Clinical Pharmacology Details


SALBUTAMOL+ BECLOMETHASONE


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Indications & Dose:

Bronchial asthma and COPD (chronic obstructive pulmonary disease), with asthmatic component.


Salbutamol + Beclometasone dipropionate is for Inhalation use only.


Children (above 6 years old):One to two puffs every 12 hours (2 times daily), or every 8 hours (three times daily), or every 6 hours (4 times daily). under adult supervision.


 


The maximum recommended daily dose is 8 puffs per day.


Dose 


Adults 2 puffs three or four times daily.


The maximum daily recommended dose is 12 puffs a day.


 

Contraindications:

Patients sensitive to any of the active substances or other components of the formulation. Pulmonary tuberculosis or viral infections.


Children less than 6 years of age.

Side Effects:

Few patients complained of hoarseness or dysphonia.


Candidiasis in the mouth or throat may occasionally. 


Very rarely cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) and myocardial ischemia.


Very common reaction (> 1/10): Candidiasis in the mouth and throat.


Common reaction (> 1/100 and <1/10): paradoxical bronchospasm.


Unusual reaction (> 1/1,000 and <1/100): slight increase in heart rate, mild muscle tremors.


Rare reaction (> 1/10,000 and <1,000): adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.


Very rare reaction (1/10,000): systemic side effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency) and arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), myocardial ischemia.

Cautions:

Precautions:

Salbutamol + Beclometasone dipropionate  should be used only during the initial period of treatment and it is not recommended for continuous use in excess of ten days.


The use, especially for prolonged periods may lead to sensitization phenomena and, exceptionally to systemic side effects. In either case, it is necessary to discontinue treatment and to establish appropriate therapy.


systemic effects such as adrenal suppression, including growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma may occur after treatment with inhaled corticosteroids in high doses for long periods.


Pregnancy & Lactation


Pregnancy: Not recommended for use in the first three months of pregnancy. The decision of administration to the patient should be weighed against the risk/benefit.


Lactation: Not recommended for use during lactation.

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: