Lisinopril Oral Tablet – Lisinopril can harm a pregnant woman’s fetus. The use of drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy may reduce fetal renal function and increase fetal and neonatal morbidity and mortality. As a result, oligohydramnios may be associated with fetal lung hypoplasia and skeletal malformations. Potential neonatal adverse effects include cranial hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, stop taking lisinopril as soon as possible
Lisinopril can harm a pregnant woman’s fetus. The use of drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy may reduce fetal renal function and increase fetal and neonatal morbidity and mortality. As a result, oligohydramnios may be associated with fetal lung hypoplasia and skeletal malformations. Potential neonatal adverse effects include cranial hypoplasia, anuria, hypotension, renal failure, and death. If pregnancy is detected, stop taking lisinopril as soon as possible [see use in specific populations (8.1)].
Lisinopril Oral Tablet
Risk Summary Lisinopril can cause fetal harm when administered to a pregnant woman. The use of drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy may reduce fetal renal function and increase fetal and neonatal morbidity and mortality. Most epidemiologic studies investigating fetal abnormalities in the first trimester after the use of antihypertensive drugs do not distinguish drugs that affect the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, stop taking lisinopril as soon as possible. The estimated background risk of major birth defects and miscarriage in the specified population(s) is unknown. General U.S. The estimated population risk of major birth defects and miscarriage in clinically diagnosed pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Related Maternal and/or Fetus/Fetal Risk Hypertension in pregnancy increases the risk of maternal preeclampsia, gestational diabetes, preterm labor, and labor complications (eg, need for cesarean delivery and subsequent hemorrhage). Hypertension increases the risk of intrauterine fetal growth restriction and intrauterine death. Pregnant women with arterial hypertension should be carefully monitored and treated appropriately. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women using the renin-angiotensin system during the second and third trimesters of pregnancy may result in: impaired fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, and skeletal malformations, including skull. Hypoplasia, hypotension and death. In the rare event that there is no suitable alternative to treatment with drugs that affect the renin-angiotensin system for a particular patient, inform the mother of the possible risk to the fetus. Perform serial ultrasound examinations to assess the amniotic environment. Fetal testing may be appropriate depending on the week of pregnancy. However, patients and doctors should be aware that oligohydramnios does not become apparent until the fetus is irreversibly damaged. Carefully monitor infants with a history of lisinopril exposure for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs in neonates with a history of in utero exposure to lisinopril, monitor blood pressure and renal perfusion. Transfusion or dialysis may be required to reverse hypotension and replace impaired renal function.
List Of Ace Inhibitors: Uses, Common Brands, And Safety Information
No evidence of a tumorigenic effect was observed when lisinopril was administered at 90 mg/kg/day to male and female rats for 105 weeks (56 or 9 times the maximum recommended human daily dose, based on body weight and body surface area, respectively. ). No evidence of carcinogenicity was observed when lisinopril was administered to rats (male and female) at 135 mg/kg/day (approximately 84 times * the maximum recommended daily dose) for 92 weeks. This dose is 6.8 times the maximum human dose in mice based on body surface area. Lisinopril was not mutagenic in the Ames microbial transformation test with or without metabolic activation. It was negative in a previous mutation assay using Chinese hamster lung cells. Lisinopril did not produce single-stranded DNA breaks in an in vitro alkaline wash assay in rat hepatocytes. In addition, lisinopril did not cause an increase in chromosomal aberrations in an in vitro test in Chinese hamster ovary cells or in an in vivo study in rat bone marrow. There were no adverse effects on reproductive function in male or female rats treated with up to 300 mg kg lisinopril. This dose is 188 times and 30 times higher than the maximum human dose, mg/kg and mg/m2, respectively. Studies in rats have shown that lisinopril crosses the blood-brain barrier poorly. Multiple-dose administration of lisinopril in rats did not result in tissue accumulation. Milk of lactating rats contains 14C radioactivity after administration of lisinopril. By whole-body autoradiography, radioactivity was observed in the placenta after administration of labeled drug to pregnant rats, but none in the fetus. * Calculations assume that the weight of a person is 50 kg, and the surface of the human body is 1.62 m.
: Advise pregnant women and women of reproductive potential of the possible risk to the fetus. Advise women of childbearing potential to notify their health care provider of a known or suspected pregnancy
Pregnancy: Advise pregnant women and women of reproductive potential of the potential risk to the fetus. Advise women of childbearing potential to notify their healthcare provider of known or suspected pregnancy [ Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Angioedema: Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including lisinopril. Advise patients to immediately report any signs or symptoms suggestive of angioedema (face, extremities, eyes, lips, tongue, difficulty swallowing or breathing) and not to take more medication until they consult their prescribing physician. Breastfeeding: Advise women not to breastfeed during lisinopril therapy [Use in Specific Populations (8.2)]. Symptomatic hypotension: Tell patients to report dizziness, especially during the first few days of treatment. If true syncope occurs, instruct the patient to discontinue the medication before consulting a physician. Advise patients that excessive sweating and dehydration may cause an excessive drop in blood pressure due to fluid depletion. Other causes of volume depletion, such as vomiting or diarrhea, can also cause a drop in blood pressure; Advise patients accordingly. Hyperkalemia: Tell patients not to use potassium-containing salt substitutes without consulting a physician. Hypoglycemia: Instruct diabetic patients treated with oral antidiabetic agents or insulin administered ACE inhibitors to closely monitor hypoglycemia, particularly during the first month of concomitant use [see drug interactions (7.2)]. Leukopenia/neutropenia: Instruct patients to report any signs of infection (eg, sore throat, fever) that may be indicative of leukopenia/neutropenia. Sandoz Inc. Princeton, NJ 08540 Rev. November 2017 MF0602REV11/17
• Drugs that act directly on the renin-angiotensin system can cause damage and death to the developing fetus [see
Lisinopril Cough And Side Effects From Ace Inhibitors
Warning: Fetal toxicity See full prescribing information for full boxed warning. • When pregnancy is confirmed, stop taking lisinopril as soon as possible. (5.1) • Drugs that act directly on the renin-angiotensin system can cause damage and death to the developing fetus. (5.1)
1 Indications and Uses Lisinopril Tablets, USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for: •Treatment of hypertension in adults and children over 6 years of age (1.1) •Adjunctive therapy for heart failure (1.2) •Treatment of acute myocardial infarction (1.3) 1.1 Hypertension Lisinopril tablets are indicated for the treatment of hypertension in adult patients and to lower blood pressure in pediatric patients 6 years of age and older. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily stroke and myocardial infarction. This benefit has been observed in controlled trials of different pharmacological classes of antihypertensive drugs. Control of hypertension should be part of comprehensive cardiovascular risk management, including appropriate lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, refer to published guidelines such as the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of Hypertension (JNC) National Hypertension Education Program. Randomized, controlled trials have shown antihypertensive drugs from different drug classes and different mechanisms of action, and it can be concluded that blood pressure lowering and not the effect of another drug. Medicines are largely responsible for this benefit. The largest and most stable cardiovascular outcome benefit is a reduction in stroke risk, and reductions in myocardial infarction and cardiovascular mortality are routinely observed. Elevated systolic or diastolic blood pressure increases cardiovascular risk, and the absolute risk increase is greater per mm Hg for high blood pressure, so modest reductions in acute blood pressure provide significant benefit. The relative risk reduction of lowering blood pressure is similar across populations, with different absolute risks, so the absolute benefit is higher in high-risk patients, regardless of their hypertension.
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