Indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Important Limitations of Use: PULMICORT RESPULES (budesonide inhalation suspension) is NOT indicated for the relief of acute bronchospasm.
Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g. mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g. histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.
INHALATION Asthma: Adult: MDI: 400 mcg daily in 2 divided doses, increased up to 1.6 mg daily in severe cases. Maintenance: 200- 400 mcg daily. As dry powd inhaler: 200- 800 mcg daily in single dose or 2 divided doses. As nebulised solution: Usual dose: 1-2 mg inhaled bid. Maintenance dose: 0.5-1 mg bid. Child: MDI: 50-400 mcg bid. Nebulised solution: 3 mth-12 yr: Initially. 0.5-1 mg bid. Maintenance dose: 0.25- 0.5 mg bid. Max Dose: Adult: Dry powd inhaler: 800 mcg bid.
No significant drug interaction has been reported.
Hypersensitivity. Acute infections uncontrolled by antimicrobial chemotherapy. Active or doubtfully quiescent tuberculosis, paradoxical bronchospasm; children, elderly; pregnancy. lactation.
Loss of skin collagen & SC atrophy; local hypopigmentation of deeply pigmented skin; dryness. irritation. epistaxis, rarely ulceration or perforation of the nasal septum; smell & taste disturbances; hoarseness & candidiasis of the mouth or throat.
Benefit should outweigh risk during pregnancy. Most experts consider inhaled corticosteroids acceptable during breastfeeding as the presence in breast milk is expected to be low and infant exposure negligible. A fully breastfed infant is expected to receive a maximum 0.3% to 1% of the weight-adjusted maternal dosage; a milk to plasma ratio between 0.4 and 0.5. Drug levels have not been detected in breastfed infants following maternal use of the inhaled drug. Oral drug at the recommended daily dose is expected to produce plasma concentrations up to 10 times higher than the inhaled drug. Due to lack of specific data with the oral or rectal formulations, some manufacturers recommend therapy be avoided.
Like any other nasally administered corticosteroids, acute overdosing is unlikely in view of the total amount of active ingredient present. Clinically significant systemic adverse events would most likely not occurs if the entire contents of the bottle were administered all at once, via either oral or nasal application. Chronic overdosage may result in signs/symptoms of hypercorticism.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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