Nipride Rtu

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders
  • CHF and arrhythmias
  • Hypertension
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Nipride Rtu Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sodium nitroprusside 0.5mg/mL (in 0.9% sodium chloride); soln for IV infusion; preservative-free.

    Pharmacological Class

    Vasodilator.

    How Supplied

    Single-dose vials (100mL)—1

    How Supplied

    Nipride RTU is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) Fliptop Vials, 20 mg/100 mL (0.2 mg/mL) Fliptop Vials and 10 mg/50 mL (0.2 mg/mL) Fliptop Vials.

    Storage

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    To protect Nipride RTU  from light, vial should be stored in its carton until used.

    Manufacturer

    Exela Pharma Sciences

    Generic Availability

    NO

    Nipride Rtu Indications

    Indications

    Induction and maintenance of controlled hypotension to reduce surgical bleeding.

    Nipride Rtu Dosage and Administration

    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

    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.

    Nipride Rtu Boxed Warnings

    Boxed Warning

    Excessive hypotension. Cyanide toxicity.

    Nipride Rtu Warnings/Precautions

    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.

    Warnings/Precautions

    Excessive Hypotension

    • May cause excessive hypotension leading to hypoperfusion of vital organs.

    • Hypotension should resolve within 1–10 minutes after discontinuing. If hypotension persists for more than a few minutes after discontinuation, consider other causes.

    • Elderly patients may be more sensitive.

    Cyanide Toxicity

    • Patients with hepatic dysfunction are more susceptible to cyanide toxicity.

    • Discontinue if cyanide toxicity develops, and consider specific treatment of cyanide toxicity.

    Thiocyanate Toxicity

    • Thiocyanate is life-threatening when levels reach ~200mg/L.

    • Routinely monitor plasma thiocyanata levels in patients with normal renal function when cumulative sodium nitroprusside doses exceed 7mg/kg/day.

    • In patients with eGFR <30mL/min/1.73m2, limit the mean infusion rate to <3mcg/kg/min.

    • In anuric patients, limit the mean infusion rate to 1mcg/kg/min.

    • In cases of severe toxicity, renal hemodialysis may be used to eliminate thiocyanate.

    Methemoglobinemia

    • Suspect methemoglobinemia in patients who received >10mg/kg of sodium nitroprusside and who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2.

    • Treat appropriately with methylene blue 1–2mg/kg administered intravenously over several minutes when methemoglobinemia is diagnosed.

    Anemia and Hypovolemia with Anesthesia

    • If possible, correct pre-existing asthma and hypovolemia prior to administration.

    Pregnancy Considerations

    Risk Summary

    • Sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus.

    • Insufficient data to inform a drug-associated risk of adverse pregnancy related outcomes.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Prolonged use and large doses of sodium nitroprusside may result in cyanide toxicity that may be fatal to the fetus.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of sodium nitroprusside in human milk, the effects on the breastfed infant, or the effects on milk production.

    Nipride Rtu Pharmacokinetics

    Metabolism

    Intraerythrocytic reaction.

    Elimination

    Renal. Half-life: ~2 minutes. 

    Nipride Rtu Interactions

    Interactions

    See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.

    Nipride Rtu Adverse Reactions

    Adverse Reactions

    Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.

    Nipride Rtu Clinical Trials

    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.

    Nipride Rtu Note

    Not Applicable

    Nipride Rtu Patient Counseling

    Patient Counseling

    Pregnancy

    • Inform female patients of reproductive potential that sodium nitroprusside Injection may cause fetal harm and to inform their prescriber of a known or suspected pregnancy.

    Nipride Rtu Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sodium nitroprusside 0.5mg/mL (in 0.9% sodium chloride); soln for IV infusion; preservative-free.

    Pharmacological Class

    Vasodilator.

    How Supplied

    Single-dose vials (100mL)—1

    How Supplied

    Nipride RTU is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) Fliptop Vials, 20 mg/100 mL (0.2 mg/mL) Fliptop Vials and 10 mg/50 mL (0.2 mg/mL) Fliptop Vials.

    Storage

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    To protect Nipride RTU  from light, vial should be stored in its carton until used.

    Manufacturer

    Exela Pharma Sciences

    Generic Availability

    NO

    Nipride Rtu Indications

    Indications

    Acute HF.

    Nipride Rtu Dosage and Administration

    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

    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.

    Nipride Rtu Boxed Warnings

    Boxed Warning

    Excessive hypotension. Cyanide toxicity.

    Nipride Rtu Warnings/Precautions

    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.

    Warnings/Precautions

    Excessive Hypotension

    • May cause excessive hypotension leading to hypoperfusion of vital organs.

    • Hypotension should resolve within 1–10 minutes after discontinuing. If hypotension persists for more than a few minutes after discontinuation, consider other causes.

    • Elderly patients may be more sensitive.

    Cyanide Toxicity

    • Patients with hepatic dysfunction are more susceptible to cyanide toxicity.

    • Discontinue if cyanide toxicity develops, and consider specific treatment of cyanide toxicity.

    Thiocyanate Toxicity

    • Thiocyanate is life-threatening when levels reach ~200mg/L.

    • Routinely monitor plasma thiocyanata levels in patients with normal renal function when cumulative sodium nitroprusside doses exceed 7mg/kg/day.

