ARB Plus Use In Pregnancy & Lactation

Pregnancy: There is no adequate data from the use of Telmisartan and Hydrochlorothiazide tablets in pregnant women. Studies in animals have shown reproductive toxicity. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE Inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and if appropriate alternative therapy should be stared.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension.
There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. 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 essential hypertension in pregnant women in rare situations where no other treatment could be used.
Breast-feeding: Because no information is available regarding the use of Telmisartan and hydrochlorothiazide tablet during breast-feeding. Telmisartan and hydrochlorothiazide tablet is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit the milk production. The use of Telmisartan and Hydrochlorothiazide tablet during breastfeeding is not recommended. If Telmisartan and Hydrochlorothiazide tablet is used during breastfeeding, doses should be kept as low as possible.