Duowell Use In Pregnancy & Lactation

Telmisartan: Fertility: The effect of telmisartan on human fertility has not been studied. In preclinical studies with female and male rates, no effects of Micardis on male and female fertility were observed.
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy. Because of the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be ignored. Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to be associated with hypothermia of the fetus and newborn, hyperkalemia, neonatal skull underdevelopment, urinary loss and/or anuria or fetal and neonatal damage including reversible or irreversible renal failure, intrauterine growth retardation and death.
Oligohydramnios which is suspected to be due to decreased fetal renal function was reported and was related to fetal limb development, craniofacial anomaly, and pulmonary growth failure. Based on retrospective data, the use of ACE inhibitors in the first trimester was associated with a potential risk of birth defects. In addition, it is not clear whether it is due to telmisartan, but it is reported that immature, intrauterine growth retardation, and patent ductus arteriosus were observed. Telmisartan like other drugs directly acting on the renin-angiotensin-aldosterone system should not be used in pregnant women or in women planning to become pregnant. When pregnancy is diagnosed, treatment with telmisartan should be stopped immediately. If a medicine that affects the renin-angiotensin-aldosterone system is prescribed in women who are likely to become pregnant, the doctor should tell patients about the potential risks of this medicine during pregnancy. If pregnant women are exposed to angiotensin II receptor antagonists after the second trimester, fetal renal function and cranial ultrasonography are recommended. Also, adequate urination, hyperkalemia, and blood pressure should be investigated in newborns who have experienced exposure to this medicine in the uterus.
Because no information is available regarding the use of telmisartan during breast-feeding and telmisartan has been shown to pass through the breast milk of rats, telmisartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Discontinue breastfeeding, if telmisartan is administered.
Rosuvastatin: Rosuvastatin is contraindicated in pregnancy and lactation. Women of child bearing potential should use appropriate contraceptive measures. Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity. If a patient becomes pregnant during use of this product, treatment should be discontinued immediately. Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans.