Sodium Nitroprusside (Sodium Nitroprusside)

Trade Name	Sodium Nitroprusside
Active Ingredient
Power	50 mg/2mL
Type / form	Tablets
Status
Manufacturer	Akorn, Inc.

Storage and handling for Sodium Nitroprusside

SODIUM NITROPRUSSIDE Vasodilation [PE],Vasodilator [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Nitroprusside (Sodium Nitroprusside) which is also known as Sodium Nitroprusside and Manufactured by Akorn, Inc.. It is available in strength of 50 mg/2mL per ml. Read more

Sodium Nitroprusside (Sodium Nitroprusside) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Rx onlyn

Sodium Nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion.
Sodium Nitroprusside Injection can cause precipitous decreases in blood pressure (seenn- Arrayn- ).nn- 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 (seenn- Arrayn- ).nn- The usual dose rate is 0.5 to 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.

Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula isn
Sodium nitroprusside whose molecular formula is Na[Fe(CN)NO] u2022 2HO, and whose molecular weight is 297.95. Dry sodium nitroprusside is a reddish-brown powder, soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins.n
Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use.n
Sodium Nitroprusside Injection is available as:n
50 mg Fliptop Vial - Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection.n

The principal pharmacological action of sodium nitroprusside is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins. Other smooth muscle (e.g., uterus, duodenum) is not affected. Sodium nitroprusside is more active on veins than on arteries, but this selectivity is much less marked than that of nitroglycerin. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs.n
In association with the decrease in blood pressure, sodium nitroprusside administered intravenously to hypertensive and normotensive patients produces slight increases in heart rate and a variable effect on cardiac output. In hypertensive patients, moderate doses induce renal vasodilatation roughly proportional to the decrease in systemic blood pressure, so there is no appreciable change in renal blood flow or glomerular filtration rate.n
In normotensive subjects, acute reduction of mean arterial pressure to 60 to 75 mm Hg by infusion of sodium nitroprusside caused a significant increase in renin activity. In the same study, ten renovascular-hypertensive patients given sodium nitroprusside had significant increases in renin release from the involved kidney at mean arterial pressures of 90 to 137 mm Hg.n
The hypotensive effect of sodium nitroprusside is seen within a minute or two after the start of an adequate infusion, and it dissipates almost as rapidly after an infusion is discontinued. The effect is augmented by ganglionic blocking agents and inhaled anesthetics.n
Pharmacokinetics and Metabolism:
The products of the nitroprusside/hemoglobin reaction are cyanmethemoglobin (cyanmetHgb) and cyanide ion (CN). Safe use of sodium nitroprusside injection must be guided by knowledge of the further metabolism of these products.n
As shown in the diagram below, the essential features of nitroprusside metabolism aren
Cyanide ion is normally found in serum; it is derived from dietary substrates and from tobacco smoke.n
Cyanide binds avidly (but reversibly) to ferric ion (Fe), most body stores of which are found in erythrocyte methemoglobin (metHgb) and in mitochondrial cytochromes. When CN is infused or generated within the bloodstream, essentially all of it is bound to methemoglobin until intraerythrocytic methemoglobin has been saturated.n
When the Fe of cytochromes is bound to cyanide, the cytochromes are unable to participate in oxidative metabolism. In this situation, cells may be able to provide for their energy needs by utilizing anaerobic pathways, but they thereby generate an increasing body burden of lactic acid. Other cells may be unable to utilize these alternative pathways, and they may die hypoxic deaths.n
CN levels in packed erythrocytes are typically less than 1 u03bcmol/L (less than 25 mcg/L); levels are roughly doubled in heavy smokers.n
At healthy steady state, most people have less than 1 % of their hemoglobin in the form of methemoglobln. Nitroprusside metabolism can lead to methemoglobin formation (a) through dissociation of cyanmethemoglobin formed in the original reaction of sodium nitroprusside with Hgb and (b) by direct oxidation of Hgb by the released nitroso group. Relatively large quantities of sodium nitroprusside, however, are required to produce significant methemoglobinemia.n
At physiologic methemoglobln levels, the CN binding capacity of packed red cells is a little less than 200 u03bcmol/L (5 mg/L). Cytochrome toxicity is seen at levels only slightly higher, and death has been reported at levels from 300 to 3000 u03bcmol/L (8 to 80 mg/L). Put another way, a patient with a normal red-cell mass (35 mL/kg) and normal methemoglobln levels can buffer about 175 mcg/kg of CN, corresponding to a little less than 500 mcg/kg of infused sodium nitroprusside.n
Some cyanide is eliminated from the body as expired hydrogen cyanide, but most is enzymatically converted to thiocyanate (SCN) by thiosulfate-cyanide sulfur transferase (rhodanase, EC 2.8.1.1), a mitochondrial enzyme. The enzyme is normally present in great excess, so the reaction is rate-limited by the availability of sulfur donors, especially thiosulfate, cystine, and cysteine.n
Thiosulfate is a normal constituent of serum, produced from cysteine by way of u03b2-mercaptopyruvate. Physiological levels of thiosulfate are typically about 0.1 mmol/L (11 mg/L), but they are approximately twice this level in pediatric and adult patients who are not eating. Infused thiosulfate is cleared from the body (primarily by the kidneys) with a half-life of about 20 minutes.n
When thiosulfate is being supplied only by normal physiologic mechanisms, conversion of CN to SCN generally proceeds at about 1 mcg/kg/min. This rate of CN clearance corresponds to steady-state processing of a sodium nitroprusside infusion of slightly more than 2 mcg/kg/min. CN begins to accumulate when sodium nitroprusside infusions exceed this rate.n
Thiocyanate (SCN) is also a normal physiological constituent of serum, with normal levels typically in the range of 50 to 250 u03bcmol/L (3 to 15 mg/L). Clearance of SCN is primarily renal, with a half-life of about 3 days. In renal failure, the half-life can be doubled or tripled.n

