BREECORT Budesonide 250mcg / mL (500mcg / 2mL) Suspension for Nebulization 2mL 1's
RXDRUG-DRP-6868-01-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of persistent bronchial asthma in patients where use of pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate.
Dosage/Direction for Use
Route of administration: For inhalation use only.
The dose should be given twice daily.
Administration once daily maybe considered in cases of mild to moderate stable asthma.
Initial dose: The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The following doses are recommended but the minimum effective dose should always be sought: Children aged 6 months and above: 250 mcg - 1 mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2 mg daily should be considered.
Adults (including elderly) and children/adolescents over 12 years of age: 500 mcg -2 mg daily. In very severe cases, the dosage may be increased further.
Maintenance dose: The maintenance dose should be adjusted to meal the requirements of the individual patient taking account of the severity of the disease and the clinical response of the patient.
When the desired clinical effect has been obtained, the maintenance dose should be reduced to the minimum required for control of the symptoms.
Children aged 6 months and above: 250 mcg - 1 mg daily.
Adults (Including the elderly) and children/adolescents over 12 years of age: 500 mcg - 2 mg daily. In severe cases the dose may be further increased.
Administration once daily: Administration once daily should be considered for children and adults with mild to moderate stable asthma and with a maintenance dose between 250 mcg and 1 mg budesonide daily. Once daily administration may be initiated both in patients who are not receiving corticosteroid treatment and in well-controlled patients who are already taking inhaled steroids. The dose may be given in the morning or evening. If a worsening of the asthma occurs, the daily dose should be increased by administering the dose twice daily.
Onset of effect: An improvement of the asthma following administration of budesonide may occur within 3 days after initiation of therapy. The maximum effect will only be obtained after 2-4 weeks of treatment.
Patients in maintenance therapy with glucocorticoids: With Budesonide 500 mcg/2 mL Suspension for Nebulization, it is possible to replace or considerably reduce the dose of oral glucocorticosteroids and still maintains or improves the control of asthma.
The dose should be given twice daily.
Administration once daily maybe considered in cases of mild to moderate stable asthma.
Initial dose: The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The following doses are recommended but the minimum effective dose should always be sought: Children aged 6 months and above: 250 mcg - 1 mg daily. For patients in maintenance therapy with oral steroids a higher initial dosage up to 2 mg daily should be considered.
Adults (including elderly) and children/adolescents over 12 years of age: 500 mcg -2 mg daily. In very severe cases, the dosage may be increased further.
Maintenance dose: The maintenance dose should be adjusted to meal the requirements of the individual patient taking account of the severity of the disease and the clinical response of the patient.
When the desired clinical effect has been obtained, the maintenance dose should be reduced to the minimum required for control of the symptoms.
Children aged 6 months and above: 250 mcg - 1 mg daily.
Adults (Including the elderly) and children/adolescents over 12 years of age: 500 mcg - 2 mg daily. In severe cases the dose may be further increased.
Administration once daily: Administration once daily should be considered for children and adults with mild to moderate stable asthma and with a maintenance dose between 250 mcg and 1 mg budesonide daily. Once daily administration may be initiated both in patients who are not receiving corticosteroid treatment and in well-controlled patients who are already taking inhaled steroids. The dose may be given in the morning or evening. If a worsening of the asthma occurs, the daily dose should be increased by administering the dose twice daily.
Onset of effect: An improvement of the asthma following administration of budesonide may occur within 3 days after initiation of therapy. The maximum effect will only be obtained after 2-4 weeks of treatment.
Patients in maintenance therapy with glucocorticoids: With Budesonide 500 mcg/2 mL Suspension for Nebulization, it is possible to replace or considerably reduce the dose of oral glucocorticosteroids and still maintains or improves the control of asthma.
Special Precautions
Paradoxical bronchospasm. Consider rapid-acting inhaled bronchodilator & medical reassessment when acute episode of dyspnea occurs. Monitor high doses & prolonged treatment. Pregnancy & lactation.
Use In Pregnancy & Lactation
Pregnancy: Results from a large prospective epidemiological study and from world-wide post marketing experience indicate that inhaled budesonide during pregnancy has no adverse effects on the health of the fetus/newborn child.
As with other drugs, the administration of budesonide during pregnancy requires that the benefits for the mother are weighted against the risk for the fetus.
Lactation: Budesonide is excreted in breast milk. However, at therapeutic doses of budesonide, no effects on the suckling child are anticipated. Budesonide can be used during breastfeeding.
Maintenance treatment with inhaled budesonide (200 or 400 mcg twice daily) in asthmatic nursing women results in negligible exposure to budesonide in breast fed infants.
As with other drugs, the administration of budesonide during pregnancy requires that the benefits for the mother are weighted against the risk for the fetus.
Lactation: Budesonide is excreted in breast milk. However, at therapeutic doses of budesonide, no effects on the suckling child are anticipated. Budesonide can be used during breastfeeding.
