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CLINICAL PHARMACOLOGY of Ramipril (click on prescribing info): altace.com: "Mechanism of Action
Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. In hypertensive patients with normal renal function treated with ALTACE alone for up to 56 weeks, approximately 4% of patients during the trial had an abnormally high serum potassium and an increase from baseline greater than 0.75 mEq/L, and none of the patients had an abnormally low potassium and a decrease from baseline greater than 0.75 mEq/L. In the same study, approximately 2% of patients treated with ALTACE and hydrochlorothiazide for up to 56 weeks had abnormally high potassium values and an increase from baseline of 0.75 mEq/L or greater, and approximately 2% had abnormally low values and decreases from baseline of 0.75 mEq/L or greater. (See PRECAUTIONS.) Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity" http://www.altace.com/ ******************************************************
Ramipril indications and dosage: Rxlist: "Hypertension: Ramipril is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
In using ramipril, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to wshow that ramipril does not have a similar risk. (See WARNINGS.)
In considering use of ramipril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema.)
Heart Failure Post-Myocardial Infarction: Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure (See CLINICAL PHARMACOLOGY, Heart Failure Post Myocardial Infarction for details and limitations of the survival trial.)
DOSAGE AND ADMINISTRATION
Hypertension: The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with ramipril alone, a diuretic can be added.
Heart Failure Post Myocardial Infarction: For the treatment of post-infarction patients who have shown signs of congestive failure, the recommended starting dose of ramipril is 2.5 mg twice daily. A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily, but all patients should then be titrated (as tolerated) toward a target dose of 5 mg twice daily." ******************************************************
Ramipril Reduces Risk of Stroke and Other Cerebrovascular Events: Americal family Physician: "(American College of Cardiology) Results of a randomized placebo-controlled trial showed that the use of ramipril (Altace), but not vitamin E, reduces the risk of stroke and other cerebrovascular events in patients by about one-third in both primary and secondary prevention as well as among patients with or without hypertension. A total of 9,451 high-risk patients who were at least 55 years of age and had either previous cardiovascular disease or diabetes plus one risk factor were randomized to receive ramipril (up to 10 mg per day) or placebo, and vitamin E (400 IU per day) or placebo, for a mean of 4.5 years. Ramipril reduced the risk of strokes, transient ischemic stroke and carotid endarterectomy. Ramipril was similarly effective in reducing the risk of a stroke among patients with or without previous cerebrovascular disease. Vitamin E did not reduce the risk of fatal or nonfatal stroke.--JACKIE BOSCH, MSC, ET AL., McMaster University, Hamilton, Canada" ******************************************************
Ramipril Reduces Risk Of Heart And Kidney Complications In Diabetics: doc guide: "Treatment with ramipril, an ACE inhibitor, can significantly reduce the risk of heart attack, stroke, cardiovascular death and kidney disease in high-risk people with diabetes, according to data reported recently at the annual meeting of the European Association for the Study of Diabetes (EASD).
Results of the groundbreaking HOPE (Heart Outcomes Prevention Evaluation) Study indicate that ramipril reduced the risk of heart attack, stroke, and cardiovascular death by 24 per cent in people with diabetes, and reduced the risk of kidney disease by 23 per cent.
Conducted at 267 centers in 19 countries, the HOPE Study was designed to compare the effects of ramipril on top of standard therapy, with placebo and vitamin E in patients at high risk for cardiovascular events. In Canada, 129 clinical investigators and 5,721 patients (60 per cent of participants) took part in the study. Because diabetes is a major risk factor for cardiovascular disease, more than one-third of the 9,500 patients in the total study population had diabetes.
"These results show that ACE inhibition with ramipril safely prevents cardiovascular outcomes and deaths. This is good news for middle-aged and older people with diabetes who are at high-risk for heart disease," said Hertzel Gerstein, M.D., co-chairman of the diabetes component of HOPE and Director of the Division of Endocrinology and Metabolism in the faculty of Health Sciences at McMaster University, Hamilton, Ontario.
