Consumer medicine information

1. Why am I using Pulmicort?

Pulmicort contains the active ingredient budesonide. Pulmicort is inhaled into the lungs for the treatment of asthma. Pulmicort may also be used to treat croup in infants and children.
For more information, see Section 1. Why am I using Pulmicort? in the full CMI.

2. What should I know before I use Pulmicort?

Do not use if you have ever had an allergic reaction to any medicine containing budesonide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Pulmicort? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Pulmicort and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Pulmicort?

• Pulmicort comes in two different forms: the Turbuhaler or Respules (containing nebulising suspension) for use in a nebuliser.

• Follow all directions given to you by your doctor or pharmacist.

5. What should I know while using Pulmicort?

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. These include sore, yellowish, raised patches in the mouth (thrush), hoarse voice, dry mouth, unpleasant taste in your mouth, cough, thirsty, headache, light-headedness, tiredness, nausea, diarrhoea, weight gain, or skin rash. However, some side effects may need medical attention. These include severe allergic reactions such as difficulty breathing, swelling of the face, lips or tongue, severe rash or mood changes such as depression). Serious side effects are rare.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Budesonide.

2 Qualitative and Quantitative Composition

Pulmicort Turbuhaler. Pulmicort Turbuhaler contains only budesonide as the active ingredient; either 100 microgram, 200 microgram or 400 microgram per dose (metered dose).
Pulmicort Respules. Pulmicort Respules contain budesonide 0.5 mg in 2 mL or 1 mg in 2 mL as the active ingredient. For the full list of Pulmicort Respules excipients, see Section 6.1.

3 Pharmaceutical Form

Pulmicort Turbuhaler. Powder for inhalation. Pulmicort Turbuhaler is a breath activated multiple dose dry powder inhaler.
Pulmicort Respules. Pulmicort Respules nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units.

4 Clinical Particulars

4.9 Overdose

Symptoms. In most cases, occasional overdosing will not produce any obvious symptoms but will decrease the plasma cortisol level and increase the number and percentage of circulating neutrophils. The number and percentage of lymphocytes and eosinophils will decrease concurrently. Habitual overdosing may cause hypercorticism and hypothalamic pituitary adrenal suppression.
Treatment. Withdrawing Pulmicort or decreasing the dose will abolish these effects, although the normalization of the HPA axis may be a slow process.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The mutagenic potential of budesonide was evaluated in 6 different test systems. No mutagenic or clastogenic effects of budesonide were found.
Carcinogenicity. The carcinogenic potential of budesonide has been evaluated in mouse and rat at oral doses up to 200 and 50 microgram/kg/day, respectively. No oncogenic effect was noted in the mouse. One study indicated an increased incidence of brain gliomas in male Sprague-Dawley rats given budesonide, however the results were considered equivocal. Further studies performed in male Sprague-Dawley and Fischer rats showed that the incidence of gliomas in the budesonide treated rats was low and did not differ from that in the reference glucocorticoid groups or the controls. It has been concluded that treatment with budesonide does not increase the incidence of brain tumours in the rat.
In male rats dosed with 10, 25 and 50 microgram/kg/day, those receiving 25 and 50 microgram/kg/day showed an increased incidence of primary hepatocellular tumours. This was observed in all three steroid groups (budesonide, prednisolone, triamcinolone acetonide) in a repeat study in male Sprague-Dawley rats thus indicating a class effect of corticosteroids.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: 16α, 17α -22R, S-propylmethylenedioxy-pregna-1, 4-diene-11β, 21-diol-3, 20-dione.
Chemical structure. Chemical structure of budesonide.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUDESO.gif CAS number. 51333-22-3.
MW: 430.5.
Molecular formula: C₂₅H₃₄O₆.
Budesonide is a white to off white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budesonide melts with decomposition between 224°C and 231.5°C.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PULMICST.gif