Carcinogenesis, Mutagenesis, Impairment Of Fertility
There was no evidence of a tumorigenic effect when Renipril was administered for 106 weeks to male and female rats at doses up to 90 mg/kg/day or for 94 weeks to male and female mice at doses up to 90 and 180 mg/kg/day, respectively. These doses are 26 times (in rats and female mice) and 13 times (in male mice) the maximum recommended human daily dose (MRHDD) when compared on a body surface area basis.
Neither Renipril maleate nor the active diacid was mutagenic in the Ames microbial mutagen test with or without metabolic activation. Renipril was also negative in the following genotoxicity studies: rec-assay, reverse mutation assay with E. coli, sister chromatid exchange with cultured mammalian cells, and the micronucleus test with mice, as well as in an in vivo cytogenic study using mouse bone marrow.
There were no adverse effects on reproductive performance of male and female rats treated with up to 90 mg/kg/day of Renipril (26 times the MRHDD when compared on a body surface area basis).
Q: Would medications such as Renipril, Zetia, and Nexium cause side effects with prolonged use? I have esophageal ulcers.
A: Nexium (esomeprazole) is indicated for the treatment of GERD or gastroesophageal reflux disease. Nexium relieves heartburn that is caused by the backflow of stomach acid from the stomach to the esophagus. Nexium is also used for the treatment of ulcers. (//www.everydayhealth.com/drugs/nexium) Common side effects associated with Nexium include dizziness, headache, diarrhea, constipation and dry mouth. Other less common side effects associated with Nexium include muscle pain, rash, back pain and chest pain. (//www.everydayhealth.com/gerd/guide/). Zetia (ezetimibe) (//www.everydayhealth.com/drugs/zetia) is used to reduce cholesterol that the body absorbs from the diet. Zetia is indicated for high cholesterol levels along with a low fat, cholesterol diet. (//www.everydayhealth.com/high-cholesterol/guide/). Common side effects with Zetia include headache, stomach pain and diarrhea, cough, and feeling tired. A search of prescribing information showed liver abnormalities with Zetia but no concern with ulcers. Vasotec (Renipril) (//www.everydayhealth.com/drugs/Renipril) is an angiotensin converting enzyme drug (ACE inhibitor) that works by relaxing blood vessels. Renipril is used for high blood pressure. //www.everydayhealth.com/high-blood-pressure/guide/. Common side effects associated with Renipril include diarrhea, dizziness, lightheadedness when standing or sitting up, nausea, and cough. A search of prescribing information did not report Renipril causing ulcers. When your doctor prescribes a new medication, be sure to discuss all your medications and over-the-counter drugs, including dietary supplements, vitamins, botanicals, minerals and herbals, as well as the foods you eat. Also keep a current list of the drugs and supplements you take and review it with your healthcare provider and your pharmacist. If possible, use one pharmacy for all your prescription medications and over-the-counter products. This allows your pharmacist to keep a complete record of all your prescription drugs and to advise you about drug interactions and side effects. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Kimberly Hotz, PharmD
How should I take Renipril?
Take Renipril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Renipril with or without food.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Renipril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.
If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.
If you need surgery, tell the surgeon ahead of time that you are using Renipril.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Store the liquid medicine in the refrigerator, do not freeze. Throw away any liquid medicine not used within 60 days.
Heart and blood pressure drugs
Taking these medications with Renipril can increase your risk of kidney problems, low blood pressure, and/or high blood potassium.
Examples of these drugs include:
- angiotensin-converting enzyme (ACE) inhibitors, such as:
4. How and when to take it
It's usual to take Renipril once or twice a day.
Your doctor may advise you to take your first dose before bedtime, because it can make you dizzy. After the first dose, if you do not feel dizzy, you can take Renipril at any time of day. Try to take it at the same time every day.
If you have Renipril twice a day, try to take it once in the morning and once in the evening. Leave 10 to 12 hours between doses if you can.
Warnings for other groups
For pregnant women: This drug can have a negative impact on the development of a fetus. Renipril should only be used during pregnancy in serious cases where it’s needed to treat a dangerous condition in the mother.
Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus. This drug should only be used if the potential risk to the fetus is acceptable given the drug’s potential benefit.
For women who are breastfeeding: Renipril may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.
For seniors: Older adults may process drugs more slowly. A normal adult dose may cause levels of this drug to be higher than normal in your body. If you’re a senior, you may need a lower dose or a different schedule.
For children: Renipril shouldn’t be used to treat high blood pressure in infants and children with severe kidney disease. The use of this medication to treat heart failure or asymptomatic left ventricular dysfunction hasn’t been studied in children. This drug shouldn’t be used to treat these conditions in people younger than 18 years.
This dosage information is for Renipril oral tablet. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:
- your age
- the condition being treated
- how severe your condition is
- other medical conditions you have
- how you react to the first dose
Administration of VASOTEC to patients with hypertension of severity ranging from mild to severe results in a reduction of both supine and standing blood pressure usually with no orthostatic component. Symptomatic postural hypotension is therefore infrequent, although it might be anticipated in volume-depleted patients (see WARNINGS).
In most patients studied, after oral administration of a single dose of Renipril, onset of antihypertensive activity was seen at one hour with peak reduction of blood pressure achieved by four to six hours.
At recommended doses, antihypertensive effects have been maintained for at least 24 hours. In some patients the effects may diminish toward the end of the dosing interval (see DOSAGE AND ADMINISTRATION).
In some patients achievement of optimal blood pressure reduction may require several weeks of therapy.
The antihypertensive effects of VASOTEC have continued during long-term therapy. Abrupt withdrawal of VASOTEC has not been associated with a rapid increase in blood pressure.
In hemodynamic studies in patients with essential hypertension, blood pressure reduction was accompanied by a reduction in peripheral arterial resistance with an increase in cardiac output and little or no change in heart rate. Following administration of VASOTEC, there is an increase in renal blood flow; glomerular filtration rate is usually unchanged. The effects appear to be similar in patients with renovascular hypertension.
When given together with thiazide-type diuretics, the blood pressure lowering effects of VASOTEC are approximately additive.
In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving VASOTEC. In this study there was no evidence of a blunting of the antihypertensive action of VASOTEC (see DRUG INTERACTIONS).
Why is this medication prescribed?
Renipril is used alone or in combination with other medications to treat high blood pressure. It is also used in combination with other medications to treat heart failure. Renipril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.
High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Excessive hypotension is rare in uncomplicated hypertensive patients treated with VASOTEC alone. Patients with heart failure given VASOTEC commonly have some reduction in blood pressure, especially with the first dose, but discontinuation of therapy for continuing symptomatic hypotension usually is not necessary when dosing instructions are followed; caution should be observed when initiating therapy (see DOSAGE AND ADMINISTRATION). Patients at risk for excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include those with the following conditions or characteristics: heart failure, hyponatremia, high-dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients with heart failure), reduce the diuretic dose or increase salt intake cautiously before initiating therapy with VASOTEC in patients at risk for excessive hypotension who are able to tolerate such adjustments (see DRUG INTERACTIONS and ADVERSE REACTIONS). In patients at risk for excessive hypotension, therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of Renipril and/or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease, in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of VASOTEC, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of VASOTEC or concomitant diuretic may be necessary.
Renipril belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. You may have been prescribed it to reduce high blood pressure (hypertension), or to prevent (or treat) heart failure. Heart failure is a condition where your heart does not work as well as it should.
Generic Name: Renipril (e NAL a pril)Brand Names: Epaned, Vasotec
Medically reviewed by Sanjai Sinha, MD Last updated on Dec 4, 2018.