LISINOPRIL
Drugs in Pregnancy and Lactation.
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Name: LISINOPRIL
Class: Antihypertensive
Risk Factor: CM*
Fetal Risk Summary
Lisinopril is a long-acting angiotensin I-converting enzyme (ACE) inhibitor used for the treatment of hypertension (see also Captopril and Enalapril). The drug is not teratogenic in mice, rats, and rabbits treated with doses up to 55, 33, and 0.15 times, respectively, the maximum recommended human daily dose based on body surface area (1).
Use of lisinopril limited to the 1st trimester does not appear to present a significant risk to the fetus, but fetal exposure after this time has been associated with teratogenicity and severe toxicity in the fetus and newborn, including death. The pattern of fetal toxicity, including teratogenicity, appears to be similar to that experienced with captopril and enalapril.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 15 newborns had been exposed to lisinopril during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Two (13.3%) major birth defects were observed (0.6 expected), one of which was polydactyly (none expected). No anomalies were observed in five other categories of defects (cardiovascular defects, oral clefts, spina bifida, limb reduction defects, and hypospadias) for which specific data were available.
Two cases of lisinopril-induced perinatal renal failure in newborns were published in a 1991 abstract (2). Additional details were not provided other than that both infants had been exposed in utero to the agent. The authors noted, however, that the effects of angiotensin-converting enzyme inhibitors in the newborn are prolonged unless removed by dialysis, because 95% of the active metabolites are eliminated by renal excretion (2).
In a 2000 report, a woman with normal amniotic fluid volume and fetal measurements by ultrasound consistent with 18 weeks' gestation presented with severe chronic hypertension (3). She had been treated before conception and during the first 16 weeks with lisinopril but had self-stopped therapy 2 weeks before presentation. Because a combination of methyldopa, nifedipine, and labetalol failed to control her blood pressure, lisinopril was re-added to her regimen. At 22 weeks' gestation, the amniotic fluid index was 8 but declined to 0 at 24 weeks. A cesarean section was performed at about 27 weeks because of deteriorating maternal and fetal condition. The growth retarded, 680-g (3rd percentile) female infant had minimal respiratory distress syndrome. Severe renal impairment (maximum urine output 0.3 mL/kg/hr) was present during the first 6 days before improving after corrective surgery for bowel perforations secondary to necrotizing enterocolitis. She was discharged home on day 102 (3).
An 18-year-old woman received lisinopril, 10 mg/day, throughout gestation for the treatment of essential hypertension (4). No mention of amniotic fluid levels during pregnancy was made in this brief report. She delivered a premature, 1.48-kg, anuric infant at 33 weeks' gestation. Fetal calvarial hypoplasia was present. The normal-sized kidneys showed no evidence of perfusion on renal ultrasonography. An open biopsy at 11 weeks of age showed extensive atrophy and loss of tubules with interstitial fibrosis. The findings were compatible with exposure to a nephrotoxic agent. Peritoneal dialysis was instituted on day 8. Measurements of the drug in the dialysate indicated that removal of lisinopril was occurring. At 12 months of age, the infant continued to require dialysis (4).
Three cases of in utero exposure to ACE inhibitors, one of which was lisinopril, were reported in a 1992 abstract (5). The infant, delivered at 32 weeks' gestation because of severe oligohydramnios and fetal distress, suffered from intrauterine growth retardation, hypocalvaria, renal tubular dysplasia, and persistent renal insufficiency. The profound neonatal hypotension and anuria observed at birth improved only after dialysis. At the time of the report, the 15-month-old infant was maintained on dialysis.
A 1992 Reference described the effects of ACE inhibitors on pregnancy outcome (6). Among 106,813 women enrolled in the Tennessee Medicaid program who delivered either a liveborn or stillborn infant, 19 had taken either lisinopril, captopril, or enalapril during gestation. Two of the infants had adverse outcomes (see Enalapril and Captopril for details).
Six pregnancies treated with lisinopril were reported in a 1997 study of 19 pregnancies exposed to ACE inhibitors (7). Lisinopril therapy was stopped in the 1st trimester in four pregnancies and at 20 and 25 weeks, respectively, in the others. No congenital anomalies or renal dysfunction were noted in the six neonates (7).
