Source: European Medicines Agency (EU) Revision Year: 2013 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Mild to moderate essential hypertension.
The recommended starting dosage is 10 mg once daily, in the morning. It may be increased to 20 mg once daily if necessary. The decision to increase the dosage should only be taken after complete stability is achieved on the initial dosage. This usually takes at least 3-6 weeks.
As there are no data in children (under 18 years) barnidipine should not be administered to children.
The dosage need not be adjusted in elderly patients. Extra care at the start of treatment is advisable.
In patients with mild to moderate renal impairment, care should be taken when increasing the dosage from 10 to 20 mg once daily. See the “Contraindications” and “Special warnings and precautions for use” sections.
See the “Contraindications” section.
Take the capsules preferably with a glass of water. Vasexten can be taken before, during and after a meal.
In general, clinical symptoms following an overdose of calcium antagonists develop within 30 to 60 minutes after administration of a dose five to ten times higher than the therapeutic dose.
Hypotension, electrophysiological effects (sinus bradycardia, prolonged AV conduction, second and third degree AV block, tachycardia), effects on the central nervous system (drowsiness, confusion and, rarely, convulsions), gastrointestinal symptoms (nausea and vomiting) and metabolic effects (hyperglycaemia) can theoretically be expected.
Hospital treatment is necessary in the event of intoxication. Symptomatic treatment and continuous ECG monitoring are indicated.
In the event of an overdose a gastric lavage should be performed as soon as possible.
An intravenous (dosage 0.2 ml/kg body weight) injection of calcium (preferably 10 ml of a calcium chloride solution of 10%) should be given over a period of 5 minutes, up to a total dose of 10 ml 10%. Contractility of the myocardium, sinus rhythm and atrioventricular conduction will thus be improved. The treatment can be repeated every 15 to 20 minutes (up to a total of 4 doses) based on the patient’s response. Calcium levels should be checked.
Shelf life: 2 years.
Do not store above 25°C.
Vasexten modified release capsules are packed in boxes containing 10, 14, 20, 28, 30, 50, 56, 98 or 100 capsules in aluminium-aluminium (with PVC and polyamide coating) blisters. A blister contains 7, 10 or 14 capsules.
Not all pack sizes may be marketed.
Do not remove granules from the capsules.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
