Candesartan use in specific populations
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Use In Specific Populations
Pregnancy
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal 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 ATACAND as soon as possible. These adverse outcomes are usually associated with 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, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue ATACAND, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to ATACAND for hypotension, oliguria, and hyperkalemia. [see USE IN SPECIFIC POPULATIONS (8. 4)]
Labor and Delivery
The effect of ATACAND on labor and delivery in humans is unknown [see WARNINGS AND PRECAUTIONS (5.1)].
Nursing Mothers
It is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue ATACAND, taking into account the importance of the drug to the mother.
Pediatric Use
Neonates with a history of in utero exposure to ATACAND:
If oliguria or hypotensionoccurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotensionand/or substituting for disordered renal function.
The antihypertensive effects of ATACAND were evaluated in hypertensive children 1 to < 17 years of age in randomized, double-blind clinical studies [see CLINICAL STUDIES (14.1)]. The pharmacokinetics of ATACAND have been evaluated in pediatric patients 1 to < 17 years of age [see Pharmacokinetics (12.3)].
Children < 1 year of age must not receive ATACAND for hypertension [see WARNINGS AND PRECAUTIONS (5.2)].[1]
References
- ↑ "ATACAND (CANDESARTAN CILEXETIL) TABLET [ASTRAZENECA LP]". Retrieved 20 February 2014.