Abbreviated Prescribing Information: PULMICORT™ formulations (budesonide)

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

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

Pulmicort Dosage: Dosage is individual and should be adjusted to the lowest dose maintaining symptom control. To minimize oropharyngeal thrush, the patient should rinse the mouth out with water after each dosing occasion.

Dosage: Pulmicort™ Nebuliser Suspension 0.125 mg/mL, 0.25 mg/mL and 0.5 mg/mL

Pulmicort Nebuliser suspension for inhalation

Adults and the elderly: In general, recommended starting dose 1.0 – 2.0 mg daily. Maintenance dose range 0.5 – 4 mg daily.

Children, 6 months and above: In general, recommended starting dose 0.25 – 0.5 mg daily. Maintenance dose range 0.25 – 2 mg daily. Maximum recommended dose in children is 1 mg twice daily. The daily dose is usually given as one or two administrations. Once-daily dosing may be considered for those patients who require a maintenance dose of 0.25-1 mg budesonide per day. If a facemask is used, the face should be washed after use to prevent skin irritation.

Dosage: Pulmicort™ Turbuhaler™

Inhalation powder 100 mcg/dose, 200 mcg/dose, 400 mcg/dose (metered doses).

Adults and the elderly: In general, recommended starting dose 200-1600 mcg daily.

Children 6 years and above: In general, recommended starting dose 200-800 mcg daily. The daily dose is usually given as one or two administrations. Once daily dosing may be considered for those patients with mild to moderate asthma that require a dose of 100 to 400 mcg budesonide per day. During exacerbations and periods of severe asthma, patients may benefit from dividing the daily dose into 3-4 administrations per day. Maximum recommended dose in adults and the elderly is 800 mcg twice daily and in children 400 mcg twice daily.

Dosage: Pulmicort™ pressurised metered dose inhaler (pMDI)-CFC

Pressurised inhalation suspension 50 mcg/dose, 100 mcg/dose, 200 mcg/dose (metered doses).

Adults and the elderly: In general, recommended starting dose 200-1600 mcg daily, divided into 2-4 administrations.

Children 2-7 years: In general, recommended starting dose 200-400 mcg daily, divided into 2-4 administrations.

Children 7 years and above: In general, recommended starting dose 200-800 mcg daily, divided into 2-4 administrations.

Dosage: Pulmicort™ pressurised metered dose inhaler (pMDI)-HFA

Pressurised inhalation suspension 100 mcg/dose, 200 mcg/dose (metered doses).

Adults and the elderly: In general, recommended starting dose 200-1600 mcg daily, divided into 2-4 administrations.

Children 2-7 years: In general, recommended starting dose 200-400 mcg daily, divided into 2-4 administrations.

Children 7 years and above: In general, recommended starting dose 200-800 mcg daily, divided into 2-4 administrations.

Contraindications: Hypersensitivity to any of the ingredients.

Warnings and precautions: Pulmicort formulations are not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. The patient 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. Excessive doses of, or long-term treatment with, glucocorticoids may lead to signs or symptoms of hypercorticism, suppression of HPA function and/or suppression of growth in children. The long-term effects of glucocorticosteroids in man are not fully known. Thegrowth of children taking glucocorticosteroids in long-term treatment by any route should be monitored and the benefits of the therapy weighed against the possibility of growth suppression. Reduced liver function may affect the elimination of glucocorticosteroids. Special consideration in patients with pulmonary tuberculosis is needed. Inhibitors of CYP 3A4 such as itraconazole and ketoconazole may increase systemic exposure to budesonide.

Interactions: Budesonide has not been observed to interact with any drug used for the treatment of asthma. 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 / new born child. As with other drugs administered during pregnancy, the benefits for the mother should be weighed against the risks to the foetus. . Budesonide is excreted in breast milk. However, at therapeutic doses of  budesonide no effects on the suckling child are anticipated. Budesonide can be used during breast-feeding.

Undesirable effects: Mild throat irritation, coughing, hoarseness. Candida infection in the oropharynx. Immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm. Facial skin irritation may occur when using facemask for nebulisation. Psychiatric symptoms such as nervousness, restlessness and depression have been observed as well as behavioural disturbances. Rare reports of skin bruising. In rare cases, through unknown mechanisms, drugs for inhalation may cause bronchospasm. In rare cases signs or symptoms of systemic glucocorticosteroid effects.

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™. Other trademarks of Pulmicort™ Turbuhaler™ are Pulmicort™ Turbohaler™, Budecort™ Turbuhaler™, Budicort™ Turbuhaler™, Pulmaxan™ Turbohaler™ and Spirocort™ Turbuhaler™. Other trademarks of Pulmicort™ pMDI are Budecort™, Budicort™ and Spirocort™.

© AstraZeneca 2007

Date of preparation: April 2007  

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