Finished product reference
Nitroprusside Sodium
Injection, Powder, for Solution · Parenteral · 50 mg
- List code
- 916
Sodium Nitroprusside Injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium Nitroprusside 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.
Indications
INDICATIONS AND 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 and administration (summary)
DOSAGE AND 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.
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.
Warnings and precautions
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 .
Pregnancy
Pregnancy: Teratogenic effects. There are no adequate, well-controlled studies of Sodium Nitroprusside Injection in either laboratory animals or pregnant women. It is not known whether Sodium Nitroprusside Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Storage and supply
HOW SUPPLIED Sodium Nitroprusside Injection is supplied in amber-colored, 50 mg/2 mL Single Dose Vials (NDC 70436-028-80). Store at 20° to 25°C (68° to 77°F). To protect Sodium Nitroprusside Injection from light, it should be stored in its carton until it is used.
Source: Sodium Nitroprusside (Sodium Nitroprusside) — US FDA prescribing information, 2020-10-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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