Nebulizer solution: 0.5 or 1 mg/2ml
Indication & Usage
Budesonide Respules is a non-halogenated corticosteroid and used in bronchial asthma, in patients where use of a pressurized Inhaler or dry powder formulation is unsatisfactory or inappropriate.
Budesonide Respules are also recommended for use in infants and children with acute laryngotracheobronchitis - Croup.
Dosage & Administration
Dosage schedules: Budesonide Respules should be administered from suitable nebulizers. 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, volume of nebulizer chamber and fill volume. An air-flow rate of 6 - 8 liter per minute through the device should be employed. A suitable fill volume for most nebulizers is 2 - 4 ml. The dosage of Budesonide Respules should be adjusted to the need of the Individual. The does should be reduced to the minimum needed to maintain good asthma control. The highest does (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 Budesonide Respules is:
Adults (including elderly): Usually 1 - 2 mg twice daily. In vary severe cases the dosage may be further increased.
Children 12 year and older: Dosage as for adults.
Children 3 months to 12 years: 0.5 - 1 mg twice daily.
The maintenance dose should be Individualized and be the lowest dose which keeps the patient symptom-free.
Adults (including elderly and children 12 years and older): 0.5 - 1 mg twice daily.
Children 3 months to 12 years: 0.25 - 0.5 mg twice daily.
- Patients maintained on oral Glucocorticosteroids:
Budesonide Respules may permit replacement or significant reduction in dosage of oral Glucocorticosteroids while maintaining asthma control.
- Acute laryngotracheobronchitis - croup
In infants and children with croup, the usual dose Is 2 mg of nebulized budesonide. This dose is given as a single administration, or as two 1 mg doses separated by 30 minutes.
Clinical trials, literature reports and post-marketing experience suggest that the following adverse drug reactions may occur:
Mild irritation in the throat, Candida infection in the oropharynx, Hoarseness and coughing
Nervousness, restlessness, depression, behavioral disturbances, immediate and delayed hypersensitivity reactions including rash contact dermatitis, urticaria, angioedema, bronchospasm and anaphylactic reaction and skin bruising.
The candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each dosing will minimize the risk.
As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. The effect is probably dependent on dose, exposure time, concomitant and previous steroid exposure, and Individual sensitivity.
Facial skin irritation has occurred in some cases when a nebulizer with a face mask has been used. To prevent irritation, the facial skin should be washed with water after use of the face mask.
History of hypersensitivity to budesonide or any of the excipients.
The metabolism of budesonide is primarily mediated by CYP3M, one of the cytochrome p450 enzymes. Inhibitors of this enzyme, e.g. Ketoconazole and Itraconazole, can therefore Increase systemic exposure to budesonide. Other potent Inhibitors of CYP3A4 are also likely to markedly increase plasma levels of budesonide.
Warnings & Precautions
Special care is needed in patients with pulmonary tuberculosis and viral infections of the airways.
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 drug, Budesonide Respules alone should be sufficient therapy.
Steroid-dependent patients: When transfer from oral corticosteroid to treatment with budesonide is initiated, the patient should be in a relatively stable phase. Budesonide is then given, in combination with the previously used oral steroid dose, for about 10 days.
After that, 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 for the oral corticosteroid.
During transfer from oral therapy to budesonide, a generally lower systemic corticosteroid action will be experienced, 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. 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.
As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. If a severe reaction occurs, treatment should be reassessed and an alternative therapy instituted if necessary.
Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during period of stress or elective surgery.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These affects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed, with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a pediatric respiratory specialist.
Budesonide Respule 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 inhaled budesonide or the addition of a long-acting beta agonist, or for a course of oral glucocorticosteroid.
Concomitant treatment with ketoconazole and ltraconazole or other potent CYP3A4 inhibitors should be avoided. If this is not possible, the time interval between administrations of the Interacting drugs should be as long as possible. A reduction in the dose of budesonide should also be considered.
Pregnancy & Lactation
The administration of budesonide during pregnancy requires that the benefits for the mother be weighed against the risk for the fetus. 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.
Budesonide is excreted in breast milk. However, at therapeutic doses of Budesonide Respules no effects on the suckling child are anticipated. Budesonide Respules can be used during breast feeding.
Store upright at controlled room temperature 20-25°C.
Do not freeze.
Keep vials in the outer carton in order to protect from light.
Keep out of the sight and reach of children.
Each pack contains 6 combipacks having 5 respules of 2 ml, totally 30 Respules as single dose unit.
CIPLA Ltd/ India
Marketing Authorization Holder in IRAN