Sodium Nitroprusside 50 mg/2mL
Sodium Nitroprusside · INJECTION, SOLUTION · Dr.Reddy's Laboratories Inc.,
Sodium Nitroprusside is a injection, solution containing sodium nitroprusside at 50 mg/2mL, taken intravenous. Manufactured by Dr.Reddy's Laboratories Inc.,.
Key Facts
- Brand Name
- Sodium Nitroprusside
- Generic Name
- Sodium Nitroprusside
- NDC Code (Product)
43598-587- Manufacturer
- Dr.Reddy's Laboratories Inc.,
- Strength
- 50 mg/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA210114
- Marketing Start
- 12/17/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.
Dosage & Administration
DOSAGE & ADMINISTRATION Dilution to proper strength for infusion: Depending on the desired concentration, the solution containing 50 mg of sodium nitroprusside injection must be further diluted in 250 to 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 sodium nitroprusside injection. 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. Avoidance of excessive hypotension: While the average effective rate in adult and pediatric patients is about 3 mcg/kg/min, some patients will become dangerously hypotensive when they receive so…
Warnings
WARNINGS (See also the boxed warning at the beginning of this insert.) The principal hazards of sodium nitroprusside injection administration are excessive hypotension and excessive accumulation of cyanide (see also OVERDOSAGE and DOSAGE AND ADMINISTRATION ). Excessive Hypotension: 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; see ADVERSE REACTIONS . Nitroprusside-induced hypotension will be self-limited within 1 to 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 sodium nitroprusside injection, sodium nitroprusside injection is not the cause, and the true cause must be sought. Cyanide Toxicity: As described in CLINICAL PHARMACOLOGY above, sodium nitroprusside infusions at rates above 2 mcg/kg/min generate cyanide ion (CN – ) faster than the body…
Contraindications
CONTRAINDICATIONS Sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting. 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. Sodium nitroprusside should not be used for the treatment of acute congestive heart failure associated with reduced peripheral vascular resistance such as high-output heart failure that may be seen in endotoxic sepsis.
Drug Interactions
DRUG INTERACTIONS 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.
Adverse Reactions
ADVERSE REACTIONS The most important adverse reactions to sodium nitroprusside are the avoidable ones of excessive hypotension and cyanide toxicity, described above under WARNINGS . The adverse reactions described in this section develop less rapidly and, as it happens, less commonly. Methemoglobinemia: As described in CLINICAL PHARMACOLOGY above, sodium nitroprusside infusions can cause sequestration of hemoglobin as methemoglobin. The back-conversion process is normally rapid, and clinically significant methemoglobinemia (>10%) is seen only rarely in patients receiving sodium nitroprusside injection. Even patients congenitally incapable of back-converting methemoglobin should demonstrate 10% methemoglobinemia only after they have received about 10 mg/kg of sodium nitroprusside, and a patient receiving sodium nitroprusside at the maximum recommended rate (10 mcg/kg/min) would take over 16 hours to reach this total accumulated dose. Methemoglobin levels can be measured by most clinical laboratories. The diagnosis should be suspected in patients who have received >10 mg/kg of sodium nitroprusside and who exhibit signs of impaired oxygen delivery despite adequate cardiac output and a…
Frequently Asked Questions
What is Sodium Nitroprusside used for?
Sodium Nitroprusside contains Sodium Nitroprusside. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Sodium Nitroprusside a controlled substance?
Sodium Nitroprusside is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Nitroprusside?
The generic name for Sodium Nitroprusside is Sodium Nitroprusside. There are 5 other brand versions of Sodium Nitroprusside.
What is the NDC code for Sodium Nitroprusside 50 mg/2mL?
The NDC (National Drug Code) for Sodium Nitroprusside 50 mg/2mL is 43598-587, listed by Dr.Reddy's Laboratories Inc.,.