Since 2016, FSUE Endopharm has advanced 13 new narcotic and psychotropic medicines, most of which intended for palliative medical care of patients suffering from chronic pain syndrome and convulsive disorder. 29 domestic narcotic and psychotropic drug products in 10 dosage forms and 53 dosages are available to medical specialists in Russia, which makes it possible to provide necessary anesthetic treatment for adults in need in all regions of the country in accordance with the recommendations of the Ministry of Health of the Russian Federation.
At the same time, the use in pediatric practice of a number of drug products from the group of narcotic analgesics manufactured by the Company was previously possible only “off-label” — through the medical commission procedure.
Pursuant to paragraph 14 of the “Minutes of the meeting on increasing the availability and quality of analgesic therapy in the provision of palliative medical care on the basis of FSUE “Moscow Endocrine Plant” under the chairmanship of M.A. Murashko, Minister of Health of the Russian Federation, dated April 26, 2002, FSUE Endopharm conducted a multicenter, open, randomized clinical trial in parallel groups on the effectiveness and safety of “Morphine, 5 mg film-coated tablets” (FSUE “Moscow Endocrine Plant”, Russia) in comparison with “Morphine, solution for injection 10 mg/ml” (FSUE “Moscow Endocrine Plant”, Russia) among pediatric patients with high intensity pain syndrome. The purpose of this study was to increase the availability of pain relief for pediatric patients who need it for medical reasons.
According to the findings, both drug products demonstrated a satisfactory safety and efficacy profile among patients with high intensity pain syndrome at the age of 3 to 17 years inclusive in the postoperative period requiring the prescription of narcotic analgesics. This, in turn, made it possible to include the data on the use of “Morphine, film-coated tablets, 5 mg, 10 mg” for children from 3 years and older in the basic prescribing information.
Besides, application in the pediatric population (3 years and older) is included in the instructions for “Morphine, oral solution 2 mg/mL, 6 mg/mL, 20 mg/mL” and “Morphine, oral drops 20 mg/mL” on the basis of previously conducted studies of bioequivalence of these preparations with “Morphine, film-coated tablets”.
The shelf life for “Morphine, oral solution, 2mg/mL, 6 mg/mL, 20 mg/mL polymeric ampoules 5 ml No. 20” has been prolonged from 2 to 3 years.
The products belong to the pharmacotherapeutic group of analgesic narcotic substances.
Proposed clinical use includes acute and chronic pain syndrome of high intensity, which cannot be controlled by other drug products.
The products belong to List II of the “Narcotic drug products, psychotropic substances and their precursors subject to control in the Russian Federation”. They are available on prescription with the restrictions provided for narcotic drug products.
Owing to the assessment of drug efficacy and safety for pediatric population, the physician can be guided by the approved basic prescribing information to achieve the best clinical result when prescribing INN morphine drug products to a child.
Comment type is not specified in the component properties.