Pulmicort™ Nebuliser Suspension, (Budesonide)
0.125 mg/mL, 0.25 mg/mL and 0.5 mg/mL (Sterile)
Nebuliser suspension for inhalation

See local Prescribing Information for full details, as Prescribing Information may vary from country to country.

Indications: Bronchial asthma requiring maintenance treatment with glucocorticosteroids for control of the underlying airway inflammation.

Dosage: Dosage is individual and should be adjusted to the lowest dose maintaining symptom control.  The daily dose is usually given as one or two administrations. Once-daily dosing may be considered both in adult and  pediatric patients, who require a maintenance dose of 0.25-1 mg budesonide per day. To minimize oropharyngeal thrush, the patient should rinse the mouth out with water after each dosing occasion. If a facemask is used, the face should be washed after use to prevent skin irritation.

Adults/elderly: In general, recommended starting dose 1-2 mg daily. Maintenance dose range 0.5 – 4 mg daily. Maximum recommended dose is 2 mg twice daily.

Children 6 months or older: In general, recommended starting dose 0.25 – 0.5 mg daily. Maintenance dose range 0.25 – 2 mg daily. Maximum recommended dose is 1 mg twice daily.

Contraindications: Hypersensitivity to any of the ingredients.

Warnings and precautions: Pulmicort Nebuliser Suspension  is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. The patients should seek medical advice if a previously effective dosage regimen no longer gives the same relief. 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, e.g. 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 glucocorticosteroid treatment with inhaled therapy sometimes unmasks allergies, e.g.  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 glucocorticosteroids. 
Inhibitors of CYP3A4 such as ketoconazole and itraconazole may increase systemic exposure to budesonide. This is of limited clinical importance for short-term (1-2 weeks) treatment, but should be taken into consideration during long-term treatment. Special consideration may be needed in patients with pulmonary tuberculosis. The long-term effects of  Pulmicort Nebuliser Suspension in man are not completely known. The growth of children taking corticosteroids by any route should be monitored and the benefit of the therapy weighed against the possibility of growth suppression.

Interactions: Budesonide has not been observed to interact with any drug used for the treatment of asthma. For itraconazole and ketoconazole (see Warnings and Precautions).  

Pregnancy and lactation: Results from a large prospective epidemiological study and from world-wide post marketing experience indicate no adverse effects of inhaled budesonide during pregnancy on the health of the foetus / newborn child. As with other drugs the administration of budesonide during pregnancy requires that the benefits for the mother be weighed against the risks for the foetus. Budesonide is excreted in breast milk. However, at therapeutic doses of  Pulmicort Nebuliser Suspension no effects on the suckling child are anticipated. Pulmicort Nebuliser Suspension can be used during breast feeding.

Undesirable effects: Common: Mild irritation in the throat, candida infection in the oropharynx, hoarseness, coughing Rare: Nervousness, restlessness, depression, behavioural disturbances, immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema,  bronchospasm, skin bruising. In rare cases, through unknown mechanisms, drugs for inhalation may cause bronchospasm. In rare cases signs or symptoms of systemic glucocorticosteroid effect, including hypofunction of the adrenal gland and reduction of growth velocity, may occur with inhaled glucocorticosteroids. Facial skin irritation has occurred in some cases when a nebuliser with a face mask has been used. To prevent irritation the facial skin should be washed with water after use of the face mask.

Legal category: On medical prescription.

Further information is available on request from AstraZeneca or local AstraZeneca subsidiaries.

Pulmicort™  is a trademark of the AstraZeneca group. Other trademarks of Pulmicort™ Nebuliser Suspension are Pulmicort™ Respules™, Pulmicort™ Nebuamp™, Budecort™, Budicort™, Pulmaxan™ and Spirocort™.

© AstraZeneca 2007