Pulmicort Respules

Pulmicort Respules Special Precautions





Full Prescribing Info
Special Precautions
Pulmicort Nebuliser Suspension is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required.
If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought. In this situation consideration should be given to the need for increased anti-inflammatory therapy, eg, higher doses of inhaled budesonide or a course of oral glucocorticosteroid.
Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time. Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Some patients feel unwell in a non-specific way during the withdrawal phase, eg, pain in muscles and joints. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies, eg, rhinitis and eczema, which were previously controlled by the systemic drug. These allergies should be symptomatically controlled with an antihistamine and/or topical preparations.
Reduced liver function may affect the elimination of corticosteroids. This may be clinically relevant in patients with severely compromised liver function.
In vivo studies have shown that oral administration of ketoconazole and itraconazole (known inhibitors of CYP3A4 activity in the liver and in the intestinal mucosa, see also Interactions) may cause an increase of the systemic exposure to budesonide. This is of limited clinical importance for short-term (1 to 2 weeks) treatment, but should be taken into consideration during long-term treatment.
The long-term local and systemic effects of Pulmicort Nebuliser Suspension in man are not completely known.
The dose should be titrated to the lowest effective maintenance dose once control of asthma is achieved.
Physicians should closely monitor the growth of children taking corticosteroids by any route and weigh the benefit of corticosteroid therapy and asthma control against the possibility of growth suppression.
Important: PULMICORT (budesonide) is a preventative agent and should not be used as sole therapy in the case of an acute asthma attack. If the asthma worsens the patient should consult treatment plan or consult the physician.
Effects on ability to drive and use machines: Pulmicort Nebuliser Suspension has no effect on the ability to drive and use machines.
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