Pulmicort Turbuhaler

Pulmicort Turbuhaler

budesonide

Manufacturer:

AstraZeneca

Distributor:

DKSH
Full Prescribing Info
Contents
Budesonide.
Description
Pulmicort Turbuhaler is free from propellants, lubricants, preservatives, carrier substances or other additives.
Action
Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. Budesonide undergoes an extensive degree (~90%) of biotransformation in the liver to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is <1% of that of budesonide.
Budesonide has shown antianaphylactic and anti-inflammatory effects in provocation studies in animals and patients, manifested as decreased bronchial obstruction in the immediate as well as the late allergic reaction.
Budesonide has also been shown to decrease airway reactivity to histamine and methacholine in hyper-reactive patients. Therapy with inhaled budesonide has effectively been used for prevention of exercise-induced asthma. After a single dose, improvement of the lung function is achieved within a few hours.
Full effect of budesonide, as for other glucocorticosteroids is, however, not achieved until after a couple of days. About 10% of the dose is deposited in the lungs. Of the fraction which is swallowed, 90% is inactivated at first passage through the liver. The maximal plasma concentration after inhalation of 1 mg budesonide is <0.01 micromole/L and is reached within 30 min.
Indications/Uses
Bronchial asthma.
Dosage/Direction for Use
The dosage of Pulmicort Turbuhaler is individual. When treatment with inhaled glucocorticosteroids is started during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage should be:
Adults: 200-1600 mcg daily, divided into 2-4 administrations (less severe cases 200-800 mcg daily, more severe cases 800-1600 mcg daily).
Children ≥6 years: 200-800 mcg daily, divided into 2-4 administrations; 400 mcg/day can be used once daily.
The maintenance dose is individual and should be the lowest possible. Twice-daily administration (morning and evening) is usually sufficient.
In patients where an increased therapeutic effect is desired, an increased dose of Pulmicort Turbuhaler is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids.
Patients Not Dependent on Oral Steroids: A therapeutic effect is usually reached within 10 days. In patients with excessive mucus secretion in the bronchi, a short (about 2 weeks) additional oral corticosteroid regimen can be given initially.
Patients Dependent on Oral Steroids: When transfer from oral steroids to Pulmicort Turbuhaler is started, the patient should be in a relatively stable phase. A high dose of Pulmicort Turbuhaler is given in combination with the previously used oral steroid for about 10 days. After that, the oral dose is gradually reduced (with eg, 2.5 mg prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute the oral steroid with Pulmicort Turbuhaler.
Note: The medication from Pulmicort Turbuhaler is delivered to the lungs as the patient inhales and therefore, it is important to instruct the patient to breathe-in forcefully and deeply through the mouthpiece. When prescribing Pulmicort Turbuhaler to young children, it is necessary to ascertain that they can follow the instruction for use.
The patient may not taste or feel any medication when using Pulmicort Turbuhaler due to the small amount of drug dispensed.
The patient should be instructed to rinse the mouth with water after each dosing occasion.
Overdosage
Acute overdosage with Pulmicort Turbuhaler, even in excessive doses, is generally not a clinical problem.
Contraindications
None.
Warnings
During transfer from oral steroid therapy to Pulmicort Turbuhaler, the patient may regain earlier symptoms eg, rhinitis, eczema and pain in muscles and joints. In these cases, a temporary increase in the dose of oral steroids is sometimes necessary. In general, insufficient steroid effect should be suspected if, in rare cases, symptoms eg, tiredness, headache, nausea and vomiting should occur.
Acute exacerbations of asthma may need complementary treatment with a short oral steroid regimen.
To minimize oropharyngeal thrush and systemic effects, the patient should rinse the mouth out with water after each dosing occasion.
Effects on the Ability to Drive or Operate Machinery: Pulmicort Turbuhaler does not affect the ability to drive or use machines.
Special Precautions
Special care is needed in patients with lung tuberculosis and fungal and viral infections in the airways.
Use in pregnancy & lactation: Administration during pregnancy should be avoided unless there are compelling reasons. In pregnant animals, administration of budesonide causes abnormalities of foetal development. The relevance of this finding to man has not been established.
If treatment with glucocorticosteroid during pregnancy is unavoidable, inhaled glucocorticosteroids should be preferred because of their lower systemic effect compared with equipotent antiasthmatic doses of oral glucocorticosteroids. There is no information regarding the passage of budesonide into breast milk.
Use In Pregnancy & Lactation
Administration during pregnancy should be avoided unless there are compelling reasons. In pregnant animals, administration of budesonide causes abnormalities of foetal development. The relevance of this finding to man has not been established.
If treatment with glucocorticosteroid during pregnancy is unavoidable, inhaled glucocorticosteroids should be preferred because of their lower systemic effect compared with equipotent antiasthmatic doses of oral glucocorticosteroids. There is no information regarding the passage of budesonide into breast milk.
Adverse Reactions
Mild irritation in the throat, coughing and hoarseness, Candida infection in the oropharynx has been reported. Coughing can usually be prevented by inhaling a β2-agonist 5-10 min before inhalation of Pulmicort.
Skin reactions (urticaria, rash, dermatitis, etc) may in rare cases, occur in association with local corticosteroid therapy.
Psychiatric symptoms eg, nervousness, restlessness and depression have been observed with budesonide as well as with other glucocorticosteroids.
Drug Interactions
The kinetics of budesonide was investigated in healthy subjects with and without cimetidine, 1000 mg daily. After a 4-mg oral dose, the values for Cmax (nmol/L) and systemic availability (%) of budesonide with and without cimetidine (3.3 versus 5.1 nmol/L and 10 versus 12%, respectively) indicated a slight inhibitory effect on hepatic metabolism of budesonide caused by cimetidine. This should be of little clinical importance.
Incompatibilities: Not applicable to this dosage form.
Storage
Store below 30°C.
ATC Classification
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Presentation/Packing
Turbuhaler 100 mcg/dose x 200 doses. 200 mcg/dose x 100 doses.
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