Sodium Nitroprusside In 0.9% Sodium Chloride
Generic Name: sodium nitroprusside in 0.9% sodium chloride
Brand Names:
Sodium Nitroprusside In 0.9% Sodium Chloride
11 DESCRIPTION Sodium nitroprusside is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is Sodium Nitroprusside has a molecular formula Na 2 [Fe(CN) 5 NO] • 2H 2 O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1 )].
Overview
11 DESCRIPTION Sodium nitroprusside is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is Sodium Nitroprusside has a molecular formula Na 2 [Fe(CN) 5 NO] • 2H 2 O and molecular weight of 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes [see Dosage and Administration ( 2.1 )].
Uses
1 INDICATIONS AND USAGE 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 ) 1.1 Immediate Reduction of Blood Pressure Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. 1.2 Induction and Maintenance of Controlled Hypotension Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.
Dosage
2 DOSAGE AND ADMINISTRATION Initiate infusion of sodium nitroprusside at a rate of 0.3 mcg/kg/min, and titrate every few minutes until the desired effect is achieved OR the maximum recommended infusion rate of 10 mcg/kg/min has been reached ( 2.2 ). 2.1 Inspection Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Sodium nitroprusside should be a clear colorless to red/brown color; do not use if solution is blue, green, or bright red. Dosing Continuously monitor blood pressure in patients receiving sodium nitroprusside. Start infusion of sodium nitroprusside at a rate of 0.3 mcg/kg/min.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Hypotension [see Warnings and Precautions ( 5.1 )] Cyanide Toxicity [see Warnings and Precautions ( 5.2 )] Thiocyanate Toxicity [see Warnings and Precautions ( 5.3 )] Methemoglobinemia [see Warnings and Precautions ( 5.4 )] Increased Intracranial Pressure [see Warnings and Precautions ( 5.5 )] Anemia and Hypovolemia [see Warnings and Precautions ( 5.6 )] Less common adverse reactions include: Cardiovascular: Bradycardia, electrocardiographic changes, tachycardia, palpitations, retrosternal discomfort Dermatologic: Rash Endocrine: Hypothyroidism Gastrointestinal: Ileus, nausea, abdominal pain Hematologic: Decreased platelet aggregation Musculoskeletal: Muscle twitching Neuro...
Warnings
WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION: Sodium nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ischemic injuries or death. Use only with continuous blood pressure monitoring [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ) ] . (B) CYANIDE TOXICITY: Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. 5 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 ) 5.1 Excessive Hypotension Sodium nitroprusside, can cause excessive hypotension leading to hypoperfusion of vital organs. Hypotension should resolve 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, consider other causes. Elderly patients may be more sensitive to the hypotensive effects of the drug. 4 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.
Pregnancy
8.1 Pregnancy 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Nitroprusside in 0.9% Sodium Chloride Injection, ready to use is supplied in amber-colored, single-dose, 50 mg/100 mL (0.5 mg/mL) Fliptop Vials (NDC 70436-207-80), 20 mg/100 mL (0.2 mg/mL) Fliptop Vials (NDC 70436-206-80) and 10 mg/50 mL (0.2 mg/mL) Fliptop Vials (NDC 70436-205-80). Store at 20° to 25°C (68° to 77°F).
Frequently Asked Questions
What is Sodium Nitroprusside In 0.9% Sodium Chloride used for?▼
1 INDICATIONS AND USAGE 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 ) 1.1 Immediate Reduction of Blood Pressure Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. 1.2 Induction and Maintenance of Controlled Hypotension Sodium nitroprusside indicated for induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.
What are the side effects of Sodium Nitroprusside In 0.9% Sodium Chloride?▼
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Hypotension [see Warnings and Precautions ( 5.1 )] Cyanide Toxicity [see Warnings and Precautions ( 5.2 )] Thiocyanate Toxicity [see Warnings and Precautions ( 5.3 )] Methemoglobinemia [see Warnings and Precautions ( 5.4 )] Increased Intracranial Pressure [see Warnings and Precautions ( 5.5 )] Anemia and Hypovolemia [see Warnings and Precautions ( 5.6 )] Less common adverse reactions include: Cardiovascular: Bradycardia, electrocardiographic changes, tachycardia, palpitations, retrosternal discomfort Dermatologic: Rash Endocrine: Hypothyroidism Gastrointestinal: Ileus, nausea, abdominal pain Hematologic: Decreased platelet aggregation Musculoskeletal: Muscle twitching Neuro...
Can I take Sodium Nitroprusside In 0.9% Sodium Chloride during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Sodium Nitroprusside In 0.9% Sodium Chloride?▼
WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION: Sodium nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ischemic injuries or death. Use only with continuous blood pressure monitoring [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 ) ] . (B) CYANIDE TOXICITY: Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. 5 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 ) 5.1 Excessive Hypotension Sodium nitroprusside, can cause excessive hypotension leading to hypoperfusion of vital organs. Hypotension should resolve 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, consider other causes. Elderly patients may be more sensitive to the hypotensive effects of the drug. 4 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.