Bleeding disorders:
Indications for: NIPRIDE RTU
Induction and maintenance of controlled hypotension to reduce surgical bleeding.
Clinical Trials:
-
Baseline-controlled clinical trials have shown that sodium nitroprusside has a prompt hypotensive effect (at least initially) in all populations.
-
In clinical trials, the hypotensive effect of sodium nitroprusside has shown to be associated with reduced blood loss in a variety of major surgical procedures.
-
In patients with acute HF and increased peripheral vascular resistance, sodium nitroprusside causes reductions in peripheral resistance, increases in cardiac output, and reductions in left ventricular filling pressure.
Pediatrics
-
Two clinical trials evaluated the effects of sodium nitroprusside in pediatric patients less than 17 years of age to induce hypotension. In both trials, at least 50% of patients were pre-pubertal, and about 50% of these pre-pubertal patients were less than 2 years of age, including 4 neonates. The primary efficacy variable was the mean arterial pressure (MAP).
-
In Study 1 during the 30-minute blinded phase, 203 patients were randomly assigned 1:1:1:1 to receive sodium nitroprusside 0.3, 1, 2, or 3 mcg/kg/min. The infusion rate was increased step-wise to the target dose rate. Results showed that MAP decreased 11 to 20 mmHg from baseline across the 4 doses.
-
In Study 2 during the open-label phase, 63 patients received sodium nitroprusside at an initial dose of 0.3 mcg/kg/min and titrated according to the BP response. Patients were then randomly assigned to receive either placebo or continue the same dose of sodium nitroprusside. Results showed that the average MAP was greater in the placebo arm vs the sodium nitroprusside arm for every time point. This showed that sodium nitroprusside was effective for at least 12 hours.
Adults and Children:
Use infusion pump only. Monitor BP closely. Initially 0.3microgram/kg/min; may increase infusion rate every few minutes until desired effect; max 10microgram/kg/min. Renal impairment (eGFR <30mL/min/1.73m2): limit to <3microgram/kg/min. Anuric: limit to 1microgram/kg/min.
NIPRIDE RTU Contraindications:
Compensatory hypertension due to aortic coarctation or arteriovenous shunting. Inadequate cerebral circulation or moribund patients requiring emergency surgery. Congenital (Lebers) optic atrophy. Tobacco amblyopia. Acute HF associated with reduced peripheral vascular resistance. Concomitant sildenafil, tadalafil, vardenafil, or riociguat.
Boxed Warning:
Excessive hypotension. Cyanide toxicity.
NIPRIDE RTU Warnings/Precautions:
Use only when available equipment and personnel allow BP to be continuously monitored. Cyanide toxicity possible (esp. at infusion rates >2micrograms/kg/min); discontinue if develops; treat appropriately. Monitor plasma thiocyanate levels if cumulative dose >7mg/kg/day. Elevated intracranial pressure. Correct pre-existing anemia and hypovolemia, esp. during anesthesia. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
NIPRIDE RTU Classification:
Vasodilator.
NIPRIDE RTU Interactions:
See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.
Adverse Reactions:
Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.
Drug Elimination:
Renal. Half-life: ~2 minutes.
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (100mL)—1
CHF and arrhythmias:
Indications for: NIPRIDE RTU
Acute HF.
Clinical Trials:
-
Baseline-controlled clinical trials have shown that sodium nitroprusside has a prompt hypotensive effect (at least initially) in all populations.
-
In clinical trials, the hypotensive effect of sodium nitroprusside has shown to be associated with reduced blood loss in a variety of major surgical procedures.
-
In patients with acute HF and increased peripheral vascular resistance, sodium nitroprusside causes reductions in peripheral resistance, increases in cardiac output, and reductions in left ventricular filling pressure.
Pediatrics
-
Two clinical trials evaluated the effects of sodium nitroprusside in pediatric patients less than 17 years of age to induce hypotension. In both trials, at least 50% of patients were pre-pubertal, and about 50% of these pre-pubertal patients were less than 2 years of age, including 4 neonates. The primary efficacy variable was the mean arterial pressure (MAP).
-
In Study 1 during the 30-minute blinded phase, 203 patients were randomly assigned 1:1:1:1 to receive sodium nitroprusside 0.3, 1, 2, or 3 mcg/kg/min. The infusion rate was increased step-wise to the target dose rate. Results showed that MAP decreased 11 to 20 mmHg from baseline across the 4 doses.
-
In Study 2 during the open-label phase, 63 patients received sodium nitroprusside at an initial dose of 0.3 mcg/kg/min and titrated according to the BP response. Patients were then randomly assigned to receive either placebo or continue the same dose of sodium nitroprusside. Results showed that the average MAP was greater in the placebo arm vs the sodium nitroprusside arm for every time point. This showed that sodium nitroprusside was effective for at least 12 hours.
