Dosage Adult and the As a pressor As a pressor As a pressor elderly IM or SC adults IM or SC adults Adults 10 to 25 Up to 30 mg in 25 to 50 mg, 25 to 50 mg, mg IV repeated increments of 3 additional doses additional doses 5 to 10 to 7.5 mg. based on based on minutes. response. response. After the Paediatric 3 development of IV adults 10 to IV adults 10 mg/kg/day or hypotension, by 25 mg repeated to 25 mg 100 mg/m2/day slow intravenous every 5 to 10 repeated IV, given in 4 to 6 administration. minutes. 5 to 10 divided doses. minutes. Children 0.5 to Paediatric 3 0.75 mg / kg mg/kg/day or Paediatric 3 body weight or 100 mg/m2/day mg/kg/day 17 25 mg / m2 IV or SC, given in or 100 body surface. 4 to 6 divided mg/m2/day doses. IV or SC, After the given in 4 to development of Bronchospasm 6 divided hypotension, by IV, IM or SC doses. slow intravenous adults 12.5 to 25 administration. mg, additional Bronchospasm doses based on IV, IM or SC response. adults 12.5 to 25 mg, additional Paediatric 3 doses based on mg/kg/day or response. 100 mg/m2/day IV or SC, given in Paediatric 3 4 to 6 divided mg/kg or 100 doses. mg/m2 IV or SC, given in 4 to 6 divided doses. We believe that the SCP Ephedrine hydrochloride injection is a safe and efficacious alternative to the current sulfate formulation, when used according to the advice provided in the proposed PI. A clean and annotated copy of the proposed PI is provided.
Dosage Adult and the elderly Up to 30 mg in increments of 3 to 7.5 mg. After the development of hypotension, by slow intravenous administration. Children 0.5 to 0.75 mg / kg body weight or 17 25 mg / m2 body surface. After the development of hypotension, by slow intravenous administration. As a pressor IM or SC adults 25 to 50 mg, additional doses based on response. IV adults 10 to 25 mg repeated every 5 to 10 minutes. Paediatric 3 mg/kg/day or 100 mg/m2/day IV or SC, given in 4 to 6 divided doses. Bronchospasm IV, IM or SC adults 12.5 to 25 mg, additional doses based on response. Paediatric 3 mg/kg/day or 100 mg/m2/day IV or SC, given in 4 to 6 divided doses. As a pressor IM or SC adults 25 to 50 mg, additional doses based on response. IV adults 10 to 25 mg repeated 5 to 10 minutes. Paediatric 3 mg/kg/day or 100 mg/m2/day IV or SC, given in 4 to 6 divided doses. Bronchospasm IV, IM or SC adults 12.5 to 25 mg, additional doses based on response. Paediatric 3 mg/kg or 100 mg/m2 IV or SC, given in 4 to 6 divided doses. As a pressor Adults 10 to 25 mg IV repeated 5 to 10 minutes. Paediatric 3 mg/kg/day or 100 mg/m2/day IV, given in 4 to 6 divided doses. We believe that the SCP Ephedrine hydrochloride injection is a safe and efficacious alternative to the current sulfate formulation, when used according to the advice provided in the proposed PI. A clean and annotated copy of the proposed PI is provided.
auspar-ephedrine-hydrochloride-171013.docx