BEXIMCO PHARMACEUTICALS LTD.
Budesonide Nebuliser suspension is indicated for the maintenance treatment and as prophylactic therapy of asthma. Budesonide Nasal Spray is indicated for- Prophylaxis and treatment of seasonal and perennial allergic rhinitis Prophylaxis and treatment of vasomotor rhinitis Symptomatic relief of nasal polyposis Prevention against nasal polyps after polypectomy Budesonide Inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Budesonide inhaler is not indicated for the relief of acute bronchospasm.
Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids
Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. The precise mechanism of corticosteroid actions on inflammation in asthma, Crohn's disease, or ulcerative colitis is not known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in the aforementioned diseases. Because budesonide undergoes significant first-pass elimination, the both oral preparations are formulated as an extended release tablet. As a result, budesonide release is delyaed until exposure to a pH 8 7 in the small intestine.
Inhaler: Asthma- Adult: As metered-dose aerosol: 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 in 2 divided doses. Max: 800 mcg bid. As nebuliser soln: Severe asthma: 1-2 mg bid. Maintenance dose: 0.5-1 mg bid. Child: 2-12 yr As metered-dose aerosol: 200-800 mcg daily in divided doses. 5-12 yr As dry powd inhaler: 200-800 mcg daily in 2 divided doses. 3 mth to 12 yr As nebuliser soln: Initially, 0.5-1 mg bid. Maintenance dose: 0.25-0.5 mg bid. Nebuliser: Croup (This is a common respiratory problem in young children): As nebuliser soln: 2 mg as a single dose or as 2 doses of 1 mg with 30 min interval, may be repeated 12 hrly for a max of 36 hr or until clinical improvement is observed. Nasal Spray: Nasal polyps- Adult: As metered-dose spray (64 mcg or 100 mcg/dose): 1 spray into each nostril bid up to 3 mth; alternatively, 2 sprays into each nostril once daily for preparations containing 64 mcg/dose. Child: 86 yr Same as adult dose. Allergic rhinitis- Adult: As metered-dose spray (64 mcg or 100 mcg/dose): Initially, 2 sprays into each nostril daily or 1 spray into each nostril bid, reduce to 1 spray into each nostril daily until symptoms are controlled. Child: 86 yr Same as adult dose
No significant drug interactions have been reported.
Hypersensitivity to any of the ingredients of this preparation.
Cushing's syndrome, adrenal suppression, growth retardation, decreased bone density, cataract, glaucoma, psychiatric/ behavioural effects.
Inhalation/Respiratory/Nasal: Pregnancy category B
Patient with TB, fungal or viral infections in the airways, CV disease, osteoporosis, peptic ulcer, cataracts, thyroid disease, seizure disorder; existing or family history of severe affective disorder, DM and glaucoma. Not intended for relief of acute bronchospasm. Avoid abrupt withdrawal when switching from systemic to oral or orally inhaled corticosteroid. Hepatic and renal impairment. Children. Pregnancy and lactation
Symptoms: Decreased motor activity, piloerection, generalised oedema. Management: Immediate gastric lavage or emesis followed by supportive and symptomatic treatment