Nidepine Dosage/Direction for Use

Dosage: NIDEPINE is intended for IV infusion use. Ampoules must be diluted with compatible intravenous fluids at a concentration of 0.1 mg/mL before infusion.
Administer by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes and does not reach final steady state for about 50 hours.
When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for about 50 hours.
Titration: For gradual reduction in blood pressure, initiate therapy at 50 mL/h (5 mg/h). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/h (2.5 mg/h) 15 minutes up to a maximum of 150 mL/h until desired reduction of blood pressure is achieved.
For more rapid blood pressure reduction, initiate therapy at 50 mL/hr (5 mg/h). If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/h) every 5 minutes up to a maximum of 150mL/h (15 mg/h), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal, the infusion rate should be decreased to 30 mL/h (3 mg/h).
Conditions requiring infusion adjustment: Hypotension or tachycardia: If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. When blood pressure has stabilized, infusion of NIDEPINE may be restarted at low doses such as 30 to 50 mL/hr (3 to 5 mg/hr) and adjusted to maintain desired blood pressure.
Infusion-site should be changed every 12 hours if administered via peripheral vein.
Mode of Administration: NIDEPINE is intended for intravenous use. Ampoules must be diluted before infusion at a concentration of 0.1 mg/mL.
Solution for dilution: The drug could be diluted with compatible solution as follows: Dextrose (5%) injection, USP; Dextrose (5%) and sodium chloride (0.45%) injection, USP; Dextrose (5%) and sodium chloride (0.9%) injection, USP; Dextrose (5%) with 40 mEq potassium, USP; Sodium chloride (0.45%) injection, USP; Sodium chloride (0.9%) injection, USP.
Remark: NIDEPINE is not compatible with sodium bicarbonate (5%) injection or Ringer's lactate injection.
The diluted solution is stable in glass or polyvinyl chloride containers for 24 hours at room temperature (20-25°C).