FDA

Sodium Nitroprusside

Approved 26 Aug 2022IntravenousSolution

The FDA lists this product in 25 strengths and forms.

Indications

Sodium nitroprusside is a direct acting vasodilator indicated for:

Immediate reduction of blood pressure ( 1.1 )
Producing controlled hypotension to reduce bleeding during surgery. ( 1.2 )
Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. ( 1.3 )

1.1Immediate Reduction of Blood Pressure

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.

1.2Induction and Maintenance of Controlled Hypotension

Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.

1.3Treatment of Acute Heart Failure

Sodium nitroprusside is indicated for the treatment of acute heart failure to reduce, left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure.

Contraindications

Diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting). Inadequate cerebral circulation or in moribund patients (A.S.A. Class 5E) coming to emergency surgery. Patients with congenital (Leber’s) optic atrophy or with tobacco amblyopia. Acute heart failure associated with reduced peripheral vascular resistance. Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat.

Diseases with compensatory hypertension (e.g. coarctation of the aorta, arteriovenous shunting) ( 4 ). Inadequate cerebral circulation or moribund patients (A.S.A. Class 5E) coming to emergency surgery ( 4 ). Congenital (Leber’s) optic atrophy or tobacco amblyopia ( 4 ). Acute heart failure with reduced peripheral vascular resistance ( 4 ). Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat ( 4 )

Warnings and precautions

Thiocynate toxicity ( 5.3 ) Methemoglobinemia ( 5.4 ) Increases in intracranial pressure ( 5.5 ) Diminished capacity to compensate for anemia and hypovolemia with anesthesia during surgery ( 5.6 )

At a glance

Brand name: Sodium Nitroprusside
Route: Intravenous
Dosage form: Solution
Applicant: Slate Run Pharma
Status: Prescription
FDA approval: 26 Aug 2022
Application: ANDA215846-001

Indications

Sodium nitroprusside is a direct acting vasodilator indicated for:

Immediate reduction of blood pressure ( 1.1 )
Producing controlled hypotension to reduce bleeding during surgery. ( 1.2 )
Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. ( 1.3 )

1.1Immediate Reduction of Blood Pressure

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.

1.2Induction and Maintenance of Controlled Hypotension

Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.

1.3Treatment of Acute Heart Failure

Contraindications

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

on animal data and mechanism of action, sodium nitroprusside may lead to cyanide exposure and potential adverse effects in the fetus [see Clinical Pharmacology ( 12.3 ) and Clinical Considerations ] . Published post-marketing reports with sodium nitroprusside use in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy related outcomes [see Data ] . There were no animal reproduction studies conducted with sodium nitroprusside during pregnancy.

However, there are published studies in pregnant sheep that demonstrate that nitroprusside crosses the placenta and that fetal cyanide levels were dose-related to maternal levels of sodium nitroprusside [see Data]. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use and large doses of sodium nitroprusside during pregnancy may result in cyanide toxicity that may be fatal to the fetus. In the unusual case that there is no appropriate alternative to therapy with sodium nitroprusside for a particular patient, apprise the mother of the potential risk to the fetus [see Warnings and Precautions ( 5.2 )] .

Data Human Data A small number of cases have reported adverse events, including stillbirths, in pregnant women with severe pregnancy-induced hypertension who were treated with sodium nitroprusside. However, methodological limitations, including small sample size and limited information on sodium nitroprusside dosage and duration of treatment, as well as the cyanide concentration in maternal blood or fetal tissue, preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of sodium nitroprusside during pregnancy.

Animal Data In three studies in pregnant ewes, nitroprusside was shown to cross the placental barrier. Fetal cyanide levels were shown to be dose-related to maternal levels of nitroprusside. The metabolic transformation of sodium nitroprusside given to pregnant ewes led to fatal levels of cyanide in the fetuses. The infusion of 25 mcg/kg/min of sodium nitroprusside for one hour in pregnant ewes resulted in the death of all fetuses.

Pregnant ewes infused with 1 mcg/kg/min of sodium nitroprusside for one hour delivered normal lambs.

Sodium Nitroprusside

Indications

1.1Immediate Reduction of Blood Pressure

1.2Induction and Maintenance of Controlled Hypotension

1.3Treatment of Acute Heart Failure

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Sodium Nitroprusside

Indications

1.1Immediate Reduction of Blood Pressure

1.2Induction and Maintenance of Controlled Hypotension

1.3Treatment of Acute Heart Failure

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Excessive Hypotension

5.2Cyanide Toxicity

5.4Methemoglobinemia

5.5Increased Intracranial Pressure

5.6Anemia and Hypovolemia with Anesthesia

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

Composition

Strengths and forms

Official product information