BUDASURE Pulmules
Budesonide Nebuliser Suspension BP (0.5mg/2ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 2 ml of
unit dose respule contains Budesonide 0.5 mg.
INDICATION: For maintenance treatment of asthma and as
prophylactic therapy in children 12 months to 8 years of age, where use
of a pMDI is unsatisfactory or inappropriate. BUDASURE respules is not
indicated for the relief of acute bronchospasm. BUDASURE respules are
also recommended for use in infants and children with croup (acute viral
upper respiratory tract infection also known as viral
laryngotracheobronchitis or laryngitis subglottica), in which
hospitalization is indicated.
DOSAGE AND METHOD OF ADMINISTRATION: Adults asthma
patients (including the elderly & children over 12 years and older):
Usually 1-2 mg twice daily. 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 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. CONTRAINDICATIONS: Primary treatment of status
asthmaticus or other acute episodes of asthma where intensive measures
are required. Hypersensitivity to any ingredient of the formulation.
WARNING AND PRECAUTION: Special caution is necessary in
patients with active or quiescent pulmonary tuberculosis and in patients
with fungal or viral infections in the airways.
UNDESIRABLE EFFECTS: Candida infection in the
oropharynx, Cough, hoarseness and throat irritation, paradoxical
bronchospasm, facial skin irritation, cataract, anxiety, depression and
risk of growth retardation in the paediatric population.
DRUG INTERACTIONS: Inhibitors of CYP3A4, such as
ketoconazole and itraconazole, can increase systemic exposure to
budesonide, necessitating caution and potential dose adjustments,
particularly when co- administered with potent inhibitors.
USE IN SPECIAL POPULATION: Patient with Hepatic Impairment -
patients with hepatic disease should be closely monitored.
Pregnant Women - Inhaled budesonide use during
pregnancy shows no increased risk for adverse effects on the foetus;
maintain therapy at lowest effective dose, weighing benefits against
potential risks. Lactating Women - Budesonide is
excreted in breast milk, but at therapeutic doses, negligible systemic
exposure is expected in breastfed infants; therefore, budesonide
respules can be safely used during breastfeeding. These highlights do
not include all the information needed to use BUDASURE Pulmules
effectively and safely. Please refer to full prescribing information
[available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 7th June 2024. Source: Prescribing Information BUDASURE
Pulmules.