Preterax Use In Pregnancy & Lactation

Preterax 2.5 mg: The presence of an angiotensin-converting enzyme inhibitor determines the contraindication for the use of this combination during pregnancy and lactation.
Linked to Perindopril: Pregnancy: No appropriate and well-controlled studies have been carried out in humans. Angiotensin-converting enzyme inhibitors cross the placenta and may lead to foetal and neonatal morbidity and mortality when administered to pregnant women.
Cases of neonatal hypotension, renal insufficiency, malformations of the face and the cranial vault and/or death have been reported when the foetus is exposed during the 2nd and 3rd trimesters of pregnancy. A reduction in foetal renal function with maternal oligohydramnios has also been observed.
Contractions of the limbs, craniofacial malformations, pulmonary hypoplasia and intrauterine growth retardation with oligohydramnios have been reported.
Infants who were exposed to angiotensin-converting enzyme inhibitors in utero should be carefully monitored for hypotension, oliguria and hyperkalaemia. Oliguria can be treated with support of blood pressure and renal blood flow.
Intrauterine growth retardation, prematurity, patent ductus arteriosus and foetal death have been reported, although no clear relationships with angiotensin-converting enzyme inhibitors or with maternal concomitant illness have been established.
No data are available on whether limited exposure in the 1st trimester of pregnancy affects the foetus.
If the patient becomes pregnant while taking an angiotensin-converting enzyme inhibitor, she must be informed of the potential risks to the foetus.
Lactation: Angiotensin-converting enzyme inhibitors can be excreted in breast milk and the effects on nursing infants are unknown. Breastfeeding is therefore contraindicated in women who are being treated with angiotensin-converting enzyme inhibitors.
Preterax 5 mg: As the combination includes an ACE inhibitor, Preterax 5 mg is contraindicated during pregnancy.
Pregnancy: Studies in animals have shown no teratogenic effects, but toxicity to the foetus was shown in several species.
In pregnant women receiving treatment with angiotensin-converting enzyme inhibitors, no epidemiological studies are available; isolated observations of pregnancies exposed in the 1st trimester are a priori reassuring with regard to malformation, with the exception of some cases of abnormalities of the skull reported with the use of angiotensin-converting enzyme inhibitors throughout pregnancy; administration during the 2nd and 3rd trimesters, particularly if continued until delivery, produces a risk of renal effects which may lead to: a reduction in renal function of the foetus, with possible oligohydramnios; neonatal renal insufficiency with hypotension and increased levels of potassium and even anuria (reversible or not).
As a consequence, the risk of malformation, if such a risk exists, is probably low. Termination of pregnancy does not appear to be appropriate if pregnancy occurs during treatment. However, the skull should be monitored by ultrasound.
In contrast, patients who discover they are pregnant while being treated with angiotensin-converting enzyme inhibitors must stop treatment immediately and for the duration of the pregnancy.
Lactation: In the absence of data, perindopril is contraindicated in women who are breastfeeding.
Linked to Indapamide: Pregnancy: As a general rule, the administration of diuretics should be avoided in pregnant women and should never be given as treatment for physiological oedema (and therefore do not require treatment) of pregnancy. Diuretics may lead to foeto-placental ischaemia, with a risk of impaired foetal growth.
Nonetheless, diuretics remain essential part of treatment of oedema from cardiac, hepatic and renal origin raised in pregnant women.
Lactation: Indapamide is excreted in small quantities in breast milk. Nonetheless, it should not be used in breastfeeding period due to the decrease and even suppression of the milk secretion; its undesirable effects in particular biological (potassium level); its belonging to sulphonamides with risks of allergy and nuclear icterus.