Nitroprusside

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Nitroprusside
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Black Box Warning

See full prescribing information for complete Boxed Warning.
* Nitropress® (Sodium Nitroprusside Injection) is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion.
  • Nitropress can cause precipitous decreases in blood pressure. In patients not properly monitored, these decreases can lead to irreversible ischemic injuries or death. Sodium nitroprusside should be used only when available equipment and personnel allow blood pressure to be continuously monitored.
  • Except when used briefly or at low (< 2 mcg/kg/min) infusion rates, sodium nitroprusside gives rise to important quantities of cyanide ion, which can reach toxic, potentially lethal levels. The usual dose rate is 0.5-10 mcg/kg/min, but infusion at the maximum dose rate should never last more than 10 minutes. If blood pressure has not been adequately controlled after 10 minutes of infusion at the maximum rate, administration of sodium nitroprusside should be terminated immediately.
  • Although acid-base balance and venous oxygen concentration should be monitored and may indicate cyanide toxicity, these laboratory tests provide imperfect guidance.

Overview

Nitroprusside is a vasodilator that is FDA approved for the {{{indicationType}}} of hypertensive crisis and acute congestive heart failure. It is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include excessive hypotension and cyanide toxicity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertensive Crisis
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion
Acute Congestive Heart Failure
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion
Reduce Bleeding During Surgery
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nitroprusside in adult patients.

Non–Guideline-Supported Use

Aortic Stenosis
  • Dosing Information
  • 1–3 μg/kg/min IV infusion[1]
Vasopressin-Induced Hypertension During Portosystemic Shunting in Patients with Cirrhosis
  • 1–2 μg/kg/min IV infusion[2]
Myocardial Infarction
  • Dosing Information
  • 10–33 μg/kg/min IV infusion, initially within 24 hours of onset of symptoms[3]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Hypertensive Crisis
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion
Acute Congestive Heart Failure
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion
Reduce Bleeding During Surgery
  • Dosing Information
  • Initial dose: 0.3 μg/kg/min IV infusion, titrate every few min to desired effect.
  • Average dose: 3 μg/kg/min IV infusion
  • Maximum dose: 10 μg/kg/min IV infusion

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nitroprusside in pediatric patients.

Non–Guideline-Supported Use

Erythromelalgia
  • Dosing Information
  • 1–5 μg/kg/min IV infusion for 2–8 days[4]
Respiratory Distress Syndrome in the Newborn
  • Dosing Information
  • 15–20 mg/day inhalation[5]
  • 0.2–6.0 μg/kg/min IV infusion[6]

Contraindications

  • Inadequate cerebral circulation or moribund patients
  • Sodium nitroprusside should not be used to produce hypotension during surgery in patients with known 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 have unusually high cyanide/thiocyanate ratios. These rare conditions are probably associated with defective or absent rhodanase, and sodium nitroprusside should be avoided in these patients.