A case of lisinopril-induced fetopathy and hypocalvaria was included in a study examining the causes of fetal skull hypoplasia (8). Among 14 known cases of hypocalvaria or acalvaria, 5 were caused by ACE inhibitors. The authors speculated that the underlying pathogenetic mechanism in these cases is fetal hypotension (8).
A 1991 article examining the teratogenesis of ACE inhibitors cited evidence linking fetal calvarial hypoplasia with the use of these agents after the 1st trimester (9). The proposed mechanism was drug-induced oligohydramnios that allowed the uterine musculature to exert direct pressure on the fetal skull. This mechanical insult, combined with drug-induced fetal hypotension, could inhibit peripheral perfusion and ossification of the calvaria (9).
In summary, ACE inhibitors present a major risk to the fetus in terms of toxicity, including fetal and neonatal renal failure, intrauterine growth retardation, prematurity, severe neonatal hypotension, and fetal and neonatal death. Oligohydramnios may occur resulting in pulmonary hypoplasia, limb contractures, persistent patent ductus arteriosus, craniofacial deformation, and neonatal death (10,11). These agents appear to be teratogenic when used in the 2nd and 3rd trimesters, causing fetal calvarial hypoplasia and renal anomalies (see also Captopril and Enalapril). The cause of these defects is probably related to fetal hypotension and decreased renal blood flow. Because of these reports, some investigators contend that drugs in this class should not be used in pregnancy (10,11,12 and 13). In those cases in which lisinopril must be used to treat the mother's disease, close monitoring of amniotic fluid levels and fetal well-being are required. Newborn renal function and blood pressure should also be monitored. If oligohydramnios occurs, stopping the drug may resolve the problem but may not improve infant outcome because of irreversible fetal damage (10). Guidelines for counseling exposed pregnant patients have been published and should be of benefit to health professionals faced with this task (9,10).
[*Risk Factor DM if used in 2nd or 3rd trimesters.]
Breast Feeding Summary
No reports describing the use of lisinopril during human lactation have been located. The drug is excreted in the milk of lactating rats (1). The molecular weight (about 442) is low enough that excretion into breast milk should be expected. Two similar agents are present in milk in low concentrations and are classified by the American Academy of Pediatrics as compatible with breast feeding (see Captopril and Enalapril).
"Official medicines" is the best online drugstore.World’s leading meds delivered to your door – and you don’t even need a prescription! Only certified, first class drugs on offer! Buy more and spend less with our great discount system. |
References
- Product information. Prinivil. Merck, 2001.
- Rosa F, Bosco L. Infant renal failure with maternal ACE inhibition (abstract). Am J Obstet Gynecol 1991;164:273.
- Tomlinson AJ, Campbell J, Walker JJ, Morgan C. Malignant primary hypertension in pregnancy treated with lisinopril. Ann Pharmacother 2000;34:180–2.
- Bhatt-Mehta V, Deluga KS. Chronic renal failure (CRF) in a neonate due to in-utero exposure to lisinopril. Presented at the 12th Annual Meeting of the American College of Clinical Pharmacy, Minneapolis, MN, August 20, 1991, Abstract No. 43.
- Pryde PG, Nugent CE, Sedman AB, Barr M Jr. ACE inhibitor fetopathy (abstract). Am J Obstet Gynecol 1992;166:348.
- Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol 1992;80:429–32.
- Lip GYH, Churchill D, Beevers M, Auckett A, Beevers DG. Angiotensin-converting-enzyme inhibitors in early pregnancy. Lancet 1997;350:1446–7.
- Barr M Jr, Cohen MM Jr. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology 1991;44:485–95.
- Brent RL, Beckman DA. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology 1991;43:543–6.
- Barr M Jr. Teratogen update: angiotensin-converting enzyme inhibitors. 1994;50:399–409.
- Shotan A, Widerhorn J, Hurst A, Elkayam U. Risks of angiotensin-converting enzyme inhibition during pregnancy: experimental and clinical evidence, potential mechanisms, and recommendations for use. Am J Med 1994;96:451–6.