The beneficial effects of ramipril on cardiovascular outcomes appear to be independent of its blood pressure-lowering effects and its protective effects on diabetes-related kidney disease, Dr. Gerstein reported. In fact, many patients with diabetes in this study had normal blood pressure." ******************************************************
Product information Ramipril: Wyeth: "The risk-reduction indication for ALTACE® (Ramipril) can benefit people 55 or older who are at high risk for cardiovascular events. Firm clinical evidence shows that more can be done for these people even when they are taking adequate medications. The need to do more is compelling, especially when there are 16 million such patients in the U.S. living with one or more cardiovascular diseases (CVDs) and who are at risk for having a heart attack or stroke.
ALTACE is the first and only angiotensin-converting-enzyme (ACE) inhibitor to receive FDA approval (on October 4, 2000) to reduce the risk of stroke, myocardial infarction, and death from cardiovascular causes in patients 55 or older at high risk of developing a major cardiovascular event, either because of a history of coronary artery disease, stroke, or peripheral vascular disease or because of diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria). ALTACE can be used in combination with other needed treatments (such as antihypertensive, antiplatelet, or lipid-lowering therapies). ALTACE is marketed by Monarch Pharmaceuticals, Inc., a wholly owned subsidiary of King Pharmaceuticals, Inc., and by WYETH.
This expanded indication is based on evidence from the landmark HOPE (Heart Outcomes Prevention Evaluation) study, in which 9,297 patients were evaluated for more than 4 years. The Independent Data and Safety Monitoring Board halted the 5-year HOPE study 1 year early because of the clear evidence of the beneficial effect of ALTACE. Patients included in the study had normal or treated blood pressure and no heart failure or left ventricular dysfunction ******************************************************
Special warnings while taking Ramipril: Health Square: "If you develop swelling of the face around your lips, tongue, or throat or difficulty swallowing, difficulty breathing, swelling of arms and legs, or infection, sore throat, and fever, you should contact your doctor immediately. You may have a serious side effect of the drug and need emergency treatment.
If you are taking Altace, your kidney function should be given a complete assessment and should continue to be monitored.
If you notice your skin or the whites of your eyes turning yellow, notify your doctor. Your liver may be affected, and you may have to stop taking Altace. Your doctor should routinely test your liver function while you are on this drug.
Altace should be used with caution if you have impaired liver or kidney function, or a disease of the connective tissue such as lupus erythematosus or scleroderma.
If you are taking diuretics and Altace, or have congestive heart failure, you may develop excessively low blood pressure.
Do not use salt substitutes containing potassium or potassium supplements without consulting your doctor. Altace can cause increased potassium levels in your blood, especially if you have diabetes and kidney problems.
Light-headedness can occur when taking Altace, especially during the first days of therapy, and should be reported to your doctor. If fainting occurs, stop taking the medication and notify your doctor immediately.
Dehydration, excessive sweating, severe diarrhea, or vomiting could deplete your body's fluids, causing your blood pressure to drop dangerously.
Altace may reduce the number of infection-fighting white blood cells in your bloodstream, especially if you have a kidney problem or a connective tissue disorder such as lupus. Contact your doctor immediately if you develop a sore throat or fever, which could be a sign of this condition.
ACE inhibitors such as Altace have been known to cause severe allergic reactions in people undergoing desensitization therapy with bee or wasp venom. These drugs have also caused severe reactions in kidney dialysis patients" ******************************************************
Ramipril article Hope for the heart: Online Newshour: "Ramipril, widely used to lower blood pressure, may also be successful in preventing heart attacks and diabetes. Ray Suarez talks with the chief of cardiology at Northwestern University Medical Center, Dr. Robert Bonow; The study, released at a meeting of the American Heart Association, looked at more than 9200 people in 19 countries. The study found that Ramipril cut deaths from heart disease by 22 percent, reduced heart attacks by more than 20 percent, cut new diabetes cases by 30 percent and resulted in 14 percent fewer coronary artery bypass operations. For more on the study we're joined by Dr. Robert Bonow, the chief of cardiology at Northwestern University Medical Center. He oversaw scientific sessions at the meeting of the American Heart Association." ******************************************************
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http://www.prescriptionforviagra.com/drugs/ace.inhibitors/altace.ramipril.hypertensives.htm Last updated by Andrew Lopez, RN on Wednesday, February 27, 2008 |
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