Ramipril

What is Ramipril?

• Ramipril (Altace) is an angiotensin converting enzyme (ACE) inhibitor used with other medications to treat high blood pressure. It is also used to reduce the risk of heart attack and stroke in patients at risk for these problems and to improve survival in patients with heart failure after a heart attack.

Ramipril

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Ramipril structure

What are the uses of this medicine?

• Ramipril (Altace) is used for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• It may be used alone or in combination with thiazide diuretics.
• In patients 55 years or older at high risk of developing a major cardiovascular event, ALTACE is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes.
• ALTACE is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction.

How does this medicine work?

• Ramipril (ra' mi pril) is an ACE inhibitor widely used in the therapy of hypertension, heart failure and for reduction in risk of myocardial infarction and stroke.
• Like other ACE inhibitors, ramipril inhibits the conversion of angiotensin I, a relatively inactive molecule, to angiotensin II which is the major mediator of vasoconstriction and volume expansion induced by the renin-angiotensin system.
• Other enzymes besides that which converts angiotensin I to II may also be inhibited, which may account for some of the side effects of ramipril and other ACE inhibitors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are hypersensitive to this product or any other ACE inhibitor.
• in combination with a neprilysin inhibitor (e.g., sacubitril)

• Do not administer ALTACE within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as indomethacin(Indocin, Tivorbex)
• diuretics ('water pills')
• lithium (Lithobid)
• potassium supplements
• valsartan and sacubitril (Entresto) or if you have stopped taking it within the last 36 hours

• Also, tell your doctor if you have diabetes and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT).

Is this medicine FDA approved?

• Ramipril was approved for use in the United States in 1991.

How should this medicine be used?

Recommended dosage: Hypertension:

• Initial dose is 2.5 mg to 20 mg once daily.
• Adjust dosage according to blood pressure response after 2–4 weeks of treatment.
• The usual maintenance dose following titration is 2.5 mg to 20 mg daily as a single dose or equally divided doses.

Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes:

• Initiate dosing at 2.5 mg once daily for 1 week, 5 mg once daily for the next 3 weeks, and then increase as tolerated, to a maintenance dose of 10 mg once daily.

Heart Failure Post-Myocardial Infarction:

• Starting dose of 2.5 mg twice daily.
• If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily.
• Increase dose as tolerated toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart.

Administration:

• Ramipril comes as a capsule to take by mouth.
• It is usually taken once or twice a day with or without food.
• To help you remember to take ramipril, take it around the same time(s) every day.
• Generally, swallow ALTACE capsules whole.
• The ALTACE capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of applesauce or mixed in 4 oz. (120 mL) of water or apple juice.
• To be sure that ramipril is not lost when such a mixture is used, consume the mixture in its entirety.
• The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.
• Concomitant administration of ALTACE with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg

This medicine is available in fallowing brand namesː

• ALTACE

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• dizziness
• fatigue
• cough
• gastrointestinal upset
• skin rash

Ramipril may cause serious side effects which may include:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• yellowing of the skin or eyes
• fever, sore throat, chills, and other signs of infection
• lightheadedness
• fainting

What special precautions should I follow?

• Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.
• Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
• Rarely, ACE inhibitors, including ALTACE, have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. Discontinue ALTACE if patient develops jaundice or marked elevations of hepatic enzymes.
• As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In such patients, monitor renal function during the first few weeks of therapy. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction of ALTACE and/or discontinuation of the diuretic may be required.
• Treatment with ACE inhibitors may be associated with mild reductions in red blood cell count and hemoglobin content, blood cell or platelet counts. Consider monitoring white blood cell counts in patients with collagen-vascular disease, especially if the disease is associated with impaired renal function.
• ALTACE can cause symptomatic hypotension, after either the initial dose or a later dose when the dosage has been increased. Correct volume- and salt-depletion before initiating therapy with ALTACE. If excessive hypotension occurs, place the patient in a supine position and, if necessary, treat with intravenous infusion of physiological saline. ALTACE treatment usually can be continued following restoration of blood pressure and volume.
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue ALTACE as soon as possible.
• Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on ALTACE and other agents that affect the RAS.
• Hyperkalemia (serum potassium >5.7 mEq/L) occurred in hypertensive patients receiving ALTACE. Monitor serum potassium in such patients.
• Persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. Consider the possibility of angiotensin converting enzyme inhibitor induced-cough in the differential diagnosis of cough.
• Ramipril is associated with a low rate of transient serum aminotransferase elevations and has been linked to rare instances of acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• hypotension

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of ramipril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities.
• Because the hypotensive effect of ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat ramipril overdose by infusion of normal saline solution.

Can this medicine be used in pregnancy?

• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
• When pregnancy is detected, discontinue ALTACE as soon as possible.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.
• Irreversible kidney damage has been observed in very young rats given a single dose of ALTACE.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• RAMIPRIL

Inactive Ingredients:

• STARCH, CORN
• GELATIN, UNSPECIFIED
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

Packager:

• Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Dispense in well-closed container with safety closure.
• Store at controlled room temperature (59°–86°F).

• Dailymed label info on Ramipril
• FDA Ramipril

Ramipril Resources
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Common ACE inhibitors include the following:

• Benazepril
• Captopril
• Enalapril
• Fosinopril
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Trandolapril