Nitroprusside

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

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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 (see DOSAGE AND ADMINISTRATION). 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 (see WARNINGS). 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 crises 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)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Nitroprusside in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

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 (see DOSAGE AND ADMINISTRATION). 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 (see WARNINGS). 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.

Description

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

• Drug

• Description

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

• Intravenous

• 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

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

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

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®

Look-Alike Drug Names

• N/A

Drug Shortage Status

Price

References

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

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