Micardis Plus Use In Pregnancy & Lactation

Pregnancy: Telmisartan: The use of angiotensin II receptor blocker is not recommended during the first trimester of pregnancy and should not be initiated during pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor blocker should be stopped immediately, and, if appropriate, alternative therapy should be started.
Unless continued angiotensin II receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Non-clinical studies with telmisartan do not indicate teratogenic effect, but have shown fetotoxicity.
The use of angiotensin II receptor blocker is contraindicated during the second and third trimester of pregnancy.
Angiotensin II receptor blocker exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Should exposure to angiotensin II receptor blocker have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor blocker should be closely observed for hypotension.
Hydrochlorothiazide: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Hydrochlorothiazide should not be used for gestational oedema, gestational hypertension or preeclampsia due to the risk of decreased plasma volume and placental hypoperfusion, without a beneficial effect on the course of the disease.
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Lactation: MICARDIS PLUS is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk. Non-clinical studies have shown excretion of telmisartan in breast milk. Thiazides appear in human milk and may inhibit lactation.
Fertility: No studies on fertility in humans with the fixed dose combination or with the individual components have been performed.
In non-clinical studies, no effects of telmisartan and hydrochlorothiazide on male and female fertility were observed.