PULMICORT NEBULISING SUSPENSION 0.25MG/ML 20 X 2ML

PULMICORT NEBULISING SUSPENSION 0.25MG/ML 20'S

Budesonide, 0.25 mg/ml. Each 2 ml Respule contains 0.5 mg of budesonide.

Therapeutic indications

Pulmicort Respules contain the potent, non-halogenated, corticosteroid, budesonide, for use in bronchial asthma, in patients where the use of a pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate.

Pulmicort Respules is also recommended for use in infants and children with croup (acute viral upper respiratory tract infection also known as viral laryngotracheobronchitis or laryngitis subglottic).

The dosage of Pulmicort Respules should be adjusted to the need of the individual.

Dosage schedules: The dose delivered to the patient varies depending on the nebulizing equipment used. The nebulization time and the dose delivered is dependent on flow rate, the volume of nebulizer chamber and fill volume. An air-flow rate of 6 - 8 liters per minute through the device should be employed. A suitable fill volume for most nebulizers is 2 - 4 ml. The dosage of Pulmicort Respules should be adjusted to the need of the individual. The dose should be reduced to the minimum needed to maintain good asthma control. The highest dose (2 mg per day) for children under 12 years should only be considered in children with severe asthma and during limited periods.

Bronchial asthma

Initiation of therapy

When treatment is started, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the recommended dose of Pulmicort Respules is:

Adults (including the elderly): Usually 1 - 2 mg twice daily. In very severe cases the dosage may be further increased.

Pediatric population

Children 12 years and older: Dosage as for adults.

Children 3 months to 12 years: 0.5 – 1 mg twice daily.

Maintenance

The maintenance dose should be individualized and be the lowest dose which keeps the patient symptom-free.

Adults (including the elderly and children 12 years and older): 0.5 - 1 mg twice daily.

Pediatric population

Children 3 months to 12 years: 0.25 - 0.5 mg twice daily.

Adverse Drug Reaction

Oropharyngeal candidiasis, Pneumonia (in COPD patients), cough, hoarseness

Immediate and delayed hypersensitivity reactions* including rash, contact dermatitis, urticaria, angioedema, and anaphylactic reaction

Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation

Anxiety, Depression, Psychomotor hyperactivity, Sleep disorders, Aggression, Behavioural changes (predominantly in children), Tremor, Cataract, blurred vision