Micardis

Micardis Use In Pregnancy & Lactation

telmisartan

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: The use of angiotensin II receptor blockers 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 blockers is contraindicated during the second and third trimester of pregnancy.
Angiotensin II receptor blockers 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.
Lactation: Telmisartan is contraindicated during lactation since it is not known whether it is excreted in human milk. Animal studies have shown excretion of telmisartan in breast milk.
Fertility: No studies on fertility in humans have been performed.
In non-clinical studies, no effects of telmisartan on male and female fertility were not observed.
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