Budesonide

Registered South African indications:

• Asthma
• Laryngotracheobronchitis-croup

Registered South African contraindications

Inhaler

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with active or quiescent pulmonary tuberculosis (TB) or with other untreated airway infections of bacterial, fungal or viral origin
• Pregnancy, unless no safe/safer medicine is available, has failed, cannot be tolerated or contraindicated and treatment cannot be avoided. Use the lowest possible efficient dose and if possible, avoid in first trimester of pregnancy. Patients should be counselled of the possibility of teratogenicity
• Breastfeeding, unless no safe/safer medicine is available, has failed, cannot be tolerated or contraindicated and treatment cannot be avoided. Use the lowest possible efficient dose and if possible, avoid in first trimester of pregnancy. Patients should be counselled of the possibility of teratogenicity

Solution for inhalation

• Hypersensitivity to the active ingredient or any of its excipients
• Patients with lung tuberculosis, fungal and viral infections in the airways
• Safety and efficacy for children less than 12 months have not been established
• Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required

Turbuhaler

• Hypersensitivity to the active ingredient or any of its excipients
• Lung tuberculosis
• Fungal and viral infections in the airways
• Pregnancy
• The safety and efficacy for children under the age of six years have not been established

South African recommendations

Caution in the following patient groups

• Pregnancy (neb)
• Breastfeeding (neb)
• Hepatic impairment

Cautions specific to budesonide inhaler

Prophylactic treatment

• Patients should also be made aware of the prophylactic nature of budesonide inhaler therapy and that it should be taken even when they are asymptomatic

Candidiasis

• The development of pharyngeal and laryngeal candidiasis may occur
• Patients with high blood levels of Candida precipitants, indicating a previous infections, are most likely to develop this complication
• Rinsing the mouth with water after each dose is recommended. The water should not be swallowed

Systemic corticosteroid therapy

• The transfer of a patient dependent on oral steroids treatment to treatment with budesonide inhaler demands special care and is preferably done when the patient is in a relatively stable phase
• Budesonide inhaler should be given in combination with the previously used oral steroid dose for about ten days
• After this period, the reduction of the oral corticosteroid can be started with a dose reduction corresponding to about 1 mg prednisolone per day per week
• Some patients may experience uneasiness during the withdrawal period due to decreased steroid effect, which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain
• Specific treatment should be initiated for these conditions
• During the withdrawal of oral steroids, patients may feel unwell in a non-specific way, even though respiratory function is maintained or improved
• Patients should be encouraged to continue with budesonide inhaler therapy whilst withdrawing the oral steroid, unless there are clinical signs to indicate the contrary
• A general insufficient glucocorticosteroid effect should be suspected if 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
• Paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing
• If this occurs, treatment with inhaled budesonide, as in budesonide inhaler, should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary
• Patients who have previously been dependent on oral steroids may, as a result of prolonged systemic steroid therapy, experience the effects of impaired adrenal function
• Recovery may take a considerable amount of time after cessation of oral steroid therapy, hence oral steroid-dependent patients transferred to budesonide, as in budesonide inhaler, may remain at risk from impaired adrenal function for some considerable time
• In such circumstances, HPA axis functions should be monitored regularly
• Acute exacerbation, accompanied by increased mucous viscosity and mucous plugging may require complementary treatment with an oral corticosteroid and/or an antibiotic, if there is an infection
• It is important to monitor intercurrent infections and treat them appropriately
• The patient should be advised to use a short-acting inhaled bronchodilator as rescue medication to relieve acute asthma symptoms
• Budesonide inhaler is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required
• If patients find short-acting bronchodilator treatment ineffective or they need more inhalations than usual, medical attention must be sought
• In this situation consideration should be given to the need for or an increase in their regular therapy, e.g. higher doses of budesonide inhaler or the addition of a long-acting beta agonist, or for a course of oral glucocorticosteroid