Warnings

See full prescribing information for complete Boxed Warning.
* Nitropress® (Sodium Nitroprusside Injection) is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion.
  • Nitropress can cause precipitous decreases in blood pressure. In patients not properly monitored, these decreases can lead to irreversible ischemic injuries or death. Sodium nitroprusside should be used only when available equipment and personnel allow blood pressure to be continuously monitored.
  • Except when used briefly or at low (< 2 mcg/kg/min) infusion rates, sodium nitroprusside gives rise to important quantities of cyanide ion, which can reach toxic, potentially lethal levels. The usual dose rate is 0.5-10 mcg/kg/min, but infusion at the maximum dose rate should never last more than 10 minutes. If blood pressure has not been adequately controlled after 10 minutes of infusion at the maximum rate, administration of sodium nitroprusside should be terminated immediately.
  • Although acid-base balance and venous oxygen concentration should be monitored and may indicate cyanide toxicity, these laboratory tests provide imperfect guidance.
  • The principal hazards of NITROPRESS administration are excessive hypotension and excessive accumulation of cyanide.
  • Small transient excesses in the infusion rate of sodium nitroprusside can result in excessive hypotension, sometimes to levels so low as to compromise the perfusion of vital organs. These hemodynamic changes may lead to a variety of associated symptoms. Nitroprusside-induced hypotension will be self-limited within 1-10 minutes after discontinuation of the nitroprusside infusion; during these few minutes, it may be helpful to put the patient into a head-down (Trendelenburg) position to maximize venous return. If hypotension persists more than a few minutes after discontinuation of the infusion of NITROPRESS, NITROPRESS is not the cause, and the true cause must be sought.
  • Cyanide Toxicity
  • Sodium nitroprusside infusions at rates above 2 mcg/kg/min generate cyanide ion (CN¯) faster than the body can normally dispose of it. (When sodium thiosulfate is given, the body’s capacity for CN¯ elimination is greatly increased.) Methemoglobin normally present in the body can buffer a certain amount of CN¯, but the capacity of this system is exhausted by the CN¯ produced from about 500 mcg/kg of sodium nitroprusside. This amount of sodium nitroprusside is administered in less than an hour when the drug is administered at 10 mcg/kg/min (the maximum recommended rate). Thereafter, the toxic effects of CN¯ may be rapid, serious, and even lethal.
  • The true rates of clinically important cyanide toxicity cannot be assessed from spontaneous reports or published data. Most patients reported to have experienced such toxicity have received relatively prolonged infusions, and the only patients whose deaths have been unequivocally attributed to nitroprusside-induced cyanide toxicity have been patients who had received nitroprusside infusions at rates (30-120 mcg/kg/min) much greater than those now recommended. Elevated cyanide levels, metabolic acidosis, and marked clinical deterioration, however, have occasionally been reported in patients who received infusions at recommended rates for only a few hours and even, in one case, for only 35 minutes. In some of these cases, infusion of sodium thiosulfate caused dramatic clinical improvement, supporting the diagnosis of cyanide toxicity.
  • Cyanide toxicity may manifest itself as venous hyperoxemia with bright red venous blood, as cells become unable to extract the oxygen delivered to them; metabolic acidosis (lactic acidosis); air hunger; confusion; and death. Cyanide toxicity due to causes other than nitroprusside has been associated with angina pectoris and myocardial infarction; ataxia, seizures, and stroke; and other diffuse ischemic damage.
  • Hypertensive patients, and patients concomitantly receiving other antihypertensive medications, may be more sensitive to the effects of sodium nitroprusside than normal subjects.

Precautions

  • General
  • Like other vasodilators, sodium nitroprusside can cause increases in intracranial pressure. In patients whose intracranial pressure is already elevated, sodium nitroprusside should be used only with extreme caution.
  • Hepatic
  • Use caution when administering nitroprusside to patients with hepatic insufficiency.
  • Use in Anesthesia
  • When sodium nitroprusside (or any other vasodilator) is used for controlled hypotension during anesthesia, the patient’s capacity to compensate for anemia and hypovolemia may be diminished. If possible, pre-existing anemia and hypovolemia should be corrected prior to administration of NITROPRESS. Hypotensive anesthetic techniques may also cause abnormalities of the pulmonary ventilation/perfusion ratio. Patients intolerant of these abnormalities may require a higher fraction of inspired oxygen. Extreme caution should be exercised in patients who are especially poor surgical risks (A.S.A. Class 4 and 4E).
  • Laboratory Tests
  • The cyanide level assay is technically difficult, and cyanide levels in body fluids other than packed red blood cells are difficult to interpret. Cyanide toxicity will lead to lactic acidosis and venous hyperoxemia, but these findings may not be present until an hour or more after the cyanide capacity of the body’s red-cell mass has been exhausted.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nitroprusside in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nitroprusside in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Antihypertensive agents
  • The hypotensive effect of sodium nitroprusside is augmented by that of most other hypotensive drugs, including ganglionic blocking agents, negative inotropic agents, and inhaled anesthetics.

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Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nitroprusside in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nitroprusside during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nitroprusside with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nitroprusside with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nitroprusside with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nitroprusside with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nitroprusside with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nitroprusside in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nitroprusside in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nitroprusside in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nitroprusside in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Dilution to proper strength for infusion
  • Depending on the desired concentration, the solution containing 50 mg of Nitropress must be further diluted in 250-1000 mL of sterile 5% dextrose injection. The diluted solution should be protected from light, using the supplied opaque sleeve, aluminum foil, or other opaque material. It is not necessary to cover the infusion drip chamber or the tubing.
  • Verification of the chemical integrity of the product
  • Sodium nitroprusside solution can be inactivated by reactions with trace contaminants. The products of these reactions are often blue, green, or red, much brighter than the faint brownish color of unreacted Nitropress. Discolored solutions, or solutions in which particulate matter is visible, should not be used. If properly protected from light, the freshly diluted solution is stable for 24 hours.
  • No other drugs should be administered in the same solution with sodium nitroprusside.

