Razine Use In Pregnancy & Lactation

Pregnancy: 375 mg tablet: There are no adequate data from the use of Ranolazine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryofetal. The potential risk for humans is unknown. Ranolazine should not be used during pregnancy unless clearly necessary.
500 mg tablet: Pregnancy Category C: In animal studies, Ranolazine at exposures 1.5 (rabbit) to 2 (rat) times the usual human exposure caused maternal toxicity and misshapen sternebrae and reduced ossification in offspring. These doses in rats and rabbits were associated with an increased maternal mortality rate. There are no adequate well-controlled studies in pregnant women. Ranolazine should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus.
Nursing Mothers: 375 mg tablet: It is unknown whether Ranolazine is excreted in human breast milk. The excretion of Ranolazine in milk has not been studied in animals. Ranolazine should not be used during breast-feeding.
500 mg tablet: It is not known whether Ranolazine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Ranolazine in nursing infants, decide whether to discontinue nursing or to discontinue Ranolazine, taking into account the importance of the drug to the mother.