Nitroprusside

Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible.

There are no adequate or well controlled studies of nitroprusside in either laboratory animals or pregnant women. It is not known whether nitroprusside can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity. Nitroprusside should be given to a pregnant woman only if clearly needed. There have been no reports on its use in the hypertension of pre-eclampsia.

Nitroprusside is used in high risk situations and there may be additional hazards associated with the drug. It crosses the placenta. Short term use for control of hypertensive crises may be safe provided the maternal pH and cyanide levels are monitored.

In three studies in pregnant ewes, nitroprusside was shown to cross the placental barrier. Foetal cyanide levels were shown to be dose related to maternal levels of nitroprusside. The metabolic transformation of nitroprusside given to pregnant ewes led to fatal levels of cyanide in the foetuses. The infusion of 25 micrograms/kg/minute of nitroprusside for one hour in pregnant ewes resulted in the death of all foetuses. Pregnant ewes infused with 1 microgram/kg/minute of nitroprusside delivered normal lambs.

It is not known whether nitroprusside or its metabolites are excreted into breast milk, nor whether they have a harmful effect on the newborn. Therefore, the drug is not recommended for nursing mothers, unless the expected benefits outweigh any potential risk.

Fertility

No data available.

No data available.