- Lindheimer MD, Katz AI. Hypertension in pregnancy. N Engl J Med 1985;313:675–80.
- Lindheimer MD, Barron WM. Enalapril and pregnancy-induced hypertension. Ann Intern Med 1988;108:91.
Q&A about Lisinopril
What is the alternative for this snake venom? It is used to regulate blood flow by expanding the blood vessels. Is there anything else that does this that is not made from snake poison?
Brand Name: Zestril, Prinivil
Drug Class And Mechanism: Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a chemical that is made by the body continuously. It narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure falls.
Interestingly, lisinopril and other ACE inhibitors were developed from the venom of a poisonous Brazilian snake.
Other Angiotensin Converting Enzyme (ACE) inhibitor include medications such as:- These medicines are mostly not made from snake poison-
benazepril
captopril
cilazapril
enalapril
enalaprilat
fosinopril
moexipril
perindopril
quinapril
ramipril
trandolapril -
I have been perscribed lisinopril for high blood pressure, and it is only 10 mg tablets and on the container it says that it may cause dizziness and not to drive a car or operate machinery until you become familiar with its effects. I work a job that involves operating machinery.
I just found out I have HBP. Doc started me w/sample of Benicar but Ins will not pay for it unless I am on Ace Inhibitor 1st. Am worried that they (like lisinopril) have more side effects. Is there much of a difference between the two, other than the fact that they are different classes of drugs?
Can she take phentermine or meridia with this medication? Lisinopril can cause weight gain is there another bp med she can get that might work better for her, any suggestions?
As for weight loss, phentermine and meridia are contraindicated for anyone with blood pressure issues. However, doctors have been using a drug for diabetics called Metformin that has produced very good weight loss results.(even in non-diabetic people) I in fact started taking Metformin about two months ago and have already lost 17 pounds!! Have her ask her doctor about using Metformin for weight loss, it will not affect her Lisinopril
I have been on lisinopril for six years and it has changed colors from white, yellow, blue, and pink each time I get a refill it like a suprise to see what color it is this time. Also they have changed shapes from circular, ovalish and triangle shaped. In my medicine bottle right now I have 3 different shapes and three different colors.
As long as your pharmcist is filling this correctly (and you can always ask), it's not a problem.
I am taking lisinopril for high blood pressure but don't have high blood pressure. The doctor told me it was to help keep my kidneys safe. Is this true?
lisinopril for high blood pressure. now have a cold. what kind of cold medicine can I take that will not cause an interaction?
I am on 10mg of Lisinopril a day, but am having a hard time falling asleep, can I still take Tylenol PM?
Note: Not all drug interactions are known or reported in the literature, and new drug interactions are continually being reported.
My fiancee has kidney failure and is on dialysis. He's on several blood pressure medications, including Lisinopril. He has inflammation that he's been taking Advil for, but is concerned about the potassium. However, he feels he needs to take something stronger.
Can he take Sulindac (Clinoril) or Diclofenac (Voltaren) with Lisinopril?
Will this have the same potassium problem?
And if you can't take them together, why not?
Renal Insufficiency
Sulindac pharmacokinetics have been investigated in patients with renal insufficiency. The disposition of sulindac was studied in end-stage renal disease patients requiring hemodialysis. Plasma concentrations of sulindac and it sulfone metabolite were comparable to those of normal healthy volunteers whereas concentrations of the active sulfide metabolite were significantly reduced. Plasma protein binding was reduced and the AUC of the unbound sulfide metabolite was about half that in healthy subjects.
Sulindac and its metabolites are not significantly removed from the blood in patients undergoing hemodialysis.
Since Clinoril is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored.
A lower daily dosage should be anticipated to avoid excessive drug accumulation.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, patients who are volume-depleted and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Clinoril in patients with advanced renal disease. Therefore, treatment with Clinoril is not recommended in these patients with advanced renal disease. If Clinoril therapy must be initiated, close monitoring of the patient's renal function is advisable.
Voltaren - NSAID
Caution should be used when initiating treatment with Voltaren in patients with considerable dehydration.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Any patient that is currently on dialysis should discuss any medications that are considering to incorporate in their daily regime with their doctor.