Adults and Children:
Use infusion pump only. Monitor BP closely. Initially 0.3microgram/kg/min; may increase infusion rate every few minutes until desired effect; max 10microgram/kg/min. Renal impairment (eGFR <30mL/min/1.73m2): limit to <3microgram/kg/min. Anuric: limit to 1microgram/kg/min.
NIPRIDE RTU Contraindications:
Compensatory hypertension due to aortic coarctation or arteriovenous shunting. Inadequate cerebral circulation or moribund patients requiring emergency surgery. Congenital (Lebers) optic atrophy. Tobacco amblyopia. Acute HF associated with reduced peripheral vascular resistance. Concomitant sildenafil, tadalafil, vardenafil, or riociguat.
Boxed Warning:
Excessive hypotension. Cyanide toxicity.
NIPRIDE RTU Warnings/Precautions:
Use only when available equipment and personnel allow BP to be continuously monitored. Cyanide toxicity possible (esp. at infusion rates >2micrograms/kg/min); discontinue if develops; treat appropriately. Monitor plasma thiocyanate levels if cumulative dose >7mg/kg/day. Elevated intracranial pressure. Correct pre-existing anemia and hypovolemia, esp. during anesthesia. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
NIPRIDE RTU Classification:
Vasodilator.
NIPRIDE RTU Interactions:
See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.
Adverse Reactions:
Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.
Drug Elimination:
Renal. Half-life: ~2 minutes.
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (100mL)—1
Hypertension:
Indications for: NIPRIDE RTU
Immediate reduction of blood pressure during hypertensive crises.
Clinical Trials:
-
Baseline-controlled clinical trials have shown that sodium nitroprusside has a prompt hypotensive effect (at least initially) in all populations.
-
In clinical trials, the hypotensive effect of sodium nitroprusside has shown to be associated with reduced blood loss in a variety of major surgical procedures.
-
In patients with acute HF and increased peripheral vascular resistance, sodium nitroprusside causes reductions in peripheral resistance, increases in cardiac output, and reductions in left ventricular filling pressure.
Pediatrics
-
Two clinical trials evaluated the effects of sodium nitroprusside in pediatric patients less than 17 years of age to induce hypotension. In both trials, at least 50% of patients were pre-pubertal, and about 50% of these pre-pubertal patients were less than 2 years of age, including 4 neonates. The primary efficacy variable was the mean arterial pressure (MAP).
-
In Study 1 during the 30-minute blinded phase, 203 patients were randomly assigned 1:1:1:1 to receive sodium nitroprusside 0.3, 1, 2, or 3 mcg/kg/min. The infusion rate was increased step-wise to the target dose rate. Results showed that MAP decreased 11 to 20 mmHg from baseline across the 4 doses.
-
In Study 2 during the open-label phase, 63 patients received sodium nitroprusside at an initial dose of 0.3 mcg/kg/min and titrated according to the BP response. Patients were then randomly assigned to receive either placebo or continue the same dose of sodium nitroprusside. Results showed that the average MAP was greater in the placebo arm vs the sodium nitroprusside arm for every time point. This showed that sodium nitroprusside was effective for at least 12 hours.
Adults and Children:
Use infusion pump only. Monitor BP closely. Initially 0.3microgram/kg/min; may increase infusion rate every few minutes until desired effect; max 10microgram/kg/min. Renal impairment (eGFR <30mL/min/1.73m2): limit to <3microgram/kg/min. Anuric: limit to 1microgram/kg/min.
NIPRIDE RTU Contraindications:
Compensatory hypertension due to aortic coarctation or arteriovenous shunting. Inadequate cerebral circulation or moribund patients requiring emergency surgery. Congenital (Lebers) optic atrophy. Tobacco amblyopia. Acute HF associated with reduced peripheral vascular resistance. Concomitant sildenafil, tadalafil, vardenafil, or riociguat.
Boxed Warning:
Excessive hypotension. Cyanide toxicity.
NIPRIDE RTU Warnings/Precautions:
Use only when available equipment and personnel allow BP to be continuously monitored. Cyanide toxicity possible (esp. at infusion rates >2micrograms/kg/min); discontinue if develops; treat appropriately. Monitor plasma thiocyanate levels if cumulative dose >7mg/kg/day. Elevated intracranial pressure. Correct pre-existing anemia and hypovolemia, esp. during anesthesia. Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
NIPRIDE RTU Classification:
Vasodilator.
NIPRIDE RTU Interactions:
See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.
Adverse Reactions:
Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.
Drug Elimination:
Renal. Half-life: ~2 minutes.
Generic Drug Availability:
NO
How Supplied:
Single-dose vials (100mL)—1