Adrenal suppression

• Adrenal suppression may occur
• Appropriate measures should be taken to protect the patient against stress situations, e.g. severe infections, surgery
• Treatment with budesonide inhaler should not be stopped abruptly
• The length of time needed for the body to regain its natural production of corticosteroids in sufficient amounts is often extensive
• During physically stressing situations such as severe infections, trauma and surgical operations, it will be necessary to give the patient an additional oral steroid dose
• Acute exacerbations, accompanied by increased mucous, viscosity and mucous plugging may require complementary treatments with an oral corticosteroid

Systemic effects

• Systemic effects may occur with any inhaled corticosteroids, such as budesonide inhaler, particularly at high doses prescribed for long periods
• Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, psychological or behavioural effects
• It is important that the dose of budesonide inhaler is titrated to the lowest dose at which effective control of asthma is maintained

Hepatic impairment

• Reduced liver function affects the elimination of corticosteroids causing lower elimination rate and higher systemic exposure
• Be aware of possible systemic side effects

CYP3A inhibitors

• Co-treatment with CYP3A inhibitors, e.g. itraconazole, ketoconazole and HIV protease inhibitors are expected to increase the risk of systemic corticosteroid side effects
• The combination should be avoided during long-term treatment
• A reduction in the dose of budesonide inhaler should also be considered (see section 4.5)

Pneumonia in patients with COPD

• An increase in pneumonia has been observed in patients with COPD receiving inhaled corticosteroids, including budesonide inhaler
• Healthcare professionals should remain vigilant for pneumonia as features overlap with COPD exacerbations
• Risk factors include current smoking, older age, low BMI and severe COPD

Visual disturbance

• Visual disturbance may be reported with systemic and topical corticosteroid use
• Patients presenting with blurred vision should be considered for referral to an ophthalmologist for evaluation of cataract, glaucoma or rare diseases like CSCR

Ethanol

• This medicine contains small amounts of ethanol (alcohol), less than 100 mg per actuation

Paediatric population - Influence on growth

• It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids, like budesonide inhaler, is regularly monitored
• If growth is slowed, therapy should be re-evaluated to reduce the dose to the lowest effective level
• The benefit of therapy and risk of growth suppression must be carefully weighed

Effects on ability to drive and use machines

• Budesonide inhaler has no or negligible influence on the ability to drive and use machines

Cautions specific to budesonide respules

Non-steroid dependent patients

• 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
• After the course of the oral medicine, budesonide inhaler alone should be sufficient therapy

Steroid-dependent patients

• When transfer from oral corticosteroid to treatment with budesonide inhaler is initiated, the patient should be in a relatively stable phase
• Budesonide inhaler is then given, in combination with the previously used oral steroid dose, for about 10 days
• The oral steroid dose should be gradually reduced (by, for example, 2,5 mg prednisolone or the equivalent each month) to the lowest possible level
• In many cases, it is possible to completely substitute budesonide inhaler for the oral corticosteroid
• Replacement of systemic steroid treatment with inhaled therapy sometimes unmasks allergies, e.g., rhinitis and eczema, which were previously controlled by the systemic medicine
• These allergies should be symptomatically controlled with an antihistamine and/or topical preparations
• Particular care is needed in patients transferring from oral steroids, since they may remain at risk of impaired adrenal function for a considerable time
• 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 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

Paradoxical bronchospasm

• Paradoxical bronchospasm may occur, manifested by an immediate increase in wheezing after dosing
• If this occurs, treatment with inhaled budesonide should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted

Adrenal insufficiency and stress

• Patients who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids may 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

Systemic effects

• Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods
• Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and psychological or behavioural effects
• It is important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained

Acute episodes

• Budesonide inhaler is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required
• If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought
• Consideration should be given to the need for increased anti-inflammatory therapy, e.g., higher doses of inhaled budesonide or a course of oral glucocorticosteroid

Hepatic function

• Reduced liver function may affect the elimination of corticosteroids, which may be clinically relevant in patients with severely compromised liver function
• After oral ingestion systemic availability of budesonide can be increased by compromised liver function due to decreased first pass metabolism
• Increases in plasma levels and hence an increased risk of systemic adverse effects could be expected

