The Ministry of Health of the Russian Federation recommended making changes to the instructions for the medical use of drugs that contain amlodipine in tablet form as an active substance. This is reported by FV with reference to the information that appeared on the Ministry of Health’s website.
The basis for the requirements of the Ministry of Health is the message of the Federal State Budgetary Institution “Research Center for the Expert Examination of Medical Devices”.
“The Ministry urges to include information in all sections that mention the use of the drug in pediatric patients. According to the current information on the experience of clinical use, the instructions should be supplemented with the indication “arterial hypertension in children aged 6-17 years,” the document says. Previously, amlodipine was allowed to patients from the age of 18,” the newspaper writes.
The letter provides data on a study involving children, where doses of amlodipine (2.5 and 5 mg) were compared with placebo. It is said that amlodipine lowered blood pressure to a much greater extent than placebo. The long-term effects of amlodipine on the growth and development of children have not been studied, however. Only limited information is available concerning the use of the drug in children under the age of six.
The initial recommended dose for children is 2.5 mg per day. Thus, for amlodipine drugs that are available in a higher dosage without a breakline, it is necessary to additionally provide information in the Method of administration and doses section (with the indication of the dosage regimen).