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Zyprexa Summary of Product Characteristics (SmPC)
Zyprexa (olanzapine): Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women.
are no adequate and well-controlled studies in pregnant women.
Patients should be advised to notify their physician if they become
pregnant or intend to become pregnant during treatment with
olanzapine. Nevertheless, because human experience is limited,
olanzapine should be used in pregnancy only if the potential benefit
justifies the potential risk to the foetus.
born infants exposed to antipsychotics (including olanzapine) during
the third trimester of pregnancy are at risk of adverse reactions
including extrapyramidal and/or withdrawal symptoms that may vary in
severity and duration following delivery. There have been reports of
agitation, hypertonia, hypotonia, tremor, somnolence, respiratory
distress, or feeding disorder. Consequently, newborns should be
a study in breast-feeding, healthy women, olanzapine was excreted in
breast milk. Mean infant exposure (mg/kg) at steady state was
estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Patients should be advised not to breast feed an infant if they are
on fertility are unknown.
[Summary of Product Characteristics]. Utrecht, The Netherlands: Eli
Lilly Nederland B.V.
Date of Last Review:December 07, 2018
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