortable, and then breathe out slowly. The patient must not breathe out into the inhaler. If another dose is required the patient should be advised to wait 30 seconds before repeating the procedure just described. Finally, patients should breathe out slowly and replace the mouthpiece cover.

The patient should be told not to rush the procedure described. It is important that the patient breathes in as slowly as possible prior to actuation. Inform the patient that if a mist appears on inhalation, the procedure should be repeated.

It may be helpful to advise children and patients with weak hands to hold the inhaler with two hands, by placing both forefingers on top of the inhaler and both thumbs at the bottom of the device.

Patients who find it difficult to co-ordinate actuation with inspiration of breath should be told to use a Volumaticâ„¢ spacer device to ensure proper administration of the product.

Young children may find it difficult to use the inhaler properly and will require help. Using the inhaler with the Volumaticâ„¢ spacer device with a face mask may help in children under 5 years.

Advise the patient to thoroughly rinse the mouth or gargle with water or brush the teeth immediately after using the inhaler.

The patient should be told of the importance of cleaning the inhaler at least weekly to prevent any blockage and to carefully follow the instructions on cleaning the inhaler printed on the Patient Information Leaflet. The inhaler must not be washed or put in water.

The patient should be told also to refer to the Patient Information Leaflet accompanying the Volumatic spacer device for the correct instructions on its use and cleaning.

Special warnings and precautions for use

Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. Patients should also be informed that Clenil Modulite should be used on a regular basis, even when they are asymptomatic.

Clenil Modulite does not provide relief of acute asthma symptoms, which require a short-acting inhaled bronchodilator. Patients should have relief medication available.

Severe asthma requires regular medical assessment, including lung-function testing, as there is a risk of severe attacks and even death. Patients should be instructed to seek medical attention if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required as this may indicate deterioration of asthma control. If this occurs, patients should be assessed and the need for increased anti-inflammatory therapy considered (eg. higher doses of inhaled corticosteroid or a course of oral corticosteroid).

Severe exacerbations of asthma must be treated in the usual way, ie. by increasing the dose of inhaled beclometasone dipropionate, giving a systemic steroid if necessary, and/or an appropriate antibiotic if there is an infection, together with ?-agonist therapy.

Treatment with Clenil Modulite should not be stopped abruptly.

Systemic effects of inhaled corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of children 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 corticosteroids, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should also be given to referring the patient to a paediatric respiratory specialist.

Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression.

Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

The transfer to Clenil Modulite of patients who have been treated with systemic steroids for long periods of time or at high doses, needs special care, since recovery from possible adrenocortical suppression may take considerable time. Reduction of the dose of systemic steroid can be commenced approximately one week after initiating treatment with Clenil Modulite. The size of the reduction should correspond to the maintenance dose of systemic steroid. For patients receiving maintenance doses of 10mg daily or less of prednisolone (or equivalent) reductions in dose of not more than 1 mg are suitable. For higher maintenance doses, larger reductions in dose may be appropriate. These oral dosage reductions should be introduced at not less than weekly intervals.

Adrenocortical function should be monitored regularly as the dose of systemic steroid is gradually reduced.

Some patients feel unwell during withdrawal of systemic steroids despite maintenance or even improvement of respiratory function. They should be encouraged to persevere with inhaled beclometasone dipropionate and to continue withdrawal of systemic steroid, unless there are objective signs of adrenal insufficiency.

Patients weaned off oral steroids whose adrenocortical function is impaired should carry a steroid warning card indicating that they may need supplementary systemic steroids during periods of stress, eg. 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 the systemic drug. These allergies should be symptomatically treated with antihistamine and/or topical preparations, including topical steroids.

As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.

Patients should be advised that this product contains small amounts of ethanol (approximately 9mg per actuation) and glycerol. At the normal doses, the amounts of ethanol and glycerol are negligible and do not pose a risk to patients .

Undesirable effects

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing, shortness of breath and cough after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Clenil Modulite should be discontinued immediately, the patient assessed and, if necessary, alternative therapy instituted.

Hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat, have been reported.

Candidiasis of the mouth and throat occurs in some patients, the incidence increasing with doses greater than 400 micrograms beclometasone dipropionate per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Patients may find it helpful to rinse their mouth thoroughly with water after inhalation. Symptomatic oral candidiasis can be treated with topical antifungal therapy while continuing with Clenil Modulite.

Hoarseness or throat irritation may occur in some patients. These patients should be advised to rinse the mouth out with water immediately after inhalation. Use of the Volumaticâ„¢ spacer device may be considered.