Normetec Use In Pregnancy & Lactation

Pregnancy: Amlodipine/Olmesartan Medoxomil (Normetec) can cause fetal harm when administered to a pregnant woman. As a precaution, Amlodipine/Olmesartan Medoxomil (Normetec) must not be used during the first trimester of pregnancy. The patient should change to an appropriate alternative form of medication before a planned pregnancy. If pregnancy occurs during therapy, Amlodipine/Olmesartan Medoxomil (Normetec) must be discontinued as soon as possible. There is no experience of the use of Amlodipine/Olmesartan Medoxomil (Normetec) in pregnant women.
Olmesartan medoxomil is contraindicated in the second and third trimesters of pregnancy. During the second and third trimesters of pregnancy, substances that act on the renin-angiotensin system may cause damage (hypotension, impairment of renal function, oliguria and/or anuria, oligohydramnia, cranial hypoplasia, intrauterine growth retardation) and death in fetuses and neonates. Cases of pulmonary hypoplasia, facial anomalies and contractions of limbs were also reported. Animal experimental studies with olmesartan medoxomil have shown furthermore that renal damage may occur in the late fetal and neonatal phase.
Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of prolonged delivery.
If Amlodipine/Olmesartan Medoxomil (Normetec) is used during pregnancy, or if the patient becomes pregnant while taking Amlodipine/Olmesartan Medoxomil (Normetec), the patient should be apprised of the potential hazard to a fetus. Should exposure to Amlodipine/Olmesartan Medoxomil (Normetec) occurred from the second trimester forward, ultrasound examinations of the renal function and of the skull are recommended. Newborns exposed to angiotensin II antagonists in utero must be closely monitored for the occurrence of hypotension, oliguria, and hyperkalemia.
Lactation: It is not known whether olmesartan medoxomil is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. Limited available data from a published clinical lactation study report that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breastfed infant have been observed. There is no available information on the effects of amlodipine on milk production. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug.