Probric
Composition:
Tablets
Each tablet contains:
Active ingredient:
– For Probric 10 mg Tablets:
Bambuterol hydrochloride …………………… 10 mg
– For Probric 20 mg Tablets:
Bambuterol hydrochloride …………………… 20 mg
Oral Solution
Each 5 ml solution contains:
Active ingredients:
Bambuterol hydrochloride ……………………… 5 mg
Pharmacological action:
– Pharmacotherapeutic group: selective β2-agonists, bambuterol.
– Bambuterol is an active precursor of the selective β2-adrenergic agonist terbutaline.
Indications:
Management of asthma, bronchospasm and/or reversible airways obstruction.
Dosage and administration:
– Probric is formulated as a tablet and should be taken once daily, shortly before bedtime. The doseshould be individualised.
– Adults: The recommended starting doses are 10 mg – 20 mg. The 10 mg dose may be increased
to 20 mg if necessary after 1 – 2 weeks, depending on the clinical effect.
– Children 6 – 12 years: The recommended starting dose is 10 mg (10 ml). Doses may be increasedto 20 mg if necessary after 1 – 2 weeks, depending on the clinical effect. Because of differences inkinetics, doses above 10 mg (10 ml) are not recommended in oriental children.
– Children 2 – 5 years: The recommended starting dose is 10 mg (10 ml), 5 mg (5 ml) in orientalchildren because of differences in kinetics.
In patients who have previously well tolerated β2-agonists, the recommended starting dose, aswell as maintenance dose, is 20 mg.
– Elderly: Dose adjustment is not required in the elderly.
– Significant hepatic dysfunction: Not recommended because of unpredictable conversion toTerbutaline.
– Moderate to severely impaired renal function (GFR< 50 ml/min): It is recommended that thestarting dose of Probric should be halved in these patients.
Package and storage:
• For Probric (10 & 20 mg) Tablets:
– Carton box containing a blister (PVC/Alu) of 10 tablets and insert leaflet.
– Store at a temperature not exceeding 30 °C in a dry place.
• For Probric Oral Solution:
– Carton box containing a glass bottle of 120 ml oral solution and insert leaflet.
– Store at a temperature not exceeding 30 °C
• Probric (10 & 20 mg) Tablets & Oral Solution should not be used beyond the expiry dateprinted on the package.
– Don’t use unless under physician’s supervision.