CYP3A inhibitors

• Co-treatment with CYP3A inhibitors is expected to increase the risk of systemic corticosteroid side effects
• The combination should be avoided unless the benefit outweighs this increased risk
• A reduction in the dose of budesonide should also be considered

Cleaning and administration

• The nebuliser chamber should be cleaned after every administration with hot water and a mild detergent
• Rinse well and dry by connecting the nebuliser chamber to the compressor or air inlet

Oral candidiasis

• Oral candidiasis may occur during the therapy and may require antifungal therapy or discontinuation of treatment
• To minimise oral candidiasis, the patient should rinse the mouth out with water after each occasion

Pneumonia in patients with COPD

• An increase in the incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids
• Medical practitioners should remain vigilant as features of such infections overlap with COPD exacerbations
• Risk factors include current smoking, older age, low BMI and severe COPD

Visual disturbance

• Visual disturbance may be reported with systemic and topical corticosteroid use
• Patients with blurred vision should be considered for referral to an ophthalmologist for evaluation of cataract, glaucoma or rare diseases such as CSCR

Facial skin irritation

• Facial skin irritation may occur when a nebuliser with face mask is used
• To prevent irritation the facial skin should be washed with water after use of the face mask

Paediatric population - Influence on growth

• The height of children receiving prolonged treatment with inhaled corticosteroids should be regularly monitored
• The dose should be titrated to the lowest effective maintenance dose once control of asthma is achieved
• Medical practitioners should weigh the benefit of therapy against the possibility of growth suppression

Effects on ability to drive and use machines

• Budesonide solution for inhalation has no effect on the ability to drive and use machines

Cautions specific to budesonide turbuhaler

Long-term effects

• The long-term local and systemic effects of budesonide in human subjects are not completely known. The dose should be titrated to the lowest effective maintenance dose once control of asthma is achieved

Growth monitoring

• Physicians should closely monitor the growth of children and adolescents taking corticosteroids by any route and weigh the benefit of corticosteroid therapy and asthma control against the possibility of growth suppression

Acute asthma episodes

• Budesonide is not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. If patients find short-acting bronchodilator treatment ineffective, or they need more inhalations than usual, medical attention must be sought

Increased anti-inflammatory therapy

• In the event of ineffective bronchodilator treatment, consideration should be given to the need for increased anti-inflammatory therapy, e.g., higher doses of inhaled budesonide or a course of oral glucocorticosteroid

Transfer from systemic therapy

• Particular care is needed in patients who are transferred from systemic to inhaled glucocorticosteroids. During this period of Hypothalamic Pituitary Adrenal (HPA) axis suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss

Emergency physiological limitations

• Although budesonide may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticosteroid systemically and does not provide the mineralocorticosteroid activity that is necessary for coping with these emergencies

Withdrawal symptoms

• 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 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

Unmasking of allergies

• 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

• Reduced liver function may affect the elimination of glucocorticosteroids as evidenced by increased systemic availability

Airway infections

• Special consideration may be needed in patients with fungal and viral infections in the airways, including pulmonary tuberculosis

Forms avail. in SA and covered in this monograph: turbo, inh, neb

South African registered indications and dosages

Prophylaxis of the symptoms of asthma

• Inhaled (inh): Initial: 400μg, dly in divided doses; In those not responding to low dose therapy, or when asthma can no longer be controlled by the maximum maintenance dose of bronchodilators: Increase up to 1600µg, dly; In controlled patients, twice dly administration may be adequate; Maintenance dose range: 100-1600μg, dly; Max: 1600μg/24hrs

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The maintenance dose should be individualised and should be the lowest possible dosage. Patients should be instructed in the correct method to use the budesonide inhaler to ensure that the inhaler activation is synchronised with inspiration

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Patients on concomitant therapy with inhaled bronchodilators should use the bronchodilators several minutes before the inhalation of budesonide to minimise possible local side effects, such as cough
The use of a spacer device is recommended when the daily dose exceeds 400µg in adults. This will improve lung deposition and will reduce the systemic absorption of budesonide
Rinse the mouth after each dosage administration. Treatment with inhaled steroids should not be stopped abruptly
Refer to product packaging for usage instructions

