Pulmicort™ pressurised Metered Dose Inhaler (pMDI), 100 micrograms/dose and 200 micrograms/dose, pressurised inhalation, suspension.

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. During exacerbations and periods of severe asthma, patients may benefit from dividing the daily dose into 3-4 administrations per day. To minimize oropharyngeal thrush, the patient should rinse the mouth out with water after each dosing occasion.

Adults/elderly: In general, recommended starting dose 200-1600 micrograms daily, divided into 2-4 administrations (less severe cases 200-800 micrograms daily, more severeds cases 800-1600 micrograms daily). Maintenance dose range 200-1600 micrograms daily. Maximum dose recommended is 800 micrograms twice daily.

Children 7 years and above: In general, recommended starting dose 200-800 micrograms daily, divided into 2-4 administrations. Maintenance dose range 200-800 micrograms daily. Maximum dose recommended is 400 micrograms twice daily.

Children 2-7 years: In general, recommended starting dose 200-400 mcg daily, divided into 2-4 administrations. Maintenance dose range 200-400 micrograms daily. Maximum dose recommended is 200 micrograms twice daily.

Contraindications: Hypersensitivity to any of the ingredients

Warnings and precautions: Pulmicort pMDI  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 pMDI 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.

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 Pulmicort pMDI 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 pMDI no effects on the suckling child are anticipated.  Pulmicort pMDI 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.

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™ pMDI are Budecort™, Budicort™ and Spirocort™.

© AstraZeneca 2007
Date of preparation: March 2007