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Droxidopa Pregnancy and Breastfeeding Warnings

Droxidopa is also known as: Northera

Droxidopa Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy. US FDA pregnancy category: C Comments: Use of adequate methods of contraception should be encouraged.

Following consecutive oral administration at doses of 60, 200, and 600 mg/kg/day to pregnant rats, increased incidences of lower body weight and occurrence of undulant rib were noted in fetuses, but they were slight and spontaneously reversed after birth. Shortening of the gestation period was observed at 600 mg/kg/day. No other teratogenic effects were observed. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Droxidopa Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Northera (droxidopa)." Chelsea Therapeutics Inc, Charlotte, NC.

References for breastfeeding information

  1. "Product Information. Northera (droxidopa)." Chelsea Therapeutics Inc, Charlotte, NC.

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