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Previous therapy: Nonsteroid treatment OR Inhaled glucocorticosteroids 

• Inhaled (turbo): Initial: 100-400μg, twice dly; Maintenance dose range: 100-1600μg, dly; Max: 800μg, twice dly

Previous therapy: Oral glucocorticosteroids

• Inhaled (turbo): Initial: 400-800μg, twice dly; Maintenance dose range: 100-1600μg, dly; Max: 800μg, twice dly

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In severe asthma and during exacerbations some patients may benefit from dividing the daily dose into 3-4 administrations per day

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Onset of effect: Improvement in asthma control following inhaled administration can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment

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Patients not receiving glucocorticosteroids: Patients who require maintenance therapy of their asthma may benefit from treatment budesonide inhaler at the doses recommended above. For patients who do not respond adequately to the starting dose, higher doses may provide additional asthma control. See additional prescriber points for other scenarios

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Asthma management
- In patients inadequately controlled by bronchodilators, thus necessitating additional treatment with steroids and who are unable to use a pressurised metered dose inhaler or unable to inhale the medicine in powder form

• Inhaled (neb): 0.5-1mg, twice dly; In some cases, the dose may be further increased; Maintenance: Dose is individual. After desired clinical effect has been obtained, the maintenance dose should be gradually reduced to the smallest amount necessary to control symptoms

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In patients where an increased therapeutic effect is required, an increased dose of budesonide respules should be considered

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See additional prescriber points for patient's dependant on oral steroids and withdrawal considerations

Paed. forms avail. in SA and covered in this monograph: turbo, inh, neb

South African registered indications and dosages

Prophylaxis of the symptoms of asthma

Younger than 6 years

• Inhaled (inh, turbo): Not established for use

6 years and older

Previous therapy: Nonsteroid treatment OR Inhaled glucocorticosteroids 

• Inhaled (turbo): Initial: 100-200μg, twice dly; Maintenance dose range: 100-800μg, dly; Max: 400μg, twice dly

Previous therapy: Oral glucocorticosteroids

• Inhaled (turbo): Initial: 200-400μg, twice dly; Maintenance dose range: 100-800μg, dly; Max: 400μg, twice dly

Older than 12 years

• Inhaled (inh): See adult dosage

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Inhaler: The maintenance dose should be individualised and should be the lowest possible dosage

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Inhaler
Patients on concomitant therapy with inhaled bronchodilators should use the bronchodilators several minutes before the inhalation of budesonide to minimise possible local side effects, such as cough
The use of a spacer device is recommended when the daily dose exceeds 400µg in adults. This will improve lung deposition and will reduce the systemic absorption of budesonide
Rinse the mouth after each dosage administration. Treatment with inhaled steroids should not be stopped abruptly
Young children may need help. To help the child, parents must first learn the technique correctly themselves, then properly guide the child to use the inhaler
The use of a spacer device is recommended for all doses in children
Refer to product packaging for usage instructions

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Turbuhaler: In severe asthma and during exacerbations some patients may benefit from dividing the daily dose into 3-4 administrations per day

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Turbuhaler
Onset of effect: Improvement in asthma control following inhaled administration can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment

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Turbuhaler: Patients not receiving glucocorticosteroids: Patients who require maintenance therapy of their asthma may benefit from treatment budesonide inhaler at the doses recommended above. For patients who do not respond adequately to the starting dose, higher doses may provide additional asthma control. See additional prescriber points for other scenarios

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Asthma management
- In patients inadequately controlled by bronchodilators, thus necessitating additional treatment with steroids and who are unable to use a pressurised metered dose inhaler or unable to inhale the medicine in powder form

Bronchodilators alone OR Inhaled corticosteroids

Younger than 12 months

• Inhaled (neb): Not established for use (See contraindications)

12 months - 6 years

• Inhaled (neb): Initial: 0.25mg, twice dly; In some cases, the dose may be further increased; Maintenance: 0.25-0.5mg, twice dly