Maintenance treatment with inhaled budesonide (200 or 400 mcg twice daily) in asthmatic nursing women results in negligible exposure to budesonide in breast fed infants.
Caution For Usage
Direction for Use: The spray container should be shaken before use.
To minimize the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.
To prevent irritation of the facial skin, the face should be washed after using the nebulizer with a mask.
The nebulizer should be cleaned after each use.
Wash the nebulizer container and mouthpiece or face-mask in warm water using a mild detergent in accordance with the manufacturer's instructions. Rinse well and dry it by connecting the nebulizer container to the compressor or the air inlet.
To minimize the risk of oropharyngeal candida infection, the patient should rinse their mouth out with water after inhaling.
To prevent irritation of the facial skin, the face should be washed after using the nebulizer with a mask.
The nebulizer should be cleaned after each use.
Wash the nebulizer container and mouthpiece or face-mask in warm water using a mild detergent in accordance with the manufacturer's instructions. Rinse well and dry it by connecting the nebulizer container to the compressor or the air inlet.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Pharmacokinetics: In a pharmacokinetic study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated lobe 1/600.
In adults the systemic bioavailability of budesonide following administration of Budesonide Suspension for Nebulization via a jet nebulizer is approximately 15% of the declared dose and 40-70% of the dose delivered to the patient. A small part of the systematically available dose comes from inhalation suspension that is allowed. The peak plasma concentration following administration of a single dose of 2 mg is achieved 10 -30 minutes after the beginning of inhalation and is approximately 4 nmol/L. In children (4 - 6 years), the systemic bioavailability of budesonide after administration of Budesonide Suspension for Nebulization via jet nebulizer is approximately 6% of the declared dose and 26% of the dose administered to the patient. The peak plasma concentration following administration of a single dose of 1 mg Is approximately 20 minutes after the beginning of inhalation and is approximately 2.4 nmol/L.
Distribution: The volume of distribution in adults is approximately 3 L/kg. Plasma protein binding is approximately 85-90%.
Metabolism: Budesonide undergoes extensive, (90%) first pass biotransformation in the liver via CYP3A4 to metabolites with a low glucocorticosteroid activity. The in-vitro activity of the main metabolites, 6,α-hydroxyprednisolone, and 16-α-hydroxyprednisolone, is less than 1% of that budesonide.
Excretion: The metabolites are excreted in unchanged or conjugated form predominantly via the kidneys.
No unchanged budesonide is found in the urine. Budesonide has a high systemic clearance (approximately 1.2 Liters/min) in healthy adults, and the elimination half-life following intravenous administration is approximately 2-3 hours. Budesonide has a systemic clearance of approximately 0.5 L/min in 4 to 6 year old asthmatic children.
Children have an approximately 50% higher clearance per kg body weight than adults. The half-life of budesonide following inhalation is about 2.3 hours in asthmatic children, which is roughly the same in healthy adults.
In adults the systemic bioavailability of budesonide following administration of Budesonide Suspension for Nebulization via a jet nebulizer is approximately 15% of the declared dose and 40-70% of the dose delivered to the patient. A small part of the systematically available dose comes from inhalation suspension that is allowed. The peak plasma concentration following administration of a single dose of 2 mg is achieved 10 -30 minutes after the beginning of inhalation and is approximately 4 nmol/L. In children (4 - 6 years), the systemic bioavailability of budesonide after administration of Budesonide Suspension for Nebulization via jet nebulizer is approximately 6% of the declared dose and 26% of the dose administered to the patient. The peak plasma concentration following administration of a single dose of 1 mg Is approximately 20 minutes after the beginning of inhalation and is approximately 2.4 nmol/L.
Distribution: The volume of distribution in adults is approximately 3 L/kg. Plasma protein binding is approximately 85-90%.
Metabolism: Budesonide undergoes extensive, (90%) first pass biotransformation in the liver via CYP3A4 to metabolites with a low glucocorticosteroid activity. The in-vitro activity of the main metabolites, 6,α-hydroxyprednisolone, and 16-α-hydroxyprednisolone, is less than 1% of that budesonide.
Excretion: The metabolites are excreted in unchanged or conjugated form predominantly via the kidneys.
No unchanged budesonide is found in the urine. Budesonide has a high systemic clearance (approximately 1.2 Liters/min) in healthy adults, and the elimination half-life following intravenous administration is approximately 2-3 hours. Budesonide has a systemic clearance of approximately 0.5 L/min in 4 to 6 year old asthmatic children.
Children have an approximately 50% higher clearance per kg body weight than adults. The half-life of budesonide following inhalation is about 2.3 hours in asthmatic children, which is roughly the same in healthy adults.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Breecort
Full Details
Dosage Strength
250 mcg / ml (500 mcg / 2 ml)
Drug Ingredients
- Budesonide
Drug Packaging
Suspension for Nebulization 2ml x 1's
Generic Name
Budesonide
Dosage Form
Suspension for Nebulization
Registration Number
DRP-6868-01
Drug Classification
Prescription Drug (RX)
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