Aprovasc Use In Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Irbesartan/Amlodipine (Aprovasc) is contraindicated during pregnancy. Irbesartan/Amlodipine (Aprovasc) should not be used in women with a potential risk of pregnancy unless effective contraceptive measures are being used. If pregnancy occurs during treatment with Irbesartan/Amlodipine (Aprovasc), this should be discontinued as soon as possible. (See Contraindications and Warnings.)
Lactation: Irbesartan/Amlodipine (Aprovasc) is contraindicated in lactation (see Contraindications).
For amlodipine: Amlodipine is excreted in breast milk. The amount of the mother's dose received by the baby is estimated to be in the interquartile range of 3 to 7%, up to a maximum of 15%. The effect of amlodipine in infants is unknown.
There have been reports of reversible biochemical changes in the heads of spermatozoids in some patients treated with calcium channel blockers. There is not sufficient clinical data to determine the possible effect of amlodipine on fertility. A study in rats showed adverse effects on male fertility.