    • In patients with eGFR <30mL/min/1.73m2, limit the mean infusion rate to <3mcg/kg/min.

    • In anuric patients, limit the mean infusion rate to 1mcg/kg/min.

    • In cases of severe toxicity, renal hemodialysis may be used to eliminate thiocyanate.

    Methemoglobinemia

    • Suspect methemoglobinemia in patients who received >10mg/kg of sodium nitroprusside and who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2.

    • Treat appropriately with methylene blue 1–2mg/kg administered intravenously over several minutes when methemoglobinemia is diagnosed.

    Anemia and Hypovolemia with Anesthesia

    • If possible, correct pre-existing asthma and hypovolemia prior to administration.

    Pregnancy Considerations

    Risk Summary

    • Sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus.

    • Insufficient data to inform a drug-associated risk of adverse pregnancy related outcomes.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Prolonged use and large doses of sodium nitroprusside may result in cyanide toxicity that may be fatal to the fetus.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of sodium nitroprusside in human milk, the effects on the breastfed infant, or the effects on milk production.

    Nipride Rtu Pharmacokinetics

    Metabolism

    Intraerythrocytic reaction.

    Elimination

    Renal. Half-life: ~2 minutes. 

    Nipride Rtu Interactions

    Interactions

    See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.

    Nipride Rtu Adverse Reactions

    Adverse Reactions

    Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.

    Nipride Rtu Clinical Trials

    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.

    Nipride Rtu Note

    Not Applicable

    Nipride Rtu Patient Counseling

    Patient Counseling

    Pregnancy

    • Inform female patients of reproductive potential that sodium nitroprusside Injection may cause fetal harm and to inform their prescriber of a known or suspected pregnancy.

    Nipride Rtu Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sodium nitroprusside 0.5mg/mL (in 0.9% sodium chloride); soln for IV infusion; preservative-free.

    Pharmacological Class

    Vasodilator.

    How Supplied

    Single-dose vials (100mL)—1

    How Supplied

    Nipride RTU is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) Fliptop Vials, 20 mg/100 mL (0.2 mg/mL) Fliptop Vials and 10 mg/50 mL (0.2 mg/mL) Fliptop Vials.

    Storage

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    To protect Nipride RTU  from light, vial should be stored in its carton until used.

    Manufacturer

    Exela Pharma Sciences

    Generic Availability

    NO

    Nipride Rtu Indications

    Indications

    Immediate reduction of blood pressure during hypertensive crises.

    Nipride Rtu Dosage and Administration

    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

    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.

    Nipride Rtu Boxed Warnings

    Boxed Warning

    Excessive hypotension. Cyanide toxicity.

    Nipride Rtu Warnings/Precautions

    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.

    Warnings/Precautions

    Excessive Hypotension

    • May cause excessive hypotension leading to hypoperfusion of vital organs.

    • Hypotension should resolve within 1–10 minutes after discontinuing. If hypotension persists for more than a few minutes after discontinuation, consider other causes.

    • Elderly patients may be more sensitive.

    Cyanide Toxicity

    • Patients with hepatic dysfunction are more susceptible to cyanide toxicity.

    • Discontinue if cyanide toxicity develops, and consider specific treatment of cyanide toxicity.

    Thiocyanate Toxicity

    • Thiocyanate is life-threatening when levels reach ~200mg/L.

    • Routinely monitor plasma thiocyanata levels in patients with normal renal function when cumulative sodium nitroprusside doses exceed 7mg/kg/day.

    • In patients with eGFR <30mL/min/1.73m2, limit the mean infusion rate to <3mcg/kg/min.

    • In anuric patients, limit the mean infusion rate to 1mcg/kg/min.

    • In cases of severe toxicity, renal hemodialysis may be used to eliminate thiocyanate.

    Methemoglobinemia

    • Suspect methemoglobinemia in patients who received >10mg/kg of sodium nitroprusside and who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2.

    • Treat appropriately with methylene blue 1–2mg/kg administered intravenously over several minutes when methemoglobinemia is diagnosed.

    Anemia and Hypovolemia with Anesthesia

    • If possible, correct pre-existing asthma and hypovolemia prior to administration.

    Pregnancy Considerations

    Risk Summary

    • Sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus.

    • Insufficient data to inform a drug-associated risk of adverse pregnancy related outcomes.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Prolonged use and large doses of sodium nitroprusside may result in cyanide toxicity that may be fatal to the fetus.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of sodium nitroprusside in human milk, the effects on the breastfed infant, or the effects on milk production.

    Nipride Rtu Pharmacokinetics

    Metabolism

    Intraerythrocytic reaction.

    Elimination

    Renal. Half-life: ~2 minutes. 

    Nipride Rtu Interactions

    Interactions

    See Contraindications. Hypotensive effect potentiated by ganglionic blocking agents and inhaled anesthetics.

    Nipride Rtu Adverse Reactions

    Adverse Reactions

    Excessive hypotension, cyanide/thiocyanate toxicity, methemoglobinemia, anemia, hypovolemia.

    Nipride Rtu Clinical Trials

    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.

    Nipride Rtu Note

    Not Applicable

    Nipride Rtu Patient Counseling

    Patient Counseling

    Pregnancy

    • Inform female patients of reproductive potential that sodium nitroprusside Injection may cause fetal harm and to inform their prescriber of a known or suspected pregnancy.

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