6 years and older

• Inhaled (neb): Initial: 0.25-0.5mg, twice dly; In some cases, the dose may be further increased; Maintenance: 0.25-0.5mg, twice dly

Oral corticosteroids

12 months - 6 years

• Inhaled (neb): Initial: 0.5mg, twice dly; In some cases, the dose may be further increased; Maintenance: 0.25-0.5mg, twice dly

6 years and older

• Inhaled (neb): Initial: 0.25-1mg, twice dly; In some cases, the dose may be further increased; Maintenance: 0.25-0.5mg, twice dly

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The maintenance dose is individual. After the desired clinical effect has been obtained, the maintenance dose should be gradually reduced to the smallest amount necessary to control symptoms

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See additional prescriber points for patient's dependant on oral steroids and withdrawal considerations

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Acute laryngotracheobronchitis-croup

Infants and children

• Inhaled (neb): 2mg, given as a single admin. or as two 1mg doses separated by 30 min.

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Budesonide respules can be mixed with 0.9% saline and with solutions for nebulisation of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide. The admixture should be used within 30 minutes

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Method of administration (Neb)

Instruction for correct use of budesonide respules: Budesonide respules should be administered via a jet nebuliser equipped with a mouthpiece or suitable face mask. The nebuliser should be connected to an air compressor with an adequate air flow (5 to 8 litres/minute), and the fill volume should be 2 to 4ml. Ultrasonic nebulisers are not suitable for the administration of budesonide respules and therefore are not recommended

The dosage of budesonide respules is individual and should be titrated to the lowest effective maintenance dose once control of asthma is achieved

Pregnancy

South African recommendations

Inhaler

• Contraindicated
• Budesonide inhaler is contraindicated in pregnancy
• In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations)
• Therapy with budesonide inhaler should be regularly reviewed and maintained at the lowest lowest effective dose. It is important for both foetus and mother to maintain an adequate asthma treatment during pregnancy

Solution for inhalation

• Caution
• Safety in pregnancy has not been established
• Inhaled glucocorticosteroids should be considered in preference to oral glucocorticosteroids because of the lower systemic effects at the doses required to achieve similar pulmonary responses

Turbuhaler

• Contraindicated
• Administration during pregnancy should be avoided as 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 glucocorticosteroids during pregnancy is unavoidable, inhaled glucocorticosteroids may be preferred because of their lower systemic effects compared with equipotent anti-asthmatic doses of oral glucocorticosteroids

Breastfeeding

South African recommendations

Inhaler

• Contraindicated
• Budesonide inhaler is contraindicated in breastfeeding
• Budesonide inhaler is excreted in breast milk. Mothers using AEROMIDE should not breastfeed their babies

Solution for inhalation

• Caution
• Safety in breastfeeding has not been established. Budesonide is excreted in breast milk. However, at maternal therapeutic doses of budesonide respules, the budesonide plasma levels in infants are at or below minimal measurable concentrations

Turbuhaler

• Caution; no information available
• There is no information regarding the passage of budesonide into breast milk

Fertility

South African recommendations

• No information available

• No dose adjustment recommended

• Caution; no dose adjustment recommended

• No dose adjustment recommended

Central Nervous System Disorders

• Restlessness
• Nervousness
• Depression
• Behavioural changes (predominantly in children)
• Sleep disorders
• Anxiety
• Psychomotor hyperactivity
• Aggression

Respiratory Disorders

• Hoarseness
• Cough
• Throat irritation
• Bronchospasm
• Dysphonia

Gastrointestinal Disorders

• Oral mucosal irritation
• Oral candidiasis

Endocrine and Metabolic Disorders

• Adrenal suppression
• Growth retardation

Musculoskeletal  Disorders

• Bone density decreased
• Muscle spasm 

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Dermatitis
• Pruritus
• Erythema
• Bruising

Immune, Blood and Lymphatic System Disorder

• Angioneurotic oedema
• Anaphylactic reaction

Sensory Disorders

• Cataract
• Glaucoma

• Inhaled beta-2 agonists
• CYP3A4 inhibitors
• CYP3A4 inducers
• Oestrogen
• Oral contraceptive
• Cimetidine