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.n
Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.n
Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.n

Sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting.n
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.n
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.n
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.n

(See also the at the beginning of this insert.)n
The principal hazards of sodium nitroprosside administration are excessive hypotension and excessive accumulation of cyanide (see also and n

No data

The most important adverse reactions to sodium nitroprusside are the avoidable ones of excessive hypotension and cyanide toxicity, described above under . The adverse reactions described in this section develop less rapidly and, as it happens, less commonly.n

Overdosage of nitroprusside can be manifested as excessive hypotension or cyanide toxicity (see or as thiocyanate toxicity (see n
The acute intravenous mean lethal doses (LD) of nitroprusside in rabbits, dogs, mice, and rats are 2.8, 5.0, 8.4, and 11.2 mg/kg, respectively.n
Treatment of cyanide toxicity:
Acidosis may not appear until more than an hour after the appearance of dangerous cyanide levels, and laboratory tests should not be awaited. Reasonable suspicion of cyanide toxicity is adequate grounds for initiation of treatment.
Treatment of cyanide toxicity consists ofn
The necessary medications for this treatment are contained in commercially available Cyanide Antidote Kits. Alternatively, discrete stocks of medications can be used.n
Hemodialysis is ineffective in removal of cyanide, but it will eliminate most thiocyanate.n
Cyanide Antidote Kits contain both amyl nitrite and sodium nitrite for induction of methemoglobinemia. The amyl nitrite is supplied in the form of inhalant ampoules, for administration in environments where intravenous administration of sodium nitrite may be delayed. In a patient who already has a patent intravenous line, use of amyl nitrite confers no benefit that is not provided by infusion of sodium nitrite.n
Sodium nitrite is available in a 3% solution, and 4 to 6 mg/kg (about 0.2 mL/kg) should be injected over 2 to 4 minutes. This dose can be expected to convert about 10% of the patient's hemoglobin into methemoglobin; this level of methemoglobinemia is not associated with any important hazard of its own. The nitrite infusion may cause transient vasodilatation and hypotension, and this hypotension must, if it occurs, be routinely managed.n
Immediately after infusion of the sodium nitrite, sodium thiosulfate should be infused. This agent is available in 10% and 25% solutions, and the recommended dose is 150 to 200 mg/kg; a typical adult dose is 50 mL of the 25% solution. Thiosulfate treatment of an acutely cyanide-toxic patient will raise thiocyanate levels, but not to a dangerous degree.n
The nitrite/thiosulfate regimen may be repeated, at half the original doses, after two hours.n

No data

Sodium Nitroprusside Injection is supplied in amber-colored, single-dose 50 mg/2 mL Fliptop Vialsn
NDC 17478-014-02 2 mL Single-dose vialn
Storage:
To protect Sodium Nitroprusside Injection from light, it should be stored in its carton until it is used.n
Akornn
Akorn, Inc. n

NDC 17478-014-02n
Sodiumn
Nitroprussiden
Injectionn
50 mg/2 mL Vialn
(25 mg/mL)n
FOR I.V. INFUSION ONLYn
2 mL Single-dose Vialn

NDC 17478-014-02n
Sodiumn
Nitroprussiden
Injectionn
50 mg/2 mL Vialn
(25 mg/mL)n
FOR INTRAVENOUS INFUSION ONLY.n
Must be diluted.n
Potent drug: Monitor bloodn
pressure before and duringn
administration.n
2 mL Single-dose Vialn
Rx only Akorn Logon