Monitoring

Blood Pressure and Urine Output
  • Because sodium nitroprusside can induce essentially unlimited blood pressure reduction, the blood pressure of a patient receiving this drug must be continuously monitored, using either a continually reinflated sphygmomanometer or (preferably) an intra-arterial pressure sensor. Special caution should be used in elderly patients, since they may be more sensitive to the hypotensive effects of the drug.
  • When sodium nitroprusside is used in the treatment of acute congestive heart failure, titration of the infusion rate must be guided by the results of invasive hemodynamic monitoring with simultaneous monitoring of urine output.

IV Compatibility

There is limited information regarding IV Compatibility of Nitroprusside in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nitroprusside in the drug label.

Pharmacology

Template:Px
Sodium nitroprusside (anhydrous)Sodium nitroprusside
Systematic (IUPAC) name
disodium pentacyano(nitroso)irondiuide
Identifiers
CAS number 15078-28-1
ATC code C02DD01
PubChem 11953895
DrugBank DB00325
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 261.918
SMILES eMolecules & PubChem
Synonyms SNP
Physical data
Density 1.72 g/cm³
Solubility in water 100 mg/mL (20 °C)
Pharmacokinetic data
Bioavailability 100% (Intravenous)
Metabolism By haemoglobin being converted to cyanmethaemoglobin and cyanide ions
Half life <2 minutes (3 days for thiocyanate metabolite)
Excretion Renal (100%; as thiocyanate)
Therapeutic considerations
Licence data

US

Pregnancy cat.

C(AU) C(US)

Legal status

Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes Intravenous

Mechanism of Action

There is limited information regarding Nitroprusside Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Nitroprusside in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nitroprusside in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Nitroprusside in the drug label.

Nonclinical Toxicology

=Carcinogenesis, Mutagenesis, and Impairment of Fertility

  • Animal studies assessing sodium nitroprusside’s carcinogenicity and mutagenicity have not been conducted. Similarly, sodium nitroprusside has not been tested for effects on fertility.

Clinical Studies

There is limited information regarding Clinical Studies of Nitroprusside in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Nitroprusside How Supplied in the drug label.

Storage

There is limited information regarding Nitroprusside Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nitroprusside in the drug label.

Precautions with Alcohol

  • Alcohol-Nitroprusside interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Nitropress®[7]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Ikram, H. (1992-02-01). "Hemodynamic effects of nitroprusside on valvular aortic stenosis". The American Journal of Cardiology. 69 (4): 361–366. ISSN 0002-9149. PMID 1734649. Unknown parameter |coauthors= ignored (help)
  2. Sirinek, K. R. (1989-01). "Simultaneous infusion of nitroglycerin and nitroprusside to offset adverse effects of vasopressin during portosystemic shunting". American Journal of Surgery. 157 (1): 33–37. ISSN 0002-9610. PMID 2491934. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  3. Yusuf, S. (1988-05-14). "Effect of intravenous nitrates on mortality in acute myocardial infarction: an overview of the randomised trials". Lancet. 1 (8594): 1088–1092. ISSN 0140-6736. PMID 2896919. Unknown parameter |coauthors= ignored (help)
  4. Stone, J. D. (1997-05). "Nitroprusside treatment of erythromelalgia in an adolescent female". The Annals of Pharmacotherapy. 31 (5): 590–592. ISSN 1060-0280. PMID 9161655. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  5. Palhares, D. B. (1998). "Endotracheal inhalatory sodium nitroprusside in severely hypoxic newborns". Journal of Perinatal Medicine. 26 (3): 219–224. ISSN 0300-5577. PMID 9773383. Unknown parameter |coauthors= ignored (help)
  6. Benitz, W. E. (1985-01). "Use of sodium nitroprusside in neonates: efficacy and safety". The Journal of Pediatrics. 106 (1): 102–110. ISSN 0022-3476. PMID 3917495. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  7. "Nitropress (sodium nitroprusside) injection, solution, concentrate".
  8. "http://www.ismp.org". External link in |title= (help)


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