None routine. Specific cases may require

• Height
• Hepatic Transaminsese (ALT, AST)

Dosing considerations in specific scenarios for budesonide turbuhaler

Patients maintained on inhaled glucocorticosteroids

• Clinical studies in man have shown an improved efficacy for the same amount of budesonide delivered via inhaled powder compared with the pressurised aerosol (pMDI). Thus, when patients treated with pMDI have been transferred to inhaled powder and control of asthma is good, it may be possible to reduce the dose of the pMDI dose. Also in patients transferred from other inhaled glucocorticosteroids, a dose reduction with inhaled powder may be considered after the patient initially has been given a similar dose as prior to transferral

Patients maintained on oral glucocorticosteroids

• Budesonide inhaled powder may permit replacement or significant reduction in the dosage of oral glucocorticosteroids with maintained or improved asthma control. Initially, budesonide inhaled powder should be used concurrently with the patient’s usual maintenance dose of oral glucocorticosteroid. After approximately one week the oral dose is gradually reduced to the lowest possible level. A slow rate of withdrawal is strongly recommended. In many cases it is possible to completely substitute the oral glucocorticosteroid with budesonide inhaled powder
• During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g. joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Budesonide inhaled powder but should be monitored for objective signs of adrenal insufficiency
• If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids

Budesonide respules

• Patients’ dependent on oral steroids: Initially, budesonide respules should be used concurrently with the patient's usual maintenance dose of oral glucocorticosteroid. After approximately 1 week the oral dose is gradually reduced to the lowest possible level, e.g., by about 2,5 mg prednisolone every 2 weeks. A slow rate of withdrawal is strongly recommended. In a proportion of cases, it is possible to completely substitute the oral glucocorticosteroid with budesonide respules
• During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with budesonide respules but should be monitored for objective signs of adrenal insufficiency
• If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or during a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids

Budesonide penetrates cellular membranes and binds to a cytoplasmic receptor protein. This induces the biosynthesis of specific proteins, such as lipocortin, which results in an inhibition of phospholipase A2. It is also possible that therapeutically effective doses of budesonide suppress cytokine-induced cyclooxygenase-2 expression.

Inhaler 100μg

• Budeflam 300 dose Hfa (Cipla) 

Inhaler 200μg

• Budeflam 300 dose Hfa (Cipla) 

Inhaler Novoliser 200μg

• Inflammide 200 Novoliser (Ingelheim)
• Inflammide 200 Novoliser refill (Ingelheim)

Inhaler Novoliser 400μg

• Inflammide 400 Novoliser (Ingelheim) originator
• Inflammide 400 Novoliser refill (Ingelheim) originator

Turbuhaler 100μg

• Pulmicort Turbuhaler (AstraZeneca) originator

Turbuhaler 200μg

• Pulmicort Turbuhaler (AstraZeneca) originator

Nebulising suspension (per ml) 0.25mg

• Arrow Budesonide (Teva Pharmaceuticals)
• Budoneb 0.25mg/ml (Teva Pharmaceuticals)
• Pulmicort Nebulising Suspension (AstraZeneca) originator

Nebulising suspension (per ml) 0.5mg

• Arrow Budesonide (Teva Pharmaceuticals)
• Budoneb (Teva Pharmaceuticals)
• Pulmicort Nebulising Suspension (AstraZeneca) originator

Also available in the following forms: Nasal spray, capsule and enema.

COMBINATION PREPARATIONS

Budesonide/ Formoterol fumarate

Inhaler 80μg/4.5μg 

• Symbicord Turbuhaler 80:45μg (AstraZeneca) originator
• Vannair 80:4.5μg (AstraZeneca) originator

Inhaler 160μg/4.5μg

• Symbicord Turbuhaler 160:45μg (AstraZeneca) originator
• Vannair 160:4.5μg (AstraZeneca) originator

Inhaler 320μg/9μg

• Symbicord Turbuhaler 320:9μg (AstraZeneca) originator