nipride rtu in sodium chloride 0.9%
Nipride Rtu in Sodium Chloride 0.9% (Sodium Nitroprusside) is a vasodilator used to treat Heart Failure, Malignant Hypertension, Intraoperative Complications.
Sodium Nitroprusside · by Exela Pharma
Key facts
- Active ingredient
- Sodium Nitroprusside
- Drug class
- Vasodilator
- Form
- Injectable
- Strength
- Sodium Nitroprusside 10MG/50ML (0.2MG/ML) **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Sodium Nitroprusside 20MG/100ML (0.2MG/ML) · Sodium Nitroprusside 50MG/100ML (0.5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Exela Pharma
- FDA application
- NDA209387
- FDA boxed warning
- Yes — see the boxed warning
What is Nipride Rtu in Sodium Chloride 0.9%?
From the FDA label:Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is Sodium Nitroprusside has 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 )] . NIPRIDE ® RTU is supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-use 100-mL vial. Each 100 mL of solution in vial contains 50 mg of sodium nitroprusside (0.5 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. NIPRIDE ® RTU is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-use 100-mL vial. Each 100 mL of solution in vial contains 20 mg of sodium nitroprusside (0.2 mg/mL), 900 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. NIPRIDE ® RTU is also supplied as a sterile, unpreserved, colorless to red-brown solution packaged in a single-use 50-mL vial. Each 50 mL of solution in vial contains 10 mg of sodium nitroprusside (0.2 mg/mL), 450 mg of sodium chloride, USP (9 mg/mL), in sterile water for injection, USP. structure
How to use
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. 2.2 Dosing Continuously monitor blood pressure in patients receiving sodium nitroprusside. Start infusion of sodium nitroprusside at a rate of 0.3 mcg/kg/min. Evaluate blood pressure for at least 5 minutes before titrating to a higher or lower dose to achieve the desired blood pressure. The dose may be titrated upward until: • the desired effect is achieved, • systemic blood pressure cannot be further reduced without compromising the perfusion of vital organs, or • the maximum recommended infusion rate of 10 mcg/kg/min has been reached, whichever occurs first. In patients with eGFR <30 mL/min/1.73 m 2 , limit the mean infusion rate to less than 3 mcg/kg/min. In anuric patients, limit the mean infusion rate to 1 mcg/kg/min. 2.3 Administration Do not administer other drugs in the same solution with sodium nitroprusside. Sodium nitroprusside must be delivered by a volumetric infusion pump…
Side effects
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 Musculoskelatal: Muscle twitching Neurologic: Increased intracranial pressure, dizziness, headache Miscellaneous: Flushing, diaphoresis, venous streaking, irritation at the infusion site Most common adverse reactions are hypotension and cyanide toxicity ( 6 ). To report SUSPECTED ADVERSE REACTIONS, Contact Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
(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. A patient’s ability to buffer cyanide will be exceeded in less than one hour at the maximum dose rate (10 mcg/kg/min); limit infusions at the maximum rate to as short a duration as possible [see Warnings and Precautions ( 5.2 )]. WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) 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. ( 2.2 , 5.1 ) (B) Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. A patient’s ability to buffer cyanide will be exceeded in less than one hour at the maximum dose rate (10 mcg/kg/min); limit infusion at the maximum rate to as short a duration as possible ( 5.2 ).
