Pronunciation:

SOE-dee-um nye-troe-PRUS-ide

Brand Names:

• Nipride RTU
• Nitropress

Dosage Forms:

• Solution

Warnings:

Sodium nitroprusside may cause precipitous decreases in blood pressure and may lead to irreversible ischemic injuries or death. Continuous blood pressure monitoring is required. Sodium nitroprusside metabolism produces dose-related cyanide and may be lethal. Limit infusions at the maximum rate (10 mcg/kg/min) to the shortest duration possible as patient's ability to buffer cyanide will be exceeded in less than 1 hour at this rate .

Sodium nitroprusside is not suitable for direct injection; the reconstituted solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside can cause precipitous decreases in blood pressure; monitor blood pressure continuously while patient is on therapy. Nitroprusside can cause cyanide toxicity which can be lethal. Infusion at the maximum dose rate (10 mcg/kg/min) should never last more than 10 minutes. Monitor acid-base balance and venous oxygen concentration while on therapy; these tests may indicate cyanide toxicity .

Classifications:

Therapeutic—

Peripheral Vasodilator

Uses of This Medicine:

Sodium nitroprusside injection is used for lowering of blood pressure immediately in adults and children with high blood pressure. This medicine is also used to reduce bleeding during surgery, and treats acute heart failure. This medicine is a direct-acting vasodilator.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sodium nitroprusside injection in children.

Older adults—

No information is available on the relationship of age to the effects of sodium nitroprusside injection in geriatric patients. However, elderly patients are more likely to have low blood pressure, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sildenafil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Hypovolemia (low blood volume)—Should be corrected first before using this medicine.

• Anuria (trouble urinating) or
• Liver disease—Use with caution. May increase risk for cyanide toxicity.

• Circulation problems or
• Heart disease (eg, arteriovenous shunting, coarctation of the aorta) or
• Heart failure, acute caused by reduced peripheral vascular resistance or
• Leber's optic atrophy, congenital or
• Tobacco amblyopia—Should not be used in patients with these conditions.

• Head injury or
• Methemoglobinemia—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not use this medicine together with riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). Using these medicines together may cause unwanted effects.

This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. Stand or sit up slowly if you are dizzy.

Tell your doctor right away if you or your child have bluish-colored lips, fingernails, or palms, dark urine, trouble breathing, unusual bleeding, bruising, or weakness while using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Chest pain or discomfort

fast, pounding, or irregular heartbeat or pulse

lightheadedness, dizziness, or fainting

slow heartbeat

trouble breathing

unusual tiredness

Incidence not known

Bluish-colored lips, fingernails, or palms

blurred vision

confusion

dark urine

difficulty with breathing

fever

headache

pale skin

rapid heart rate

sore throat

sweating

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal or stomach pain

constipation

depressed mood

dizziness

dry skin and hair

feeling cold or warmth

hair loss

headache

hoarseness or husky voice

increased sweating

irritation at the infusion site

muscle cramps, stiffness, or twitching

nausea

rash

redness of the face, neck, arms, and occasionally, upper chest

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.