![]() The combination product may be substituted for the individually titrated components on a mg for mg basis, or, if blood pressure control is not satisfactory, the dose of one or both agents may be increased when the combination tablet is initiated. Dosage should be initiated based on current blood pressure control. Assure that volume and/or sodium depletion is corrected prior to administration. Amlodipine olmesartan is available in 4 strength combinations (amlodipine 5 mg/olmesartan 20 mg, amlodipine 5 mg/olmesartan 40 mg, amlodipine 10 mg/olmesartan 20 mg, and amlodipine 10 mg/olmesartan 40 mg). The dosing range of amlodipine is 5-10 mg/day PO and olmesartan is 20-40 mg/day PO. If oliguria or hypotension occurs, blood pressure and renal perfusion support may be required, as well as exchange transfusion or dialysis to reverse hypotension and/or support decreased renal function. Closely observe newborns with histories of in utero exposure to amlodipine olmesartan for hypotension, oliguria, and hyperkalemia. It should be noted that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, discontinue amlodipine olmesartan unless it is considered life-saving for the mother. In rare cases when another antihypertensive agent cannot be used to treat a pregnant patient, serial ultrasound examinations should be performed to assess the intraamniotic environment. ![]() Amlodipine has been shown to prolong the gestation period and duration of labor in rats at this dose. Litter size for rats was decreased by about 50%, and the number of intrauterine deaths was increased by approximately 5-fold. Data from animal reproductive studies indicate no evidence of adverse developmental effects when pregnant rats and rabbits received oral amlodipine during organogenesis at doses approximately 10- and 20-times the maximum recommended human dose, respectively. Data with amlodipine use in pregnancy are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There were no statistically significant differences in the rates of major birth defects, spontaneous abortions, or preterm births between women with chronic hypertension treated with an ARB versus methyldopa. The rates of prematurity and reduced birth weight were also increased in the ARB group. The authors noted that there was a higher risk of major birth defects with ARB therapy beyond 6 weeks of gestation compared to discontinuation of ARBs before week 6, 7.3% and 2.8%, respectively. An observational cohort study evaluating the outcomes of angiotensin receptor blockers (ARBs) use during the first trimester of pregnancy found an increased rate of major birth defects compared to non-hypertensive pregnancies, 5.4% and 3%, respectively the difference did not reach statistical significance. The authors concluded that the presence of hypertension likely contributed to the development of birth defects rather than the use of medications. Infants born to mothers with hypertension, either treated or untreated, had a higher risk of birth defects than those born to mothers without hypertension. ![]() However, a much larger observational study (n = 465,754) found that the risk of birth defects was similar in infants exposed to ACE inhibitors during the first trimester, in infants exposed to other antihypertensives during the first trimester, and in those whose mothers were hypertensive but were not treated. Retrospective data indicate that first trimester use of ACE inhibitors has been associated with a potential risk of birth defects. Development of oligohydramnios may be associated with decreased fetal renal function leading to anuria and renal failure and results in fetal limb contractures, craniofacial deformation, hypotension, hypoplastic lung development, and death. ![]() Anhydramnios and oligohydramnios have also been reported. Use of drugs that affect the renin-angiotensin system during pregnancy can cause fetal death or injury such as hypotension, neonatal skull hypoplasia, reversible or irreversible renal failure and death. When used during the second and third trimesters, medications that affect the renin-angiotensin system (e.g., ACE inhibitors, angiotensin II receptor antagonists) have been associated with reduced fetal renal function and increased fetal and neonatal morbidity and death. Women of child-bearing age should be made aware of the potential risk, and olmesartan should only be given after careful counseling and consideration of individual risks and benefits. When pregnancy is detected, every effort should be made to discontinue amlodipine olmesartan therapy. ![]()
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