Warnings
Important safety information
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. 5.2 Cyanide Toxicity Sodium nitroprusside infusions above 2 mcg/kg/min generate cyanide ion (CN¯) faster than the body can normally dispose of it. At the maximum recommended infusion rate of 10 mcg/kg/min, the patient’s ability to buffer CN¯ will be exceeded in less than one hour [see Overdose ( 10 )] . Patients with hepatic dysfunction are more susceptible to cyanide toxicity. An early manifestation of cyanide toxicity is increasing dosage requirements to maintain blood pressure control. Metabolic acidosis may not be evident for more than an hour after toxic cyanide levels accumulate. If cyanide toxicity develops, discontinue sodium nitroprusside, and consider specific treatment of cyanide toxicity [see Overdosage ( 10 )] . 5.3 Thiocyanate Toxicity Most of the cyanide produced during metabolism of sodium nitroprusside is eliminated in the form of thiocyanate. Thiocyanate is mildly neurotoxic (tinnitus, miosis, hyperreflexia) at serum levels of 1 mmol/L (60 mg/L). Thiocyanate is life-threatening when levels reach ~200 mg/L. Therefore, routine monitoring of plasma thiocyanate levels is recommended in patients with normal renal function when cumulative sodium nitroprusside doses exceed 7 mg/kg/day. In patients with eGFR <30 mL/min/1.73 m2, limit the mean infusion rate to less than 3 mcg/kg/min. In anuric patients, limit the mean infusion rate to 1 mcg/kg/min. Renal hemodialysis may be used to eliminate thiocyanate in cases of severe toxicity. 5.4 Methemoglobinemia Sodium nitroprusside infusions cause conversion of hemoglobin to methemoglobin in a dose-dependent manner. Methemoglobin binds oxygen more strongly than does hemoglobin, and when methemoglobin levels are elevated, oxygen release from red blood cells in tissue capillaries may be impaired. However, conversion of methemoglobin back to hemoglobin is normally rapid, and clinically significant methemoglobinemia is infrequent. Suspect methemoglobinemia in patients who have received >10 mg/kg of sodium nitroprusside and who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2. Methemoglobinemic blood is chocolate brown, without the expected color change on exposure to air. Methemoglobin levels >10% are considered clinically significant. When methemoglobinemia is diagnosed, the treatment of choice is 1-2 mg/kg of methylene blue, administered intravenously over several minutes. 5.5 Increased Intracranial Pressure Like other vasodilators, sodium nitroprusside can cause increases in intracranial pressure. 5.6 Anemia and Hypovolemia with 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, correct pre-existing anemia and hypovolemia prior to administration.
Who should not take Nipride Rtu in Sodium Chloride 0.9%
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 )
Overdose — what happens if you take too much
Overdosage of nitroprusside can be manifested as excessive hypotension or cyanide toxicity [see Warnings and Precaution ( 5.1 , 5.2 )] or as thiocyanate toxicity [see Warnings and Precautions ( 5.3 )] . Cyanide toxicity causes venous hyperoxemia with bright red venous blood. Cells become unable to extract the oxygen delivered to them, leading to air hunger, confusion and death. Lactic acidosis may occur, but its emergence may lag other life-threatening manifestations of cyanide toxicity. Cyanide levels can be measured by many laboratories, and blood-gas studies that can detect venous hyperoxemia or acidosis are widely available. Acidosis may not appear until more than an hour after the appearance of dangerous cyanide levels. Suspicion of cyanide toxicity is adequate grounds for initiation of treatment. Treatment of cyanide toxicity consists of: • discontinuing sodium nitroprusside; • administration of sodium nitrite to convert as much hemoglobin into methemoglobin as the patient can safely tolerate; and then • infusing sodium thiosulfate to convert the cyanide into thiocyanate. Hemodialysis is ineffective in removal of cyanide, but it will eliminate most thiocyanate. Sodium nitrite is available in a 3% solution, and 4-6 mg/kg (about 0.2 mL/kg) should be injected over 2-4 minutes. This dose can be expected to convert about 10% of the patient’s hemoglobin into methemoglobin;…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Nipride Rtu in Sodium Chloride 0.9% treat?
- Nipride Rtu in Sodium Chloride 0.9% (Sodium Nitroprusside) may be used to treat heart failure, malignant hypertension, intraoperative complications, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Nipride Rtu in Sodium Chloride 0.9%?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nipride Rtu in Sodium Chloride 0.9%. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nipride Rtu in Sodium Chloride 0.9%?
- Nipride Rtu in Sodium Chloride 0.9% is marketed by Exela Pharma. You can see Exela Pharma's full profile, rating, and other products on pharmaranks.
- Is Nipride Rtu in Sodium Chloride 0.9% a brand-name or generic drug?
- Nipride Rtu in Sodium Chloride 0.9% is a brand-name product with the active ingredient Sodium Nitroprusside.
- Is Nipride Rtu in Sodium Chloride 0.9% available over the counter?
- No. Nipride Rtu in Sodium Chloride 0.9% is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nipride Rtu in Sodium Chloride 0.9% come in?
- Nipride Rtu in Sodium Chloride 0.9% is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Nipride Rtu in Sodium Chloride 0.9%?
- Nipride Rtu in Sodium Chloride 0.9% is classified as vasodilator, per the FDA's Established Pharmacologic Class.
- Is Nipride Rtu in Sodium Chloride 0.9% FDA-registered?
- Nipride Rtu in Sodium Chloride 0.9% is on record with the U.S. FDA under application number NDA209387. You can verify this on its official FDA label.
- Is Nipride Rtu in Sodium Chloride 0.9% safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Nipride Rtu in Sodium Chloride 0.9%. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Nipride Rtu in Sodium Chloride 0.9%?
- Nipride Rtu in Sodium Chloride 0.9%'s side effects are taken directly from its FDA label. From the label: 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 Warn… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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