Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Hypertensive crisis

Intravenous 0 years up to 18 years Initial dose: 0.5 - 2.5 microg./kg/minute, continuous infusion. Maintenance dose: Titrate every 3-5 minutes to effect until desired blood pressure level is reached, up to: 3 - 8 microg./kg/minute, continuous infusion. Administer under IC monitoring. Start with low doses and double every 3-5 minutes. Gradually decrease the infusion rate towards the end of the infusion Nitroprusside is converted into a dose related amount of cyanide. The maximum capacity to buffer cyanide is reached after only 1 hour at the maximum infusion rate. The maximum infusion rate should be applied for as short a time as possible (see further Warnings and Precautions in Children).

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Adjustment is not required

GFR 30-50 ml/min/1.73 m2

Adjustment is not required

GFR 10-30 ml/min/1.73 m2

Dose normally but do not use for longer than 48 hours or else determine the thiocyanate concentration

GFR < 10 ml/min/1.73 m2

Dose normally but do not use for longer than 48 hours or else determine the thiocyanate concentration

Clinical consequences

Nitroprusside is quickly converted in tissue and erythrocytes to cyanogen (cyanide radical). It is converted to thiocyanate in the liver; this is excreted in the urine. Therapeutic plasma concentration of thiocyanate: 6-30 mg/l; toxic plasma concentration of thiocyanate > 50 mg/l (in renal function disorders).

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Administer under IC monitoring. Be aware of the possibility of cyanide accumulation. Cyanide is converted in the liver to thiocyanate, which is excreted by the kidney. Therapeutic plasma concentration thiocyanate: 6-30 mg/l; toxic plasma concentration of thiocyanate > 50 mg/l (in renal function disorders). Do not use for longer than 48 hours. Do not give to patients with renal function disorders due to the formation of toxic metabolites. Unstable under the influence of light.

At an infusion rate of more than 2 mcg/kg/min not all cyanide can be converted into thiocyanate anymore. Methaemoglobin still works as a buffer until a total amount of 500 micrograms/kg nitroprusside has been administered. After that cyanide will accumulate with intoxication as a result. This means that with an infusion rate of 8 mcg/kg/min, intoxication already occurs after 1 hour. The consequences of this intoxication are very severe and can be fatal.

Sodium thiosulphate can be administered in cases of cyanide intoxication, as this can also convert cyanide into thiocyanate.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• CARDIOVASCULAR SYSTEM
• ANTIHYPERTENSIVES

ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Hydrazinophthalazine derivatives
	Dihydralazine Related Medicines Menu">	C02DB01

Pyrimidine derivatives
	Minoxidil Related Medicines Menu">	C02DC01

References

1. Heijden, van der AJ et al, Werkboek Kindernefrologie, VU Uitgeverij, 2010, 2e druk
2. Exela Pharma Sciences, LLC, Prescribing information Nipride RTU, www.fda.gov, 2017, Maart
3. Shenoi RP, Timm N; COMMITTEE ON DRUGS; COMMITTEE ON PEDIATRIC EMERGENCY MEDICINE., Drugs Used to Treat Pediatric Emergencies, Pediatrics., 2020, 145(1), e20193450 (PMID: 31871244.)

Changes

Therapeutic Drug Monitoring

Overdose