RiteMED Losartan potassium + Amlodipine besilate Use In Pregnancy & Lactation

Pregnancy: Pregnancy Categories C (first trimester) and D (second and third trimester).
Fetal Toxicity: When pregnancy is detected, discontinue losartan + amlodipine FDC as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Losartan potassium: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan as soon as possible. These adverse outcomes are usually associated with the use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, the mother should be informed of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue losartan, unless it is considered life-saving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. However, patients and physicians should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with history of in utero exposure to losartan should be closely observed for hypotension, oliguria and hyperkalemia. If oliguria or hypotension occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
Lactation: It is not known whether losartan or amlodipine is distributed in human milk. Discontinue breastfeeding or the drug due to potential risk to breastfeeding infants, taking into consideration the importance of the drug to the mother.