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Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see Use in Pregnancy & Lactation).
When pregnancy is detected, Aprovel should be discontinued as soon as possible (see Precautions).
Lactation: Irbesartan is excreted in the milk of lactating rats. It is not known whether irbesartan or its metabolites are excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Aprovel to the therapy of the mother and the potential risk to the infant.
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